Registration No. HOKLAS 805S Page 1 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所有限公司 ADDRESS 地址 Main facility: 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四樓 Branch facilities: Central Branch : PathLab Medical Laboratory - 1005A Melbourne Plaza, 33 Queen’s Road Central, Hong Kong. 栢立醫學化驗所 - 香港中環皇后大道中33 號萬邦行1005A室 Causeway Bay Branch : PathLab Medical Laboratory - 1810 East Point Centre, 555 Hennessy Road, Hong Kong. 栢立醫學化驗所 - 香港銅鑼灣軒尼詩道555號東角中心1810室 Kowloon Branch : PathLab Medical Laboratory - 1215 Argyle Centre, Phase 1, 688 Nathan Road, Mongkok, Kln. 栢立醫學化驗所 - 九龍旺角彌敦道688號旺角中心第一期1215室 LABORATORY DIRECTOR 化驗所主管 : Biomedical Scientist Director 醫務科學主管: Mrs Marianne LEUNG YANG Shih-ti 梁楊世嫡女士 BS, MT(ASCP)(USA), MIBMS(UK) AUTHORISED REPRESENTATIVE 委任代表 ENQUIRY 查詢 CLIENTELE 服務對象 Mrs Marianne LEUNG YANG Shih-ti 梁楊世嫡女士 : Ms Countess TAM Chung-mei 譚宗薇女士 Tel. 電話 : 3983 1800 Fax. 傳真 : 2529 6082 E-mail 電子郵箱 : [email protected] Website Address 網頁地址 : www.pathlabhk.com : Private physicians, medical centres, private and public hospitals and other medicallyrelated institutions 私家醫生,醫療中心, 私營及公營醫院和與醫療有關的機構 PATHOLOGIST IN CHARGE OF THE ACCREDITED DISCIPLINE : Nil 負責認可範疇的病理學專科醫生 SCOPE OF ACCREDITATION 認可範圍: Accredited Test Category Medical Testing 認可測試類別 醫務化驗 Accredited Discipline Chemical Pathology Clinical Microbiology and Infection 認可範疇 化學病理學 臨床微生物學及傳染病 Haematology Immunology 血液學 免疫學 Medical Genetics 醫學遺傳學 Registration No. HOKLAS 805S Page 2 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Chemical Pathology Drug of abuse testing Urine Amphetamines / Methampetamine II by Immunoassay (Fluorescent label) Barbiturates by Immunoassay (Fluorescent label) Abbott Axsym System Amphetamine/ Methamphetamine II assay Abbott Axsym System Barbiturates assay Benzodiazepines by Immunoassay (Fluorescent label) Abbott Axsym System Benzodiazepines assay Cannabinoids (THC) by Immunoassay (Fluorescent label) Abbott Axsym System Cannabinoids assay Cocaine Metabolites by Immunoassay (Fluorescent label) Abbott Axsym System Cocaine Metabolites assay Methadone by Immunoassay (Fluorescent label) Abbott Axsym System Methadone assay Opiates by Immunoassay (Fluorescent label) Phencyclidine (PCP) by Immunoassay (Fluorescent label) General chemistry Fluoride Plasma Serum Abbott Axsym System Opiates assay Abbott Axsym System Phencyclidine assay Glucose by Spectrophotometry Ortho-Vitros Fusion 5.1 System GLU slides Albumin by Spectrophotometry Ortho-Vitros Fusion 5.1 System ALB slides Alanine Aminotransferase (ALT) by Spectrophotometry Ortho-Vitros Fusion 5.1 System ALT slides Alkaline Phosphatase (ALP) by Spectrophotometry Ortho-Vitros Fusion 5.1 System ALKP slides Amylase by Spectrophotometry Ortho-Vitros Fusion 5.1 System AMYL slides Aspartate Aminotransferase (AST) by Spectrophotometry Ortho-Vitros Fusion 5.1 System AST slides Registration No. HOKLAS 805S Page 3 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Chemical Pathology (cont’d) General chemistry (cont’d) Serum (cont’d) Bicarbonate [CO2 content] by Spectrophotometry Ortho-Vitros Fusion 5.1 System ECO2 slides Bilirubin, Direct by Spectrophotometry Ortho-Vitros Fusion 5.1 System TBIL and BuBc slides Bilirubin, Neonatal by Spectrophotometry Ortho-Vitros Fusion 5.1 System BuBc slides Bilirubin, Total by Spectrophotometry Ortho-Vitros Fusion 5.1 System TBIL slides Calcium by Spectrophotometry Ortho-Vitros Fusion 5.1 System CA slides Chloride by Potentiometry (Ion Selective Electrode) Ortho-Vitros Fusion 5.1 System CL slides Cholesterol, Total by Spectrophotometry Ortho-Vitros Fusion 5.1 System CHOL slides Cholesterol, HDL by Spectrophotometry Ortho-Vitros Fusion 5.1 System HDL slides Cholesterol, LDL by Immunoassay (colorimetric method) Creatine Kinase (CK), Total by Spectrophotometry Ortho-Vitros Fusion 5.1 System dLDL reagent Ortho-Vitros Fusion 5.1 System CK slides Creatinine by Spectrophotometry Ortho-Vitros Fusion 5.1 System CREA slides Gamma Glutamyl Transferase (GGT) by Spectrophotometry Ortho-Vitros Fusion 5.1 System GGT slides Iron by Spectrophotometry Ortho-Vitros Fusion 5.1 System FE slides Lactate Dehydrogenase (LDH) by Spectrophotometry Ortho-Vitros Fusion 5.1System LDH slides Registration No. HOKLAS 805S Page 4 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Chemical Pathology (cont’d) General chemistry (cont’d) Serum (cont’d) Lipase by Spectrophotometry Ortho-Vitros Fusion 5.1 System LIPA slides Magnesium by Spectrophotometry Ortho-Vitros Fusion 5.1 System MG slides Phosphorus by Spectrophotometry Ortho-Vitros Fusion 5.1 System PHOS slides Potassium by Potentiometry (Ion Selective Electrode) Ortho-Vitros Fusion 5.1 System K slides Protein, Total by Spectrophotometry Ortho-Vitros Fusion 5.1 System TP slides Sodium by Potentiometry (Ion Selective Electrode) Ortho-Vitros Fusion 5.1 System NA slides Total Iron Binding Capacity (TIBC) by Spectrophotometry Ortho-Vitros Fusion 5.1 System dTIBC slides Triglyceride by Spectrophotometry Ortho-Vitros Fusion 5.1 System TRIG slides Urea Nitrogen (BUN) by Spectrophotometry Ortho-Vitros Fusion 5.1 System BUN slides Uric acid Spectrophotometry Urine Albumin by Immunoturbidimetry Amylase by Spectrophotometry Ortho-Vitros Fusion 5.1 System URIC slides Ortho-Vitros Fusion 5.1System with Roche TinaQuant Reagent Ortho-Vitros Fusion 5.1 System AMYL slides Calcium by Spectrophotometry Creatinine by Spectrophotometry Ortho-Vitros Fusion 5.1 System CA slides Ortho-Vitros Fusion 5.1 System CREA slides Registration No. HOKLAS 805S Page 5 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Chemical Pathology (cont’d) General chemistry (cont’d) Urine (cont’d) Glucose by Spectrophotometry Ortho-Vitros Fusion 5.1 System GLUC slides Magnesium by Spectrophotometry Ortho-Vitros Fusion 5.1 System MG slides Phosphorus by Spectrophotometry Ortho-Vitros Fusion 5.1 System PHOS slides Potassium by Potentiometry (Ion Selective Electrode) Ortho-Vitros Fusion 5.1 System K slides Protein by Spectrophotometry Ortho-Vitros Fusion 5.1 System UPRO slides Sodium by Potentiometry (Ion Selective Electrode) Ortho-Vitros Fusion 5.1 System NA slides Urea Nitrogen (BUN) by Hormones Serum Spectrophotometry Ortho-Vitros Fusion 5.1 System BUN slides Uric acid by Spectrophotometry Ortho-Vitros Fusion 5.1 System URIC slides Cortisol, by Immunoassay (Fluorescent label) Dehydroepiandrosterone Sulphate (DHEA-S) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Cortisol assay Siemens Immulite XPi System DHEA-S assay Estradiol (E2) by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System Estradiol assay Follicle Stimulating Hormone (FSH) by Immunoassay (Chemiluminescent label) Growth Hormone (GH) by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System FSH assay Siemens Immulite XPi System Growth Hormone assay Registration No. HOKLAS 805S Page 6 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Chemical Pathology (cont’d) Hormones (cont’d) Serum (cont’d) Luteinising Hormone (LH) by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System LH assay Parathyroid Hormone (PTH) by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System PTH assay Progesterone by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System Progesterone assay Prolactin by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System Prolactin assay Testosterone, Total by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System Testosterone assay T Uptake by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System T-Uptake assay Thyroxine, Free (FT4) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Free T4 assay Thyroxine, Total (T4) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Total T4 assay Triiodothyronine, Free (FT3) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Free T3 assay Triiodothyronine, Total (T3) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Total T3 assay Thyroid Stimulating Hormone (TSH) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System TSH assay Registration No. HOKLAS 805S Page 7 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Chemical Pathology (cont’d) Proteins, qualitative analysis Serum C Reactive Protein (CRP) by Immunoturbidimetry Ortho-Vitros Fusion 5.1 System CRP slides Proteins, quantitative analysis Serum Ferritin by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Ferritin assay Special chemistry EDTA whole blood Haemoglobin A1c (HbA1c) by Ion Exchange High Performance Liquid Chromatography (HPLC) Serum Bio-Rad D-10 Haemoglobin Testing System HbA1c assay Folate by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System Folate assay Vitamin B12 by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System Vitamin B12 assay Vitamin D by Immunoassay (Enzyme-based label) Bio-Rad Evolis ELISA Microplate System IDS 25-Hydroxy Vitamin D EIA assay Therapeutic drug monitoring Serum Carbamazepine by Immunoassay (Fluorescent label) Abbott Architect i2000SR System Carbamazepine assay Digoxin by Immunoassay (Enzyme-based label) Abbott Architect i2000SR System Digoxin assay Phenobarbital by Immunoassay (Fluorescent label) Abbott Architect i2000SR System Phenobarbital assay Phenytoin by Immunoassay (Fluorescent label) Abbott Architect i2000SR System Phenytoin assay Valproic Acid by Immunoassay (Fluorescent label) Abbott Architect i2000SR System Valproic Acid assay Registration No. HOKLAS 805S Page 8 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Chemical Pathology (cont’d) Tumour markers Serum Alpha-feto Protein (AFP) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System AFP assay Beta-Human Chorionic Gonadotropin (-HCG), quantitative, by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Beta-HCG assay CA 15-3 by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System CA15-3 assay CA19-9 by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System CA19-9 assay CA 125 by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System CA 125 assay Carcinoembryonic Antigen (CEA) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System CEA assay Prostate Specific Antigen, Free (FPSA) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Free PSA assay Prostate Specific Antigen, Total (TPSA) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Total PSA assay Thyroglobulin (TG) by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System Thyroglobulin assay Registration No. HOKLAS 805S Page 9 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Clinical Microbiology Bacteriology – Culture and and Infection sensitivity tests and microscopy Genital samples (including HVS, endocervical swab, urethral swab, etc) Microscopy for Cell Morphology and Microorganisms by Gram stain Manual method as documented in M015 Culture and Antimicrobial Susceptibility Tests for Genital Pathogens (including Neisseria gonorrhoeae) by Aerobic and CO2 culture Culture: Method as documented in M100 Antimicrobial susceptibility tests: Method as documented in MMID Vitek ID and AST Set Up PRO and MMST Disc Diffusion PRO Lower respiratory tract samples (including sputum, bronchial aspirate, tracheal Microscopy for Cell Morphology and Microorganism by Gram stain Manual method as documented in M015 aspirate etc) Culture and Antimicrobial Susceptibility Tests for Respiratory Tract Pathogens by Aerobic culture Culture (sputum and tracheal aspirate): Method as documented in M200L Antimicrobial susceptibility tests: MMID Vitek ID and AST Set Up PRO, MMST Disc Diffusion PRO Culture (bronchial aspirate): M200L and M600 Antimicrobial susceptibility tests: MMID Vitek ID and AST Set Up PRO, MMST Disc Diffusion PRO and MMST ETest PRO Upper respiratory tract samples (including throat swab, nasal swab etc) Microscopy for Cell Morphology and Microorganisms by Gram stain Manual method as documented in M015 Culture and Antimicrobial Susceptibility Tests for Respiratory Tract Pathogens by Aerobic culture Culture: Method as documented in M200U, M600 and MMST MRSA and MRS PRO ID Antimicrobial susceptibility tests: MMID Vitek ID and AST Set Up PRO, MMST Disc Diffusion PRO Registration No. HOKLAS 805S Page 10 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Clinical Microbiology Bacteriology – Culture and and Infection sensitivity tests and microscopy (cont’d) (cont’d) Enteric samples (including stool and rectal swab) Culture and Antimicrobial Susceptibility Tests for Enteric Pathogens by Aerobic & Microaerophilic culture Culture: Method as documented in M400 Antimicrobial susceptibility tests: method as documented in MMID Vitek ID and AST Set Up PRO and MMST Disc Diffusion PRO Culture Antimicrobial Susceptibility Tests of Clostridium difficile by Anaerobic culture Culture: Method as documented in M600 Antimicrobial susceptibility tests: method as documented in MMST ETest PRO Superficial wound samples (including eye, ear, skin swabs, etc) Microscopy for Cell Morphology and Microorganisms by Gram stain Manual method as documented in M015 Culture and Antimicrobial Susceptibility Tests for Pathogens by Aerobic culture Culture: Method as documented in M300 Antimicrobial susceptibility tests: Method as documented in MMID Vitek ID and AST Set Up PRO and MMST Disc Diffusion PRO Deep wound samples fluid, (including abscess pus or tissue, etc) Urine Microscopy for Cell Morphology and Microorganisms by Gram stain Manual method as documented in M015 Culture and Antimicrobial Susceptibility Tests for Pathogens by Aerobic culture Culture: Method as documented in M500 Antimicrobial susceptibility tests: Method as documented in MMID Vitek ID and AST Set Up PRO and MMST Disc Diffusion PRO Registration No. HOKLAS 805S Page 11 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 DISCIPLINE 專科範疇 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Clinical Microbiology Bacteriology – Serology and Infection Serum (cont’d) Helicobacter pylori Antibody (IgG) by Immunoassay (Chemiluminescent label) Siemens Immulite XPi System H. pylori IgG Ab assay Mycoplasma pneumoniae Antibodies (IgG ) by Indirect Immunofluorescence Euroimmun Analyser 1 Mycoplasma pneumonia IgG Ab assay Microbiology – Miscellaneous tests Serum Toxoplasma gondii Antibody (IgG) by Immunoassay (Enzyme-linked fluorescent label) bioMerieux Vitek ImmunoDiagnostic Assay System (VIDAS) Toxoplasma IgG Ab assay Parasitology Stool Stool for Routine Ova, Cysts, and Trophozoites (O&P) by Direct & Stained smears and concentration Manual method as documented in U004 method Syphilis Serology Serum Rapid Plasma Reagin Antibody (RPR) by Flocculation method Cortez Diagnostics, Inc, RPR assay Treponema pallidum Antibody by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Syphilis assay Treponema pallidum Antibody (FTA-Abs) by Indirect Immunofluorescence Euroimmun Analyser 1 Treponema pallidum IgG Ab assay Urinalysis and/or urine microscopy Urine Urinalysis by Dipstick Siemens Clinitek 500 Urine Chemistry System using Siemens Multistix 10 SG Urine Formed Elements by Wet smear microscopic examination Method as documented in U001 using Neubauer Chamber Diasys Micro System and Sysmex UF-100 Micro System Registration No. HOKLAS 805S Page 12 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Clinical Microbiology Virology – Serology and Infection (cont’d) Serum Cytomegalovirus Antibody (IgG) by Immunoassay (Enzyme-linked fluorescent label) bioMerieux Vitek ImmunoDiagnostic Assay System (VIDAS) CMV IgG Ab assay Hepatitis A Virus Antibody (IgG) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR HAV IgG Ab assay Hepatitis A Virus Antibody (IgM) by Immunoassay (Enzyme-linked fluorescent label) bioMerieux Vitek ImmunoDiagnostic Assay System (VIDAS) HAV IgM Ab assay Hepatitis B Core Virus Antibody (HBcAb) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System HBcAb II assay Hepatitis B Virus Antibody (HBsAb) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System HBsAb assay Hepatitis B Surface Antigen (HBsAg) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System HBsAg assay Hepatitis C Virus Antibody (anti-HCV) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System HCV Ab assay Human Immunodeficiency Virus I and II Antibody and p24 Antigen by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System HIV Ag/Ab Combo assay HTLV 1& 2 Antibodies by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System HTLV 1&2 Ab assay Measles Virus Antibody (IgG) by Immunoassay (Enzyme-linked fluorescent label) bioMerieux Vitek ImmunoDiagnostic Assay System (VIDAS) Measles IgG Ab assay Rubella Virus Antibody (IgG) by Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System Rubella IgG Ab assay Varicella-zoster Virus Antibody (IgG) by Immunoassay (Enzyme-linked fluorescent label) bioMerieux Vitek ImmunoDiagnostic Assay System (VIDAS) Varicella-zoster IgG Ab assay Registration No. HOKLAS 805S Page 13 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Haematology Haematology – General EDTA whole blood Complete Blood Count including - Haemoglobin - Haematocrit - Leucocyte count (WBC count) Bayer Advia 120 Haematology System Bayer Advia 2120i Haematology System Method as documented in H018 - Leucocyte differential count - Mean Corpuscular volume (MCV) - Mean corpuscular haemoglobin concentration (MCHC) - Mean corpuscular haemoglobin (MCH) - Platelet count - Red cell count - Red cell distribution width (RDW) Peripheral Blood Smear Examination by Wright stain Haematology – Immunohaematology Clotted blood or EDTA whole blood Manual method as documented in P067 ABO and Rh(D) Typing by Red Cell Agglutination Grifols WADiana 8XT System Manual method as documented in H001 Registration No. HOKLAS 805S Page 14 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Immunology Autoantibodies Serum Antinuclear antibodies by Indirect immunofluorescence ANA Hep-20-10 assay dsDNA antibody by Immunoassay (Enzyme-based label) Euroimmun Analyser 1 System dsDNA assay Immunochemistry Serum C3 Complement by Immunoturbidimetry Ortho-Vitros Fusion 5.1 System C3 reagent C4 Complement by Immunoturbidimetry Ortho-Vitros Fusion 5.1 System C4 reagent Immunoglobulin A (IgA) by Immunoturbidimetry Ortho-Vitros Fusion 5.1 System IgA reagent Immunoglobulin E (IgE), Total by Immunoassay (Chemiluminescent label) Siemens Immunite XPi System Total IgE assay Immunoglobulin G (IgG) by Immunoturbidimetry Ortho-Vitros Fusion 5.1 System IgG reagent Immunoglobulin M (IgM) by Immunoturbidimetry Ortho-Vitros Fusion 5.1 System IgM reagent Rheumatoid Arthritis Factor (RA Factor) by Immunoturbidimetry Ortho-Vitros Fusion 5.1 System RF reagent Registration No. HOKLAS 805S Page 15 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Main facility: DISCIPLINE 專科範疇 4/F, Henan Building, 90-92 Jaffe Road, Wanchai, Hong Kong. 香港灣仔謝斐道90至92號豫港大廈四字樓 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Medical Genetics Molecular Genetics Cervical scraping and cervical aspirate, endocervical swab, vaginal swab, male urethral swab and urine Chlamydia trachomatis – detection by Real-time Polymerase Chain Reaction, qualitative (Target region: cryptic plasmid and ompA gene) Nucleic acid extraction, amplification and detection by COBAS 4800 using cobas® 4800 CT/NG Test Neisseria gonorrhoeae – detection by Real-time Polymerase Chain Reaction, qualitative Nucleic acid extraction, amplification and detection by COBAS 4800 using cobas® 4800 (Target region: DR-9) CT/NG Test Registration No. HOKLAS 805S Page 16 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Kowloon Branch : DISCIPLINE 專科範疇 1215 Argyle Centre, Phase 1, 688 Nathan Road, Mongkok, Kowloon. 九龍旺角彌敦道688號旺角中心第一期1215室 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Clinical Microbiology Urinalysis and/or urine and Infection microscopy Urine Urinalysis by Dipstick Method as documented in U001 using Siemens Multistix 10 SG Urine Formed Elements by Wet smear microscopic examination Method as documented in U001 using Neubauer Chamber Registration No. HOKLAS 805S Page 17 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Kowloon Branch : DISCIPLINE 專科範疇 1215 Argyle Centre, Phase 1, 688 Nathan Road, Mongkok, Kowloon. 九龍旺角彌敦道688號旺角中心第一期1215室 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Haematology Haematology – General EDTA whole blood Complete Blood Count including - Haemoglobin Sysmex XS-1000i Haematology System - Haematocrit Manual method as documented in H018 - Leucocyte count (WBC count) - Leucocyte differential count - Mean corpuscular volume (MCV) - Mean corpuscular haemoglobin concentration (MCHC) - Mean corpuscular haemoglobin (MCH) - Platelet count - Red cell count - Red cell distribution width (RDW) Peripheral Blood Smear Examination by Wright stain Manual method as documented in P067 Registration No. HOKLAS 805S Page 18 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Central Branch : DISCIPLINE 專科範疇 1005A Melbourne Plaza, 33 Queen’s Road Central, Hong Kong. 香港中環皇后大道中 33 號萬邦行 1005A TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Clinical Microbiology Urinalysis and/or urine and Infection microscopy Urine Urinalysis by Dipstick Urine Formed Elements by Wet smear microscopic examination Method as documented in U001 using Siemens Multistix 10 SG Method as documented in U001 using Neubauer Chamber Registration No. HOKLAS 805S Page 19 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Central Branch : DISCIPLINE 專科範疇 1005A Melbourne Plaza, 33 Queen’s Road Central, Hong Kong. 香港中環皇后大道中 33 號萬邦行 1005A TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Haematology Haematology – General EDTA whole blood Complete Blood Count including - Haemoglobin - Haematocrit - Leucocyte count (WBC count) - Leucocyte differential count - Mean corpuscular volume (MCV) - Mean corpuscular haemoglobin concentration (MCHC) - Mean corpuscular haemoglobin (MCH) - Platelet count - Red cell count - Red cell distribution width (RDW) Peripheral Blood Smear Examination by Wright stain Cell Dyn 3700 Haematology System Manual method as documented in H018 Manual method as documented in P067 Registration No. HOKLAS 805S Page 20 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Causeway Bay Branch : DISCIPLINE 專科範疇 1810 East Point Centre, 555 Hennessy Road, Hong Kong. 香港銅鑼灣軒尼詩道 555 號東角中心 1810 室 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Clinical Microbiology Urinalysis and/or urine and Infection microscopy Urine Urinalysis by Dipstick Method as documented in U001 using Siemens Multistix 10 SG Urine Formed Elements by Wet smear microscopic examination Method as documented in U001 using Neubauer Chamber Registration No. HOKLAS 805S Page 21 of 21 18 August 2014 Ref: 805S-16 805 MED PathLab Medical Laboratories Limited 栢立醫學化驗所 Causeway Bay Branch : DISCIPLINE 專科範疇 1810 East Point Centre, 555 Hennessy Road, Hong Kong. 香港銅鑼灣軒尼詩道 555 號東角中心 1810 室 TEST AREA OR SAMPLE TYPE SPECIFIC EXAMINATION OR PROPERTY MEASURED METHOD OR TECHNIQUE USED 測試範圍或樣本種類 特定測試或量度的特性 方法或應用技術 This laboratory is accredited for performing examinations listed in the scope below. Haematology Haematology – General EDTA whole blood Complete Blood Count including - Haemoglobin - Haematocrit Sysmex XS-1000i Haematology System Manual method as documented in H018 - Leucocyte count (WBC count) - Leucocyte differential count - Mean corpuscular volume (MCV) - Mean corpuscular haemoglobin concentration (MCHC) - Mean corpuscular haemoglobin (MCH) - Platelet count - Red cell count - Red cell distribution width (RDW) Peripheral Blood Smear Examination by Wright stain Manual method as documented in P067
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