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The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes. Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical Biochemistry 1. Serum, Heparinized Plasma, Urine, CSF, Sweat Electrolyte: - Potassium - Sodium - Chloride Potentiometric: Olympus AU 640 and Beckman Coulter AU 680 Analyzer Whole Blood, Serum, Potentiometric: Diestro 103 Analyzer Plasma, Urine 2. Serum, Heparinized Plasma, Urine and Stool Bicarbonate Enzymatic Colorimetric: Olympus AU 640 and Beckman Coulter AU 680 Analyzer Serum, Enzymatic Colorimetric: Hitachi 902 and Heparinized Plasma Humalyzer 3000 Analyzer 3. Serum, Chloride Potentiometric : Sherwood Chloride Heparinized Plasma, Analyzer 923S Sweat, Plural Fluid, Urine and CSF 4. Whole Blood, Serum, Blood Gas: HCO3, PO2, Potentiometric and (PO2) Amperometric Plasma PCO2 and pH and (HCO3) Henderson-Hasselbalch: Nova Stat Profile pHOx Plus C Analyzer Bureau of Laboratory Quality Standards Page 1 of 26 Accreditation Number 4091 / 54 Date of Accreditation : 26 December 2012 Date of Expiration : 25 December 2014

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Page 1: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Laboratory Services (CLS)

Clinical Biochemistry

1. Serum, Heparinized Plasma, Urine, CSF, Sweat

Electrolyte: - Potassium - Sodium - Chloride

Potentiometric: Olympus AU 640 and Beckman Coulter AU 680 Analyzer

Whole Blood, Serum, Potentiometric: Diestro 103 Analyzer

Plasma, Urine

2. Serum, Heparinized Plasma, Urine and Stool

Bicarbonate Enzymatic Colorimetric: Olympus AU 640 and Beckman Coulter AU 680 Analyzer

Serum, Enzymatic Colorimetric: Hitachi 902 and

Heparinized Plasma Humalyzer 3000 Analyzer

3. Serum, Chloride Potentiometric : Sherwood Chloride

Heparinized Plasma, Analyzer 923S

Sweat, Plural Fluid,

Urine and CSF

4. Whole Blood, Serum, Blood Gas: HCO3, PO2, Potentiometric and (PO2) Amperometric

Plasma PCO2 and pH and (HCO3) Henderson-Hasselbalch:

Nova Stat Profile pHOx Plus C Analyzer

Bureau of Laboratory Quality Standards Page 1 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 2: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

5. Urine, Serum Osmolality Freezing Point Depression: Advanced

Microosmometer 3MO Analyzer

6. Heparin-Fluoride or EDTA-Fluoride Plasma, CSF

Glucose Enzymatic Colorimetric, Hexokinase: Olympus AU 640 and Beckman Coulter AU 680 Analyzer

Serum, Heparinized Enzymatic, Glucose Oxidase

Plasma colorimetric: Hitachi 902, Humalyzer 3000

Analyzer and Manual method:

Perkin and Elmer Spectrophotometer

7. K2-EDTA or NH4- Glycosylated Hemoglobin Colorimetric and Latex Agglutination

Heparinized Whole Blood (HbA1c) Inhibition Assay: Olympus AU 640

And Beckman Coulter AU 680 Analyzer

Colorimetric and Turbidimetric Inhibition

Immunoassay: Hitachi 902 Analyzer

8. Serum, Heparin or Creatinine Jaffe Colorimetric Kinetic or Enzymatic EDTA-plasma, Urine colorimetric: Olympus AU 640, Hitachi 902, Humalyzer 3000 and Beckman Coulter AU 680 Analyzer

9. CSF, Urine Total Protein Colorimetric: Olympus AU 640 and

Beckman Coulter AU 680 Analyzer Manual method:

Perkin and Elmer Spectrophotometer

Bureau of Laboratory Quality Standards Page 2 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 3: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

10. Serum, Heparin or Urea/ Enzymatic Colorimetric: Olympus AU640,

EDTA Plasma, Urine Blood Urea Nitrogen (BUN) Hitachi 902, Humalyzer 3000

and Beckman Coulter AU 680 Analyzer

11. Serum, Heparin or Uric Acid Enzymatic Colorimetric: Olympus AU640,

EDTA Plasma, Urine Hitachi 902, Humalyzer 3000

and Beckman Coulter AU 680 Analyzer

12. Serum, Heparin or Total Protein Colorimetric, Cupric Violet Complex:

EDTA Plasma Olympus AU 640, Hitachi 902,

Humalyzer 3000 and Beckman Coulter

AU 680 Analyzer

13. Urine Vanilmandelic Acid (VMA) Anion Exchange Resin Separation Followed by Spectrophotometric

Quantitation Manual method: Perkin

and Elmer Spectrophotometer

14. Serum, Plasma, Urine Specific Gravity Refractometric

Bureau of Laboratory Quality Standards Page 3 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 4: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

15. Serum, Heparin or Albumin Colorimetric, Albumin BCG Complex:

EDTA Plasma Olympus AU 640, Hitachi 902,

Humalyzer 3000 and Beckman Coulter

AU 680 Analyzer

16. Urine, CSF Micro-Albumin Turbidimetric Antiserum Agglutination

Assay: Olympus AU 640, Hitachi 902

and Beckman Coulter AU 680 Analyzer

17. Serum, Heparin or Total Cholesterol Enzymatic Colorimetric: Olympus AU640,

EDTA Plasma Hitachi 902, Humalyzer 3000

and Beckman Coulter AU 680 Analyzer

18. Serum, Heparinized HDL-Cholesterol Immunometric Blocking and Enzymatic Plasma Colorimetric: Olympus AU 640 and Beckman Coulter AU 680 Analyzer Selective Blocking and Enzymatic Colorimetric: Hitachi 902 Analyzer Manual method: Perkin and Elmer Spectrophotometer

19. Serum, Heparinized LDL-Cholesterol Protecting LDL and Enzymatic Plasma Colorimetric: Olympus AU 640 and Beckman Coulter AU 680 Analyzer

Serum, Heparin or Selective Solubilization of LDL and EDTA-plasma Enzymatic Colorimetric: Hitachi 902 Analyzer

Bureau of Laboratory Quality Standards Page 4 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 5: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

20. Serum, Heparin or Triglycerides Enzymatic Colorimetric: Olympus AU640,

EDTA Plasma Hitachi 902, Humalyzer 3000 and

Beckman Coulter AU 680 Analyzer

21. Serum, Heparin or Total Bilirubin Colorimetric, Diazonium ion-Azobilirubin:

EDTA Plasma Olympus AU 640, Hitachi 902,

Humalyzer 3000 and Beckman Coulter

AU 680 Analyzer

Manual method: Perkin and Elmer

Spectrometer

22. Serum, Heparin or Direct Bilirubin Colorimetric, Diazonium ion-Azobilirubin:

EDTA Plasma Olympus AU 640, Humalyzer 3000 and

Beckman Coulter AU 680 Analyzer

Manual method: Perkin and

Elmer Spectrometer

23. Serum, Heparinized Alkaline Phosphatase (ALP) Kinetic, AMP Buffer: Olympus AU 640,

Plasma Hitachi 902, Humalyzer 3000

and Beckman Coulter AU 680 Analyzer

24. Serum, Heparin or Alanine Aminotransferase Kinetic without P-5-P: Olympus AU 640,

EDTA Plasma (ALT) Hitachi 902, Humalyzer 3000

and Beckman Coulter AU 680 Analyzer

Bureau of Laboratory Quality Standards Page 5 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 6: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

25. Serum, Heparin or Aspartate Aminotransferase Kinetic without P-5-P: Olympus AU 640,

EDTA Plasma (AST) Hitachi 902, Humalyzer 3000

and Beckman Coulter AU 680 Analyzer

26. Serum, Heparin or Gamma Glutamyl Transferase Kinetic: Olympus AU 640, Hitachi 902,

EDTA Plasma (GGT) Humalyzer 3000 and Beckman Coulter

AU 680 Analyzer

27. Serum Acid Phosphatase (ACP), Kinetic with 1-naphthyl phosphate as

Total substrate: Olympus AU 640, Hitachi 902,

Humalyzer 3000 and Beckman Coulter

AU 680 Analyzer

28. Serum Acid Phosphatase (ACP), Tartarate inhibited Kinetic with 1-naphthyl

Non-Prosthetic phosphate as substrate: Olympus AU640,

Hitachi 902, Humalyzer 3000

and Beckman Coulter AU 680 Analyzer

29. Serum, Heparinized Amylase Kinetic: Olympus AU 640, Hitachi 902,

Plasma, Urine Humalyzer 3000 and Beckman Coulter

AU 680 Analyzer

30. Serum, Heparinized Lactate Dehydrogenase Kinetic: Olympus AU 640, Hitachi 902, Plasma (LDH) Humalyzer 3000 and Beckman Coulter AU 680 Analyzer

Bureau of Laboratory Quality Standards Page 6 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 7: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

31. Serum, Heparinized Creatine Kinase (CK) Kinetic: Olympus AU 640, Hitachi 902,

Plasma or EDTA Plasma Humalyzer 3000 and Beckman Coulter

AU 680 Analyzer

32. Serum, Heparinized Creatine Kinase MB Antibody Inhibition and Kinetic:

Plasma or EDTA-plasma Iso-Enzyme (CK-MB) Olympus AU 640, Hitachi 902,

Humalyzer 3000 and Beckman Coulter

AU 680 Analyzer

33. Serum, Heparinized Total Calcium Colorimetric, Arsenazo III Complex:

Plasma and Urine Olympus AU 640 and Beckman Coulter

AU 680 Analyzer

Colorimetric, O-Cresolphthalein Complex:

Hitachi 902 and Humalyzer 3000 Analyzer

34. Whole Blood, Serum, Ionized Calcium (ICa) Potentiometric by Selective Glass

Plasma, Urine Membrane: Diestro 103 Analyzer

35. Serum, Heparin or Inorganic Phosphorous Colorimetric, Ammonium EDTA Plasma, Urine Phosphomolybdate Complex: Olympus AU 640, Hitachi 902, Humalyzer 3000 and Beckman Coulter AU 680 Analyzer

Bureau of Laboratory Quality Standards Page 7 of 23

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 8: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

36. Serum, Heparinized Total Magnesium Colorimetric, Xylidyl Blue Complex:

Plasma, Urine Olympus AU 640 and Hitachi 902

Analyzer

37. Serum and Total Iron Colorimetric, TPTZ Blue Complex:

Heparinized Plasma Olympus AU 640 and Beckman Coulter

AU 680 Analyzer

Colorimetric, FerroZine Magenta

Complex: Hitachi 902 Analyzer

38. Serum and Unsaturated Iron Binding Colorimetric, Nitroso-PSAP Green

Heparinized Plasma Capacity (UIBC) Complex: Olympus AU 640 and Beckman

Coulter AU 680 Analyzer

Colorimetric FerroZine magenta complex:

Hitachi 902 Analyzer

39. Urine, Stool pH Potentiometric : Beckman pH Meter

40. Serum Total Tri-iodothyronine (T3) Chemiluminescent Immunoassay: Immulite 1000 Analyzer

41. Serum Total Thyroxine (T4) Chemiluminescent Immunoassay: Immulite 1000 Analyzer

Bureau of Laboratory Quality Standards Page 8 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 9: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

42. Serum Thyroid Stimulating Hormone Chemiluminescent Immunoassay:

(TSH) Immulite 1000 Analyzer

43. Serum Free Tri-iodothyronine (FT3) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

44. Serum Free Thyroxine (FT4) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

45. Serum Prolactin Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

46. Serum Luteinizing Hormone (LH) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

Bureau of Laboratory Quality Standards Page 9 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 10: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

47. Serum Follicle Stimulating Hormone Chemiluminescent Immunoassay:

(FSH) Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

48. Serum, Urine Total Human Chorionic Chemiluminescent Immunoassay:

Gonadotrophin (HCG) Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

49. Serum Estradiol/ Oestrogen Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

50. Serum Testosterone Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

Bureau of Laboratory Quality Standards Page 10 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 11: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International

Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

51. Serum Progesterone Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

52. Serum Cortisol Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

53. Serum, Heparin Complement 3 (C3) Colorimetric Antiserum Agglutination

or EDTA-plasma Assay: Olympus AU 640 and Beckman

Coulter AU 680 Analyzer

54. Serum, Heparin Complement 4 (C4) Colorimetric Antiserum Agglutination

or EDTA Plasma Assay: Olympus AU 640 and Beckman

Coulter AU 680 Analyzer

55. Serum, Heparin Immunoglobulin A (IgA) Colorimetric Antiserum Agglutination

or EDTA Plasma Assay: Olympus AU 640 and Beckman

Coulter AU 680 Analyzer

56. Serum Immunoglobulin E (IgE) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Bureau of Laboratory Quality Standards Page 11 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 12: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International

Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

57. Serum Ferritin Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

Serum, Heparin Colorimetric Antiserum Agglutination

or EDTA Plasma Assay: Olympus AU 640 Analyzer

58. Serum, Heparin Ceruloplasmin Colorimetric, Rate of Oxidation of

or EDTA-plasma p-phenylenediamine, Manual method:

Perkin and Elmer Spectrophotometer

Colorimetric Antiserum Agglutination

Assay: Olympus AU 640 and Beckman

Coulter AU 680 Analyzer

59. Serum, Heparinized Complement Reactive Protein Colorimetric Antiserum Agglutination

Plasma (CRP) Assay: Olympus AU 640 and Beckman

Coulter AU 680 Analyzer

60. Serum, Heparin Immunoglobulin G (IgG) Colorimetric Antiserum Agglutination

or EDTA Plasma, CSF Assay: Olympus AU 640 and Beckman

Coulter AU 680 Analyzer

Bureau of Laboratory Quality Standards Page 12 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 13: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Biochemistry (Continued)

61. Serum, Heparin Immunoglobulin M (IgM) Colorimetric Antiserum Agglutination

or EDTA Plasma Assay: Olympus AU 640 and Beckman

Coulter AU 680 Analyzer

62. Serum, Whole Blood Folic Acid Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

63. Serum Vitamin B-12 Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

Chemiluminescent Microparticle

Immunoassay: Architect i 1000 SR

Analyzer

Serodiagnostics and Molecular Biology

64. Serum Widal Agglutination Method: Biotech

Salmonella Febrile Ag

Widal Testing With Omega Salmonella

Febrile Antigens

65. Serum Weil-Felix Agglutination Method: Fortress Febrile Ag Agglutination Method: Omega Febrile Antigens

Bureau of Laboratory Quality Standards Page 13 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 14: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Serodiagnostics and Molecular Biology (Continued)

66. Serum Brucella Agglutination Method: Fortress

Febrile Ag

Agglutination Method: Omega

Febrile Antigens

67. Serum Anti-streptolysin O (ASO titer) Agglutination Method: Biotest ASO

Latex Test Kit

ASO Testing with Omega Diagnostics

Latex Test Kit

68. Serum Rheumatoid Arthritis/ Agglutination Method: SERODIA-RA

Rheumatoid Factor (RA/RF) Test Kit

69. Serum Rose-Waaler test Agglutination Method: Omega

Agglutination Kit

70. Serum Syphilis Rapid Plasma Reagin:

RPR Qualitative/Quantitative: Fortress

Agglutination Kit and RPR Qualitative/

Quantitative: Omega Agglutination Kit

71. Serum Syphilis Treponema Pallidum Particle

Agglutination: SERODIA TPPA Test Kit

72. Serum Hepatisis B Surface Antigen ELISA Qualitative Method: Hepnostica

HBsAg Ultra Enzyme Immunoassay

Bureau of Laboratory Quality Standards Page 14 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 15: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International

Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Serodiagnostics and Molecular Biology (Continued)

73. Serum Anti-Hepatisis B Surface Chemiluminescent Immunoassay:

Antigen (Anti- HBsAg Immulite 1000 Analyzer

Quantitative)

74. Serum Anti-Hepatitis B core Ag ELISA Qualitative Method: DiaSorin

(Anti-HBc) Immunoassay

75. Serum Anti-Hepatitis B core Ag IgM ELISA Qualitative Method: DiaSorin

(Anti-HBc IgM) Enzyme Immunoassay

76. Serum Hepatitis B e Antigen Test ELISA Qualitative Method: DiaSorin

(HBeAg) Immunoassay

77. Serum Anti- Hepatitis C Virus ELISA Qualitative Method: Hepnostica

(Anti-HCV) Immunoassay

78. Serum Anti-Hepatitis E Virus ELISA Qualitative Method: MP

(Anti-HEV IgM) Biomedicals Immunoassay

79. Serum Prostate Specific Antigen Chemiluminescent Immunoassay:

(PSA) Immulite 1000 Analyzer

80. Serum Alpha-Feto Protein (AFP) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

81. Serum Carcino-Embryonic Antigen Chemiluminescent Immunoassay:

(CEA) Immulite 1000 Analyzer

Bureau of Laboratory Quality Standards Page 15 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 16: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Serodiagnostics and Molecular Biology (Continued)

82. Serum Dengue IgG and IgM Detection Immunochromatographic assay:

PanBio Dengue Duo Cassette

83. Serum Dengue IgM Detection Capture ELISA Method: PanBio

Dengue IgM Capture ELISA

84. Serum Dengue IgG Detection Capture ELISA Method: PanBio

Dengue IgM Capture ELISA

85. Serum Cancer Antigen 125 (CA 125) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

86. Serum Cancer Antigen 15-3 (CA 15-3) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

87. Serum Cancer Antigen 19-9 (CA 19-9) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

88. Serum Anti-Helicobacter pylori IgG Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

89. Serum Anti-Nuclear Antibodies (ANA) ELISA Qualitative Method:

AESKULISA ANA-8S IgG Capture

Assay

Bureau of Laboratory Quality Standards Page 16 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 17: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Serodiagnostics and Molecular Biology (Continued)

90. Serum Toxoplasma (IgM) Chemiluminescent Immunoassay: Immulite 1000 Analyzer ELISA Qualitative Method: MP Biomedicals Immunoassay

91. Serum Toxoplasma (IgG) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

ELISA Qualitative Method: MP

Biomedicals Immunoassay

92. Serum Rubella (IgM) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

93. Serum Rubella (IgG) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

94. Serum Cytomegalovirus IgM (CMV) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

ELISA Qualitative Method: MP

Biomedicals Immunoassay

95. Serum Cytomegalovirus IgG (CMV) Chemiluminescent Immunoassay:

Immulite 1000 Analyzer

ELISA Qualitative Method: MP

Biomedicals Immunoassay

Bureau of Laboratory Quality Standards Page 17 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 18: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Serodiagnostics and Molecular Biology (Continued)

96. Serum Herpes Simplex Virus 1 IgM ELISA Qualitative Method: MP

(HSV 1 IgM) Biomedicals Immunoassay

97. Serum Herpes Simplex Virus 1 IgG ELISA Qualitative Method: MP

(HSV 1 IgG) Biomedicals Immunoassay

98. Serum Herpes Simplex Virus 2 IgM ELISA Qualitative Method: MP

(HSV 2 IgM) Biomedicals Immunoassay

99. Serum Herpes Simplex Virus 2 IgG ELISA Qualitative Method: MP

(HSV 2 IgG) Biomedicals Immunoassay

100. Whole Blood w/EDTA Malaria Antigen Chromatographic Immunoassay: SD

Bioline Antigen Test

101. Urine Pregnancy Test Chromatographic Immunoassay: hCG

One Step Pregnancy Test

102. Serum Anti-Double Stranded ELISA Qualitative and Quantitative

Dinucleotide Acid Method: AESKULISA Immunoassay

(Anti- ds DNA)

Bureau of Laboratory Quality Standards Page 18 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

Page 19: The Diagnostic Service of Clinical and Research …webdb.dmsc.moph.go.th/ifc_qa/DBQA/ifc_qa/userfiles/4091...Type of Sample Test Method Clinical Laboratory Services (CLS) Clinical

The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Hematology

103. Whole Blood Complete Blood Count (CBC) Flow Cytometry, Hydro Dynamic

Focusing Method: Sysmex XT 1800i

Analyzer

Manual Method : Microhematocrit

Centrifuge and Microscopic

Examination: Wright Stain

104. Whole Blood Erythrocyte Sedimentation Wintrobe method - ESR Analyzer

Rate (ESR)

105. Whole Blood Cell Morphology (Peripheral Wright Stain

Blood Film)

106. Whole Blood Malaria Parasites Thick Film: Wright Stain

107. Whole Blood Direct Coombs Test Agglutination

108. Serum Indirect Coombs test Agglutination

109. Whole Blood Prothrombin Time (PT) Fibrin Clot Formation: DiaMed CD4

Coagulation Analyzer Biological Activation with Scattered Light Detection: Sysmex CA560 Analyzer

Bureau of Laboratory Quality Standards Page 19 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

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The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Hematology (Continued)

110. Whole Blood Activated Partial Fibrin Clot Formation: DiaMed CD4 Thromboplastin Time (APTT) Coagulation Analyzer

Biological Activation with Scattered Light Detection: Sysmex CA560 Analyzer

111. Whole Blood Detection of Hemoglobin Electrophoresis: Capillarys 2 Sebia Variants and Globulin Variants Analyzer

112. Urine Urinalysis (UA) Urinalysis: Aution Max Analyzer

Manual Method:

- Physical Examination

- Chemical Examination

- Microscopic Examination

113. Stool Stool Examination - Physical Examination

- Microscopic Examination

114. Stool Occult Blood Chemical Reaction

Clinical Microbiology

115. Blood Blood Culture - Culture: BacT ALERT and

Versa TREK Analyzer

- Isolation and Identification

- Antimicrobial Susceptibility

Bureau of Laboratory Quality Standards Page 20 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

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The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Microbiology (Continued)

116. Stool/ Rectal Swab Stool Culture for Shigella spp. - Culture

- Isolation and Identification

- Antimicrobial Susceptibility

117. Stool/ Rectal Swab Stool Culture for - Culture

Salmonella spp. - Isolation and Identification

- Antimicrobial Susceptibility

118. Stool/ Rectal Swab Stool Culture for Vibrio spp. - Culture

- Isolation and Identification

- Antimicrobial Susceptibility

119. Stool/ Rectal Swab Stool Culture for - Culture

Campylobacter spp. - Isolation and Identification

- Antimicrobial Susceptibility

120. Urine Urine Culture - Culture

- Isolation and Identification

- Antimicrobial Susceptibility

121. Body Fluid Specimens Body Fluid Culture - Culture: Versa TREK Analyzer - Isolation and Identification

Bureau of Laboratory Quality Standards Page 21 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

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The Diagnostic Service of Clinical and Research Laboratories, International

Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Microbiology (Continued)

Throat Swab, Culture - Culture

Upper Respiratory - Isolation and Identification

Specimens, Sputum, - Antimicrobial Susceptibility

Culture Conjunctival

Swab, Ear Swab, Genital

Specimen

122. Stool or Rectal Swab Vibrio Identification Microscopic Examination: Dark Field

preserved in Cary Blair Microscopy

Media or Bile Peptone

Broth

123. Body Fluid Body Fluid Analysis Microscopic Examination

- Physical appearance

- Red cell and white cell count

- Differential count

124. Throat Swab Kleb Loefflers Bacillus Microscopic Examination:

Albert Staining

125. Isolate, Body Specimen Gram Stain Microscopic Examination: Gram Staining

126. Skin Scraping, KOH Wet Mount for Microscopy Microscopic Examination: Body Specimen KOH Solution

Bureau of Laboratory Quality Standards Page 22 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

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The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Clinical Microbiology (Continued)

127. Vaginal Swab Identification of Trichomonas Microscopic Examination

128. CSF, Urine, Sputum Acid Fast Bacilli Stain (AFB) Microscopic Examination:

Ziehl-Neelsen Staining

Research Laboratories

Nutritional Biochemistry

129. Serum Retinol High Performance Liquid

Chromatography (HPLC)

130. Serum 25-OH Vitamin D Enzyme Linked Immunosorbent Assay (ELISA)

131. Serum Ferritin Terbidometric: Hitachi 902 Analyzer

132. Serum sTransferrin Receptor Terbidometric: Hitachi 902 Analyzer

133. Serum C-Reactive Protein Terbidometric: Hitachi 902 Analyzer

134. Serum Lead Graphite Furnace Atomic Absorption Spectrometry (GFAAS)

135. Serum Vitamin B12 Chemiluminescence: Cobas e601 Analyzer

136. Serum Folate Chemiluminescence: Cobas e601 Analyzer

Bureau of Laboratory Quality Standards Page 23 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

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The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Nutritional Biochemistry (Continued)

137. Urine Iodine Enzyme Linked Immunosorbent Assay (ELISA)

138. Serum Alpha-Tocopherol High Performance Liquid Chromatography (HPLC)

Tuberculosis Laboratory

139. Sputum, Laryngeal Swabs, Skin Scrap, Soft Tissue, Urine, Stool, Gastric Lavage, Pus, CSF, Bone Marrow, Biopsy Tissue, Ascitic fluid, Tracheal Fluid, Synovial fluid, Pleural Fluid

Acid Fast Bacilli (AFB) - Microscopic Examination: Ziehl-Neelsen Staining - Fluorescence Microscopic

Examination: Auramine O Fluorescence Acid-Fast Staining: Light Emitting Diode (LED)

140. Sputum, Laryngeal Swabs, Skin Scrap, Soft Tissue, Urine, Stool, Gastric Lavage, Pus, CSF, Bone Marrow, Biopsy Tissue, Ascitic Fluid, Tracheal Fluid, Synovial Fluid, Pleural Fluid

Mycobacterium tuberculosis - Culturing - Drug Susceptibility Testing

Bureau of Laboratory Quality Standards Page 24 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

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The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Virology Laboratory

141. Serum, Plasma, Whole Blood

Anti-HIV 1/2 ELISA: Veronostika HIV Uni-Form II Ag/Ab test kit, Biomerieux, Boxtel, Netherlands

Immunoblot: Western Blot; INNO-LIA HIV I/II score kit, Innogenetics N.V., Belgium

Immunochromatography: Determine HIV-1/2, Inverness Medical Japan Co., Ltd

Immunochromatography: Unigold TM HIV, Trinity Biotech PLC, Ireland

Immunochromatography: SD Bioline HIV-1/2 3.0, Standard Diagnostics, Inc, Korea

Blood Bank

142. EDTA Blood, Malaria Immunochromatography Serum, Plasma

143. Serum, Plasma Rapid Plasma Regin (RPR) Flocculation

144. Whole Blood Direct Coombs Test Agglutination

Bureau of Laboratory Quality Standards Page 25 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014

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The Diagnostic Service of Clinical and Research Laboratories, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has been accepted as an accredited laboratory in the field of medical laboratory for the following scopes.

Type of Sample Test Method

Blood Bank (Continued)

145. Whole Blood, Serum ABO Blood Grouping Agglutination: Tube and Slide Method

Whole Blood or Packed Rh Typing Agglutination: Diamed Gel Card Red Blood Cells System Analyzer

Bureau of Laboratory Quality Standards Page 26 of 26

Accreditation Number 4091 / 54

Date of Accreditation : 26 December 2012

Date of Expiration : 25 December 2014