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Laboratory Name PATHCARE LABS PRIVATE LIMITED, C/O VISAKHA INSTITUTE OF MEDICAL

SCIENCES, HANUMANTHAWAKA JUNCTION, GREATER VISAKHAPATNAM - 530040,


VISAKHAPATNAM, ANDHRA PRADESH , INDIA

Accreditation Standard ISO 15189:2012

Certificate Number MC-3203 Page No. : 1/8

Validity 11/07/2019 to 10/07/2021 Last Amended on -

S.No Discipline Product / Material of Specific Test Test Method Range of Testing/ %CV
Test Performed Limits of Detection
Permanent Facility

1 CLINICAL EDTA Whole Blood Glycosylated HPLC 3.0 % to 18.0 % 6.0


BIOCHEM Hemoglobin (HbA1c)
ISTRY

2 CLINICAL Plasma Glucose Hexokinase 0.01 mg/dL to 500 6.5


BIOCHEM mg/dL
ISTRY

3 CLINICAL Serum Albumin Bromocresol purple 0.6 g/dL to 8 g/dL 4.2


BIOCHEM dye - binding
ISTRY

4 CLINICAL Serum Aspartate IFCC P5P 0.01 U/L to 1000 U/L 8.0
BIOCHEM Aminotransferase
ISTRY (SGOT)

5 CLINICAL Serum Bilirubin Total Diazotization 0.1 mg/dL to 25 mg/dL 6.0


BIOCHEM
ISTRY

6 CLINICAL Serum Cholesterol - Total CHOD PAP 50 mg/dL to 600 mg/dL 6.5
BIOCHEM
ISTRY

7 CLINICAL Serum Creatinine Kinetic Jaffe 0.15 mg/dL to 20 7.0


BIOCHEM mg/dL
ISTRY

8 CLINICAL Serum Thyroxine - Free (FT4) Chemiluminescence 0.25 ng/dL to 6.0 ng/dL 7.0
BIOCHEM
ISTRY

9 CLINICAL Serum Alanine Transaminase IFCC P5P 6.0 U/L to 1000 U/L 9.6
BIOCHEM (ALT/ SGPT)
ISTRY

10 CLINICAL Serum Alkaline Phosphatase Kinetic Based on IFCC 10 U/L to 1000 U/L 7.8
BIOCHEM (ALP) (PNPP)
ISTRY

This is annexure to 'Certificate of Accreditation' and does not require any signature.
Laboratory Name PATHCARE LABS PRIVATE LIMITED, C/O VISAKHA INSTITUTE OF MEDICAL
SCIENCES, HANUMANTHAWAKA JUNCTION, GREATER VISAKHAPATNAM - 530040,
VISAKHAPATNAM, ANDHRA PRADESH , INDIA

Accreditation Standard ISO 15189:2012

Certificate Number MC-3203 Page No. : 2/8

Validity 11/07/2019 to 10/07/2021 Last Amended on -

S.No Discipline Product / Material of Specific Test Test Method Range of Testing/ %CV
Test Performed Limits of Detection

11 CLINICAL Serum Bilirubin Direct Diazotization 0.5 mg/dL to 16 mg/dL 5.8


BIOCHEM
ISTRY

12 CLINICAL Serum Blood Urea Nitrogen Urease, GLDH 1 mg/dL to 150 mg/dL 7.5
BIOCHEM (BUN)
ISTRY

13 CLINICAL Serum Calcium O - cresolphthalein 5 mg/dL to 15 mg/dL 8.0


BIOCHEM complexon (OCPC)
ISTRY

14 CLINICAL Serum Cholesterol - HDL Direct 0.3 mg/dL to 150 9.0


BIOCHEM mg/dL
ISTRY

15 CLINICAL Serum Follicle Stimulating Chemiluminescence 0.2 mIU/mL to 250 6.8


BIOCHEM Hormone (FSH) mIU/mL
ISTRY

16 CLINICAL Serum Gamma Glutamyl IFCC 0.01 U/L to 800 U/L 8.5
BIOCHEM Transferase (GGT)
ISTRY

17 CLINICAL Serum Luteinising Hormone Chemiluminescence 0.2 mIU/mL to 200 8.8


BIOCHEM (LH) mIU/mL
ISTRY

18 CLINICAL Serum Phosphorus UV Phospho molybdate 0.5 mg/dL to 9.0 mg/dL 6.5
BIOCHEM
ISTRY

19 CLINICAL Serum Prolactin Chemiluminescence 0.25 mIU/mL to 200 8.0


BIOCHEM mIU/mL
ISTRY

20 CLINICAL Serum Protein Total Biuret 2 g/dL to 12 g/dL 6.5


BIOCHEM
ISTRY

This is annexure to 'Certificate of Accreditation' and does not require any signature.
Laboratory Name PATHCARE LABS PRIVATE LIMITED, C/O VISAKHA INSTITUTE OF MEDICAL
SCIENCES, HANUMANTHAWAKA JUNCTION, GREATER VISAKHAPATNAM - 530040,
VISAKHAPATNAM, ANDHRA PRADESH , INDIA

Accreditation Standard ISO 15189:2012

Certificate Number MC-3203 Page No. : 3/8

Validity 11/07/2019 to 10/07/2021 Last Amended on -

S.No Discipline Product / Material of Specific Test Test Method Range of Testing/ %CV
Test Performed Limits of Detection

21 CLINICAL Serum Thyroid Stimulating Chemiluminescence 0.015 µIU/mL to 100 5.0


BIOCHEM Hormone (TSH) µIU/mL
ISTRY

22 CLINICAL Serum Thyroxine Total (TT4) Chemiluminescence 0.5 µg/dL to 30.0 µg/dL 8.0
BIOCHEM
ISTRY

23 CLINICAL Serum Tri Iodothyronine Free Chemiluminescence 0.88 pg/mL to 30 6.0


BIOCHEM (FT3) pg/mL
ISTRY

24 CLINICAL Serum Tri Iodothyronine Total Chemiluminescence 0.1 ng/mL to 8.0 ng/mL 6.8
BIOCHEM (TT3)
ISTRY

25 CLINICAL Serum Triglycerides GPO – POD 0.2 mg/dL to 300 8.5


BIOCHEM mg/dL
ISTRY

26 CLINICAL Serum Urea Urease GLDH 1 mg/dL to 321 mg/dL 7.8


BIOCHEM
ISTRY

27 CLINICAL Serum Uric Acid Uricase PAP 0.01 mg/dL to 20 7.5


BIOCHEM mg/dL
ISTRY

28 CLINICAL Serum Vitamin B12 Chemiluminescence 50 pg/mL to 1500 7.2


BIOCHEM pg/mL
ISTRY

29 CLINICAL Stool Stool Examination Physical Examination/ Qualitative NA


PATHOLO Microscopy
GY

30 CLINICAL Stool Stool for Occult Blood Guaiac acid test Qualitative(Positive/ NA
PATHOLO (Hemospot) Negative)
GY

This is annexure to 'Certificate of Accreditation' and does not require any signature.
Laboratory Name PATHCARE LABS PRIVATE LIMITED, C/O VISAKHA INSTITUTE OF MEDICAL
SCIENCES, HANUMANTHAWAKA JUNCTION, GREATER VISAKHAPATNAM - 530040,
VISAKHAPATNAM, ANDHRA PRADESH , INDIA

Accreditation Standard ISO 15189:2012

Certificate Number MC-3203 Page No. : 4/8

Validity 11/07/2019 to 10/07/2021 Last Amended on -

S.No Discipline Product / Material of Specific Test Test Method Range of Testing/ %CV
Test Performed Limits of Detection

31 CLINICAL Urine Appearance Macroscopic Qualitative(Descriptive) NA


PATHOLO Examination
GY

32 CLINICAL Urine Bilirubin Reagent strip Qualitative(Negative to NA


PATHOLO Reflectance - Reaction +++)
GY of Bilirubin with
Diazonium salt

33 CLINICAL Urine Blood Reagent Strip Qualitative(Negative/ NA


PATHOLO Reflectance (Diazonum Positive)
GY Method)

34 CLINICAL Urine Casts Microscopic Qualitative(Present/ NA


PATHOLO Examination Absent)
GY

35 CLINICAL Urine Colour Macroscopic Qualitative(Descriptive) NA


PATHOLO Examination
GY

36 CLINICAL Urine Crystals Microscopic Qualitative(Present/ NA


PATHOLO Examination Absent)
GY

37 CLINICAL Urine Epithelial Cells Microscopic Qualitative(Interpretive) NA


PATHOLO Examination
GY

38 CLINICAL Urine Glucose Reagent strip Qualitative(Negative to NA


PATHOLO Reflectance (GOD- ++++)
GY POD) Benedict's Semi
Quantitative Method

39 CLINICAL Urine Ketone Bodies Reagent strip Qualitative(Negative to NA


PATHOLO Reflectance - ++++)
GY Nitroprusside
Reaction/Dumn &
Shipleys Reaction.

This is annexure to 'Certificate of Accreditation' and does not require any signature.
Laboratory Name PATHCARE LABS PRIVATE LIMITED, C/O VISAKHA INSTITUTE OF MEDICAL
SCIENCES, HANUMANTHAWAKA JUNCTION, GREATER VISAKHAPATNAM - 530040,
VISAKHAPATNAM, ANDHRA PRADESH , INDIA

Accreditation Standard ISO 15189:2012

Certificate Number MC-3203 Page No. : 5/8

Validity 11/07/2019 to 10/07/2021 Last Amended on -

S.No Discipline Product / Material of Specific Test Test Method Range of Testing/ %CV
Test Performed Limits of Detection

40 CLINICAL Urine Nitrites Reagent Strip Qualitative(Negative/ NA


PATHOLO Reflectance (Diazonum Positive)
GY Method)

41 CLINICAL Urine pH Reagent strip Qualitative(5 - 9) NA


PATHOLO Reflectance - Double
GY indicator Principle

42 CLINICAL Urine Pregnancy Test Immunochromatograph Qualitative NA


PATHOLO y
GY

43 CLINICAL Urine Protein Reagent strip Qualitative(Negative to NA


PATHOLO Reflectance - ++++)
GY Tetrabromophenol blue

44 CLINICAL Urine Pus Cells Microscopic Qualitative(Present/ NA


PATHOLO Examination Absent)
GY

45 CLINICAL Urine Red Blood Cells Microscopic Qualitative(Present/ NA


PATHOLO Examination Absent)
GY

46 CLINICAL Urine Specific gravity Reagent Strip Qualitative(1.005 - NA


PATHOLO Reflectance (Ion 1.030)
GY Exchange)

47 CLINICAL Urine Urobilinogen Reagent strip Qualitative(Absent/ NA


PATHOLO Reflectance - Modified Present)
GY Ehrlich's Aldehyde
Reaction

48 HAEMAT EDTA Whole Blood Absolute Eosinophil Staining & Microscopic 1 Cells/µL to 20000 NA
OLOGY & Count Examination Cells/µL
IMMUNOH
AEMATOL
OGY

This is annexure to 'Certificate of Accreditation' and does not require any signature.
Laboratory Name PATHCARE LABS PRIVATE LIMITED, C/O VISAKHA INSTITUTE OF MEDICAL
SCIENCES, HANUMANTHAWAKA JUNCTION, GREATER VISAKHAPATNAM - 530040,
VISAKHAPATNAM, ANDHRA PRADESH , INDIA

Accreditation Standard ISO 15189:2012

Certificate Number MC-3203 Page No. : 6/8

Validity 11/07/2019 to 10/07/2021 Last Amended on -

S.No Discipline Product / Material of Specific Test Test Method Range of Testing/ %CV
Test Performed Limits of Detection

49 HAEMAT EDTA Whole Blood Packed Cell Volume Calculated NA 3.2


OLOGY & (PCV)
IMMUNOH
AEMATOL
OGY

50 HAEMAT EDTA Whole Blood Platelet Count (PC) Cell Impedance 0 x 10⁹/L to 999 x 10⁹/L 13.2
OLOGY &
IMMUNOH
AEMATOL
OGY

51 HAEMAT EDTA Whole Blood RBC Count Cell Impedance 0 x 10¹²/L to 8 x 10¹²/L 3.9
OLOGY &
IMMUNOH
AEMATOL
OGY

52 HAEMAT EDTA Whole Blood Total Leucocyte Count Cell Impedance / 0 x 10⁹/L to 99.9 x 5.1
OLOGY & (TLC) Microscopy 10⁹/L
IMMUNOH
AEMATOL
OGY

53 HAEMAT EDTA Whole Blood & Blood Grouping (A B Tube Agglutination Qualitative(A, B, AB, O) NA
OLOGY & Serum O) and Rh Type method (Forward and
IMMUNOH Reverse)
AEMATOL
OGY

54 HAEMAT EDTA Whole Blood Blood Picture - Leishman stain & Qualitative NA
OLOGY & Peripheral Smear Microscopy
IMMUNOH Examination
AEMATOL
OGY

This is annexure to 'Certificate of Accreditation' and does not require any signature.
Laboratory Name PATHCARE LABS PRIVATE LIMITED, C/O VISAKHA INSTITUTE OF MEDICAL
SCIENCES, HANUMANTHAWAKA JUNCTION, GREATER VISAKHAPATNAM - 530040,
VISAKHAPATNAM, ANDHRA PRADESH , INDIA

Accreditation Standard ISO 15189:2012

Certificate Number MC-3203 Page No. : 7/8

Validity 11/07/2019 to 10/07/2021 Last Amended on -

S.No Discipline Product / Material of Specific Test Test Method Range of Testing/ %CV
Test Performed Limits of Detection

55 HAEMAT EDTA Whole Blood Hemoglobin Cyanmethmoglobin 0.01 g/dL to 25 g/dL 3.8
OLOGY &
IMMUNOH
AEMATOL
OGY

56 HAEMAT EDTA Whole Blood Malarial Parasite Microscopy Qualitative(Positive / NA


OLOGY & Identification Negative)
IMMUNOH
AEMATOL
OGY

57 HAEMAT EDTA Whole Blood Retic Count New methylene blue Qualitative(%) NA
OLOGY & staining and
IMMUNOH microscopic
AEMATOL examination
OGY

58 MICROBI Serum Dengue IgG - Rapid Immunochromatograph Qualitative(Negative/ NA


OLOGY & y Positive)
SEROLO
GY

59 MICROBI Serum Dengue IgM - Rapid Immunochromatograph Qualitative(Negative/ NA


OLOGY & y Positive)
SEROLO
GY

60 MICROBI Serum Dengue NS1 - Rapid Immunochromatograph Qualitative(Negative/ NA


OLOGY & y Positive)
SEROLO
GY

61 MICROBI Serum HBsAg - Rapid Immunochromatograph Qualitative(Negative/ NA


OLOGY & y Positive)
SEROLO
GY

This is annexure to 'Certificate of Accreditation' and does not require any signature.
Laboratory Name PATHCARE LABS PRIVATE LIMITED, C/O VISAKHA INSTITUTE OF MEDICAL
SCIENCES, HANUMANTHAWAKA JUNCTION, GREATER VISAKHAPATNAM - 530040,
VISAKHAPATNAM, ANDHRA PRADESH , INDIA

Accreditation Standard ISO 15189:2012

Certificate Number MC-3203 Page No. : 8/8

Validity 11/07/2019 to 10/07/2021 Last Amended on -

S.No Discipline Product / Material of Specific Test Test Method Range of Testing/ %CV
Test Performed Limits of Detection

62 MICROBI Serum HCV - Rapid Immunochromatograph Qualitative(Non- NA


OLOGY & y Reactive/ Reactive)
SEROLO
GY

63 MICROBI Serum HIV 1 & 2 Antibody Immunochromatograph Qualitative(Non- NA


OLOGY & Rapid y Reactive/ Reactive)
SEROLO
GY

64 MICROBI Serum HIV 1 & 2 Antibody Immunofiltration Qualitative(Negative/ NA


OLOGY & Rapid Positive)
SEROLO
GY

65 MICROBI Serum HIV 1&2 Antibody Indirect Solid Phase Qualitative(Reactive/ NA


OLOGY & Immunoassay Non-reactive)
SEROLO
GY

66 MICROBI Serum Widal Test Slide Agglutination Qualitative(Negative/ NA


OLOGY & Positive)
SEROLO
GY

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

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