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3 DiaSorin Murex HBsAg Confirmatory Version

3 Immunochromatographic Test Alere Determine HBsAg - HBeAg by Immunoassay (chemiluminescent label) Roche Cobas HBeAg Scope of Accreditation Registration No. HOKLAS 801P Page

3 of

34 Issue Date:

1 April

2019 Ref: HOKLAS801P-36

801 MED PTP Department of Health - Centre for Health Protection, Public Health Laboratory Services Branch, Microbiology Division o生署,o生防护中心,公共o生化验服务处,微生物部 ASE Laboratory: 5/F, 9/F &

10/F, Public Health Laboratory Centre,

382 Nam Cheong Street, Shek Kip Mei, Kowloon, HK 香港九龙石硖尾,南昌街

382 号,公共o生检测中心五楼、九楼及十楼 MEDICAL TESTING DISCIPLINE 专科 TEST AREA OR SAMPLE TYPE 测试围或样本种类 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定测试或量度的特性 METHOD OR TECHNIQUE USED 方法或应用技术 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed in the scope below. Clinical Virology C Serology (cont'

d) Microbiology Serum (cont'

d) Human immunodeficiency virus antigen and and Infection antibody by (cont'

d) Immunoassay (enzyme-based label) DiaSorin Murex HIV Ag/Ab Combination BioRad Genscreen Ultra HIV Ag-Ab Enzyme-linked Fluorescent Assay bioMérieux VIDAS HIV DUO Ultra Human immunodeficiency virus antibody by Immunoblot assay INNO-LIA HIV I/II Score Western Blot MP Diagnostics HIV Blot 2.2 MP Diagnostics HIV-2 Blot 1.2 Human T-cell lymphotropic virus I antibody by Particle Agglutination Test Fujirebio Serodia HTLV-1 Western Blot MP Diagnostics HTLV Blot 2.4 Urine Human immunodeficiency virus I antibody by IgG Antibody Capture Particle Adherence Test Method as documented in MIC-MTH-ASE-HIV-PAT (GACPAT) Western Blot MP Diagnostics HIV Blot 2.2 Syphilis serology Serum Treponema pallidum antibody by - Enzyme immunoassay DiaSorin Murex ICE Syphilis on EVOLIS automated Immunoassay analyser - Fluorescent treponemal antibody- Immuno Diagnostics AccuDiag FTA-ABS (Syphilis) IFA absorption test (FTA-ABS) - Treponema pallidum Passive Particle Method as documented in MIC-MTH-ASE-SYP-TPA Agglutination test (TPPA) Reagin antibodies in response to Treponemal infection by Serum - Rapid Plasma Reagin (RPR) BD Macro-Vue RPR card Tests Serum and CSF - Venereal Disease Research Laboratory Method as documented in MIC-MTH-ASE-SYP-VDR test (VDRL) Scope of Accreditation Registration No. HOKLAS 801P Page

4 of

34 Issue Date:

1 April

2019 Ref: HOKLAS801P-36

801 MED PTP Department of Health - Centre for Health Protection, Public Health Laboratory Services Branch, Microbiology Division o生署,o生防护中心,公共o生化验服务处,微生物部 BAC Laboratory: 6/F &

8/F, Public Health Laboratory Centre,

382 Nam Cheong Street, Shek Kip Mei, Kowloon, HK 香港九龙石硖尾,南昌街

382 号,公共o生检测中心六楼及八楼 MEDICAL TESTING DISCIPLINE 专科 TEST AREA OR SAMPLE TYPE 测试围或样本种类 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定测试或量度的特性 METHOD OR TECHNIQUE USED 方法或应用技术 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed in the scope below. Clinical Bacteriology C Culture and Microbiology sensitivity tests and/or and Infection microscopy (cont'

d) Blood Culture and antimicrobial susceptibility test for pathogens by Aerobic and anaerobic broth culture Culture: Method as documented in MIC-MTH-BAC-B01 using BD BACTEC FX40 Identification of isolates: Method as documented in MIC-MTH-BAC-ID3 Antimicrobial susceptibility tests: Method as documented in MIC-MTH-BAC-AST Blood and bone marrow Culture for acid-fast bacilli (AFB) by Aerobic broth culture Method as documented in MIC-MTH-BAC-B01 using BD BACTEC FX40 CSF Microscopy for Method as documented in MIC-MTH-BAC-B02 Cell count by Counting chamber Cell morphology by Giemsa stain Bacteria by Gram stain Encapsulated yeast by India ink stain Culture and antimicrobial susceptibility test for pathogens by Aerobic, CO2 and anaerobic culture Culture: Method as documented in MIC-MTH-BAC-B02 Identification of isolates: Method as documented in MIC-MTH-BAC-ID3 Antimicrobial susceptibility tests: Method as documented in MIC-MTH-BAC-AST CSF Culture for pathogens by (Postmortem) Aerobic and anaerobic broth culture Culture: Method as documented in MIC-MTH-BAC-B02 using BD BACTEC FX40 Identification of isolates: Method as documented in MIC-MTH-BAC-ID3 Scope of Accreditation Registration No. HOKLAS 801P Page