trinity uni gold hiv presentation for tx

CLINICAL CHEMISTRY | COAGULATION | INFECTIOUS DISEASE | POINT OF CARE

Presentation forPresentation forTexas HIV / STD meeting in AustinTexas HIV / STD meeting in Austin

Uni-Gold™ Recombigen® HIV

Heather Wilson – Account ManagerAdam Hewitt – Territory Manager


Uni-Gold™ Recombigen® HIV

Presentation Overview

Trinity Biotech Overview

Trinity Rapid HIV Experience

Why Choose the Trinity Uni-Gold assay

Trinity Uni-Gold Procedure

Trinity UniGold QC Performance (Hands on)

Questions

Trinity Biotech Family of Companies

Mardx, Primus, Clark laboratories, Sigma Diagnostics, Bartels

We specialize in the development, manufacture and marketing of diagnostic test kits, Trinity Biotech’s continued success is based on the fact that as a company it consistently achieves standards of excellence in the quality of all it does.

– The test kits manufactured by Trinity Biotech are used in the clinical laboratory and point-of-care segments of the diagnostic market to detect infectious diseases, sexually transmitted diseases, blood coagulation and autoimmune disorders. The company is also a significant provider of raw materials to the life sciences industry.

Worldwide Corporate HeadquartersWorldwide Corporate Headquarters

Number of Employees:

650

3 Main Subsidiaries: UK - Germany – USA

Network of 300 Independent

Distributors covering 78

CountriesTrinity Biotech plc,

HeadquartersBray, Ireland

USA Corporate HeadquartersUSA Corporate Headquarters

Trinity Biotech Inc400 Connell Drive

Suite 7100Berkeley Heights, NJ

07922800-325-3424

Infectious Disease SolutionsInfectious Disease Solutions

Western Blot

STD’s beyond HIV

Trinity manufactures many STD tests for use in the lab. Here are a couple of the ELISA 96 well assays:

1. TrepSure Syphilis – This assay detects both IgG and IgM and has a sensitivity and specificity >99%

2. HSV–Type Specific for HSV 1 IgG and HSV 2 IgG. Very efficient assay with shorter room temperature incubation times.

Trinity Rapid HIV Experience

Leading manufacturer of HIV Rapid Tests

First HIV Rapid Test Produced in 1995

Sell more Rapid HIV worldwide then any other US company.

Why use the Uni-Gold™ Recombigen® HIV

Ease of Use

Speed

3rd Generation Technology

Cost Savings

Ease of Use

CLIA Waived

– Add One Drop of Sample– Add Four Drops of Buffer

Complete Sample Flexibility

– Serum– Plasma– Whole blood

Storage Flexibility

– Room Temp– Refrigerated

Speed

− Test Results in 10 minutes

3rd Generation Technology

− Antigen Sandwich Design Increases

Sensitivity− Can Detect Antibodies Between 3-8

Weeks Earlier Than Other 2nd

Generation Rapid Tests− 100% Sensitivity − 99.7% Specificity (few false positives)

Cost Savings

– Because Trinity manufactures so many Rapid HIV Tests worldwide, we are able to do so at a lower cost, passing these savings on to our customers.

– Lower cost = more patients tested!

Common Features of Rapid Tests

Positives are presumptive and have to be confirmed by confirmatory test

CLIA WAIVER

FDA restrictions also require that any facility planning to perform rapid tests must have a quality assurance plan – step-by-step activities that ensure testing is carried out correctly, results are accurate, and mistakes are found and corrected

Trinity has produced a document; “Uni-Gold Quality Control Guidelines” which can be used for this purpose.


(For complete instructions please refer to the Uni-Gold™ Recombigen® HIV package insert)

Uni-Gold™ Recombigen® HIV Test Procedure

Uni-Gold™ HIVProduct Information

Kit Contents:a) Each kit contains 20 Test Devices b) Wash Reagent (5.0 ml)c) 20 Pipettesd) 25 Fingerstick Pipettese) 20 Subject Information Leafletsf) Package Insert

Always refer to the Directional Insert

Uni-Gold™ HIV Assay Procedure

• Remove the required number of Uni-Gold™ Recombigen® HIV devices from their pouches.• It is not recommended to perform more than 10 tests simultaneously.


Lay the devices on a clean flat surface.

Draw up adequate sample to the first gradation on the pipette (serum, plasma or venipuncture whole blood)using one of the disposable pipettes supplied.

Uni-Gold™ HIV Assay Procedure (serum, plasma, or WB)


• Holding the pipette vertically over the sample port, add one (1) free falling drop of sample (approx. 50µl) and allow to absorb into membrane. • Do not add full volume of pipette.


Add Four Drops of Wash Solution


Read test after 10 minutes but

no more than 12 minutes

following the addition of the patient sample

and wash solution.

Uni-Gold™ HIV Fingerstick Procedure

•Select puncture site and clean with Alcohol Wipe (Dry)

•Puncture with a sterile lancet just off the center of the finger

•Wipe away the first drop of blood with a sterile gauze pad


•Holding the collection device horizontally, place the tip of the device into the sample. DO NOT squeeze the bulb at any time during collection

•Maintain this position until the flow of sample into the collection device has stopped (massage if needed, do not excessively squeeze the finger).

The device fills by capillary action.

•Collect the sample until it reaches the black line on the collection device


•Hold the collection device vertically (1 inch) over the sample port and squeeze the bulb until the sample is fully discharged into the sample port.•If the Collection device does not fully dispense, cover holes adjacent to the black line on the device and repeat the previous step.•Allow the sample to absorb into the sample port pad (Full Red Color)


Read test after 10 minutes but

no more than 12 minutes

following the addition of the patient sample

and wash solution.

Interpretation

Control Line Area

Test Line Area

Sample Port

For a CLIA waived test result to be valid, there must be a control line present and full red color in the sample port

Moderately Complex Environment

When using with serum or plasma, color will not

appear in the sample port

CLIA Waived Environment

When using with fingerstick whole blood, red color must appear in the sample port for the test to be valid

Uni-Gold™

TRINITYBIOTECH

HIV

Control

Test

Sample

Interpretation

Uni-Gold™

TRINITYBIOTECH

HIV

Control

Test

Sample

Interpretation

Preliminary Positive Test Result (+)

A line of any intensity at the control region and the test

region indicates a preliminary positive result.

There is full red color in the sample port.

Negative (Non-Reactive) Test Result (-)

A line of any intensity at the control region only indicates a

negative result

There is full red color in the sample port.

OR

Interpretation

Any intensity of color is considered to be a “valid line”

Both of these tests are considered “preliminary positive” even though the intensity of the lines vary

Interpretation (CLIA Waived)

Invalid Results

1. Sample port does not have full redcolor

2. No control line

3. No control line

1 2 3

Interpretation

All “Invalid” results should be repeated in duplicate with newdevices

All “Reactive” results should be reported as “Preliminary Positive” and followed up with a confirmatory test

All “Non-Reactive” (Negative) should be reported as “Negative”

Performance

Performance Serum Plasma Whole Blood (Venipuncture)

Sensitivity 100%

95% CI =99.5- 100.0%

100%

95% CI =99.5 – 100.0%

100%95% CI =99.5 – 100.0%

Specificity 99.7%

95% CI= 99.4-99.9%

99.8%

95% CI=99.4-99.9%

99.7%

95% CI=99.4%-99.9%

Uni-Gold™ HIV QC Performance

“When do I need to run controls?”

– Have I ran External Controls?– Has Anyone ran External Controls with this Lot Number?– Has Anyone ran External Controls with this Shipment?– Have the storage temperatures been acceptable?– Am I in compliance with our Quality Assurance Guidelines?

If the answer to any of the above is “No”, you need to run the QC

Uni-Gold QC Determination

When using with Uni-Gold External Kit Controls, the sample port will not have full red color. QC Determination is valid without the full red color in the sample port.

Uni-Gold Fingerstick Procedure

When using with fingerstick whole blood, full red color must appear in the sample port for the test to be valid

Uni-Gold™

TRINITYBIOTECH

HIV

Control

Test

Sample

Uni-Gold™ HIV QC Performance

Uni-Gold™

TRINITYBIOTECH

HIV

Control

Test

Sample

Trinity Uni-Gold™ Recombigen® HIV

Questions?

trinity uni gold hiv presentation for tx

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