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Clinical HPLC and Toxicology2016/2017
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 3
Clinical HPLC
Biogenic Amines 04 − 08
Homocysteine Assay for Risk Assessment Testing 09 − 10
Bone and Mineral Testing 11 − 12
Vitamin Assays 13 − 14 33
Toxicology
Alcohol Abuse Monitoring 17 − 18
Therapeutic Drug Monitoring 19 − 26
Drug Screening 27 − 30
Overview: Analytes and Controls 31 − 33
Hard- & Software Requirements 34
OverviewClinical HPLC and Toxicology 2016/2017 At Bio-Rad, it is a priority to provide laboratorians with the appropriate resources for speciality testing, so that assays can be completed with the greatest accuracy and efficiency. Bio-Rad offers the convenienceof ready-to-use kits for the analysis of biogenic amines, homocysteine, vitamins, bone markers and alcoholabuse markers as well as for therapeutic drug monitoring and drug screening. These kits coupleconvenience with specificity, sensitivity and reliability for routine operation in the clinical laboratory.
Ordering Information • CE Marked
Catalog Description
195-5390 Urinary Catecholamines by HPLC Reagent Kit .................... 100 tests195-5391 Urinary Catecholamines by HPLC Reagent Kit, automated method ... 300 tests
Additional Required Items
195-5369 Analytical Cartridge (incl. 2 Micro-Guard™ Cartridges) ... 600 injections195-5925 Analytical Cartridge Holder..................1 unit195-5030 Micro-Guard™ Cartridge Holder ..........1 unit195-4088 Capillary Connecting Set.....................1 unit195-5976 Application CD ROM for Biogenic Amines on ASPEC™ .............1 unit195-5368 Test Mix ...............................................1 mL196-1012 Sample Vials ................................1000 vials195-5232 Piercable Caps ............................. 500 caps
4 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
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Clinical HPLC
Biogenic Amines
New manual method and automated method on Gilson ASPEC™
Catecholamines like dopamine, epinephrine and norepi-nephrine play important roles as neurotransmitters and hormonal signals. For example, they control the body´s response to acute and chronic stress by influencing cardi- ovascular and metabolic organ activities. Catecholamine-secreting tumors like pheochromocytomas and neuroblastomas dramatically influence the balance of naturally occurring catecholamines.
Bio-Rad´s Urinary Catecholamines by HPLC application is designed for the quantitative determination of free catecholamines (epinephrine, norepinephrine, dopamine) in urine for the diagnosis and follow-up of patients with pheochromocytoma and related neurogenic tumors.
In addition, this application is compatible with Bio-Rad´s Urinary Metanephrines by HPLC assay because the same analytical cartridge and mobile phase are used.
The new Urinary Catecholamines by HPLC assay features:
■■ Fast sample preparation – one disposable column instead of two
■■ Increased reliability – pH indicator in dilution reagent displays optimal pH range
■■ Excellent robustness – interfering substances eliminated during specimen preparation
■■ Maximized throughput – automated application on Gilson ASPEC™ XL or GX271 available
■■ Improved economic efficiency – increased lifetime of the analytical cartridge
Sample preparation:
■■ Type: sample purification on disposable column■■ Duration: <20 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 11 minutes■■ Sample volume:
1 mL urine (manual method) 400 μL urine (automated method)
■■ Flow rate: 0.8 mL/min■■ Electrochemical detection: 550 mV
Urinary Catecholamines by HPLC
Biogenic Amines
Urinary Catecholamines by HPLC
Chromatogram of the Biogenic Amines Calibrator
HPLC Automation
Bio-Rad has developed automated protocols for many of our HPLC kits by making use of the Gilson ASPEC™ XL or GX-271. Each protocol is validated so you can have confidence in the results. These methods help reduce laboratory costs by dramatically decreasing labour hours. Contact your local Bio-Rad representative for more information about the Gilson ASPEC™ methods.
See Also
For items available separately, please
see “Instruction for use” or webpage.
Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
195-5880 Plasma Catecholamines by HPLC Reagent Kit ........................................................................................... 100 tests
Additional Required Items
195-5886 Analytical Cartridge (includes 2 Micro-Guard™ cartridges) .................................................................... 500 injections195-5925 Analytical Cartridge Holder................................................................................................................................ 1 unit195-5030 Micro-Guard™ Cartridge Holder ........................................................................................................................ 1 unit195-4088 Capillary Connecting Set................................................................................................................................... 1 unit270-0336 Prefilters ......................................................................................................................................................... 10 pcs270-0338 Holder for Prefilter ............................................................................................................................................. 1 unit195-5368 Test Mix .............................................................................................................................................................1 mL
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 5
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Clinical HPLC
Biogenic Amines
Neuroendocrine tumors are rare, but dangerous. They will cause serious cardiovascular complications and death if not recognized and properly treated.
To improve the screening for these neurochromaffin tu- mors the usual recommendation is that tests should combine measurements of urinary or plasma catecholamines with determinations of urinary or plasma metanephrines.
This kit is an optimized assay for the quantitative determina- tion of catecholamines in human plasma for the diagnosis of pheochromocytoma and related neurogenic tumors.
The Plasma Catecholamines by HPLC assay features:
■■ Improved usability – simplified sample preparation■■ High confidence in results – low detection limit
Sample preparation:
■■ Type: sample purification on disposable column■■ Duration: <20 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 19 minutes■■ Sample volume: 1 mL plasma■■ Flow rate: 0.7 mL/min■■ Electrochemical detection: 550 mV
Plasma Catecholamines by HPLC
Plasma Catecholamines by HPLC
Chromatogram of the Plasma Catecholamines Calibrator
See Also
For items available separately, please see “Instruction for use” or webpage. Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-5411 Urinary Metanephrines by HPLC Reagent Kit .............................................................................................. 100 tests195-5412 Urinary Metanephrines by HPLC Reagent Kit, automated method .............................................................. 200 tests
Additional Required Items
195-5369 Analytical Cartridge (includes 2 Micro-Guard™ Cartridges) ................................................................... 600 injections195-5925 Analytical Cartridge Holder................................................................................................................................ 1 unit195-5030 Micro-Guard™ Cartridge Holder ........................................................................................................................ 1 unit196-1012 Sample Vials .............................................................................................................................................. 1000 vials195-5232 Piercable caps ........................................................................................................................................... 500 caps195-5413 Test Mix .............................................................................................................................................................1 mL195-5976 Application CD ROM for Biogenic Amines on ASPEC™ ..................................................................................... 1 unit
6 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
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Clinical HPLC
Biogenic Amines
Improved manual method and automated method on Gilson ASPEC™
It has been found that in 1 of 200 hypertensive patients, the disease is due to a neuroendocrine tumor(1). Since pheochromocytoma is surgically curable, it is desirable to screen all hypertensive patients.
This HPLC test is designed for the quantitative determina- tion of metanephrine, normetanephrine and 3-methoxy- tyramine in urine, supporting the diagnosis of pheochro-mocytoma and related neurogenic tumors.
In addition, this application is easily compatible with Bio-Rad´s Urinary Catecholamines by HPLC assay because the same analytical cartridge and mobile phase are used.
The Urinary Metanephrines by HPLC assay features:
■■ Fast sample preparation – one disposable column instead of two
■■ Increased reliability - improved separation of metanephrine and normetanephrine - pH indicator in dilution reagent displays optimal pH range
■■ Maximized throughput - simplified test procedure reduces hands-on time - automated application on Gilson ASPEC™ XL or
GX271 available
Sample preparation:
■■ Type: sample purification on disposable column■■ Duration: <40 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 14 minutes■■ Sample volume:
1 mL urine (manual method) 400 μL urine (automated method)
■■ Flow rate: 1.2 mL/min■■ Electrochemical detection: 600 mV
Urinary Metanephrines by HPLC
(1) WHO Library: Kathib OMN: Clinical Guidelines for the Management of Hypertension; EMRO Technical Publications Series; 29; 2005
Chromatogram of the Biogenic Amines Calibrator
Urinary Metanephrines by HPLC
HPLC Automation Bio-Rad has developed automated protocols for many of our HPLC kits by making use of the Gilson ASPEC™ XL or GX-271. Each protocol is validated so you can have confidence in the results. These methods help reduce laboratory costs by dramatically decreasing labour hours. Contact your local Bio-Rad representative for more information about the Gilson ASPEC™ methods.
See Also
For items available separately, please
see “Instruction for use” or webpage.
Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-4129 VMA/HVA/5-HIAA by HPLC Reagent Kit ..................................................................................................... 100 tests195-4135 VMA/HVA/5-HIAA by HPLC Reagent Kit, automated method ..................................................................... 300 tests
Additional Required Items
195-5961 Analytical Column (includes 1 Micro-Guard™ Cartridge) ....................................................................... 500 injections195-5030 Micro-Guard™ Cartridge Holder ........................................................................................................................ 1 unit195-4088 Capillary Connecting Set................................................................................................................................... 1 unit195-5976 Application CD ROM for Biogenic Amines on ASPEC™ ..................................................................................... 1 unit
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 7
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Clinical HPLC
Biogenic Amines
Improved application for VMA only by HPLC. Manual method and automated method on Gilson ASPEC™
This assay permits either simultaneous quantitative determination of vanillylmandelic acid (VMA), homovanillic acid (HVA) and 5-hydroxyindoleacetic acid (5-HIAA) or the quantitative determination of vanillylmandelic acid (VMA) only in urine by HPLC for diagnosis of pheochromocy-toma, neuroblastoma, and carcinoid syndrome.
The VMA/HVA/5-HIAA by HPLC assay features:
■■ Excellent flexibility – simultaneous determination of VMA, HVA and 5-HIAA or determination of VMA only
■■ Maximized throughput – automated application on Gilson ASPEC™ XL or GX271 available
Sample preparation:
■■ Type: sample purification on disposable column■■ Duration: <10 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 19 minutes (for VMA, HVA
and 5-HIAA) or 10 minutes (for VMA only)■■ Sample volume: 50 μL (manual method) / 50 μL (auto-
mated method) urine■■ Flow rate: 1.05 mL/min■■ Electrochemical detection: 750 mV
VMA/HVA/5-HIAA by HPLC
VMA/HVA/5-HIAA by HPLC
Chromatogram of theVMA/HVA/5-HIAA Calibrator (VHH method)
HPLC Automation Bio-Rad has developed automated protocols for many of our HPLC kits by making use of the Gilson ASPEC™ XL or GX-271. Each protocol is validated so you can have confidence in the results. These methods help reduce laboratory costs by dramatically decreasing labour hours. Contact your local Bio-Rad representative for more information about the Gilson ASPEC™ methods.
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See Also
For items available separately, please see “Instruction for use” or webpage. Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-5854 Serotonin by HPLC Reagent Kit .................................................................................................................. 100 testsConsisting of:
195-5854R Reagent Set ..................................................................................................................................................... 1 unit195-5859 Calibrator Set ................................................................................................................................................... 1 unit
Additional Required Items
195-5855 Analytical Column (includes 2 Micro-Guard™ cartridges). ..................................................................... 500 injections195-5030 Micro-Guard™ Cartridge Holder ........................................................................................................................ 1 unit195-4088 Capillary Connecting Set................................................................................................................................... 1 unit196-1012 Sample Vials ............................................................................................................................................. 1000 vials195-5232 Piercable Caps .......................................................................................................................................... 500 caps
8 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
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Clinical HPLC
Biogenic Amines
Chromatogram of the Serotonin Urine Standard
Urine control material now available separately
Serotonin plays an important role as a neurotransmitter in the central nervous system, influencing sleep, perception of pain, social behavior and mood.
Tumors like carcinoids, which often become malignant and metastasize, dramatically influence the balance of naturally occurring levels of serotonin.
This assay provides quantitative determination of serotonin in urine and serum by specific and precise HPLC separation for diagnosis and follow-up of patients with carcinoid syndrome.
The improved application provides:
■■ Excellent reliability – separately available, bi-level control
■■ High flexibility – determination of serotonin levels in human serum or urine
Sample preparation:
■■ Type: sample purification on disposable column■■ Duration: <15 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 7.5 minutes■■ Sample volume: 500 μL serum or 1 mL urine■■ Flow rate: 1.0 mL/min■■ Electrochemical detection: 600 mV
Serotonin by HPLC
Serotonin by HPLC
See Also
For items available separately, please
see “Instruction for use” or webpage.
Find separately available controls on page: 31 - 33
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 9
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Clinical HPLC
Homocysteine Assays
Sample preparation:
■■ Type: Fluorescence labelling with subsequent protein precipitation
■■ Duration: <20 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 5 minutes■■ Sample volume: 50 μL plasma or serum■■ Flow rate: 0.7 mL/min■■ Fluorescence Detection: excitation: 385 nm,
emission: 515 nm
Homocysteine by HPLC
Chromatograms of a normal (left) and an elevated (right) patient sample
The presence of elevated total homocysteine levels in plasma or serum has been connected to the increased risk of thrombosis, neural tube defects and atherosclerotic vascular disease. With the steadily growing demand for testing, laboratories require a fast, reliable determination that is cost-effective to process. This application provides a rapid and cost-effective method for quantitative homocysteine analysis in serum or plasma and offers:
■■ Maximized throughput - One-step derivatization & reduction - Five minutes incubation time
■■ Excellent reliability – specific fluorescent labeling which eliminates interfering substances
Homocysteine by HPLC
Homocysteine Assay for Risk Assessment Testing
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-4075 Homocysteine by HPLC ............................................................................................................................. 100 tests
Additional Required Items
195-4076 Analytical Cartridge (includes 2 Micro-Guard™ Cartridges) ................................................................... 500 injections195-5023 Analytical Cartridge Holder. ............................................................................................................................... 1 unit195-5030 Micro-Guard™ Cartridge Holder......................................................................................................................... 1 unit195-4088 Capillary Connecting Set................................................................................................................................... 1 unit196-1012 Sample Vials .............................................................................................................................................. 1000 vials195-5232 Piercable Caps ........................................................................................................................................... 500 caps195-4089 Test Mix .............................................................................................................................................................2 mL
10 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
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Clinical HPLC
Homocysteine Assays
From sample to results in 20 minutes
Homocysteine by HPLC Assay Protocol
of supernatant
See Also
For items available separately, please
see “Instruction for use” or webpage.
Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-9501 Hydroxyproline by HPLC Reagent Kit ......................................................................................................... 100 tests Consisting of:
195-9501R Reagent Set ..................................................................................................................................................... 1 unit195-9515 Mobile Phase Set ....................................................................................................................................... 2 x 2.0 L195-9509 Hydrolysis glass tubes .............................................................................................................................. 100 tubes
Additional Required Items
195-9520 Analytical Column (includes 2 Micro-Guard™ Cartridges) ..................................................................... 500 injections195-5030 Micro-Guard™ Cartridge Holder ....................................................................................................................... 1 unit195-4088 Capillary Connecting Set .................................................................................................................................. 1 unit196-1012 Sample Vials ............................................................................................................................................. 1000 vials195-5232 Piercable Caps ........................................................................................................................................... 500 caps
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 11
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Clinical HPLC
Bone and Mineral Testing
Hydroxyproline is a frequently used marker for bone density. A high secretion of hydroxyproline is of clinical importance and a signal of destructive processes in the skeletal system.
Measurement of hydroxyproline allows early diagnosis and control of progression of bone metastases of malignant diseases as well as control of progression or therapy of osteoporosis, acromegaly, rheumatoid arthritis, or Morbus Paget and diagnosis of hyperparathyroidism.
This assay is intended for the quantitative determination of hydroxyproline in urine.
The Hydroxyproline by HPLC Kit features:
■■ High patient acceptance - Only an 18-hour collagen-free diet is required - Only a 2-hour urine collection is necessary
■■ Improved quality of life - Early diagnosis of malignant diseases
Hydroxyproline by HPLC
Bone and Mineral Testing
Sample preparation:
■■ Type: hydrolysis with subsequent derivatization■■ Duration: including 16h hydrolysis <17h
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 6 minutes■■ Sample volume: 1 mL urine■■ Flow rate: 1.5 mL/min■■ UV Detection: 471 nm
Hydroxyproline by HPLC Chromatogram of the Hydroxyproline Calibrator
See Also
For items available separately, please see “Instruction for use” or webpage. Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-6576 Pyridinium-Crosslinks by HPLC Reagent Kit ............................................................................................... 100 testsConsisting of:
195-6576R Reagent Set .................................................................................................................................................... 1 unit195-6579 Calibrator Set ................................................................................................................................................... 1 unit
Additional Required Items
195-5929 Analytical Cartridge (includes 2 Micro-Guard™ Cartridges) ................................................................... 500 injections195-5925 Analytical Cartridge Holder ............................................................................................................................... 1 unit195-5030 Micro-Guard™ Cartridge Holder ........................................................................................................................ 1 unit195-4088 Capillary Connecting Set .................................................................................................................................. 1 unit195-5915 Test Mix .........................................................................................................................................................2,5 mL
12 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
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Clinical HPLC
Bone and Mineral Testing
Chromatogram of thePyridinium-Crosslinks Test Mix
The pyridinium derivatives, pyridinoline (PYD) and deoxy- pyridinoline (DPD), are considered to be the most specific markers of bone resorption. Measurement of these bio- chemical markers of bone metabolism provides information concerning the dynamics of bone transformation and the related loss of bone mass and allows control of progression or therapy of osteoporosis, for example.
This assay is intended for the quantitative determination of pyridinoline (PYD) and deoxypyridinoline (DPD) in urine.
The Pyridinium Crosslinks by HPLC Kit features:
■■ High patient acceptance – no dietary restrictions required
■■ Excellent robustness – interfering substances eliminated during easy specimen preparation
■■ Excellent reliability – Calibrator traceable to CDC Candidate Reference Material
Sample preparation:
■■ Type: sample purification on disposable column■■ Duration: <10 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 16 minutes■■ Sample volume: 150 μL urine■■ Flow rate: 0.7 mL/min■■ Fluorescence Detection: excitation: 295 nm,
emission: 400 nm
Pyridinium Crosslinks by HPLC
Pyridinium Crosslinks by HPLC
See Also
For items available separately, please
see “Instruction for use” or webpage.
Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-4100 25-OH-Vitamin D3/D2 by HPLC Reagent Kit .........................100 tests Consisting of:
195-4100R Reagent Set ....................................... 1 unit195-6527 Serum Calibrator Set .......................... 1 unit
Additional Required Items
195-4105 Analytical Cartridge (includes 2 Micro-Guard™ Cartridges) .......600 injections195-5925 Analytical Cartridge Holder.................. 1 unit195-5030 Micro-Guard™ Cartridge Holder .......... 1 unit195-4088 Capillary Connecting Set..................... 1 unit195-4097 Test Mix ............................................... 1 mL196-1012 Sample Vials ................................ 1000 vials195-5232 Piercable Caps ..............................500 caps
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 13
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Clinical HPLC
Vitamin Assays
Sample preparation:
■■ Type: Precipitation with subsequent centrifugation■■ Duration: <15 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 11 minutes■■ Sample volume: 500 μL serum or plasma■■ Flow rate: 1.1 mL/min■■ UV Detection: 265 nm
Chromatogram of the 25-OH vitamin D3/D2 Calibrator
(1) American Journal of Clinical Nutrition 2007;85:1586-1591(2) Medical Journal of Australia 2007;187:59-60
Vitamin D3/D2 by HPLC
Vitamin Assays
Improved application for simultaneous measurement of 25-OH vitamin D3 & D2
Vitamin D is an essential bioregulator of calcium metabolism and thus significant for bone mineralization. Vitamin D deficiency is recognized to be a cause of secondary hyperparathyroidism, increased bone turnover and bone loss (osteopenia) in eldery people. Therefore vitamin D testing is essential in the management of patients with various disorders of calcium metabolism.
Studies have suggested that vitamin D may play a role in protecting against cancer(1) and in regulating normal immune function. Deficiency has been linked with auto-immune conditions such as type 1 diabetes(2), multiple sclerosis and rheumatoid arthritis.
Vitamin D supplementation to prevent and treat deficiency can be provided in the form of 25-OH vitamin D3 or 25-OH vitamin D2. Serum concentration of 25-OH vitamin D has been accepted as the clinical indicator of a patient’s vitamin D status. In order to identify and correct the defi- ciency of these 25-OH metabolites it becomes more and more essential to measure them accurately.
When an accurate 25-OH vitamin D level is critical for diagnosis or a clinical decision, the Bio-Rad 25-OH vitamin D3/D2 by HPLC assay provides precise and accurate test results for circulating 25-OH vitamin D3 and 25-OH vitamin D2 levels by offering:
■■ New! Improved economic efficiency – lifetime of the analytical cartridge increased by 20% to 600 injections
■■ Excellent robustness – interfering substances eliminated during specimen preparation
■■ Maximized efficiency – simultaneous determination of 25-OH vitamin D3 and D2 in a single run
■■ Excellent reliability - - New!: Improved separation of 25-OH vitamin D2 in the chromatogram - Human serum based calibrator traceable to the NIST
Standard Reference Material®
Vitamin D3/D2 by HPLC
See Also
For items available separately, please see “Instruction for use” or webpage. Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-5869 Vitamin A/E by HPLC Reagent Kit ............................................................................................................... 100 testsConsisting of:
195-5869R Reagent Set ..................................................................................................................................................... 1 unit195-5878 Calibrator Set ................................................................................................................................................... 1 unit
Additional Required Items
195-5870C Analytical Cartridge ............................................................................................................................. 600 injections195-6636 Prefilter ............................................................................................................................................................2 units270-0338 Holder for Prefilter ............................................................................................................................................. 1 unit195-5925 Cartridge Holder ............................................................................................................................................... 1 unit196-1012 Sample Vials .............................................................................................................................................. 1000 vials195-5232 Piercable Caps ........................................................................................................................................... 500 caps
14 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
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Clinical HPLC
Vitamin Assays
Improved application
Vitamins A and E serve many important functions in the body. Vitamin A, for example, plays a role in vision and immune function. The antioxidant properties of vitamin E are probably the most important and best known.
Deficiencies in these vitamins affect mainly infants and children. According to the WHO, deficiencies can lead to blindness and premature death if not recognized and properly treated.
For patients receiving treatment, supplement therapy has to be monitored carefully to avoid severe side effects of hypervitaminosis. Therefore testing for these vitamins is essential for routine screening & monitoring of patients during treatment.
This assay provides quantitative determination of vitamin A (Retinol) and vitamin E (Tocopherol) in serum by HPLC for diagnosis of vitamin deficiency or to monitor supplement therapy.
The Vitamin A/E by HPLC assay features:
■■ New! Increased economic efficiency – with the lifetime of the analytical cartridge being increased by 20% to 600 injections
■■ Excellent robustness – interfering substances eliminated during specimen preparation
■■ Maximized efficiency – simultaneous determination of vitamin A and E in a single run
■■ Excellent reliability – Human serum based calibrator traceable to the NIST Standard Reference Material®
Sample preparation:
■■ Type: Precipitation with subsequent centrifugation■■ Duration: <10 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 7 minutes■■ Sample volume: 200 μL serum or plasma■■ Flow rate: 0.6 mL/min■■ UV Detection: 340 nm (Vitamin A), 295 nm (Vitamin E)
Vitamin A/E by HPLC
Chromatogram of vitamin A/E Serum Calibrator
Vitamin A/E by HPLC
See Also
For items available separately, please
see “Instruction for use” or webpage.
Find separately available controls on page: 31 - 33
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 15
Notes
Alcohol Abuse Monitoring 17 − 18
Therapeutic Drug Monitoring 19 − 26
Drug Screening 27 − 30
Overview: Analytes and Controls 31 − 33
Hard- & Software Requirements 34
Toxicology
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 17
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TOXICOLOGY
Alcohol Abuse Monitoring
Sample preparation:
■■ Type: Iron saturation plus protein precipitation■■ Duration: <45 minutes
Test characteristics:
■■ Principle: Gradient HPLC method (Anion-exchange)■■ Duration of chromatography: 10 minutes■■ Sample volume: 150 μL serum or plasma■■ Flow rate: 1.8 min■■ UV Detection: 460 nm
Ready-Prep %CDT by HPLC™
(1) Helander A, Husa A, Jeppson JO. Improved HPLC Method for Carbohydrate-Deficient Transferrin in Serum. Clin. Chem. 2003; 49:11, 1881-1890
Ready-Prep %CDT by HPLCTM
Alcohol Abuse Monitoring
Simplified test procedure
Currently CDT (carbohydrate deficient transferrin) is the most specific biochemical marker for the detection of alcohol abuse and for monitoring of abstinence during treatment. Daily consumption of 50 - 80 grams ethanol for one week or longer results in elevated levels of %CDT. The Ready-Prep %CDT by HPLC™ assay measures the relative amounts of single transferrin isoforms (e.g. disialotransferrin) to total transferrin.
The Bio-Rad Ready-Prep %CDT by HPLC™ kit is designed for reliable, fast and easy determination of %CDT in human serum.
Sample preparation reagents are provided in a premixed, ready-to-use form. Two kit configurations - for use with either manual or automated dispensing procedures - allow for testing of 100 or 300 samples.
A bi-level calibrator set is available to assist laboratories in the standardization of Bio-Rad %CDT testing.
The Ready-Prep %CDT by HPLC™ assay offers:
■■ Maximum flexibility – includes routine screening and confirmatory testing options
■■ Minimized hands on-time – rapid and convenient sample preparation
■■ Excellent reliability – - Detection of genetic transferrin variants - Human based calibrator traceable to IFCC reference - Excellent correlation with candidate reference method(1)
Scheme of the preparative phase for determining the Ready-Prep %CDT by HPLC™, 100 tests.
For each samplepipette 150 μl ofserum into acorrespondinglylabelled vial, pre- filled with 350 μL of Ready-PrepReagent.
Mixed thoroughlyon a Vortex mixer.
Incubate for aminimum of 30minutes up to amaximum of 60minutes at roomtemperature orincubate up to 24hours at 2-8°C.
Centrifuge for10 minutes at10,000 x g.
Carefully pipette400 μl of the super- natant into anautosampler vial.
For analysis 100 μl are injected.
100 μl0-60 min
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-6670 Ready-Prep %CDT by HPLC™ Reagent Kit ................................................................................................. 100 tests195-6671 Ready-Prep %CDT by HPLC™ Reagent Kit ................................................................................................. 300 tests
Additional Required Items
195-6662 Analytical Cartridge .............................................................................................................................. 600 injections195-6663 Holder for Analytical and Guard Cartridge ......................................................................................................... 1 unit195-6665 Test Mix .............................................................................................................................................................1 mL195-6666 Vial Hold Down Assembly (online method) ........................................................................................................ 1 unit196-1012 Sample Vials . ............................................................................................................................................ 1000 vials195-5232 Piercable Caps . ......................................................................................................................................... 500 caps
18 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
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TOXICOLOGY
Alcohol Abuse Monitoring
Sample from a light drinker (white) compared to a heavy drinker (green)
Chromatogram of a patientwith a BC variant
Chromatogram of a patientwith a CD variant
Ready-Prep %CDT by HPLCTM
See Also
For items available separately, please
see “Instruction for use” or webpage.
Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-5917 Amiodarone by HPLC Reagent Kit ..100 testsConsisting of:
195-5917R Reagent Set ...................................1 unit195-5921 Calibrator Set .................................1 unit
Additional Required Items
195-5918 Analytical HPLC Cartridge (includes 2 Micro-Guard™ cartridges) ...500 injections195-5023 Analytical Cartridge Holder...............1 unit195-5030 Micro-Guard™ Cartridge Holder .......1 unit195-4088 Capillary Connecting Set .................1 unit195-1012 Sample vials ........................... 1000 vials195-5232 Piercable Caps .........................500 caps
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 19
www.bio-rad.com
TOXICOLOGY
Therapeutic Drug Monitoring
Sample preparation:
■■ Type: protein precipitation■■ Duration: <20 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 6 minutes■■ Sample volume: 200 μL plasma or serum■■ Flow rate: 0.7 mL/min■■ UV Detection: 242 nm
Amiodarone, an antiarrhythmic drug, is often used when other antiarrhythmic drugs are inefficient. The medication is effective e. g. in controlling reentry-type arrhythmias associated with Wolff-Parkinson-White syndrome.
The known side effects like pulmonary toxicity of Amiodarone necessitate careful monitoring of the serum concentration of the drug.
The Bio-Rad Amiodarone by HPLC Reagent Kit permits therapeutic drug monitoring of amiodarone and its metabolite desethylamiodarone in serum. The Amiodarone by HPLC assay features:
■■ Maximized throughput – only 6 minutes per HPLC run■■ Minimized hands on-time –
- With ready-to-use reagents - Easy specimen preparation
Therapeutic drug monitoring (TDM) is the measurement of drugs at various intervals of treatment in order to maintain a relatively constant concentration of the medication in the bloodstream. TDM is an established procedure for cardiac drugs, antidepressants, antipsychotics, or immunsuppressants for example. Drugs that are monitored tend to have a narrow “therapeutic range”. The concentration required to be effective is not far from the concentration that causes significant side effects and/or signs of toxicity. Maintaining this steady state is not as simple as giving a standard dose of medication. Each person will absorb, metabolize, utilize, and eliminate drugs at a different rate based upon their age, general state of health, genetic make-up, and the interference of other medications that they are taking. Therapeutic drug monitoring is a valid tool to optimize pharmacotherapy. It identifies patient noncompliance, effects of drug interactions, and helps to tailor dosages to fit the current needs of the specific patient.
Amiodarone by HPLC
Therapeutic Drug Monitoring
Chromatogram of Amiodarone Serum Calibrator
0 1 2 3 4 5 6-0.1
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
Time (min.)
Volts
Amid
aron
e
Des
ethy
lam
idar
one
Amiodaroneby HPLC
See Also
For items available separately, please see “Instruction for use” or webpage. Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-6210 Antiepileptics by HPLC Reagent Kit ....................................100 tests Consisting of:195-6210R Reagent Set. ........................................................................... 1 unit195-6205 Calibrator A Set ....................................................................... 1 unit195-6220 Antiepileptics by HPLC Reagent Kit (online method) ..........200 testsConsisting of:195-6220R Reagent Set ............................................................................ 1 unit195-6205 Calibrator A Set ....................................................................... 1 unit 195-5981 Mobile Phase 1 Set ................................................................. 1 unit
Additional Required Items
195-6206 Analytical Column (includes 1 Micro-Guard™ Cartridge) ...600 injections195-6219 Extraction Cartridge (online method) ............................500 injections195-5030 Micro-Guard™ Cartridge Holder ............................................... 1 unit270-0613 Extraction Cartridge Holder (online method) ............................. 1 unit195-6682 Prefilter Holder (online method) ................................................ 1 unit270-0338 Prefilter Holder ......................................................................... 1 unit195-6636 HPLC Prefilter .........................................................................2 units 195-4088 Capillary Connecting Set.......................................................... 1 unit196-1012 Sample Vials .................................................................... 1000 vials195-5232 Piercable Caps .................................................................. 500 caps195-5898 Test Mix ................................................................................... 2 mL195-5896 Calibrator B Set ................................................................. 2 x 1 mL195-6208 Calibrator C Set ................................................................ 2 x 1 mL195-6215 Control A Set (bi-level) ........................................................ 2 x 1 mL195-6500 Control B Set (bi-level) ........................................................ 2 x 1 mL195-6218 Control C Set (bi-level) ........................................................ 2 x 1 mL
20 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
www.bio-rad.com
TOXICOLOGY
Therapeutic Drug Monitoring
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of the chromatography:
10-14 min. (manual method) / 12-16 min. (online method)■■ Sample volume: 100 μL (manual method) /
40 μL (online method) serum or plasma■■ Flow rate: 0.8 mL/min■■ UV Detection: 210 nm
Antiepileptics by HPLC
Chromatogram of the Antiepileptics Calibrator A
• 10-OH-Carbazepine• Desmethylmeth-suximide• Lamotrigine• Oxcarbazepine*
• Sultiame• Zonisamide• Lacosamid• Eslicarbazepine acetate*
Chromatogram of the Antiepileptics Calibrator B
• Carbamazepine• Carbamazepine-Epoxide• Ethosuximide• Phenobarbital• Phenytoin• Primidone
Chromatogram of the Antiepileptics Calibrator C
• Felbamate
Manual method and automated online method –with expanded analyte panel
This assay is suitable for reliable, fast and easy quantita-tive determination of a broad range of first and second generation antiepileptic drugs in plasma and serum. The analytes can be extracted and separated with a fully automatable method by online column switching between an extraction cartridge and an analytical column.
The Antiepileptics by HPLC assay offers:
■■ New! Broader analyte portfolio – 2 additional antidepressants added
■■ Increased economic efficiency - By ordering the analytes of interest only - Determination of multiple drugs in one run
■■ Minimized hands-on time – online sample preparation
Antiepileptics by HPLC
* This assay does not provide a quantitative test result for this prodrug, but it provides additional valuable information for the inter-pretation of TDM test results
See Also
For items available separately, please
see “Instruction for use” or webpage.
Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-6690 Levetiracetam by HPLC Reagent Kit .......................................................................................................... 100 testsConsisting of:195-6690R Reagent Set .................................................................................................................................................... 1 unit195-6698 Standard Set ................................................................................................................................................... 1 unit
Additional Required Items
195-6206 Analytical Column (includes 1 Micro-Guard™ Cartridge) ....................................................................... 500 injections195-6003 Micro-Guard™ Cartridge ..................................................................................................................................2 units195-5030 Micro-Guard™ Cartridge Holder ........................................................................................................................ 1 unit195-4088 Capillary Connecting Set................................................................................................................................... 1 unit195-6636 HPLC Prefilter ..................................................................................................................................................2 units270-0338 Prefilter Holder ................................................................................................................................................. 1 unit
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 21
www.bio-rad.com
TOXICOLOGY
Therapeutic Drug Monitoring
New application
Levetiracetam is an antiepileptic drug used in the treatment of certain types of seizures in epileptic patients. This assay provides a reliable, easy-to-use method for the quantitative determination of Levetiracetam in plasma and serum.
Customers can easily switch between the Levetiracetam by HPLC and the Antiepileptics by HPLC application as the same analytical column is used with both.
The Levetiracetam by HPLC assay offers:
■■ Maximal compatibility – same analytical column as in the Antiepileptics by HPLC application
■■ Excellent reliability - Separately available calibrator material - Bi-level control set
Sample preparation:
■■ Type: sample purification on disposable column■■ Duration: <10 minutes
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 15 minutes■■ Sample volume: 100 μL serum or plasma■■ Flow rate: 0.8 mL/min■■ UV Detection: 210 nm
Levetiracetam by HPLC
Chromatogram of Levetiracetam Calibrator
Levetiracetam by HPLC
See Also
For items available separately, please see “Instruction for use” or webpage. Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-5720 TDM by HPLC Basic Reagent Set .. 200 testsConsisting of:195-6686 Mobile Phase 1 Set............................ 1 unit195-6687 Mobile Phase 2 Set ........................... 1 unit195-5702 Extraction Set 1 ................................. 1 unit
Additional Required Items
195-6684 Analytical Column (includes 2 Micro-Guard™ cartridges) ....600 injections195-5030 Micro-Guard™ Cartridge Holder ......... 1 unit270-0613 Holder for Extraction Cartridge........... 1 unit195-6682 Holder for Prefilter .............................. 1 unit195-6636 HPLC Prefilter ...................................2 units195-4088 Capillary Connecting Set.................... 1 unit196-1012 Sample Vials .............................. 1000 vials195-5232 Piercable Caps .............................500 caps
Modular system: select analyte dependent calibrator & control set
195-6607 Calibrator A (mono-level) ..................... 5 mL195-6606 Calibrator C (mono-level) ................... 5 mL195-6677 Control A Set (bi-level) ................. 2 x 5 mL195-6678 Control C Set (bi-level) ................. 2 x 5 mL195-6626 Internal Standard 1 ............................. 4 mL
22 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
www.bio-rad.com
TOXICOLOGY
Therapeutic Drug Monitoring
Online application - fully compatible with Benzo/TCA & SSRIs applications
Bio-Rad´s application for Rapid Analysis of Psychiatric Drugs (RAPsyD) is suitable for reliable, fast and easy simultaneous quantitative measurement of clozapine, olanzapine, quetiapine, risperidone, and their pharma-cologically active metabolites. The antipsychotics are extracted and separated with an HPLC method that involves online column switching between an extraction cartridge and an analytical column.
With its fully automated HPLC method, the RAPsyD assay allows for time-saving and convenient measurement of the prescribed drugs. RAPsyD by HPLC provides physicians with an efficient tool for initial determination of dosage and for subsequent therapeutic drug monitoring.
This application is easily compatible with Bio-Rad´s new SSRIs by HPLC test and also with the Benzo/TCA by HPLC assay because the same core components including analytical column, extraction cartridge and mobile phases are used. The modular concept allows for flexible ordering of required components only.
The RAPsyD by HPLC assay offers:
■■ Economical - Order only the analytes of interest - Determination of multiple drugs in one run
■■ Minimized hands-on time – online sample preparation
Sample preparation:
■■ Type: online sample preparation■■ Duration: no hands on sample prep required
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of chromatography: 27 minutes■■ Sample volume: 600 μL serum or plasma■■ Flow rate: 0.8 mL/min■■ UV Detection: 254 nm (clozapine, olanzapine,
quetiapine); 278 nm (risperidone)
RAPsyD by HPLC
RAPsyD by HPLC
Chromatogram of RAPsyD by HPLC Calibrator A• Clozapine• Norclozapine• Olanzapine• Quetiapine
Chromatogram of RAPsyD by HPLC Calibrator C• Risperidone• 9-OH Risperidone
min5 10 15 20 25
mAU
-1
0
1
2
3
4
5
6
7
Clo
zapi
ne
Inte
rnal
Sta
ndar
d 1
Que
tiapi
ne
Ola
nzap
ine
Nor
cloz
apin
e
min5 10 15 20 25
mAU
-1
0
1
2
3
4
5
6
7
Risperidone
9-OH-Risperidone
Inte
rnal
Sta
ndar
d 1
See Also
For items available separately, please
see “Instruction for use” or webpage.
Find separately available controls on page: 31 - 33
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-5720 TDM by HPLC Basic Reagent Set .............................................................................................................. 200 testsConsisting of:195-6686 Mobile Phase 1 Set........................................................................................................................................... 1 unit195-6687 Mobile Phase 2 Set........................................................................................................................................... 1 unit195-5702 Extraction Set 1 ................................................................................................................................................ 1 unit
Additional Required Items
195-6684 Analytical Column (includes 2 Micro-Guard™ cartridges) ...................................................................... 600 injections195-5030 Micro-Guard™ Cartridge Holder ........................................................................................................................ 1 unit195-6682 Holder for Prefilter ............................................................................................................................................. 1 unit270-0613 Holder for Extraction Cartridge.......................................................................................................................... 1 unit195-4088 Capillary Connecting Set................................................................................................................................... 1 unit196-1012 Sample Vials ............................................................................................................................................. 1000 vials195-5232 Piercable Caps ........................................................................................................................................... 500 caps
Modular system: select analyte dependent calibrator & control set
195-6552 Calibrator A (mono-level) .............................................................................................................................. 1 x 5 mL195-6553 Calibrator B (mono-level).............................................................................................................................. 1 x 5 mL195-6554 Calibrator C (mono-level) ............................................................................................................................. 1 x 5 mL195-6555 Calibrator D (mono-level) ............................................................................................................................. 1 x 5 mL195-6569 Calibrator E (mono-level) .............................................................................................................................. 1 x 5 mL195-6559 Control A Set (bi-level) ........................................................................................................................... 2 x 2 x 5 mL195-6562 Control B Set (bi-level) ........................................................................................................................... 2 x 2 x 5 mL195-6565 Control C Set (bi-level) ........................................................................................................................... 2 x 2 x 5 mL195-6568 Control D Set (bi-level). .......................................................................................................................... 2 x 2 x 5 mL195-6587 Control E Set (bi-level)............................................................................................................................ 2 x 2 x 5 mL195-6626 Internal Standard 1 ...................................................................................................................................... 1 x 4 mL195-6551 Internal Standard 2 ...................................................................................................................................... 1 x 4 mL
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 23
www.bio-rad.com
TOXICOLOGY
Therapeutic Drug Monitoring
Online application - fully compatible with RAPsyD & SSRIs applications
This assay provides a reliable, fast and easy-to-use method for the analysis of 25 antidepressants, benzodiazepines, selective serotonin re-uptake inhibitors (SSRIs), and their pharmacologically active metabolites.
New! Included in the panel of antidepressive drugs are clobazam, norclobazam and nitrazepam.
The analytes are extracted and separated by online column switching between an extraction cartridge and an analytical column. With its fully automated HPLC method, this assay allows for time-saving and convenient measurement of prescribed drugs. This application is easily compatible with Bio-Rad´s new SSRIs by HPLC test and also with the RAPsyD by HPLC assay because the same core components including analytical column, extraction cartridge and mobile phases are used. The modular concept allows for flexible ordering of required components only.
The Benzodiazepines & Tricyclics Andidepressants by HPLC Kit offers:
■■ Increased economic efficiency - Order only the analytes of interest - Determination of multiple drugs in one run
■■ Minimized hands-on time – online sample preparation
Sample preparation:
■■ Type: online sample preparation■■ Duration: no hands on sample prep required
Test characteristics:
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of the chromatography:
34 min (Analyte panel A) / 24 min (Analyte panel B - E)■■ Sample volume: 600 μL serum or plasma■■ Flow rate: 1.1 mL/min (Analyte panel A) / 0.6 mL/min
(Analyte Panel B - E)■■ UV Detection: 250 nm (Analyte panel A, C & E) / 233 nm
(Analyte panel B & D)
Benzodiazepines & Tricyclics Antidepressants by HPLC
See Also
For items available separately, please see “Instruction for use” or webpage. Find separately available controls on page: 31 - 33
24 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
www.bio-rad.com
TOXICOLOGY
Therapeutic Drug Monitoring
Benzodiazepines & Tricyclics Antidepressants by HPLC
Chromatogram of Benzo/TCA by HPLC Calibrator A
• Amitriptyline• Clomipramine• Desipramine• Doxepine• Imipramine• Norclomipramine• Nordoxepine• Nortrimipramine• Nortriptyline• Trimipramine
Chromatogram of Benzo/TCA by HPLC Calibrator B
• Alprazolam• Chlordiazepoxide• Desalkylflurazepam• Diazepam
• Nordiazepam• Oxazepam• Trazodone
Chromatogram of Benzo/TCA by HPLC Calibrator D
• Bromazepam• Lorazepam• Temazepam
Chromatogram of Benzo/TCA by HPLC Calibrator C
• Clonazepam• Flunitrazepam• Nitrazepam
Chromatogram of Benzo/TCA by HPLC Calibrator E
• Clobazam• Norclobazam
min5 10 15 20 25 30
mAU
-2
-1
0
1
2
3
4
5
6
7
Nordo
xepine
Desipramine
Nortriptylin
eNortrim
ipramine
Norclom
ipramine
Doxep
ine
Imipramine
Amitriptylin
e
Clom
ipramine
Trim
ipramine
Inte
rnal
Sta
ndar
d 1
min5 10 15 20
mAU
-5
0
5
10
15
20
Oxazepa
m
Chlordiazepo
xide
Alprazolam
Desalkyl�urazep
am Nordiazep
am
Trazod
one
Diazepa
m
Inte
rnal
Sta
ndar
d 2
min5 10 15 20
mAU
-5
0
5
10
15
20
Brom
azep
am
Lorazepa
m
Temazep
am
Inte
rnal
Sta
ndar
d 2
Ordering Information • CE Marked
Catalog Description
Reagent Kit
195-5720 TDM by HPLC Basic Reagent Set ......................................... 200 testsConsisting of:195-6686 Mobile Phase 1 Set...................................................................... 1 unit195-6687 Mobile Phase 2 Set...................................................................... 1 unit195-5702 Extraction Set 1 ........................................................................... 1 unit
Additional Required Items
195-6684 Analytical Column (includes 2 Micro-Guard™ cartridges) ....600 injections195-5030 Micro-Guard™ Cartridge Holder ................................................... 1 unit195-6682 Holder for Prefilter ........................................................................ 1 unit270-0613 Holder for Extraction Cartridge..................................................... 1 unit195-4088 Capillary Connecting Set.............................................................. 1 unit196-1012 Sample Vials. ........................................................................ 1000 vials195-5232 Piercable Caps ...................................................................... 500 caps195-5734 Extraction Set 2 (for analyte panel “D” and “F”) ............................ 1 unit 195-5807 Sample Loop, 200 μL (for analyte panel “F” only) ......................... 1 unit
Modular system: select analyte dependent calibrator & control set
195-5710 Calibrator A ............................................................................ 1 x 5 mL195-5711 Calibrator B ............................................................................ 1 x 5 mL 195-5712 Calibrator C ............................................................................ 1 x 5 mL195-5713 Calibrator D ............................................................................ 1 x 5 mL195-5714 Calibrator E............................................................................. 1 x 5 mL195-5715 Calibrator F ............................................................................. 1 x 5 mL195-5706 Control A Set .................................................................... 2 x 2 x 5 mL195-5709 Control B Set .................................................................... 2 x 2 x 5 mL 195-5724 Control C Set .................................................................... 2 x 2 x 5 mL195-5727 Control D Set .................................................................... 2 x 2 x 5 mL195-5730 Control E Set .................................................................... 2 x 2 x 5 mL195-5733 Control F Set .................................................................... 2 x 2 x 5 mL195-6626 Internal Standard 1 ................................................................. 1 x 4 mL195-6551 Internal Standard 2 ................................................................. 1 x 4 mL 195-5983 Internal Standard 3 ................................................................. 1 x 4 mL195-5984 Internal Standard 4 ................................................................. 1 x 4 mL195-5985 Internal Standard 5 ................................................................. 1 x 4 mL
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 25
www.bio-rad.com
TOXICOLOGY
Therapeutic Drug Monitoring
Online Application - fully compatible with BENZO/TCA & RAPsyD tests
The method focuses on selective serotonin re-uptake inhibitors (SSRIs), a class of antidepressants considered to be the current standard of drug treatment for depression.
The Bio-Rad SSRIs by HPLC method permits a quick, reproducible, and specific quantification of therapeutic concentrations for 17 drugs and/or their metabolites in serum or plasma.
The analytes are extracted and separated by online column switching between an extraction cartridge and an analytical column. With its fully automated HPLC method, this assay allows for time-saving and convenient measurement of the prescribed drugs. This application is easily compatible with Bio-Rad´s Benzo/TCA by HPLC test and also with the RAPsyD by HPLC assay because the same core components including analytical column, extraction cartridge and mobile phases are used. The modular concept allows for flexible ordering of required components only.
The SSRIs by HPLC assay offers:
■■ New! Broader analyte portfolio – 12 additional antidepressants added
■■ Increased economic efficiency - Order only the analytes of interest - Determination of multiple drugs in one run
■■ Minimized hands-on time – online sample preparation
Sample preparation:
■■ Type: online sample preparation■■ Duration: no hands on sample prep required
Test characteristics (depending on analyte panel):
■■ Principle: Isocratic HPLC method (Reversed Phase)■■ Duration of the chromatography: 18 - 30 min■■ Sample volume: 600 - 700 μL serum or plasma■■ Flow rate: 0.8 mL/min■■ UV Detection: 230 - 290 nm■■ Fluorescence Detection: excitation = 230/240 nm,
emission = 310 nm
SSRIs by HPLC
SSRIs by HPLC
See Also
For items available separately, please see “Instruction for use” or webpage. Find separately available controls on page: 31 - 33
26 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
www.bio-rad.com
TOXICOLOGY
Therapeutic Drug Monitoring
Chromatogram of SSRIs by HPLC Calibrator B
• Citalopram• Desmethyl-citalopram• Fluvoxamine
Chromatogram of SSRIs by HPLC Calibrator D
• Desmethyl-mirtazapine 1)
• Paroxetine• Mirtazapine• Reboxetine
Chromatogram of SSRIs by HPLC Calibrator A
• Venlafaxine• O-desmethyl-venlafaxine• N-desmethyl-venlafaxine
Chromatogram of SSRIs by HPLC Calibrator C
• Fluoxetine• Norfluoxetine
Chromatogram of SSRIs by HPLC Calibrator F
• N-desmetyhl-sertraline• SertralineChromatogram of SSRIs by HPLC Calibrator E
• Bupropion • Duloxetine• Hydroxy-bupropion
1) This assay does not provide quanti- tative test results for pharmacologically inactive metabolites, but it provides additional valuable information for the interpretation of TDM test results
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 27
www.bio-rad.com
TOXICOLOGY
Drug Screening
TOX/See™ is a one-step, hand-held, point-of-care test device for the qualitative detection of 14 drugs or drug metabolites in human urine. Bio-Rad’s TOX/See™ product portfolio includes specific tests for drugs of abuse, such as oxycodone, buprenorphine, ecstasy, and propoxyphene to meet today´s customers´ demands and features a variety of combinations of 14 drugs listed below. The simple test protocol is designed for use in hospitals, emergency departments, correctional facilities, juvenile facilities, police departments, workplaces, and recovery and rehabilitation programs.
■■ Walkway flexibility: Test results are stable for reading for up to 1 hour to accommodate busy laboratory schedules.
■■ Comprehensive test panels: Simultaneous detection of as many as 12 drugs per cassette.
■■ Rapid results: Test results are available in 5 minutes.
■■ Differentiate between amphetamine, methamphetamine, and ecstasy in one step: Provides specific
information to clinicians for better patient management.
■■ Specific tests for emerging drugs of abuse: oxycodone, buprenorphine, ecstasy, and propoxyphene.
■■ One-step test protocol: Allows for easy training.
TOX/See™ Rapid Urine Drug Screen Tests
Drug Screening
28 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
www.bio-rad.com
TOXICOLOGY
Drug Screening
A One-Step Urine Test for Rapid Drug Screen
TOX/See™ Protocol Sheet
■■ Add 3 drops of urine to each well
■■ Check control line and read results at 5 minutes after the addition of sample
Add Urine Check Control Read Results
The presence of a colored line beside the C (control) serves as verification that:
■■ A sufficient volume of specimen was added
■■ A proper flow was obtained
■■ Results remain stable for up to one hour
■■ Line = negative■■ No line = positive
In the example, the test is positive for COC.
1 2 3
Interpretation
POSITIVE: A colored line in the control region (C) and NO COLORED LINE next to the respective drug name
NEGATIVE: A colored line in the control region (C) and a COLORED LINE next to the respective drug name. Note: The presence of any line, regardless of intensity, should beinterpreted as a negative result
INVALID: a control line fails to appear.
■■ Insufficient specimen or incorrect procedural techniques are most likely reasons for control line failure
■■ Review procedure and repeat the test with a new test device■■ If problem persists, discontinue using the lot immediately and contact
Bio-Rad office
c
coc
c
coc
c
coc
c
coc
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 29
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TOXICOLOGY
Drug Screening
Ordering Information
Catalog Description
194-5221 TOX/See™ Drug Screen Test AMP, BAR, BZO, COC, MDMA, MET, MTD, OPI,OXY, PCP,TCA, THC ............. 25 tests
194-5225 TOX/See™ Drug Screen Test AMP, BAR, BZO, COC, MDMA, MET, MTD, OPI, PCP, THC ............................. 25 tests
194-5228 TOX/See™ Drug Screen Test AMP, BAR, BZO, COC, MET, MTD, OPI, PCP, TCA, THC................................. 25 tests
194-5230 TOX/See™ Drug Screen Test AMP, BAR, BZO, COC, MET, OPI,PCP, TCA, THC ........................................... 25 tests
194-5182 TOX/See™ Drug Screen Test AMP, BAR, BZO, COC, MET, MTD, OPI, THC .................................................. 25 tests
194-5183 TOX/See™ Drug Screen Test AMP, BAR, BZO, COC, MTD, OPI 2000, PCP, THC ......................................... 25 tests
194-5209 TOX/See™ Drug Screen Test AMP, BAR, BZO, COC, MTD, OPI, PCP, THC .................................................. 25 tests
194-5216 TOX/See™ Drug Screen Test AMP, BZO, COC, OPI, THC ............................................................................. 25 tests
194-5200 TOX/See™ Drug Screen Test AMP, COC, OPI, PCP, THC .............................................................................. 25 tests
194-5184 TOX/See™ Drug Screen Test AMP. ................................................................................................................ 25 tests
194-5185 TOX/See™ Drug Screen Test BAR ................................................................................................................. 25 tests
194-5205 TOX/See™ Drug Screen Test BUP. ................................................................................................................ 25 tests
194-5186 TOX/See™ Drug Screen Test BZO ................................................................................................................. 25 tests
194-5188 TOX/See™ Drug Screen Test COC ................................................................................................................ 25 tests
194-5224 TOX/See™ Drug Screen Test MDMA ............................................................................................................. 25 tests
194-5190 TOX/See™ Drug Screen Test MET ................................................................................................................. 25 tests
194-5191 TOX/See™ Drug Screen Test MTD ................................................................................................................ 25 tests
194-5192 TOX/See™ Drug Screen Test OPI .................................................................................................................... 5 tests
194-5203 TOX/See™ Drug Screen Test OXY. ................................................................................................................ 25 tests
194-5194 TOX/See™ Drug Screen Test PCP ................................................................................................................. 25 tests
194-5204 TOX/See™ Drug Screen Test PPX ................................................................................................................... 5 tests
194-5234 TOX/See™ Drug Screen Test TCA ................................................................................................................. 25 tests194-5187 TOX/See™ Drug Screen Test THC ................................................................................................................. 25 tests
Intended Use of TOX/See™ Drug Screen Test
■■ This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The preferred method for confirmation testing and the method estab-lished by the Substance Abuse and Mental Health Services Administration (SAMHSA) is gas chromatography/mass spectrometry (GC/MS).
■■ Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
■■ The use of external positive and negative control material is recommended to test each new lot or shipment of product and every 30 days thereafter.
■■ This protocol sheet is only for general instructions only. The number of drugs and strips may vary depending on which product has been ordered. For specific information, please refer to the package insert.
Our Tests Feature a Combination of the Following Drugs at These Cutoffs:
Amphetamine AMP. ................ 1000 ng/mLOpiates OPI .............................. 300 ng/mLOpiates OPI2000 .................... 2000 ng/mLBenzodiazepines BZO .............. 300 ng/mLMethadone MTD ...................... 300 ng/mL
Cocaine COC ........................... 300 ng/mLOxycodone OXY. ...................... 100 ng/mLBuprenorphine BUP. ................... 10 ng/mLTetrahydrocannabinol THC. ........ 50 ng/mLMethamphetamine MET. ......... 1000 ng/mL
Barbiturates BAR ...................... 300 ng/mLTricyclic Antidepressants TCA .. 1000 ng/mLEcstasy MDMA ......................... 500 ng/mLPhencyclidine PCP. ..................... 25 ng/mLPropoxyphene PPX. ................. 300 ng/mL
30 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
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Clinical HPLC & Toxicology
Overview: Analytes and Controls
An
alyt
eS
amp
le s
pec
imen
Kit
No
. O
f te
sts
Cat
alo
g
nu
mb
er
Au
tom
atio
n o
r o
nlin
e m
eth
od
av
aila
ble
Co
ntr
ols
Pag
e
Uri
ne
Pla
sma
Ser
um
Cat
alo
g n
um
ber
10-O
H-C
arb
aze
pin
e•
•A
ntie
pile
ptic
s by
HP
LC10
0
200
195-
6210
195-
6220
•19
5-62
15
Con
trol
A S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
3-M
eth
oxy
tyra
min
e•
Urin
ary
Met
anep
hrin
es
100
200
195-
5411
195-
5412
•37
5x
376
377
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
Min
iPak
(bi-l
evel
)
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Nor
mal
Lev
el
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Ab
orm
al L
evel
6
5-H
ydro
xyin
do
lea
ce
tic
ac
id
(5-H
IAA
)•
VM
A/H
VA/5
-HIA
A b
y H
PLC
100
300
195-
4129
195-
4135
•37
5x
376
377
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
Min
iPak
(bi-l
evel
)
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Nor
mal
Lev
el
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Ab
orm
al L
evel
7
9-O
H R
isp
eri
do
ne
••
RA
Psy
D b
y H
PLC
200
195-
5720
•19
5-66
78C
ontr
ol C
Set
(bi-l
evel
) for
RA
Psy
D b
y H
PLC
22
Alp
razo
lam
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6562
C
ontr
ol B
Set
(bi-l
evel
) for
Ben
zo/T
CA
by
HP
LC23
-24
Am
iod
aro
ne
•A
mio
dar
one
by H
PLC
100
195-
5917
Am
iod
aron
e C
ontr
ol c
omm
erci
ally
ava
ilab
le (e
.g. U
TAK
Ser
um T
oxic
olog
y
Con
trol
Bi-
Leve
l Am
iod
aron
e m
id-r
ange
cat
. no.
610
13; h
igh
rang
e ca
t. no
. 610
12)
19
Am
itri
pty
line
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6559
Con
trol
A S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
Bro
ma
zep
am
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6568
Con
trol
D S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
Bu
pro
pio
n•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
30S
SR
Is C
ontr
ol E
Set
(bi-l
evel
)25
-26
Ca
rba
ma
zep
ine
••
Ant
iep
ilept
ics
by H
PLC
100
200
195-
6210
195-
6220
•19
5-65
00
Con
trol
B S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
Ca
rba
ma
zep
ine
-Ep
oxi
de
••
Ant
iep
ilept
ics
by H
PLC
100
200
195-
6210
195-
6220
•19
5-65
00
Con
trol
B S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
Ca
rbo
hyd
rate
de
fic
ien
t
tra
nsf
err
in•
Rea
dy-
Pre
p %
CD
T by
HP
LC10
0
300
195-
6670
195-
6671
195-
6669
C
ontr
ol S
et (b
i-lev
el) f
or R
ead
y P
rep
%C
DT
by H
PLC
17-1
8
Ch
lord
iaze
po
xid
e•
•B
enzo
dia
zep
ines
& T
ricyc
lic a
ntid
epre
ssan
ts b
y H
PLC
200
195-
5720
•19
5-65
62
Con
trol
B S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
Cit
alo
pra
m•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
09S
SR
Is C
ontr
ol B
Set
(bi-l
evel
)25
-26
Clo
ba
zam
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6587
Con
trol
E S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
Clo
mip
ram
ine
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6559
Con
trol
A S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
Clo
na
zep
am
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6565
C
ontr
ol C
Set
(bi-l
evel
) for
Ben
zo/T
CA
by
HP
LC23
-24
Clo
zap
ine
••
RA
Psy
D b
y H
PLC
200
195-
5720
•19
5-66
77C
ontr
ol A
Set
(bi-l
evel
) for
RA
Psy
D b
y H
PLC
22
De
seth
yla
mio
da
ron
e•
•A
mio
dar
one
by H
PLC
100
195-
5917
Am
iod
aron
e C
ontr
ol c
omm
erci
ally
ava
ilab
le (e
.g. U
TAK
Ser
um T
oxic
olog
y C
ontr
ol
Bi-
Leve
l Am
iod
aron
e m
id-r
ange
cat
. no.
610
13; h
igh
rang
e ca
t. no
. 610
12)
19
De
oxy
pyr
idin
olin
e•
Pyr
idin
ium
cro
sslin
ks b
y H
PLC
100
195-
6576
195-
5959
Pyr
idin
ium
-Cro
sslin
ks b
y H
PLC
Con
trol
Set
(bi-l
evel
)12
De
salk
ylfl
ura
zep
am
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6562
C
ontr
ol B
Set
(bi-l
evel
) for
Ben
zo/T
CA
by
HP
LC23
-24
De
sip
ram
ine
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6559
Con
trol
A S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
De
sme
thyl
-cit
alo
pra
m•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
09S
SR
Is C
ontr
ol B
Set
(bi-l
evel
)25
-26
De
sme
thyl
me
thsu
xim
ide
••
Ant
iep
ilept
ics
by H
PLC
100
200
195-
6210
195-
6220
•19
5-62
15C
ontr
ol A
Set
(bi-l
evel
) for
Ant
iep
ilept
ics
by H
PLC
20
De
sme
thyl
-mir
taza
pin
e•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
27S
SR
Is C
ontr
ol D
Set
(bi-l
evel
)25
-26
Dia
zep
am
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6562
C
ontr
ol B
Set
(bi-l
evel
) for
Ben
zo/T
CA
by
HP
LC23
-24
Do
pa
min
e•
Urin
ary
Cat
echo
lam
ines
by
HP
LC
100
300
195-
5390
195-
5391
•37
5x
376
377
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
Min
iPak
(bi-l
evel
)
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Nor
mal
Lev
el
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Ab
orm
al L
evel
4
•P
lasm
a C
atec
hola
min
es b
y H
PLC
100
195-
5880
535x
Lyp
hoch
ek® E
ndoc
rine
Con
trol
, Min
iPak
(bi-l
evel
)5
Do
xep
ine
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6559
Con
trol
A S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
Du
loxe
tin
e•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
30S
SR
Is C
ontr
ol E
Set
(bi-l
evel
) for
Ben
zo/T
CA
by
HP
LC25
-26
Ep
ine
ph
rin
e•
Urin
ary
Cat
echo
lam
ines
by
HP
LC
100
300
195-
5390
195-
5391
•37
5x
376
377
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
Min
iPak
(bi-l
evel
)
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Nor
mal
Lev
el
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Ab
orm
al L
evel
4
•P
lasm
a C
atec
hola
min
es b
y H
PLC
100
195-
5880
535x
Lyp
hoch
ek® E
ndoc
rine
Con
trol
, Min
iPak
(bi-l
evel
)5
Overview: Analytes and Controls
An
alyt
eS
amp
le s
pec
imen
Kit
No
. O
f te
sts
Cat
alo
g
nu
mb
er
Au
tom
atio
n o
r o
nlin
e m
eth
od
av
aila
ble
Co
ntr
ols
Pag
e
Uri
ne
Pla
sma
Ser
um
Cat
alo
g n
um
ber
Esl
ica
rba
zep
ine
••
Ant
iep
ilept
ics
by H
PLC
100
200
195-
6210
195-
6220
•19
5-62
15
Con
trol
A S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
Eth
osu
xim
ide
••
Ant
iep
ilept
ics
by H
PLC
100
200
195-
6210
195-
6220
•19
5-65
00
Con
trol
B S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
Fe
lba
ma
te•
•A
ntie
pile
ptic
s by
HP
LC10
0
200
195-
6210
195-
6220
•19
5-62
18C
ontr
ol C
Set
(bi-l
evel
) for
Ant
iep
ilept
ics
by H
PLC
20
Flu
nit
raze
pa
m•
•B
enzo
dia
zep
ines
& T
ricyc
lic a
ntid
epre
ssan
ts b
y H
PLC
200
195-
5720
•19
5-65
65
Con
trol
C S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
Flu
oxe
tin
e•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
24S
SR
Is C
ontr
ol C
Set
25-2
6
Flu
voxa
min
e•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
09S
SR
Is C
ontr
ol B
Set
(bi-l
evel
)25
-26
Ho
mo
cys
tein
e•
•H
omoc
yste
ine
by H
PLC
100
195-
4075
195-
4085
Hom
ocys
tein
e C
ontr
ol S
et (b
i-lev
el)
9
Ho
mo
van
illic
ac
id (
HV
A)
•V
MA
/HVA
/5-H
IAA
by
HP
LC
100
300
195-
4129
195-
4135
•37
5x
376
377
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
Min
iPak
(bi-l
evel
)
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Nor
mal
Lev
el
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Ab
orm
al L
evel
7
Hyd
roxy
-bu
pro
pio
n•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
30S
SR
Is C
ontr
ol E
Set
(bi-l
evel
)25
-26
Hyd
roxy
pro
line
•H
ydro
xyp
rolin
e by
HP
LC
100
195-
9501
375x
376
377
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
Min
iPak
(bi-l
evel
)
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Nor
mal
Lev
el
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Ab
orm
al L
evel
11
Imip
ram
ine
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6559
Con
trol
A S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
La
co
sam
ide
••
Ant
iep
ilept
ics
by H
PLC
100
200
195-
6210
195-
6220
•19
5-62
15
Con
trol
A S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
La
mo
trig
ine
••
Ant
iep
ilept
ics
by H
PLC
100
200
195-
6210
195-
6220
•19
5-62
15
Con
trol
A S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
Lev
eti
rac
eta
m•
•Le
vetir
acet
am b
y H
PLC
100
195-
6690
195-
6695
Con
trol
Set
(bi-l
evel
) for
Lev
etira
ceta
m b
y H
PLC
21
Lo
raze
pa
m•
•B
enzo
dia
zep
ines
& T
ricyc
lic a
ntid
epre
ssan
ts b
y H
PLC
200
195-
5720
•19
5-65
68C
ontr
ol D
Set
(bi-l
evel
) for
Ben
zo/T
CA
by
HP
LC23
-24
Me
tan
ep
hri
ne
•U
rinar
y M
etan
ephr
ines
100
200
195-
5411
195-
5412
•37
5x
376
377
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
Min
iPak
(bi-l
evel
)
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Nor
mal
Lev
el
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Ab
orm
al L
evel
6
Mir
taza
pin
e•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
27S
SR
Is C
ontr
ol D
Set
(bi-l
evel
)25
-26
N-d
esm
eth
yl-v
en
lafa
xin
e•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
06S
SR
Is C
ontr
ol A
Set
(bi-l
evel
)25
-26
N-d
esm
ety
hl-
sert
ralin
e•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
33S
SR
Is C
ontr
ol F
Set
(bi-l
evel
)25
-26
Nit
raze
pa
m•
•B
enzo
dia
zep
ines
& T
ricyc
lic a
ntid
epre
ssan
ts b
y H
PLC
200
195-
5720
•19
5-65
65
Con
trol
C S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
No
rclo
ba
zam
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6587
Con
trol
E S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
No
rclo
mip
ram
ine
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6559
Con
trol
A S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
No
rclo
zap
ine
••
RA
Psy
D b
y H
PLC
200
195-
5720
•19
5-66
77C
ontr
ol A
Set
(bi-l
evel
) for
RA
Psy
D b
y H
PLC
22
No
rdia
zep
am
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6562
C
ontr
ol B
Set
(bi-l
evel
) for
Ben
zo/T
CA
by
HP
LC23
-24
No
rdo
xep
ine
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6559
Con
trol
A S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
No
rep
ine
ph
rin
e•
Urin
ary
Cat
echo
lam
ines
by
HP
LC
100
300
195-
5390
195-
5391
•37
5x
376
377
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
Min
iPak
(bi-l
evel
)
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Nor
mal
Lev
el
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Ab
orm
al L
evel
4
•P
lasm
a C
atec
hola
min
es b
y H
PLC
100
195-
5880
535x
Lyp
hoch
ek® E
ndoc
rine
Con
trol
, Min
iPak
(bi-l
evel
)5
No
rflu
oxe
tin
e•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
24S
SR
Is C
ontr
ol C
Set
(bi-l
evel
)25
-26
No
rme
tan
ep
hri
ne
•U
rinar
y M
etan
ephr
ines
100
200
195-
5411
195-
5412
•37
5x
376
377
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
Min
iPak
(bi-l
evel
)
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Nor
mal
Lev
el
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Ab
orm
al L
evel
6
No
rtri
mip
ram
ine
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6559
Con
trol
A S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
No
rtri
pty
line
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6559
Con
trol
A S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
O-d
esm
eth
yl-v
en
lafa
xin
e •
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
06S
SR
Is C
ontr
ol A
Set
(bi-l
evel
)25
-26
Ola
nza
pin
e•
•R
AP
syD
by
HP
LC20
019
5-57
20•
195-
6677
Con
trol
A S
et (b
i-lev
el) f
or R
AP
syD
by
HP
LC22
Oxa
zep
am
••
Ben
zod
iaze
pin
es &
Tric
yclic
ant
idep
ress
ants
by
HP
LC20
019
5-57
20•
195-
6562
C
ontr
ol B
Set
(bi-l
evel
) for
Ben
zo/T
CA
by
HP
LC23
-24
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 31
www.bio-rad.com
Clinical HPLC & Toxicology
Overview: Analytes and Controls
An
alyt
eS
amp
le s
pec
imen
Kit
No
. O
f te
sts
Cat
alo
g
nu
mb
er
Au
tom
atio
n o
r o
nlin
e m
eth
od
av
aila
ble
Co
ntr
ols
Pag
e
Uri
ne
Pla
sma
Ser
um
Cat
alo
g n
um
ber
Oxc
arb
aze
pin
e•
•A
ntie
pile
ptic
s by
HP
LC10
0
200
195-
6210
195-
6220
•19
5-62
15
Con
trol
A S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
Pa
roxe
tin
e•
•S
SR
Is b
y H
PLC
200
195-
5720
•19
5-57
27S
SR
Is C
ontr
ol D
Set
(bi-l
evel
)25
-26
Ph
en
ob
arb
ita
l•
•A
ntie
pile
ptic
s by
HP
LC10
0
200
195-
6210
195-
6220
•19
5-65
00
Con
trol
B S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
Ph
en
yto
in•
•A
ntie
pile
ptic
s by
HP
LC10
0
200
195-
6210
195-
6220
•19
5-65
00
Con
trol
B S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
Pri
mid
on
e•
•A
ntie
pile
ptic
s by
HP
LC10
0
200
195-
6210
195-
6220
•19
5-65
00
Con
trol
B S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
Pyr
idin
olin
e•
Pyr
idin
ium
cro
sslin
ks b
y H
PLC
100
195-
6576
195-
5959
Pyr
idin
ium
-Cro
sslin
ks b
y H
PLC
Con
trol
Set
(bi-l
evel
)12
Qu
eti
ap
ine
••
RA
Psy
D b
y H
PLC
200
195-
5720
•19
5-66
77C
ontr
ol A
Set
(bi-l
evel
) for
RA
Psy
D b
y H
PLC
22
Re
bo
xeti
ne
••
SS
RIs
by
HP
LC20
019
5-57
20•
195-
5727
SS
RIs
Con
trol
D S
et (b
i-lev
el)
25-2
6
Ris
pe
rid
on
e•
•R
AP
syD
by
HP
LC20
019
5-57
20•
195-
6678
Con
trol
C S
et (b
i-lev
el) f
or R
AP
syD
by
HP
LC22
Se
roto
nin
••
Ser
oton
in b
y H
PLC
100
195-
5854
195-
5988
Urin
e C
ontr
ol S
et (b
i-lev
el) f
or S
erot
onin
by
HP
LC8
Se
rtra
line
••
SS
RIs
by
HP
LC20
019
5-57
20•
195-
5733
SS
RIs
Con
trol
F S
et (b
i-lev
el)
25-2
6
Su
ltia
me
••
Ant
iep
ilept
ics
by H
PLC
100
200
195-
6210
195-
6220
•19
5-62
15
Con
trol
A S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
Tem
aze
pa
m•
•B
enzo
dia
zep
ines
& T
ricyc
lic a
ntid
epre
ssan
ts b
y H
PLC
200
195-
5720
•19
5-65
68C
ontr
ol D
Set
(bi-l
evel
) for
Ben
zo/T
CA
by
HP
LC23
-24
Tra
zod
on
e•
•B
enzo
dia
zep
ines
& T
ricyc
lic a
ntid
epre
ssan
ts b
y H
PLC
200
195-
5720
•19
5-65
62
Con
trol
B S
et (b
i-lev
el) f
or B
enzo
/TC
A b
y H
PLC
23-2
4
Trim
ipra
min
e•
•B
enzo
dia
zep
ines
& T
ricyc
lic a
ntid
epre
ssan
ts b
y H
PLC
200
195-
5720
•19
5-65
59C
ontr
ol A
Set
(bi-l
evel
) for
Ben
zo/T
CA
by
HP
LC23
-24
Va
nill
ylm
an
de
lic a
cid
(V
MA
)•
VM
A/H
VA/5
-HIA
A b
y H
PLC
100
300
195-
4129
195-
4135
•37
6
377
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Nor
mal
Lev
el
Lyp
hoch
ek® Q
uant
itativ
e U
rine
Con
trol
, Ab
orm
al L
evel
7
Ve
nla
faxi
ne
••
SS
RIs
by
HP
LC20
019
5-57
20•
195-
5706
SS
RIs
Con
trol
A S
et25
-26
Vit
am
in A
••
Vita
min
A/E
by
HP
LC10
019
5-58
6919
5-58
79V
itam
in A
/E S
erum
Con
trol
Set
(bi-l
evel
)14
Vit
am
in D
2•
•V
itam
in D
3/D
2 by
HP
LC10
019
5-41
00
195-
6548
Vita
min
D3/
D2
Ser
um C
ontr
ol S
et (b
i-lev
el)
13
Vit
am
in D
3•
•V
itam
in D
3/D
2 by
HP
LC10
019
5-41
00
195-
6548
Vita
min
D3/
D2
Ser
um C
ontr
ol S
et (b
i-lev
el)
13
Vit
am
in E
••
Vita
min
A/E
by
HP
LC10
019
5-58
6919
5-58
79V
itam
in A
/E S
erum
Con
trol
Set
(bi-l
evel
)14
Zo
nis
am
ide
••
Ant
iep
ilept
ics
by H
PLC
100
200
195-
6210
195-
6220
•19
5-62
15
Con
trol
A S
et (b
i-lev
el) f
or A
ntie
pile
ptic
s by
HP
LC20
32 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
www.bio-rad.com
Clinical HPLC & Toxicology
Overview: Analytes and Controls
HP
LC M
OD
UL
ES
(Har
dw
are)
Rec
om
men
ded
So
ftw
are
solu
tio
ns
Ap
plic
atio
ns
Deg
ass
erIs
ocr
atic
P
um
pQ
uat
ern
ary
Pu
mp
Au
tosa
mp
ler
Co
lum
n H
eate
r U
V/V
IS
Det
ecto
r
Ele
ctro
chem
ical
D
etec
tor
+ A
/D In
terf
ace
Bo
x
Flu
ore
scen
ce
Det
ecto
r
Au
tom
ate
d
sam
ple
p
rep
arat
ion
Inst
ant
Pilo
t +
C
DM
So
ftw
are
Ag
ilen
t C
hem
Sta
tio
n S
oft
war
e
Bio
ge
nic
A
min
es
Uri
nar
y C
atec
ho
lam
ines
19
5-53
90 R
eage
nt K
it 10
0 te
sts
19
5-53
91 R
eage
nt K
it, A
utom
ated
Met
hod
300
test
s 19
5-53
69 A
naly
tical
Car
trid
ge 5
00
inje
ctio
ns
√√
√√
√√
(for
auto
mat
ed
met
hod
only
)√
√
Pla
sma
Cat
ech
ola
min
es
195-
5880
Rea
gent
Kit
100
test
s 19
5-58
86 A
naly
tical
Car
trid
ge 5
00
inje
ctio
ns√
√√
√√
√√
Uri
nar
y M
etan
eph
rin
es
195-
5411
Rea
gent
Kit
100
test
s 19
5-54
12 R
eage
nt K
it, A
utom
ated
Met
hod
200
test
s 19
5-53
69 A
naly
tical
Car
trid
ge 5
00
inje
ctio
ns
√√
√√
√√
(for
auto
mat
ed
met
hod
only
)√
√
VM
A/H
VA
/5-H
IAA
19
5-41
29 R
eage
nt K
it 10
0 te
sts
195-
4135
Rea
gent
Kit,
Aut
omat
ed M
etho
d 30
0 te
sts
195-
5961
Ana
lytic
al C
artr
idge
50
0 in
ject
ions
√√
√√
√√
(for
auto
mat
ed
met
hod
only
)√
√
Ser
oto
nin
19
5-58
54 R
eage
nt K
it 10
0 te
sts
195-
5855
Ana
lytic
al C
artr
idge
50
0 in
ject
ions
√√
√√
√√
√
Ca
rdio
vasc
ula
rH
om
ocy
stei
ne
195-
4075
Rea
gent
Kit
100
test
s 19
5-40
76 A
naly
tical
Car
trid
ge 5
00
inje
ctio
ns√
√√
√√
√√
Bo
ne
&
Min
era
l
Hyd
roxy
pro
line
195-
9501
Rea
gent
Kit
100
test
s 19
5-95
20 A
naly
tical
Col
umn
500
inje
ctio
ns√
√√
√√
√√
Pyr
idin
ium
Cro
sslin
ks
195-
6576
Rea
gent
Kit
100
test
s 19
5-59
29 A
naly
tical
Car
trid
ge 5
00
inje
ctio
ns√
√√
√√
√√
Vit
amin
D3
195-
410
0 R
eage
nt K
it 10
0 te
sts
195-
4105
Ana
lytic
al C
artr
idge
60
0 in
ject
ions
√√
√√
√√
√
Vit
am
ine
sV
itam
in A
/E
195-
5869
Rea
gent
Kit
100
test
s 19
5-58
70C
Ana
lytic
al C
artr
idge
60
0 in
ject
ions
√√
√√
√√
√
TD
M/
Toxi
co
log
y
CD
T b
y H
PLC
19
5-66
70 R
eage
nt K
it 10
0 te
sts
195-
6671
Rea
gent
Kit,
Aut
omat
ed M
etho
d 30
0 te
sts
195-
6662
Ana
lytic
al C
artr
idge
60
0 in
ject
ions
√√
√√
√√
(for
auto
mat
ed
met
hod
only
)√
√
Am
iod
aro
ne
195-
5917
Rea
gent
Kit
100
test
s 19
5-59
18 A
naly
tical
Car
trid
ge 5
00
inje
ctio
ns√
√√
√√
√√
RA
Psy
D b
y H
PLC
19
5-57
20 T
DM
Rea
gent
Kit
200
test
s 19
5-66
84 A
naly
tical
Car
trid
ge 6
00
inje
ctio
ns√
√ (2
isoc
ratic
p
ump
s)√
√√
√√
Ben
zod
iaze
pin
es &
Tri
cycl
ics
195-
5720
TD
M R
eage
nt K
it 20
0 te
sts
195-
6684
Ana
lytic
al C
artr
idge
60
0 in
ject
ions
√√
√√
√√
√
An
tiep
ilep
tics
by
HP
LC
195-
6210
Rea
gent
Kit
100
test
s
195-
6220
Rea
gent
Kit,
Onl
ine
Met
hod
200
test
s
195-
6206
Ana
lytic
al C
artr
idge
50
0 in
ject
ions
√
√ (fo
r on
line
met
hod
2 is
ocra
tic
pum
ps)
√√
√√
√
SS
RIs
19
5-57
20 T
DM
Rea
gent
Kit
200
test
s 19
5-66
84 A
naly
tical
Car
trid
ge 6
00
inje
ctio
ns√
√ (2
isoc
ratic
p
ump
s)√
√√
(for
cert
ain
anal
ytes
)
√
(fo
r ce
rtai
n an
alyt
es)
√√
Lev
etir
acte
tam
19
5-66
90 R
eage
nt K
it 10
0 te
sts
195-
6206
Ana
lytic
al C
artr
idge
50
0 in
ject
ions
√√
√√
√√
√
For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com | 33
www.bio-rad.com
Clinical HPLC & Toxicology
Hard-& Software requirements for the clinical HPLC Kits
34 | For ordering or additional information please contact your local Bio-Rad office or visit us at www.biorad.com
www.bio-rad.com
Notes
Visit us on the Webwww.bio-rad.com
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Clinical Diagnostics Group
© 2016 Bio-Rad Laboratories, Inc. Printed in Germany EU-HPLC-103-02/16E Rev. 02/2016
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