laboratory name anand diagnostic laboratory, anand …€¦ · test method specification against...

S.No Discipline Materials or Productstested

Component,parameter orcharacteristic tested /Specific TestPerformed / Tests ortype of testsperformed

Test Method Specification againstwhich tests are performed and / orthe techniques / equipment used

%CV

Permanent Facility

1 CLINICALBIOCHEMISTRY

Serum Cholesterol VLDL Calculation NA


Serum/Li- HeparinPlasma/K2 EDTAPlasma

Apolipoprotein B PEG immunoturbidimetric 16.7


24 Hour Urine Electrolyte Potassium Indirect Potentiometry 1.3


24 Hour Urine Electrolyte Sodium Indirect Potentiometry 1.4


24 Hour Urine Electrolyte Chloride Indirect Potentiometry 1.2


24 HR / Random Urine Creatinine Enzymatic 0.8


24 Hr Urine Uric Acid Uricase/Peroxidase 1.7


24 Hr Urine/Random Microalbumin PEG-enhanced immunoturbidimetric 5.5


CSF/Urine Total Protein Dye Binding 11.1

This is annexure to 'Certificate of Accreditation' and does not require any signature.

Laboratory Name ANAND DIAGNOSTIC LABORATORY, ANAND TOWER, #54, BOWRING HOSPITALROAD, SHIVAJI NAGAR, BENGALURU, KARNATAKA, INDIA

Accreditation Standard ISO 15189:2012

Certificate Number MC-2388 Page No. : 1 / 34

Validity 28/10/2019 to 27/10/2021 Last Amended on -




%CV


EDTA Plasma Lactate Lactate oxidase, colorimetric 3.4


EDTA Plasma Lactate Lactate oxidase to pyruvate andhydrogen peroxide

2.2


EDTA Whole Blood Glycosylated Hb HPLC 3.2


Heparin/ EDTA Plasma Ammonia Enzymatic 10.3


Serum Bicarbonate(Co2) Enzymatic 6.8


Serum CPK Total NAC activated 3.7


Serum Albumin BCG Dye Binding 1.7


Serum Total Iron BindingCapacity

Sequential release and uptake ofiron

1.7


Serum UIBC Ferene 14.4









%CV


Serum Acid Phosphatase Naphthol Phosphate Substrate.Hillman’s Kinetic

13.1


Serum Calcium – Ionized Ion Selective Electrode 5.8


Serum eGFR Calculated using CKD-EPI formula NA


Serum /LI- HeparinPlasma

Direct LDL Elimination/catalase 5.1


Serum / LI- HeparinPlasma/ Fluoride, K2EDTA, CSF

Glucose, (FBS / PPBS /RBS / GTT)

Hexokinase 1.8


Serum / EDTA/LI-Heparin Plasma

Direct HDL Elimination/catalase 2.7


Serum / HeparinPlasma

Alkaline Phosphatase Modified IFCC 3.1


Serum / HeparinPlasma

Cholesterol Total Enzymatic 3.1


Serum / Li HeparinPlasma

Total Bilirubin Vanadate oxidation 6.1









%CV


Serum / LI- HeparinPlasma

Transferrin Calculated NA



Direct Bilirubin Vanadate oxidation 4.6



LDH (Lactatedehydrogenase)

Lactate/NAD 2.1



Lipase Colorimetric rate 8.9


Serum /EDTA Plasma Lithium Colorimetric rate 9.4



Calcium Arsenazo III 4.8



SGPT (ALT) (Alanineamino transferase)

Modified IFCC (WITH P5P) 5.5



Apolipoprotein A-1 PEG immunoturbidimetric 3.9


Serum /Li- HeparinPlasma

Electrolyte Chloride Indirect Potentiometry 1.5









%CV



Electrolyte Potassium Indirect Potentiometry 1.8



Amylase Ethylidene Blocked-pNPG7 3.8



Cholinesterase Butyryl thiocholine/5-thio-2-nitrobenzoate

9.4



Creatinine Enzymatic 2.2



Apolipoprotein B PEG immunoturbidimetric 5.9



SGOT (AST)(Aspartate aminotransferase)

Modified IFCC (WITH P5P) 4.8



Electrolyte Sodium Indirect Potentiometry 1.2



GGTP (Gammaglutamyltranspeptidase)

Modified IFCC 4.5



Inorganic Phosphorous Phosphomolybdate/UV 4.1









%CV



Iron Ferrozine 2.7



Lipoprotein (a) Immunoturbidimetry 4.7



Magnesium Xylidyl Blue 6.2


Serum/ HeparinPlasma

AngiotensinConvertingEnzyme

Enzymatic 9.2



CRP (C ReactiveProtein)

Latex enhancedimmunoturbidimetric

8.3



Urea Nitrogen Urease with GLDH 3.3


Serum/Body Fluids Adenosine deaminase Enzymatic 12.3


Serum/Li HeparinPlasma

Protein (Total) Biuret 2.6


Serum/Li- HeparinPlasma

Uric Acid Uricase/Peroxidase 1.4









%CV



Triglycerides GPO 1.1



Triglycerides GPO, Trinder without serum blank 2.1


Serum/Lithium /HeparinPlasma

Albumin BCG Dye Binding 1.9


Serum/Lithium /HeparinPlasma

Amylase Ethylidene Blocked-pNPG7 1.3


Serum/Lithium HeparinPlasma

CPK Total Enzymatic 6.2



Electrolyte Chloride Indirect Integrated MultisensorTechnology (IMT)

0.9



Electrolyte Potassium Indirect Integrated MultisensorTechnology (IMT)

0.5



Electrolyte Sodium Indirect Integrated MultisensorTechnology (IMT)

0.8



LDH (Lactatedehydrogenase)

Lactate / NAD 0.9









%CV



Lipase Colorimetric rate 2.7



Magnesium Xylidyl Blue 2.2



SGOT (AST)(Aspartate aminotransferase)

Modified IFCC 8.1



SGPT (ALT) (Alanineamino transferase)

Modified IFCC 5.6



Calcium Arsenazo - Colorimetric 1.5



Cholesterol Colorimetric: cholesterol esteraseand cholesterol oxidase conversionfollowed by a Trinder endpoint

1.1



Creatinine Jaffe, alkaline picrate, kinetic withblank rate correction

2.3



Direct Bilirubin Vanadate oxidation 6.9



GGTP Modified IFCC 3.8









%CV



Inorganic Phosphorous Phosphomolybdate 2.9



Total Bilirubin Vanadate oxidation 1.3



Total Protein Biuret 1.3



Uric Acid Uricase/Peroxidase 1.3


Serum/Lithium HeparinPlasma/EDTAPlasma/Sodiumfluoride plasma

Glucose, (FBS / PPBS /RBS / GTT)

Hexokinase 1.2


Serum/Lithium HeparinPlasma/Urine

Urea Nitrogen Urease with GLDH 3.4


Serum/Urine Osmolality Vapor Pressure 4.2


Urine Calcium Arsenazo III 3.1


Urine Urea Nitrogen Urease with GLDH 2.3









%CV


Urine Inorganic Phosphorous Phosphomolybdate/UV 6.9


Urine Magnesium Xylidyl Blue 9.4

84 CLINICALPATHOLOGY

Semen Automated withAnalyzer

A. Macroscopy: I. Physical: a.Volume b. Viscosity c. liquefaction.II.Chemical: a. pH b. FructoseIII.Automated Analysis: a. SpermConcentration b. Morphology c.Motility B. Microscopy: I. Vitality II.Agglutination III. Other cells

NA


Stool Stool Occult Blood Standard Guaiac Method NA


Urine Pregnancy Test Rapid membrane chromatography NA


Urine Routine Analysis a).Protein

Chemical automated stripreader/manual method(automated/Sulfosalicylic acidmethod)

NA


Urine Routine analysis b)Sugar

Automated/strip (GOD – POD) /Benedicts method

NA


Urine Routine Analysis c). pH automated / litmus paper NA









%CV


Urine Routine Analysis d). SpGravity

Automated /Urinometer NA


Urine Routine Analysis e).Blood

Automated NA


Urine Routine Analysis f).Bilirubin

Automated NA


Urine Routine Analysis g).Bile salts

Sulfur powder NA


Urine Routine Analysis h).Bile pigment

Fouchets NA


Urine Routine Analysis i).Urobilinogen

Automated / Ehrlich reagent test NA


Urine Routine Analysis j).Ketone bodies

Automated / Rothera's test NA


Urine Routine Analysis k).Ascorbic acid

Automated NA


Urine Routine Analysis l).Nitrite

Automated NA









%CV


Urine Routine Analysis m).Leukocytes

Automated NA


Semen SemenAnalysis(ManualMethod)

A. Macroscopy: I. Physical: a.Volume b. Viscosity c. liquefaction.II.Chemical: a. pH b. Fructose B.Microscopy: I. SpermConcentration. II. Motility III.Morphology IV. Vitality V.Agglutination VI. Other cells

NA


Stool Occult Blood Immunochromatography NA


Stool Routine Analysis I. Physical : A. Macroscopy: i.Colour ii. Consistency II. Chemical:A. pH B. Occult blood C. ReducingSubstance III. Microscopy: A. CellsB. Parasites C. Fat globules

NA


Synovial Fluid AndOther Body Fluids

Crystals Sediment preparation andexamination under polarized light forcrystals

NA


Urine Phase ContrastMicroscopy ForDysmorphic RBCs

Centrifuged sediment Examinationunder phase contrast microscopy

NA


Urine RoutineAnalysis(Automated)

I. Macroscopy : 1. Colour 2.Appearance. II. Microscopy by FlowCytometry: 1. RBCs 2. WBCs 3.Epithelial Cells 4. Bacilli 5. Casts

RBC: 8.7WBC: 8.6Epithelial Cells: 17.1Bacilli: 8.4Cast: 24









%CV

106 CYTOPATHOLOGY

Fluid Aspirated FromSerosal Cavities. UrineCsf

Exfoliative Cytologicanalysis

Centrifuged deposit smears(cytocentrifuge for clear fluids likeurine and CSF) - Smear preparation(dry / wet fixed) - Stain (MGG / H&E/ PAP) - Microscopic evaluation orwhole slide imaging andinterpretative report includingpresence / absence of malignancy,with recommendations (if any)

NA

107 CYTOPATHOLOGY

Material Obtained FromPalpable / NonpalpableLesions In The Body

Fine Needle AspirationCytology

Obtaining representative material byaspiration / non-aspirationtechnique, either as a blindprocedure or under imagingguidance. - Preparation of smears(air dried / wet fixed) - Staining withMGG / H&E / PAP and any otherspecial stains as found necessary -Microscopic study of stained slide orwhole slide imaging andinterpretative report withrecommendations (if any)

NA

108 CYTOPATHOLOGY

Slide With Smear(Stained)

Second Opinion Slides Microscopic study or whole slideimaging and interpretative reportwith recommendations (if any)

NA









%CV

109 CYTOPATHOLOGY

Smear From ECTO /ENDO Cervix / Vagina

PAP Smear study-Conventional smear

Obtaining representative materialfrom the sites specified usingcytobrush and spatula Preparationand Fixation of smear - Stainingwith PAP stain / H&E (in case ofdried smears) - Microscopic study orwhole slide imaging andinterpretative report on lines ofBethesda System withrecommendations (if any)

NA

110 CYTOPATHOLOGY

Smear From ECTO /ENDO Cervix / Vagina

PAP Smear study-Liquid based cytology

Obtaining representative materialfrom the sites specified usingcytobrush. Preparation and Fixationof smear in Preserve Cyt-C.Process in ThinPrep processor.Staining with PAP stain / H&E (incase of dried smears) - Microscopicstudy or whole slide imaging andinterpretative report on lines ofBethesda System withrecommendations (if any)

NA

111 CYTOPATHOLOGY

Smear From Tissue Special Stains Appropriate special stains like PAS,AFB, etc. Microscopic study ofslides or whole slide imaging andinterpretative report withrecommendations (if any)

NA

112 HAEMATOLOGY &IMMUNOHAEMATOLOGY

Body Fluids Total count andDifferential cell count

Microscopy,Particle cell counter(Automated Flow cytometry), Celltype

NA









%CV


EDTA Blood Absolute Basophilcount

Automated Cell Counter: Flowcytometry method using semi-conductor laser

4.9


EDTA Blood Absolute Basophilcount

Automated Cell Counter: CoulterPrinciple.

52.8


EDTA Blood Absolute Eosinophilcount

Automated Cell Counter: Flowcytometry method using semi-conductor laser.

8.9


EDTA Blood Absolute Eosinophilcount


8.7


EDTA Blood Absolute Lymphocytecount


4.8


EDTA Blood Absolute Lymphocytecount


4.4









%CV


EDTA Blood Absolute Monocytescount


12.7


EDTA Blood Absolute Monocytescount

Automated Cell Counter: Flowcytometry method using semi-conductor laser / Coulter Principle.

9.1


EDTA Blood Absolute Neutrophilcount


2.6


EDTA Blood Absolute Neutrophilcount

Automated Cell Counter: Flowcytometry method using semi-conductor laser.

4.1


EDTA Blood Differential WBC countNeutrophils%Lymphocytes%Eosinophils %Monocytes%Basophils%Blasts%Promyelocytes%Myelocytes%Metamyelocytes%Bandforms%Lymphoidcells%


Neutrophils: 3.0,Lymphocytes:3.9,Eosinophils:8.8,Monocytes:8.5,Basophils:3.5









%CV


EDTA Blood Differential WBC countNeutrophils%Lymphocytes%Eosinophils%Monocytes%Basophils%Blasts % Promyelocytes %Myelocytes %Metamyelocytes %Band forms %Lymphoid cells

Coulter Principle 6.8, 5.9, 18.4, 12.5,51.1


EDTA Blood Hemoglobin Cell counter SLS method 1.2


EDTA Blood Immature plateletfraction

Fluorescence based FlowCytometry

2.9


EDTA Blood Mean corpuscularhemoglobin (MCH)

Calculated from hemoglobin andRBC count

1.1


EDTA Blood Mean corpuscularhemoglobinconcentration (MCHC)

Calculated from hemoglobin andHCT count

1.9









%CV


EDTA Blood Mean corpuscularvolume (MCV)

Particle cell counter Calculated fromRBC and HCT

1.5


EDTA Blood Nrbc Automated Cell Counter: Flowcytometry method using semi-conductor laser

NA


EDTA Blood Packed cell volume(PCV)

Calculated from RBC and MCV 1.1


EDTA Blood Platelet count Electrical impedence,Flowcytometry for optical plateletcount

5.4


EDTA Blood RDW - CV Calculated 1.1


EDTA Blood Reticulocyte count FlowCytometry 5.8









%CV


EDTA Blood Total leukocyte count Particle cell counter: Flow cytometrymethod using semi-conductor laser

2.8


EDTA Blood /Unstained Smears

Sudan Black B Cytochemical stain; Lightmicroscopy with interpretation

NA


EDTA Blood/Smears MPO Cytochemical Stain NA


Sodium Citrate Blood LupusanticoagulantScreeningand Confirmatory

Dilute Russel viper venom test 13.66.9


SodiumHeparin/Unstainedsmears

LAP Score Cytochemical stain NA


Blood/ Sodium Heparin Nitroblue TetrazoliumReduction test for workup of Primaryimmunodeficiency

Free radical mediated NBT dyereduction

NA









%CV


Body Fluids Differential count Neubauer chamber NA


Body Fluids Total leukocyte count Neubauer chamber NA


Bone Marrow Bone marrow trephinebiopsy

Processing of tissue, paraffin block,H&E and other relevant stain onsections and microscopy

NA


Bone Marrow Smears /Aspirate

Bone marrow slidesstudy

Staining with MGG stain and otherrelevant stains and microscopicevaluation

NA


Citrate Blood Activated Partialthromboplastin time

Photo Optical clot detection method 3.6


Citrate Blood Activated Partialthromboplastin time

Clot detection (manual method) NA









%CV


Citrate Blood Activated Protein CResistance

Clot detection 26.9


Citrate Blood Mixing studies Coagulometer assisted manualmethod

NA


Citrate Blood Prothrombin time Quicks method (automated) - PhotoOptical clot detection method

7.4


Citrate Blood Prothrombin time Clot detection manual method NA


Citrate Plasma Anti Thrombin III Chromogenic 19.3


Citrate Plasma Factor VIII Clot detection 12.9









%CV


Citrate Plasma Protein C Chromogenic 12.6


Citrate Plasma Protein S Immunoturbidimetric 10.7


Citrate Plasma Von Willibrand factorantigen

Immunotubidimetric 5.9


EDTA Blood Blood group and Rhtyping

Agglutination Gel Method (Solidphase)

NA


EDTA Blood Coombs test – Direct Direct agglutination’ Gel method(solid phase)

NA


EDTA Blood DU test Gel method NA









%CV


EDTA Blood ESR Red cell aggregation by Kineticphotometry

8.5


EDTA Blood ESR Westegren method NA


EDTA Blood G6PD Quantitative UV kinetic 17.5


EDTA Blood Hemoglobin Photometric method 0.8


EDTA Blood Mean corpuscularhemoglobin (MCH)

Calculated from hemoglobin andRBC count

1.2


EDTA Blood Mean corpuscularhemoglobinconcentration (MCHC)

Calculated from hemoglobin andHCT count

1.3









%CV


EDTA Blood Mean corpuscularvolume (MCV)

Derived from RBC histogram 0.5


EDTA Blood Microfilaria parasite Microscopy, QBC, Wet mountpreparation and Knott'sconcentration method

NA


EDTA Blood Nrbc Coulter Principle NA


EDTA Blood Packed cell volume(PCV)

Electrical impedance 2.9


EDTA Blood Peripheral Smear Automated Smear andStain/Microscopy

NA


EDTA Blood Platelet count Coulter Principle 2.7









%CV


EDTA Blood RBC count Electrical impedance 2.1


EDTA Blood RBC count Coulter Principle 1.1


EDTA Blood RDW - CV Calculated 1.3


EDTA Blood Reticulocyte count Supravital staining and smear study NA


EDTA Blood Sickling test Incubation with E.Coli induceshypoxic state in vitro, andmicroscopic examination

NA


EDTA Blood Total leukocyte count Coulter Principle 2.4









%CV


EDTA Blood & Serum HAMS test Acidified serum lysis NA


EDTA Blood / Smear Malarial parasite withindex

Fluorescence based detection –Parasight (BD) and QBC

NA


EDTA Blood / Smear Malarial parasite withindex

Stained smear microscopy NA


EDTA Blood / Smear Peripheral smearexamination

Manual staining and microscopy NA


EDTA Blood/Serum Anti A Titre Column Agglutination NA


EDTA Blood/Serum Anti B Titre Column Agglutination NA









%CV


Heparin Blood Osmotic fragility By lysis in hypotonic saline NA


Serum Coombs test – Indirect Agglutination Gel method (solidphase) Manual Method

NA


Serum Cryoglobulins Screening manual method NA


Serum & EDTA Blood Cold agglutinins Screening manual method NA


Whole Blood WithoutAnticoagulants

Clot Retraction Macfarlane’s method NA









%CV

188 HISTOPATHOLOGY

Biopsy In FormalinKidney/Liver / LymphNode/Bone MarrowBiopsy Other ExcisedOr Biopsied TissuesFrom Various OrgansAnd Tissues Of TheBody.Foetus/Abortus

Histopathology report Fixation of tissue, Gross descriptionand sampling of representativetissue, processing through gradedchemicals, paraffin impregnationand blocks, microtomy, stain withH&E and other appropriate specialstains. Microscopic study of slidesor whole slide imaging andinterpretative report withrecommendations (if any)

NA

189 HISTOPATHOLOGY

Paraffin Block FromProcessed Tissue

Second Opinion ofHistopathology report

Microtomy, staining with H&E andother appropriate special stains,microscopic study or whole slideimaging and interpretative reportwith recommendations (if any)

NA

190 HISTOPATHOLOGY

Section From ParaffinEmbedded Tissue

Specific histochemicalstains (ancillary to H&Estain)

Appropriate special stains like PAS,MAT, Jones etc. Microscopic studyof slides or whole slide imaging andinterpretative report withrecommendations (if any)

NA

191 HISTOPATHOLOGY

Slide With Stained /Unstained Section

Second Opinion ofHistopathology report

Microscopic study of stained slide orwhole slide imaging andinterpretative report withrecommendations (if any)

NA

192 HISTOPATHOLOGY

Unfixed Tissue Biopsy Frozen Section Cryostat sections, staining with H&Eand Toluidine Blue, Microscopicstudy and Interpretative report

NA

193 MICROBIOLOGY &SEROLOGY

Bacterial/Yeast/MouldsPathogens

Identification MALDI-TOF NA









%CV


Fungal Pathogens(Yeasts)

Fungal Identificationand anti fungalSusceptibility Testing

Identification by colonycharacteristics and microscopy,manual/automated method

NA


Bacterial Pathogens Antibiotic SusceptibilityTesting

1.Automated identification &sensitivity 2.Manual sensitivity byKirby-Bauer disc diffusion method

NA


Bacterial Pathogens Identification Identification by colonycharacteristics and microscopy

NA


BLOOD in CultureBroth,Pus, Swab, BodyFluids, Tissue, OtherFluids, Tips (ET, CVP)

Anaerobic culture Culture in Robertson Cooked MeatMedium Incubation in Anaerobic jarIdentification using anaerobiccassette Vitek 2 Compact

NA


Blood, Sputum, BodyFluids, CornealScrapings/ Button,Urine, Tips (ET, CVP),Nail, Skin and Hair,Inoculated Plates,Stool, Media

Fungal Culture Culture on Sabaraud DextroseAgar/ DTM/Chromagar

NA


Blood/Bone Marrow inCulture Broth

Aerobic Culture Culture in liquid broth(automated) /manual blood bottles withsubculture on basic media plates.

NA









%CV


CSF Cryptococcus India Ink Preparation NA


CSF Modified VDRL Flocculation NA


CSF, Pus, Sputum,Bronchial Wash, BodyFluids, Tissue, BoneMarrow Aspirate,Biopsy, EndometrialTissue Aspirate,Lymphnode, Semen)

Mycobacterium TBCulture

Culture: a. Culture on LJ slopes b.Rapid culture by Colorimetry c. MPT64 Rapid cardimmunochromatography

NA


CVP TIP Aerobic Culture Culture on basic media plates NA


Hair, Nail, SkinScrapings, Sputum,Body Fluids, CornealScrapings, Urine, Pus,Tips, ET Secretions,Tissue, Bone)

Fungal Smear(KOHWet Mount/ Gramstain)

Light Microscopy NA









%CV


Pus, Body Fluids,Sputum, Swabs,Corneal Scrapings/Button,Tissues,Semen,Inoculated Plate, OtherCatheter Tips

Aerobic Culture Culture on basic media plates. NA


Samples to be tested(Respiratory samples,Swabs)

a. Modified Z N Stainb.AuramineFluorescence c. Gramstain

Light Microscope/ FluorescentMicroscope

NA


Serum Brucella Antibody Tube Agglutination NA


Serum Heterophile antibodiesfor IM

Slide Agglutination NA


Serum Typhoid IgM Antibody Immunochromatography NA


Serum Weil Felix Tube Agglutination NA









%CV


Serum WIDAL Tube Agglutination NA


Serum / CSF Treponema Pallidumhemagglutination(TPHA)

Hemagglutination NA


Serum / CSF RPR Slide Flocculation NA


Serum/ Plasma(EDTA,Heparin, Citrate)

Chikungunya IgMAntibody

Rapid ChromatographicImmunoassay

NA


Sputum / Bronchialwash

Calcofluor White Fluorescent Microscopy NA


Sputum, Throat swab,Pus, Cornealscrapings, Body fluid,Tissue, Urethraldischarge, Genitaldischarge, Urine,Prepared smear, ETsecretions

Gram Stain Light Microscopy NA









%CV


Stool Aerobic Culture Culture on XLD agar plates/SeleniteF broth & alkaline peptone water /TCBS agar plate

NA


Stool Hanging drop andMono stain withsafranin

Light Microscope NA


Stool Calprotectin Immuno chromatography NA


Stool ClostridiumdifficileGDH,Toxin Aand Toxin B

Immuno chromatography NA


Throat swab Albert Stain Light Microscopy NA


Urine, BAL, ETSecretion

Aerobic Culture SemiQuantitative Culture on basicmedia plates

NA









%CV


Urine, Pus, Sputum,Bronchial wash, Bodyfluids, Tissue, ETsecretions, FNAC,Surgical biopsyaspirate, Prepared andStained/ Unstainedsmear slide

a. AuramineFluorescence b. ZiehlNeelsen Method

Fluorescent Microscopy / LightMicroscopy

NA






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