Accreditation Standard ISO 15189:2012 - AnandLab · Rate Nephlometry 50 IU/mL to 1600 IU/mL 5.1 36 CLINICAL BIOCHEM ISTRY Serum Pregnancy Associated Plasma Protein A (PAPPA) Trace

S.No Discipline Product / Material ofTest

Specific TestPerformed

Test Method Range of Testing/Limits of Detection

%CV

Permanent Facility

1 CLINICALBIOCHEMISTRY

Dry Blood Spot CongenitalHypothyroidism

Fluorimetry 2.8 microIU/mL to 76.3microIU/mL

11.1


24 hr urine Metanephrines LC-MS/MS 49.5 ng/mL to 5000ng/mL

9.7


Dry Blood Spot Acetylcarnitine (C2) LC-MS/MS 2 micromol/L to 300micromol/L

5.4


Dry Blood Spot Alanine LC-MS/MS 50 micromol/L to 1200micromol/L

4.0


Dry Blood Spot Arginine LC-MS/MS 10 micromol/L to 200micromol/L

4.8


Dry Blood Spot Biotinidase deficiency Fluorimetry 11.1 U to 374.9 U 13.4


Dry Blood Spot Butyrylcarnitine (C4) LC-MS/MS 0.2 micromol/L to 20micromol/L

13.7


Dry Blood Spot Citrulline LC-MS/MS 5 micromol/L to 550micromol/L

15.4


Dry Blood Spot Cystic Fibrosis Fluorimetry 0.7 µg/L to 340.3 µg/L 11.6


Dry Blood Spot Decanoylcarnitine(C10)

LC-MS/MS 0.12 micromol/L to 2micromol/L

9.7

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

Laboratory Name NEUBERG ANAND REFERENCE LABORATORY, ANAND TOWER, #54, BOWRINGHOSPITAL ROAD, BENGALURU, KARNATAKA , INDIA

Accreditation Standard ISO 15189:2012

Certificate Number MC-2784 Page No. : 1 / 46

Validity 22/06/2018 to 21/06/2020 Last Amended on 09/07/2019




%CV


Dry Blood Spot Dodecanoylcarnitine(C12)

LC-MS/MS 0.12 micromol/L to 1.5micromol/L

6.4


Dry Blood Spot Free carnitine (C0) LC-MS/MS 2 micromol/L to 250micromol/L

12.6


Dry Blood Spot G6PD(Glucose -6-phosphatedehydrogenase

Fluorimetry 0 microIU/gHb to 12.5microIU/gHb

6.1


Dry Blood Spot Galactosemia(Galactose)

Flourimetry 0 mg/dL to 65.6 mg/dL 13.5


Dry Blood Spot Glutarycarnitine(C5DC)


13.0


Dry Blood Spot Glycine LC-MS/MS 50 micromol/L to 750micromol/L

9.8


Dry Blood Spot Hexanoylcarnitine (C6) LC-MS/MS 0.12 micromol/L to 6micromol/L

7.4


Dry Blood Spot Hydroxyisovalerylcarnitine (C5OH)


14.0


Dry Blood Spot Isovalerylcarnitine (C5) LC-MS/MS 0.2 micromol/L to 25micromol/L

12.5


Dry Blood Spot Leucine LC-MS/MS 50 micromol/L to 3000micromol/L

2.5









%CV


Dry Blood Spot Methionine LC-MS/MS 5 micromol/L to 350micromol/L

10.4


Dry Blood Spot Myristoylcarnitine (C14) LC-MS/MS 0.12 micromol/L to 7micromol/L

9.4


Dry Blood Spot Octanoylcarnitine (C8) LC-MS/MS 0.12 micromol/L to 6micromol/L

2.9


Dry Blood Spot Ornithine LC-MS/MS 50 micromol/L to 500micromol/L

8.6


Dry Blood Spot Palmitoylcarnitine(C16)


6.3


Dry Blood Spot Phenylalanine LC-MS/MS 10 micromol/L to 500micromol/L

1.5


Dry Blood Spot Propionylcarnitine (C3) LC-MS/MS 0.2 micromol/L to 100micromol/L

6.9


Dry Blood Spot Stearoylcarnitine (C18) LC-MS/MS 0.12 micromol/L to 20micromol/L

5.7


Dry Blood Spot Tyrosine LC-MS/MS 50 micromol/L to 1000micromol/L

5.6


Dry Blood Spot Valine LC-MS/MS 30 micromol/L to 500micromol/L

1.1









%CV


EDTA plasma Cyclosporine LC-MS/MS 15 ng/mL to 2500ng/mL

8.8


EDTA Plasma Renin CLIA 1.96 µIU/mL to 500µIU/mL

6.7


EDTA Plasma Tacrolimus LC-MS/MS 1 ng/mL to 50 ng/mL 7.7


K2/ K3 EDTA plasma ACTH (AdrenoCorticotropic Hormone)

Chemiluminescence 5 pg/mL to 1,250pg/mL

3.8


Serum Anti Streptolysin O(ASLO)

Rate Nephlometry 50 IU/mL to 1600IU/mL

5.1


Serum Pregnancy AssociatedPlasma Protein A(PAPPA)

Trace technology 0.004 IU/L to 90 IU/L 3.7


Serum IgG4 Particle enhancedimmuno Nephlometry

1.4 g/L to 46 g/L 5.5


Serum 25 hydroxy Vitamin Dtotal

LC-MS/MS 2.5 ng/mL to 160ng/mL

10.8


Serum Free Beta HCG Time resolvedimmunofluroscenceassay

0.16 IU/L to 50000

IU/L

3.3


Serum Protein ElectrophoresisAlpha 2

CapillaryElectrophoresis

0 g/dL to 0.94 g/dL 5









%CV


Serum Protein ElectrophoresisBeta


0 g/dL to 1.6 g/dL 8.5


Serum ProteinElectrophoresisAlpha 1


NA 9.6


Serum Androstenedione LC-MS/MS 0.100 ng/mL to 10ng/mL

16.7


Serum Free Triiodothyronine(FT3)

Chemiluminescence 0.2 pg/mL to 20.0pg/mL

1.5


Serum TSH ChemiluminescentMicroparticleImmunoassay

0 to 100 mIU/mL 6.6


Serum Voriconazole LC-MS/MS 75.15 µg/mL to10019.52 µg/mL

15.0


Serum /Lithium Heparinplasma

Thyro peroxidaseantibody (anti TPO)

Chemiluminescence 28 U/mL to 1300 U/mL 10.6


Serum/ Li Heparinplasma/ K3 EDTAplasma

Cortisol Chemiluminescence 0.5 µg/dL to 75 µg/dL 10.7


Serum/ LithiumHeparin, K3 EDTA,Potassium OxalatePlasma

DHEA Sulphate LCMS/MS 100 ng/mL to 10562ng/mL

7.7


Whole blood Lead Electrochemical (ASV) 3.3 µg/dL to 65 µg/dL 6..1









%CV


EDTA plasma Everolimus LC-MS/MS 2 ng/mL to 50 ng/mL 9


Serum 25 Hydroxy Vitamin D3 LC-MS/MS 2.343 ng/mL to 150ng/mL

13.4


Serum 25 Hydroxy Vitamin D2 LC-MS/MS 2.343 ng/mL to 150ng/mL

13


Serum 11 Deoxy Cortisol LC-MS/MS 0.100 ng/mL to10ng/mL

9.6


Serum Testosterone (Total) LC-MS/MS 20 ng/dL to 2000 ng/dL 13.1


Serum 17 OH Progesterone LC-MS/MS 0.100 ng/mL to10ng/mL

10.6


CSF Aminoacids disordersby TLC

Manual Qualitative NA


Dry Blood Spot Congenital adrenalhyperplasia(CAH)17OHP

Fluorimetry 0.3 to 275.9 16.8


EDTA Plasma Aminoacids disordersby TLC



Urine Alcaptonuria tests Manual Qualitative NA









%CV


Urine Aminoacids disordersby tlc



Urine Dinitrophenylhydrazine(dnph) test



Urine Ferric chloride test Manual Qualitative NA


Urine Methylmalonic acid test Manual Qualitative NA


Urine MPS screening Manual Qualitative NA


Urine Nitrosonaphthol test Manual Qualitative NA


Urine Reducing Substancetest



24 hr urine VMA (Vanillyl MandelicAcid)

ColumnChromatography

1.9 mg/L to 300 mg/L 14.7


24 hr urine 5 HIAA(5 Hydroxyindole acetic acid)

ColumnChromatography

0.9mg/L to 200mg/L 13.4


Citrate plasma D Dimer ELFA 45 ng/mL to 10000ng/mL

7.6









%CV


Citrate plasma, EDTAPlasma

Fibrinogen Rate Nephelometry 59 mg/dL to 940 mg/dL 12.9


CSF/Serum CSF OligoclonalBanding

Iso-electric focusing Qualitative(NA) NA


EDTA whole blood Glycosylated Hb CapillaryElectrophoresis

4 % to 14.7 % 3.2


Serum Inhibin A Chemiluminescence 1 pg/mL to 1500 pg/mL 4.2


Serum Erythropoietin ChemiluminescentCompetitiveImmunoassay

1 mIU/mL to 750mIU/mL

8.4


Serum 25 hydroxy vitamin Dtotal

Chemiluminescence 4 ng/mL to 150 ng/mL 10.6


Serum Unconjugated Estriol ChemiluminescentCompetitiveImmunoassay

0.07 ng/mL to 11.2ng/mL

9.0


Serum Carbamazepine Chemiluminescence 1.25 µg/mL to 20µg/mL

3.4


Serum ProteinElectrophoresisAlbumin


0 g/dL to 5.2g/dL 2.5


Serum ProteinElectrophoresisGamma


0g/dL to 3.1g/dL 4.6









%CV


Serum Vitamin D Total Chemiluminescence 4.20 to 150.0 ng/mL 6.1


Serum Alpha I antitrypsin Rate Nephelometry 0.162 g/L to 5.2 g/L 6.0


Serum Anti Mullerian Harmone Chemiluminescence 0.02 ng/mL to 24ng/mL 10.1


Serum BHCG ChemiluminescentMicroparticleImmunoassay

0 to 15,000 mIU/mL 5.6


Serum Follicle StimulatingHormone

Chemiluminescence 0.30 to 200.0 mIU/mL 4.1


Serum Free Thyroxine (FT4) Chemiluminscence 0.1 to 12.0 ng/dL 3.13


Serum Growth Hormone Chemiluminescenceimmunometric assay

0.05 ng/mL to 40ng/mL

6.1


Serum IgG Nephelometry 140mg/dL to4600mg/dL

3.4


Serum Luteinizing Hormone Chemiluminescence 0.07 to 200.0 mIU/mL 3.6


Serum Progesterone Chemiluminescence 0.21 to 60.0 ng/mL 7.3









%CV


Serum Prolactin Chemiluminescence 0.30 to 200.0 ng/mL 3.1


Serum T3 (TotalTriiodothyronine)

Chemiluminescence 0.10 to 8.00 ng/mL 10.2


Serum T4 (Total thyroxine) Chemiluminescence 0.3 to 30.0 µg/dL 9.9


Serum / Heparin /EDTAPlasma/ Amniotic fluid

AFP (Alfa feto protein) Chemiluminescence 0.495 ng/mL to 520ng/mL

7.9


Serum / HeparinPlasma

soluble TransferrinReceptors (sTfR)

Particle enhancedimmuno nephlometricassay

0.14 mg/L to 4.4 mg/L 6.7



Complement C4 Rate Nephelometry 6 g/dL to 190 mg/dL 5.8



Complement C3 Rate Nephelometry 12 mg/dL to 410 mg/dL 4.0



Troponin I ChemiluminescentMicroparticleImmunoassay

0.01 to 50 ng/mL 4.5


Serum / LithiumHeparin, EDTA Plasma

Estradiol Chemiluminescence 11.8 pg/mL to 3000pg/mL

8.0


Serum / LithiumHeparin, EDTA Plasma

CA 19-9 Chemiluminescence 1.2 U/mL to 700 U/mL 9.8









%CV


Serum / LithiumHeparin, K3 EDTAPlasma

Immunoglobulin E (IgE) Chemiluminescence 1.5 IU/mL to 3000IU/mL

8.7


Serum / LithiumHeparin, SodiumHeparin, K2,K3 EDTAPlasma

25 Hydroxy Vitamin D ChemiluminescentMicroparticleImmunoassay

3.4 to 155.9 ng/mL 5.7


Serum /EDTA/ HeparinPlasma

Beta-2-Microglobulin Rate Nephelometry 0.18 mg/L to 5.8 mg/L 6.4


Serum /Lithium Heparin Luteinizing Hormone(LH)

Chemiluminescence 0.07 mIU/mL to 200mIU/mL

7.1



Anti - TG Chemiluminescence 15 U/mL to 500 U/mL 12.8



Prolactin Chemiluminescence 0.3 mIU/mL to 200mIU/mL

7.2



Follicle StimulatingHormone (FSH)


9.9


Serum, Urine Immunofixation Gel electrophoresis Qualitative NA


Serum/ EDTA,Heparin,Citrate plasma

Antibody to cycliccitrullinated peptide(Anti CCP)

Chemiluminescence 7 U/mL to 500 U/mL 6.8


Serum/ EDTA/HeparinPlasma

Haptoglobin Rate Nephelometry 0.26 g/L to 8.3 g/L 4.8









%CV


Serum/ EDTA/HeparinPlasma

IgA Rate Nephelometry 25mg/dL to 800mg/dL 5.7


Serum/ HeparinPlasma

Cystatin C Rate Nephelometry 0.23 mg/L to 8 mg/L 8.9


Serum/ HeparinPlasma

Ceruloplasmin Rate Nephelometry 0.07 g/L to 2.2 g/L 5.5


Serum/ Plasma/ Urine Free Lambda-LightChains

Rate Nephelometry 5 mg/L to 160 mg/L 10.9


Serum/ Plasma/ Urine Free Kappa-LightChains

Rate Nephelometry 5.9 mg/L to 190 mg/L 9.5


Serum/EDTA Plasma Aldosterone Chemiluminescence 0.97 ng/dL to 100ng/dL

11.2


Serum/EDTA Plasma Anti-Thyroglobulin Chemiluminescence 15 to 500 U/mL 5.1


Serum/Heparin Plasma Creatine Kinase MB Chemiluminescence 0.18 to 300.0 ng/mL 3.1


Serum/Heparin Plasma Rheumatoid Factor(RF/RA test)

Rate Nephelometry 10 IU/mL to 640 IU/mL 4.6


Serum/Heparin plasma/K2, K3 EDTA

Phenobarbital Chemiluminescence 5 µg/mL to 80 µg/mL 8.0









%CV


Serum/Heparinplasma/K2, K3 EDTA

Phenytoin Chemiluminescence 0.5 µg/mL to 40 µg/mL 7.2


Serum/Heparin/EDTAPlasma

Anti-ThyroidPeroxidase (TPO)

Chemiluminescence 28 to 1300 U/mL

4.4



IgM Rate Nephelometry 20mg/dL to 640mg/dL 8.8



Troponin I Chemiluminescence 0.006 to 30.0 ng/mL 3.7



Vitamin B12 Chemiluminescence 45 to 2000 pg/mL 7.5


Serum/Li Heparinplasma /K3 EDTAplasma

Testosterone Chemiluminescence 10 ng/dL to 1500 ng/dL 8.5


Serum/Li Heparinplasma/ K2,K3 EDTAplasma

Total Beta H C G(Human ChorionicGonadotropin)


13.6


Serum/Li Heparinplasma/K3 EDTAplasma

TSH (thyroidstimulating hormone)

Chemiluminescence 0.008 µIU/mL to 150µIU/mL

5.4



Ferritin Chemiluminescence 0.5 ng/mL to 1650ng/mL

7.3



Free T3 Chemiluminescence 0.2 pg/mL to 20 pg/mL 6.4









%CV



Total thyroxine (T4) Chemiluminescence 0.3 µg/dL to 30 µg/dL 4.5



CKMB Chemiluminescence 0.18 to 300 ng/mL 6.6



Free T4 Chemiluminescence 0.1ng/dL to 12 ng/dL 9.0



T3 (Total tri-iodothyronine)

Chemiluminescence 0.1 ng/mL to 8 ng/mL 7.1



Vitamin B12 Chemiluminescence 45 pg/mL to 2000pg/mL

8.9



Intact ParathyroidHormone

Chemiluminescence 6.3 pg/mL to 1900pg/mL

8.8



Progesterone Chemiluminescence 0.21 ng/mL to 60ng/mL

22.0



Valproic Acid Chemiluminescence 10 µg/mL to 200 µg/mL 4.9



Homocysteine Chemiluminescence 0.5µmol/L to 65 µmol/L 9.8



CEA(CarcinoembryonicAntigen)

Chemiluminescence 0.5 ng/mL to 100ng/mL

16.5









%CV



PSA (Free Hormone)(Prostate SpecificAntigen)


11.4



PSA (Prostate SpecificAntigen)


17.3



Folate Chemiluminescence 0.35 ng/mL to 24ng/mL

15.8


Serum/Li Heparinplasma/K3 EDTAplasma/Fluid

CA 125 Chemiluminescence 2 U/mL to 600 U/mL 7.0


Serum/Li Heparinplasma/Na citrateplasma /K3 EDTAplasma

Insulin chemiluminescence 0.5 mU/mL to 300mU/mL

8.1


Serum/LI- HeparinPlasma

SHBG (Sex HormoneBinding Globulin) Andcalculated freetestosterone

Chemiluminescence 2.00 nmol/L to 180nmol/L

5.4


Serum/LI-Heparin /K3EDTA Plasma

C-Peptide Chemiluminescence 0.05 ng/mL to 30ng/mL

10.1


Serum/Lithium Heparinplasma/ EDTA Plasma

Thyroglobulin Chemiluminescence 0.20 ng/mL to 300ng/mL

6.4


Serum/Lithium HeparinPlasma/EDTA Plasma

TSH (ThyroidStimulating Hormone)

Chemiluminscent 0.008 to 150.0 µIU/mL 5.3


Serum/LithiumHeparin/EDTA Plasma

Homocysteine Chemiluminescence 0.50 to 65.0 µmol/L 4.4









%CV


Serum/LithiumHeparin/EDTA Plasma

Total IgE Chemiluminescence 1.5 to 3000.0 IU/mL 2.9


Serum/LithiumHeparin/SodiumHeparin/EDTA Plasma

Estradiol (E2) Chemiluminescence 11.80 to 3000.0 pg/mL 6.0



Intact ParathyroidHormone

Chemiluminescence 6.3 to 2000.0 pg/mL 2.2



Testosterone Chemiluminescence 7.00 to 1500.00 ng/dL 8.2


Serum/Urine Cortisol Chemiluminescence 0.50 to 75.0 µg/dL

3.9


Serum/Urine Insulin Chemiluminescence 0.5 to 300.0 mU/L 3.3


Serum/Whole blood Folate Chemiluminscence 0.35 to 24 ng/mL 11.2


Stone/Calculus Kidney Stone Analysis FTIR NA NA


Urine Amphetamine Lateral flowimmunochromatography

Qualitative(NA) NA


Urine Morphine Lateral flowimmunochromatography

Qualitative(NA ) NA









%CV


Urine Protein Electrophoresis CapillaryElectrophoresis

Qualitative NA


Urine Bence Jones Proteins Gel Electrophoresis Qualitative NA


Urine Tetrahydro Cannabinol Lateral flowimmunochromatography

Qualitative(NA) NA


Urine Barbiturates Lateral flowimmunochromatography

Qualitative(NA) NA


Urine Benzodiazepines Lateral flowimmunochromatography

Qualitative(NA) NA


Urine Beta-2-Microglobulin Rate Nephelometry 0.18 to 5.8 mg/L 6.4


Urine Cocaine Lateral flowimmunochromatography

Qualitative(NA) NA


Urine Phencyclidine Lateral flowimmunochromatography

Qualitative(NA ) NA

169 GENETICS

Amniotic fluid Chromosome13/18/21/X/Y

Fluorescent insituHybridization

Interpretative < 5% NA

170 GENETICS

Amniotic fluid Di-George (TUPLE) Fluorescent insituHybridization


171 GENETICS

Amniotic fluid Praderwill /AngelmanSyndrome











%CV

172 GENETICS

Amniotic fluid William Syndrome Fluorescent insituHybridization


173 GENETICS

Amniotic fluid / Cordblood

Pre-natal diagnosis Culture with GTGBanding, SoftwareAided MicroscopicAnalysis

Interpretative NA

174 GENETICS

Bone marrow T(11;14) Mantle celllymphoma



175 GENETICS

Bone marrow aspirate Multiple MyelomaPanel(CDKN2C/CKS1B,DLEU1/DLAMP,P53/Cep17, IGH)



176 GENETICS

Bone marrow aspirate/PBL

E2A/PBX Fluorescent insituHybridization


177 GENETICS

Bone marrowaspirate/paraffin block

C-Myc Fluorescent insituHybridization


178 GENETICS

Bone marrowaspirate/PBL

JAK2BA Fluorescent insituHybridization


179 GENETICS


PDGFRB Fluorescent insituHybridization


180 GENETICS


4q12 Fluorescent insituHybridization


181 GENETICS


FGFR1 Fluorescent insituHybridization


182 GENETICS

Bone marrow (Heparin) Karyotype Analysis Unstimulated Culturewith GTG Banding,Software AidedMicroscopic Analysis

Interpretative NA

183 GENETICS

Bone marrow aspiratepost BMT

Chromosome 21/X/Y Fluorescent insituHybridization










%CV

184 GENETICS


IGH/MYC (8;14) ALL-L3 Burkitt’s Lymphoma



185 GENETICS


CLL ProfilerPanelD13S319/13qter/12 Centromere,p53/ATM Probe/ MYBDeletion (6q23)



186 GENETICS


RARA BreakapartProbe (AML-M3)



187 GENETICS


CBFß/MYH 11 Fluorescent insituHybridization


188 GENETICS


AML-1/ETO Fluorescent insituHybridization


189 GENETICS


MLL Fluorescent insituHybridization


190 GENETICS


TEL/AML 1 Fluorescent insituHybridization


191 GENETICS


PML/RARA Fluorescent insituHybridization


192 GENETICS

Bone marrow aspirate/Peripheral blood

MDS panel: del(5q);del(7q); del(20q); CEP8



193 GENETICS

Bone marrow aspirate/Peripheral blood

BCR/ABL 1 Fluorescent insituHybridization


194 GENETICS

Cultured stem cells intissue culture flask/petridish

Karyotype Analysis GTG Banding,Software AidedMicroscopic Analysis

Interpretative NA

195 GENETICS

Paraffin sections ALK –EML 4 Fluorescent insituHybridization


196 GENETICS

Paraffin sections EGFR Fluorescent insituHybridization










%CV

197 GENETICS

Paraffin sections HER-2 NEU Fluorescent insituHybridization


198 GENETICS

Peripheral blood Di-George (TUPLE) Fluorescent insituHybridization


199 GENETICS

Peripheral blood Praderwill /AngelmanSyndrome



200 GENETICS

Peripheral blood SRY Fluorescent insituHybridization

Qualitative(Interpretative < 5%)

NA

201 GENETICS

Peripheral blood William Syndrome Fluorescent insituHybridization


202 GENETICS

Peripheral blood(Heparin)

Karyotype Analysis Culture with GTGBanding, SoftwareAided MicroscopicAnalysis

Interpretative NA

203 GENETICS

Peripheral blood of newborn

Chromosome13/18/21/X/Y



204 GENETICS

Urine Bladder cancerP16 -9p21.3, cep 3/7 and 17chromosome



205 HAEMATOLOGY &IMMUNOHAEMATOLOGY

EDTA whole blood PNH Flow Cytometry NA NA


EDTA whole blood/Heparin whole blood

Double negative T cells(TCR alpha beta, CD4-CD8-)

Flow Cytometry Semi Quantitative NA









%CV


EDTA whole blood CD19 counts Flowcytometry usingCD19

Internal control cellsused as reference forgating/expression

NA


EDTA whole blood CD20 counts Flowcytometry usingCD20

Internal control cellsused as reference forgating/expression

NA


EDTA whole blood CD3 Counts Flow Cytometry 1.5 to 3000/mcL 18.6


EDTA whole blood CD4 Counts Flow Cytometry 1.5 to 3000/mcL 21.3


EDTA whole blood CD45 Counts Flow Cytometry 0 to 100000/mcL NA


EDTA whole blood CD8 Counts Flow Cytometry 6 to 1200 cells/mcL 18.1









%CV


EDTA whole blood Enumeration of B cells Flow Cytometry usingCD19

35cells/µL to900cells/µL

14.4


EDTA whole blood Enumeration of NKcells

Flow Cytometry usingCD56 and CD16


15.3


EDTA whole blood Enumeration of T cells Flow Cytometry usingCD3


21.7


EDTA whole blood Hemoglobin Variants-A


0.9 to 9% 0.2


EDTA whole blood Hemoglobin Variants-HbA2


0 to 12.2% 6.1


EDTA whole blood Reticulocyte Count Flow Cytometry 0.05% to 30% 5.8









%CV


EDTA whole blood Screening forhereditarySpherocytosis

Flow cytometry usingEosin 5 Maleimide

Qualitative(MFI ofcontrol and test used tocalculate results)

NA


EDTA wholeblood/Heparin wholeblood

CD18 for leucocyteadhesion defect

Flowcytometry usingCD18 and CD11b

Qualitative NA


EDTA Wholeblood/Heparin Wholeblood

Dihydrorhodamine testfor work up of Primaryimmunodeficiency

Flow Cytometry Qualitative NA









%CV


EDTA wholeblood/Heparin wholeblood/EDTA bonemarrow/ Heparin bonemarrow

Immunophenotyping fora. AcuteLeukemiaCD45, CD13,CD33, CD14, CD117,HLADR, TdT, CD34,SCD3, CD4,CD8,CD79Ampo,CD19, CD10, CD20,CD7, CD1A, cCD3,CD38, CD66c, CD5,CD56, CD16, CD64,CD36, CD2, CD41,CD61b. CLPD – CD45,CD3, CD4, CD8, CD5,CD19, CD20, CD23,CD10, FMC7, KAPPA,LAMBDA, CD79b,CD200, CD103,CD11c, CD1a, CD38,CD7, CD56, CD43,CD49d, CD25, CD123

Flow Cytometry Qualitative NA


EDTA wholeblood/peripheral wholeblood/bone marrowaspirate

CD34 (Stem Cell)Enumeration

Flow Cytometry 0 cells/µL to 2000cells/µL

16.6


Heparin blood Lymphocyte CrossMatch - CDC

Complementdependent cytotoxicity

Degree of cell lysis NA









%CV


Heparin blood Lymphocyte CrossMatch (Tcells/Bcellpopulation)

Flow Cytometry Semi Quantitative 6.0

226 HISTOPATHOLOGY

Fresh unfixed tissue insaline / Michelstransport medium

ImmunoflourescenceMicroscopyspecificmonospecificantibodies -IgG, IgA,IgM, C3c, C1q, Kappaand Lambda

Cryostat sections andstaining with specificmonospecificantibodies conjugatedwith FITC. (Directimmunofluorescence)

NA

227 HISTOPATHOLOGY

IHC stained slides Digital Image Analysisof Nuclear andMembrane StainingAntibodies

Software basedalgorithm for scoring

NA

228 HISTOPATHOLOGY

Section from paraffinembedded tissue

Immunohistochemistry-Prognostic/ Theranosticmarkers – ER, PR,Her2/neu, Ki67, p16-OtherImmunohistochemistrymarkers used asancillary tohistopathologicaldiagnosis

Automated methodbased on heat inducedepitope antigenretrieval and stainingwith specific antibodies.Microscopic study ofstained slide to assesslocalization andintensity of stain.Scoring oftheranostic/prognosticmarkers bymanual/digital scoring

NA

229 MICROBIOLOGY &SEROLOGY

EDTA whole blood Amleogenin genedetection

PCR Qualitative(mutationdetection Detected/Notdetected )

NA









%CV


EDTA whole blood Beta Thalassemiamutation detection forthe following mutations:IVS 1/1, IVS 1/5. Co8/9, Co 41/42, -619 bpdel, Co 16, Co 15, Cap1+, -28 bp del, -88 bpdel

ARMS PCR Qualitative(mutationdetection Detected/Notdetected )

NA


EDTA whole blood Detection of the AlphaThalassemia genemutation for the -3.7kbdeletion and the AlphaThalassemia genetriplication


NA


EDTA whole blood Detection of Ychromosomemicrodeletion in thefollowing loci: AZF 1 AProximal, AZF 1 ADistal, AZF 2 AProximal, AZF 2 ADistal, AZF 1 BProximal, AZF 1 BDistal, AZF 2 BProximal, AZF 2 BDistal, AZF 1 CProximal, AZF 1 CDistal, AZF 2 CProximal, AZF 2 CDistal


NA


EDTA whole blood Factor V Leiden genemutation detection forthe G1691A mutation

PCR followed by RFLP Qualitative(mutationdetection Detected/Notdetected )

NA









%CV


EDTA whole blood Hemoglobin C mutationdetection for the Glu toLys mutation

PCR Qualitative(mutationdetectionDetected/Notdetected )

11.3


EDTA whole blood Hemoglobin D mutationdetection for the Glu toGln mutation


NA


EDTA whole blood Hemoglobin E mutationdetection for the Glu toLys mutation


NA


EDTA whole blood JAK 2 V 617F genemutation detection


11.3


EDTA whole blood MTHFR IPolymorphismdetection for the C677Tpolymorphism


NA


EDTA whole blood MTHFR IIPolymorphismdetection for theA1298C polymorphism


NA


EDTA whole blood Prothrombin genemutation detection forthe G20210A mutation


NA


EDTA whole blood Sickle Cell mutationdetection for the Glu toVal mutation


NA









%CV


EDTA whole blood SRY (Sex DeterminingRegion Y) detection


NA


EDTA whole blood,FNAC sample, FFPEtissue

Immunoglobin generearrangementdetection


NA


EDTA whole blood,FNAC sample, FFPEtissue

T cell generearrangementdetection


NA


Nil, TB antigen &Mitogen tube + 5ml Li -Heparin plasma

Quantiferon TB- Gold IGRA- InterferonGamma ReleasingAssay (Quantiferon TB-Gold)

Qualitative(Positive/Negative)

NA


Nil, TB antigen &Mitogen tube + 5ml Li -Heparin plasma

Quantiferon TB- Gold IGRA- InterferonGamma ReleasingAssay (Quantiferon TB-Gold)


NA


Serum Varicella Zoster IgGAntibody

ELFA Qualitative NA


Serum Inihibin B ELISA 2.95 pg/mL to 364.12pg/mL

8.4


Serum Inihibin B ELISA 2.95 pg/mL to 364.12pg/mL

8.4









%CV


Serum Dengue Ig G Antibody ELISA Qualitative NA


Serum Dengue Ig M CaptureAntibody

ELISA Qualitative 11.4


Serum Dengue NS1 Antigen ELISA Qualitative 11.4


Serum Leptospira IgMAntibody

ELISA Qualitative 9.7


Serum Measles IgG Antibody ELFA Qualitative NA


Serum Mumps IgG Antibody ELFA Qualitative NA


Serum/ EDTA Plasma Connective tissueDisorder / ANA screen

Fluoroscence EnzymeImmunoassay-ELiA

0.03 to 32 Ratio 10.6


Serum/ Heparin plasma Procalcitonin ELFA 0.05 ng/mL to 200ng/mL

7.0









%CV


Serum/ Li - Heparinplasma

Hepatitis B SurfaceAntigen

ELFA Qualitative NA


Serum/ Plasma AHBs CMIA 2.5 to 1000 mIU/mL 7.6


Serum/ Plasma Anti Hbe CMIA Qualitative 3.3


Serum/ Plasma CMV IgG Antibody CMIA Qualitative( SemiQuantitative0 - 250.0AU/mL)

6.7


Serum/ Plasma CMV IgM Antibody CMIA Qualitative 9.8


Serum/ Plasma HAV IgM CMIA Qualitative 8.1


Serum/ Plasma HBc IgM CMIA Qualitative 6.9


Serum/ Plasma HBc Total CMIA Qualitative 3.0









%CV


Serum/ Plasma HBe Ag CMIA Qualitative 6.9


Serum/ Plasma HBsAg CMIA Qualitative 7.6


Serum/ Plasma HBsAg Neutralization CMIA Qualitative NA


Serum/ Plasma HCV IgG CMIA Qualitative 6.9


Serum/ Plasma HIV I & 2 Ag & Abdetection

CMIA Qualitative 7.5


Serum/ Plasma Rubella IgG CMIA 0.02 to 500.0 IU/mL 6.7


Serum/ Plasma Rubella IgM CMIA Qualitative 18.9


Serum/ Plasma Toxo IgG CMIA 0 to 200.0 IU/mL 5.3









%CV


Serum/ Plasma Toxo IgM CMIA Qualitative 10.3


Serum/ Plasma Antiphospholipase A2Receptor

IndirectImmunoflourescence


NA


Serum/CitratePlasma/EDTAPlasma/HeparinPlasma

Herpes Simplex Virus -1 IgG

ELISA 2 RU/ml to 200 RU/ml 14.9



Herpes Simplex Virus -1 IgM

ELISA Semi Quantitative 10.7



Antibodies to Foodallergens

Immuno Blot Assay Qualitative(Positive (+to +++++) /Negative)

NA



Chlamydia IgGAntibody



Serum/Citrateplasma/EDTAplasma/Heparin plasma

Antibodies toRespiratory allergens

Immuno Blot Assay Qualitative(Positive (+to +++++)/ Negative)

NA



Antiplatelet Antibody Indirect Immuno-fluorescence

Qualitative(Positive (+to +++) /Negative)

NA









%CV



Antisperm Antibody Indirect Immuno-fluorescence


NA



Autoimmune HepatitisProfile Antibodiesagainst1.AMA-M22.LKM-13.LC-14.SLA/LP

Immuno Blot Assay Qualitative(Positive (+to +++) /Negative)

NA



A N A Blot Antibodiesagainst 1. nRNP/Sm 2.Sm 3. SS-A 4. Ro-52 5.SS-B 6. Scl 70 7. PM-Scl 8. Jo-1 9. CENP B10. PCNA 11.ds D

Immuno Blot Assay Qualitative(Positive (+to +++) /Negative)

NA


Serum/CSF Cryptococcal Antigen Cryptococcal AntigenLatex AgglutinationSystem (CALAS)

Qualitative(Positive (+to ++++) /Negative)

NA


Serum/EDTA Plasma Jo-1 Fluoroscence EnzymeImmunoassay-ELiA

0.3 to 240 U/ml 12.6


Serum/EDTA Plasma HAV IgM ELFA Qualitative NA


Serum/EDTA Plasma HEV IgM ELFA Qualitative NA









%CV


Serum/EDTA Plasma SSA/Ro Fluoroscence EnzymeImmunoassay-ELiA

0.3 to 7.1


Serum/EDTA Plasma SSA/Ro Fluoroscence EnzymeImmunoassay-ELiA

0.3 to 7.1


Serum/EDTA Plasma Allergen Specific IgE EIA Immunocap 0.1 to 100 kUA/L 7.3


Serum/EDTA Plasma HEV IgG ELFA Qualitative NA


Serum/EDTA Plasma Tryptase EIA Immunocap 1.0 to 200µg/L 13.5


Serum/EDTA Plasma Anti GliadinDeaminated peptideIgA


0.1 to 142 U/mL 9.4


Serum/EDTA Plasma Anti GliadinDeaminated peptideIgG


0.4 to 302 U/mL 14.6


Serum/EDTA Plasma Anti TissueTransglutaminase IgG


0.1 to 128.0 U/mL 7.6









%CV


Serum/EDTA Plasma Sm (Smith) Fluoroscence EnzymeImmunoassay-ELiA

0.6 to 480 U/mL 15.0


Serum/EDTA Plasma SSB/La Fluoroscence EnzymeImmunoassay-ELiA

0.3 to 320 U/mL 11.0


Serum/EDTA Plasma Anti ß-2 glycoproteinIgM


2.9 U/ml to 576 U/mL 8.4


Serum/EDTA Plasma Anti TissueTransglutaminase IgA


0.6 to 600 U/mL 8.8


Serum/EDTA Plasma Anticardiolipin IgG Fluoroscence EnzymeImmunoassay-ELiA

0.5 to 418 GPLU/mL 10.3


Serum/EDTA Plasma Anticardiolipin IgM Fluoroscence EnzymeImmunoassay-ELiA

0.8 to 472 MPLU /mL 9.2


Serum/EDTA Plasma Antiß-2 glycoproteinIgG


0.6 to 32 U/mL 10.5


Serum/EDTAPlasma/Whole blood

Food Intolerance IgGAntibody

Microarray+ Elisa <24U/mL - Negative24- 30 U/mL - Borderline>30U/mL - Positive

NA









%CV


Serum/Heparin Plasma Anti HCV IgG ELFA Qualitative NA


Serum/Heparin/Citrate/EDTA Plasma

Anti ds DNA Antibody Indirect Immuno-fluorescence

Qualitative(Positive (+to +++)/Negative)

NA



Anti-Mitochondrialantibody

Indirect Immuno-fluorescence


NA


Serum/Li HeparinPlasma

NT Pro BNP ELFA 20 pg/ml to 25,000pg/ml

8.0


Serum/Plasma Helicobacter pyloriAntibody IgG



Serum/Plasma dsDNA NcX IgGAntibody

ELISA 10 to 800 IE/mL 5.6


Serum/Plasma Granulocyte mosaic c-ANCA p-ANCA

IndirectImmunoflurescence


NA


Serum/Plasma Granulocyte mosaic c-ANCA p-ANCA

IndirectImmunoflurescence


NA









%CV


Serum/Plasma Anti - Proteinase 3 ELISA 2 to 200 RU/ml 10.1


Serum/Plasma HBeAg ELFA Qualitative NA


Serum/Plasma Anti Myeloperoxidase ELISA 2 RU/ml to 200 RU/ml 10.7


Serum/Plasma Anti treponemalantibody

CMIA Qualitative 2.9


Serum/Plasma Hepatitis E Virus IgMAntibody

ELISA Qualitative(Positive/Negative)

NA


Serum/Plasma HIV 1 & 2 Antibodyconfirmatory test(Western Blot)

RecombinantImmunoblot Assay


NA


Serum/Plasma HIV 1 & 2 AntibodyScreening

Immunoconcentration Qualitative(Reactive/Non-Reactive)

NA


Serum/Plasma HIV 1 & 2 Antigen andAntibody detection

ELFA Qualitative(Reactive/Nonreactive)

NA









%CV


Serum/Plasma Intrinsic factor/ Parietalcells

IndirectImmunofluorescence

Qualitative(Positive (+to ++++) /Negative)

NA


Serum/Plasma Neuronal AntigenProfile

Immuno Blot Qualitative(Positive (+to ++++) /Negative)

NA


Serum/Plasma Helicobacter pylori IgA ELISA Semi Quantitative 11.6


Serum/Plasma/CSF Aquaporin - 4 IndirectImmunoflourescence


NA


Serum/Plasma/CSF Neuromyelitin opticaspectrum disorder

IndirectImmunoflorescence

Qualitative NA


Serum/Plasma/CSF Autoimmuneencephalitis Antibodiesagainst1.Glutamatereceptor (NMDA,AMPA 1&2)2. CASPR2 3. LGI 14. GABAReceptor B1 & B2

IndirectImmunoflourescence


NA


Whole blood Filarial AntigenDetection

Immunochromatography card test

Qualitative(Detected/Not detected)

NA









%CV


Whole blood Malarial AntigenDetection HRP-II(Histidine Rich Protein -II), pLDH (Plasmodiumlactate dehydrogenase)

Immunochromatography card test


NA


Blood Culture BeepedBottle

Multiplexed nucleicacid-based in vitrodiagnostic test forSimultaneous detectionand identification ofmultiple bacterial, viral,yeast nucleic acids,parasites and selectgenetic determinants ofantimicrobial.

Multiplex PCR usingBiofire Filmarray

Qualitative(Present /Absent)

NA


CSF 1.PCR amplification oftarget DNA and Internalcontrol.2.Simultaneousdetection of PCRamplicons byfluorescent dye labelledprobes.

DNA Detection of HSV1 and HSV 2 by RT-PCR


NA


CSF sample Multiplexed nucleicacid-based in vitrodiagnostic test forSimultaneous detectionandidentification ofmultiple bacterial, viral,yeast nucleic acids,parasites and selectgenetic determinants ofantimicrobial.



NA









%CV


Culture positiveisolates fromMycobacterial culture

Molecular GeneticAssay for identificationof the Clinical mostrelevant Mycobacterialspecies from CulturedMaterial Mycobacterialsps: M.avium sps,M.chelonae,M.abscess,M.fortuitum,M.gordonae,M.intracellulare,M.scrofulaceum,M.interjectum,M.kansasii,M.malmoenese,M.peregrinum,M.marinum/M.ulcerans,M.tuberculosis complexand M.xenopi.

Line probe Assay Qualitative(Positive /Negative)

NA


EDTA blood Tropical Fever Multiplex PCRsyndrome- detection ofNucleic acid ofPlasmodium, Dengue,Chikumgunya,Salmonella,Leptospira,Rickettsia,West-Nile virus

Qualitative(Detection ofPlasmodium, Dengue,Chikumgunya,Salmonella, Leptospira,Rickettsia,West-Nilevirus)

NA


EDTA blood, Urine,CSF

Cytomegalovirus DNAquantitative- viral load

Real-time PCR forQuantitative detectionof CMV DNA ( usingQIAGEN Artus kit)

100 to 1000000copies/mL

21.9


EDTA blood,urine,CSF Cytomegalovirus DNA-quantitative- viral load

Real time PCR (usingQIAGEN Artus kit)

100 to 1,000,000copies/ml

to beupdated









%CV


EDTA blood,urine,CSF Qualitative detection ofCytomegalovirus DNA

Real time PCR (usingQIAGEN Artus kit)

Qualitative(Amplification of CytomegalovirusDNA and detection)

NA


EDTA Plasma HBV Viral Load-Realtime PCR(Ampliprep/CobasTaqman)

HBV DNA Viral load -Real Time PCR

9 IU/mL to 170,000,000IU/mL

16.4


EDTA Plasma HIV viral load-Real timePCR(Ampliprep/CobasTaqman)

HIV RNA Viral load-Real time PCR

20 to 10,000,000copies/mL

23.3


EDTA Plasma NASBA (Nucleic acidsequence basedamplification) anddetection withmolecular beacons.

HIV Viral Load-NASBA(Nucleic acid sequencebased amplification)and detection withmolecular beacons

10 copies/ml to10,000,000copies/ml

NA


EDTA Plasma Reverse transcriptasePCR for HIV 1 Viralload using Genexpert.

HIV Viral load -Reversetranscriptase PCR (RTPCR)

40 to 10,000,000copies /m

21


EDTA Plasma RT PCR for HCV RNAviral load usingGenexpert

HCV(RNA) Viral loadby RT PCR

10 IU/mL to100,000,000 IU/mL

21.8


EDTA whole blood Detection of the TPMTgene mutation for thefollowing mutations:TPMT 460 G>A, TPMT719 A>C, TPMT 238G>C

PCR Qualitative(mutationdetection Detected/Notdetected)

NA









%CV


EDTA Whole blood(Direct method) orIsolated Genomic DNAof the patient sample

Samples are analysedusing a Microarray,which containsimmobilised Probeswhich arecomplementary to theAmplified DNA, thespecificbinding(Hybridisation)ofthe fluorescing PCRproduct of thecorrespondingMicroarray spot isdetected using aSpecial MicroArrayscanner.

HLA B27 Microarray Qualitative(Positive/Negative for HLA -B27exon 2 and exon 3)

NA


Nasal/throat/nasopharyngealswabs

Detection of InfluenzaA,B/H1N192009

Multiplex PCR Qualitative(Detection ofInfluenza virus A,B andH1N1 (2009) strain oftype A.)

NA


Nasopharyngeal Swabin Viral TransportMedia

Multiplexed nucleicacid-based in vitrodiagnostic test forSimultaneous detectionandidentification ofmultiple bacterial, viral,yeast nucleic acids,parasites and selectgenetic determinants ofantimicrobial.



NA









%CV


Respiratory tractsamples, Pus, Tissue,Urine, CSF,Body fluids,Positive for AFBsamples, Culturepositive isolates

MTB complex detectionand RifampicinResistant/Sensitive

CBNAAT(PCR)-GeneXpert

Semi QuantitativeDetected/Not detected

NA


Respiratory tractsamples, Pus, Tissue,Urine, CSF,Body fluids,Positive for AFBsamples, Culturepositive isolates

MTB complex detectionand RifampicinResistant/Sensitive

CBNAAT(PCR)-GeneXpert

Semi QuantitativeDetected/Not detected

NA


Respiratory tractsamples, Pus, Tissue,Urine, CSF, Bodyfluids, Positive for AFBsamples, Culturepositive isolates, FFPE

MTB complex detectionand gyrA,gyrB,rrs,eisgene specific detection.

Line probe assay forMTB Second LineDrugs

Qualitative(Qualitativeanalysis of MTBcomplex Detected/Notdetected andFluoroquinolones andAminoglycosides(capreomycin,viomycin,kanamycin,amikacin,)Resistant/Sensitive )

NA


Respiratory tractsamples, Pus, Tissue,Urine, CSF, Bodyfluids, Positive for AFBsamples, Culturepositive isolates,FFPE?

MTB complex detectionand rpoB + KatG +InhAgene detection

Line probe Assay forMTB(PCR)

Qualitative(Qualitativeanalysis of MTBcomplex Detected/Notdetected andRifampicin andIsoniazidResistant/Sensitive)

NA









%CV


Respiratory tractsamples, Pus, Tissue,Urine, CSF, Bodyfluids, Positive for AFBsamples, Culturepositive isolates,FFPE?

MTB complex detectionand rpoB + KatG +InhAgene detection

Line probe Assay forMTB(PCR)

Qualitative(Qualitativeanalysis of MTBcomplex Detected/Notdetected andRifampicin andIsoniazidResistant/Sensitive)

NA


Serum Toxoplasma IgM ELFA Qualitative NA


Serum / EDTA Plasma U1RNP Fluoroscence EnzymeImmunoassay-ELiA

0.3 to 240 U/ml NA


Serum/ EDTA Plasma Scl-70 Fluoroscence EnzymeImmunoassay-ELiA

0.4 to 320 U/ml NA


Serum/ EDTA Plasma Centromere (CENP) Fluoroscence EnzymeImmunoassay-ELiA

0.4 to 240 U/ml 6.0



Herpes Simplex Virus -2 IgG




Herpes Simplex Virus -2 IgM

ELISA Semi Quantitative 6.9









%CV



Antibodies to EB VirusAntibodies against1.EBV-CA IgG 2.EBV-CA IgM 3.EBV-EA IgG4. EBNA 5. AVIDITY


Qualitative(Positive (+to +++) /Negative+High or Low avidity)

NA



Anti GBM Antibody Indirect Immuno-fluorescence


NA



Anti Smooth MuscleAntibody



NA



Anti-Nuclear Antibody Indirect Immuno-fluorescence


NA


Stool Calprotectin 2 Fluoroscence EnzymeImmunoassay-ELiA

15.0 to 3000 mg/kg 11.1


Stool sample in CaryBlair Transport Media

Multiplexed nucleicacid-based in vitrodiagnostic test forSimultaneous detectionandidentification ofmultiple bacterial, viral,yeast nucleic acids,parasites and selectgenetic determinants ofantimicrobial.



NA









%CV


Stool Suspension Rotavirus/AdenovirusCombi Test

Immunochromatography

Qualitative(PositiveNegative)

NA


Stool Suspension Cryptosporidium/Giardia/Entamoeba CombiTest

Immunochromatography


NA






Documents

Accreditation Standard ISO 15189:2012 - AnandLab · Rate Nephlometry 50 IU/mL to 1600 IU/mL 5.1 36 CLINICAL BIOCHEM ISTRY Serum Pregnancy Associated Plasma Protein A (PAPPA) Trace