Registration No. HOKLAS 817P Page 1 of 34 22 October 2014
Registration No. HOKLAS 817P Page 1 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 ADDRESS 地址 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 (i) (ii) (iii) (iv) (v) (vi) LABORATORY DIRECTOR 化驗所主管 Autopsy Service, B03, Blk. S Anatomical Pathology Laboratory, L02, Blk. S Chemical Pathology Laboratory, L02, Blk. S Microbiology Laboratory, L02, Blk. S Haematology Laboratory, L02, Blk. S Blood Bank, L02, Blk. S : Pathologist Director 病理學主管 : Dr Eudora CHOW Yu-de 周于德醫生 MBBS (HK), FRCPC (Canada), FHKCPath, FHKAM (Pathology) AUTHORISED REPRESENTATIVE 委任代表 ENQUIRY 查詢 Ms Alice YIP Shuk-fun 葉淑芬女士 : Ms Alice YIP Shuk-fun 葉淑芬女士 Tel. Fax. E-mail CLIENTELE 服務對象 PATHOLOGIST IN CHARGE OF THE ACCREDITED DISCIPLINE 負責認可範疇的病理學 專科醫生 電話 傳真 電郵 : 3949 6517 : 3949 5613 : [email protected] : Public and private hospitals and clinics 公營及私營醫院和診所 Anatomical Pathology 解剖病理學 Dr Nancy YUEN Wah-fun Clinical Microbiology and Infection Dr Kitty FUNG Sau-chun Haematology 血液學 Dr Eudora CHOW Yu-de 阮華芬醫生 (Full-time 臨床微生物學及傳染病 馮秀珍醫生 (Full-time 全職) 周于徳醫生 全職) (Full-time 全職) SCOPE OF ACCREDITATION 認可範圍: Accredited Test Category Medical Testing 認可測試類別 醫學測試 Accredited Discipline Anatomical Pathology Chemical Pathology Clinical Microbiology and Infection Haematology Immunology Medical Genetics 認可範疇 解剖病理學 化學病理學 臨床微生物學及傳染病 血液學 免疫學 醫學遺傳學 Registration No. HOKLAS 817P Page 2 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Anatomical Pathology Laboratory: L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 DISCIPLINE 專科範疇 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Anatomical Pathology Cytopathology Gynaecological specimens Gynaecological cytology examination by Papanicolaou staining Specimen preparation and routine staining: ThinPrep + Papanicolaou stain Conventional smear + Papanicolaou stain Method as documented in OPACPU001, 002, 011, 012, 014, 015 & 016; OPACST001 & 003 Non-gynaecological specimens Non-gynaecological cytology examination by H&E, Papaniolaou and special staining Specimen preparation and routine staining: Haematoxylin and Eosin stain Papanicolaou stain Method as documented in OPACPU001- 010, 013 -016; OPACST001, 003 & 004 Special staining (manual method): Method as documented in OPACST002; OPAHST012, 027 & 037 Cresyl Fast Violet stain Grocott's Methenamine Silver stain Perls' Prussian Blue stain Ziehl-Neelsen stain and other staining methods in Histopathology Lab Fine needle aspirates Fine Needle Aspiration cytology examination by H&E, Papaniolaou and special staining Specimen collection, preparation and routine staining (both automatic and manual method): Haematoxylin and Eosin stain Papanicolaou stain May Grunwald-Giemsa stain Cell block preparation and other staining methods in Histopathology Lab: Method as documented in OPACRE001; OPAFNA003-005; OPACPU001 - 005, 009; OPACST001, 003 & 004; OPAHST001 - 038 Registration No. HOKLAS 817P Page 3 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Anatomical Pathology Laboratory: L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 DISCIPLINE 專科範疇 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Anatomical Pathology Histopathology (cont’d) Surgical pathology Histology examination by H&E and special staining Specimen preparation and Haematoxylin and Eosin staining by manual and automatic staining method: Method as documented in OPAHGE001 - 024; OPAHST013 & 014 Special staining (manual method): Method as documented in OPAHST 001 - 038 Alcian Blue stain Bielschowsky's Silver stain Chromotrope-Aniline Blue stain Crystal Violet stain Giemsa stain Gomori's Trichrome (Rapid, one step) stain Gordon & Sweet's stain Gram stain Grocott's Methenamine Silver stain Hale's Colloidal Iron stain Highman's Congo Red stain Lactate Dehydrogenase Reaction Long Ziehl-Neelsen stain Martius yellow - Scarlet red - soluble Blue (MSB) stain Masson Trichrome stain Oil red O stain Orcein (Tarzer-Unna) stain Periodic Acid-Schiff stain with or without digestion Periodic Acid-Silver Methenamine (PASM) stain Perls' Prussian Blue stain Schmorl stain with/without bleaching Solochrome Cyanide stain Southgate's Mucicarmine stain Toluidine Blue stain Van Gieson stain Victoria Blue stain Von Kossa stain Wade-Fite stain Warthin-Starry stain Ziehl-Neelsen stain Registration No. HOKLAS 817P Page 4 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Anatomical Pathology Laboratory: L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 DISCIPLINE 專科範疇 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Anatomical Pathology Histopathology (cont’d) (cont’d) Muscle Biopsies Enzyme Studies by Special staining Method as documented in OPAIHC007, 010-012; OPAHST009, 023 & 026 AdenosineTriphosphatase (ATPase) stain at pH4.2, 4.6 and 9.4 Gomori's Trichrome stain Nicotinamide Adenine Dinucleotide - Tetrazolium Reductase (NADH-TR) stain Oil Red O stain Periodic Acid Schiff stain with or without digestion Succinate Dehydrogenase (SDH-NBT) stain Rectal Biopsies Enzyme Studies by Special staining Special Staining: Method as documented in OPAIHC006 & 009 Acetylcholinesterase stain Intra-operative frozen Frozen section followed by paraffin section section for fresh tissue histology examination by H&E staining specimens Specimen preparation and routine staining: Method as documented in OPAHGE009 & OPAHST014 Routine staining used: Haematoxylin and Eosin stain (manual) Registration No. HOKLAS 817P Page 5 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Anatomical Pathology Laboratory: L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 DISCIPLINE 專科範疇 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Anatomical Pathology Immunohistochemistry (cont’d) Renal and Skin Biopsies Immunofluorescence Examination by Manual method Specimen preparation and staining IgA / IgM / IgG / Complement 3 / Fibrinogen / C1q by Direct Immunofluorescence Method Method as documented in OPAIHC004 & 005; OPAHST013 & 014 Histological and Cytological specimen Immunohistochemical examination for various antigen markers by Automation and manual method Slide preparation and staining (Ventana BenchMark ULTRA Advanced Staining System): Method as documented in OPAIHC001 - 003 Detection system: Ventana i-view and Ultra-view DAB detection kit Antigen retrieval: Pressure-cooking or enzymatic digestion Dako Autostainer Link 48: Method as documented in OPAIHC001 – 003, OPAIHC013 Detection System: Envision Flex Antigen retrieval: Heat-induced epitope retrieval (Pressure cooking / PT Link) Registration No. HOKLAS 817P Page 6 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Anatomical Pathology Laboratory: L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 DISCIPLINE 專科範疇 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Medical Genetics Molecular Genetics Histological and Cytological specimen Epstein-Barr Virus Early RNA (EBV EBER) – Detection by In-situ Hybridization (ISH) examination Slide preparation and staining (Ventana BenchMark ULTRA Advanced Staining System): Method as documented in OPAIHC002 - 003 Detection system: Ventana ISH i-view blue detection kit Human Epidermal Growth Factor Receptor 2 (HER2) – Detection by Fluorescence in-situ hybridization (FISH) examination Slide preparation and staining : Method as documented in OPAMOL001 Registration No. HOKLAS 817P Page 7 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Autopsy Service: B03, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓地庫三 DISCIPLINE 專科範疇 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Anatomical Pathology Autopsy Adult, fetal and perinatal Autopsy examination by Autopsy method and specimen preparation: autopsy Method as documented in OPDAUT001 & 002 H&E and special staining Routine staining: Haematoxylin and Eosin stain Special staining as in Histopatholog Method as documented in OPAHST 001 - 038 Registration No. HOKLAS 817P Page 8 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology General Chemistry Serum Albumin by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Albumin assay Body Fluid or CSF Albumin by Immunoturbidimetry Roche Diagnostics cobas 6000 and 8000 Albumin assay Serum Alanine Aminotransferase (ALT) by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 ALT assay Alkaline Phosphatase (ALP) by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 ALP assay EDTA plasma Ammonia by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Ammonia assay Serum or Body Fluid Amylase by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Amylase assay Serum Aspartate Aminotransferase (AST) by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 AST assay Serum or Body Fluid Bilirubin- Total by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Bilirubin-Total assay Serum Bilirubin- Direct by Spectrophotometry Roche Diagnostics cobas 8000 Bilirubin-Direct assay Serum or Body Fluid Calcium by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Calcium assay Registration No. HOKLAS 817P Page 9 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology General Chemistry (cont’d) (cont’d) Serum Chloride by Potentiometry (Ion Selective Electrode) Roche Diagnostics cobas 6000 and 8000 Chloride assay Serum or Fluid Cholesterol by Spectrophotometry Roche Diagnostics cobas 8000 Cholesterol assay Serum Cholesterol, HDL by Spectrophotometry Roche Diagnostics cobas 8000 HDL-Cholesterol assay Creatine Kinase (CK) by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 CK assay Serum or Body Fluid Creatinine by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Creatinine assay Serum Gamma Glutamyltransferase (GGT) by Spectrophotometry Roche Diagnostics cobas 8000 GGT assay Fluoride plasma, Body Fluid or CSF Serum Glucose by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Glucose assay Iron by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Iron assay Fluoride plasma or CSF Lactate by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Lactate assay Serum, Body Fluid or CSF Lactate Dehydrogenase (LDH) by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 LDH assay Serum Magnesium by Spectrophotometry Roche Diagnostics cobas 8000 Magnesium assay Registration No. HOKLAS 817P Page 10 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology General Chemistry (cont’d) (cont’d) Serum or Body Fluid Phosphate by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Phosphate assay Serum or Body Fluid Potassium by Potentiometry (Ion Selective Electrode) Roche Diagnostics cobas 6000 and 8000 Potassium assay CSF Protein by Turbidimetric method Roche Diagnostics cobas 6000 and 8000 U/ CSF Protein assay Serum or Body Fluid(except CSF) Total Protein by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Total Protein assay Serum or Body Fluid Sodium by Potentiometry (Ion Selective Electrode) Roche Diagnostics cobas 6000 and 8000 Sodium assay Serum Total Iron Binding Capacity (TIBC) by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 UIBC and Iron assay Serum or Body Fluid Triglycerides by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Triglyceride assay Urate by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Urate assay Urea by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Urea assay Urine (24 hrs or Spot) Albumin by Immunoturbidimetry Roche Diagnostics cobas 6000 and 8000 Albumin assay Amylase by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Amylase assay Registration No. HOKLAS 817P Page 11 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology General Chemistry (cont’d) (cont’d) Urine (24 hrs or Spot) Calcium by (cont’d) Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Calcium assay Chloride by Potentiometry (Ion Selective Electrode) Roche Diagnostics cobas 6000 and 8000 Chloride assay Creatinine by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Creatinine assay Magnesium by Spectrophotometry Roche Diagnostics cobas 8000 Magnesium assay Phosphate by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Phosphate assay Potassium by Potentiometry (Ion Selective Electrode) Roche Diagnostics cobas 6000 and 8000 Potassium assay Protein by Turbidimetric method Roche Diagnostics cobas 6000 and 8000 U/ CSF Protein assay Sodium by Potentiometry (Ion Selective Electrode) Roche Diagnostics cobas 6000 and 8000 Sodium assay Urate by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Urate assay Urea by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Urea assay Registration No. HOKLAS 817P Page 12 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology Blood gases and (cont’d) Co-oximetry Heparinized Whole Blood pH by Potentiometry (Ion Selective Electrode) Roche Diagnostic OMNI System Siemens RAPIDLAB 1260 System Siemens RAPIDLAB 1265 System pCO2 Potentiometry (pCO2-Sensing Electrode) Roche Diagnostic OMNI System Siemens RAPIDLAB 1260 System Siemens RAPIDLAB 1265 System pO2 by Polarography (Oxygen-Sensing Roche Diagnostic OMNI System Amperometric Electrode) Siemens RAPIDLAB 1260 System Siemens RAPIDLAB 1265 System Base Excess by Calculation Roche Diagnostic OMNI System Siemens RAPIDLAB 1260 System Siemens RAPIDLAB 1265 System Bicarbonate by Calculation Roche Diagnostic OMNI System Siemens RAPIDLAB 1260 System Siemens RAPIDLAB 1265 System Co-oximetry by Spectrophotometry Siemens RAPIDLAB 1265 System Ionized Calcium by Potentiometry (Ion Selective Electrode) Siemens RAPIDLAB 1260 System, Siemens RAPIDLAB 1265 System Carboxyhaemoglobin by Co-oximetry Siemens RAPIDLAB 1265 System Methaemoglobin by Co-oximetry Siemens RAPIDLAB 1265 System Registration No. HOKLAS 817P Page 13 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology Blood gases and (cont’d) Co-oximetry (cont’d) Heparinized Whole Blood (cont’d) O2 Saturation by Calculation Roche Diagnostic OMNI System Siemens RAPIDLAB 1260 System Siemens RAPIDLAB 1265 System Therapeutic Drug monitoring Serum Carbamazepine by Immunoassay (Enzyme-based label) Roche Diagnostics cobas 8000 Carbamazepine assay Digoxin by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 Digoxin assay Lithium by Potentiometry (Ion Selective Electrode) Roche Diagnostics 9180 Electrolyte Analyzer Phenobarbital by Immunoassay (Enzyme-based label) Roche Diagnostics cobas 8000 Phenobarbital assay Phenytoin by Kinetic Interaction of Microparticle in a Solution (KIMS) Roche Diagnostics cobas 8000 Phenytoin assay Theophylline by Kinetic Interaction of Microparticle in a Solution (KIMS) Roche Diagnostics cobas 8000 Theophylline assay Valproic Acid by Kinetic Interaction of Microparticle in a Solution (KIMS) Roche Diagnostics cobas 8000 Valproic Acid assay Registration No. HOKLAS 817P Page 14 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology Toxicology (cont’d) Serum Ethanol by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Ethanol assay Paracetamol by Spectrophotometry Roche Diagnostics cobas 6000 and 8000 Acetaminophen assay Salicylate by Spectrophotomety Roche Diagnostics cobas 6000 and 8000 Salicylate assay Hormones EDTA plasma Adrenocorticotrophic Hormone (ACTH) by Immunoassay (Chemiluminescent label) Siemens IMMULITE 1000 Immunoassay System ACTH kit Serum Cortisol by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 Cortisol assay Urine (24 hrs) Cortisol by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 Cortisol assay Serum Estradiol (E2) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 Estradiol assay Follicular Stimulating Hormone (FSH) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 FSH assay Growth Hormone by Immunoassay (Chemiluminescent label) Siemens IMMULITE 1000 Immunoassay System Growth Hormone (hGH) kit Registration No. HOKLAS 817P Page 15 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology Hormones (cont’d) (cont’d) Serum (cont’d) Human Chorionic Gonadotropin by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 HCG+B assay Insulin by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 Insulin assay Luteinizing Hormone (LH) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 LH assay Thyroxine, Free (FT4) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 FT4 assay Triiodothyronine, Free (FT3) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 FT3 assay EDTA plasma Parathyroid Hormone (PTH) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 PTH assay Serum Prolactin by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 Prolactin assay Testosterone by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 Testosterone assay Thyroid Stimulating Hormone (TSH) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 TSH assay Registration No. HOKLAS 817P Page 16 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology Tumor Markers (cont’d) Serum Alpha-FetoProtein (AFP) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 AFP assay Cancer Antigen 125 (CA 125) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 CA 125 assay Carcinoembryonic antigen (CEA) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 CEA assay Prostate Specific Antigen, total (PSA) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 PSA assay Proteins, quantitative analysis Serum Ceruloplasmin by Immunoturbidimetry Roche Diagnostics cobas 8000 Ceruloplasmin assay C-Reactive Protein (CRP) by Immunoturbidimetry Roche Diagnostics cobas 8000 CRP assay Ferritin by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 Ferritin assay EDTA plasma Troponin T (high-sensitive) by Immunoassay (Chemiluminescent label) Roche Diagnostics cobas 6000 Troponin-hs assay Registration No. HOKLAS 817P Page 17 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology Proteins, qualitative and (cont’d) semi-quantitative analysis Urine Bence Jones Protein (BJP) by Electrophoresis Sebia HYDRASYS electrophoresis system HYDRAGEL B1/B2 kit Serum or Urine Immunofixation (IFE) by Electrophoresis Sebia HYDRASYS electrophoresis system HYDRAGEL IF kit Serum Serum Protein Electrophoresis (SPE) by Electrophoresis Sebia HYDRASYS electrophoresis system HYDRAGEL B1/B2 kit Body Fluid or Urine pH by Potentiometry (Glass Electrode) Corning 540 pH meter Porphobilinogen, urine (screening) by Qualitative colour reaction Method as documented in OPCMANU_012/01 Porphyrins, urine (screening) by UV Fluorescence Urine or Stool Reducing Substance by Qualitative colour reaction Urine Method as documented in OPCMANU_013/01 Method as documented in OPCMANU_014/01 Urine Specific Gravity by Refractometry Refractometer Urine Urobilinogen by Qualitative colour reaction [Diazonium Medi-Test Urbi test strip salt] Heavy metals and Trace Elements Serum Copper by Atomic Absorption Perkin Elmer PinAAcle 900T Atomic Absorption Spectrometer system EDTA plasma Lead by Atomic Absorption Perkin Elmer PinAAcle 900T Atomic Absorption Spectrometer system Registration No. HOKLAS 817P Page 18 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Chemical Pathology Special Chemistry or other (cont’d) tests Heparinized plasma Bilirubin, Neonatal by Spectrophotometry Leica Unistat Bilirubinometer System Urine Bilirubin by Qualitative colour reaction Medi-Test Urbi test strip Urine Myoglobin (screening) by Qualitative colour reaction Amicon Microcon YM-30 device Siemens Hemastix Stool Occult Blood by Qualitative colour reaction Siemens Hematest Reagent Tablet Serum or Urine Osmolality by Freezing point depression ARKRAY Osmostation OM-6050 Registration No. HOKLAS 817P Page 19 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Chemical Pathology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations listed below. Immunology Immunochemistry Serum Complement C3 by Immunoturbidimetry Roche Diagnostics cobas 8000 C3c assay Complement C4 by Immunoturbidimetry Roche Diagnostics cobas 8000 C4 assay Haptoglobin by Immunoturbidimetry Roche Diagnostics cobas 8000 Haptoglobin assay Immunoglobulin A (IgA) by Immunoturbidimetry Roche Diagnostics cobas 8000 IgA assay Immunoglobulin G (IgG) by Immunoturbidimetry Roche Diagnostics cobas 8000 IgG assay Immunoglobulin M (IgM) by Immunoturbidimetry Roche Diagnostics cobas 8000 IgM assay Rheumatoid Factor by Immunoturbidimetry Roche Diagnostics cobas 8000 RF assay Registration No. HOKLAS 817P Page 20 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Haematology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Haematology General Haematology EDTA whole blood Complete blood count including - Haemoglobin Sysmex XE5000 - Haematocrit Beckman Coulter LH750 - Leucocyte count (WBC count) Beckman Coulter LH780 - Mean corpuscular volume (MCV) - Mean corpuscular haemoglobin concentration (MCHC) - Mean corpuscular haemoglobin (MCH) - Platelet count - Red cell count - Red cell distribution width (RDW) - Mean Platelet Volume (MPV) Erythrocyte Sedimentation Rate (ESR) by automated method Haemoglobin H inclusion bodies by Vesmatic 30 Method as documented in OPHROU010 Brilliant Cresyl Blue stain Leucocyte differential count, automated Sysmex XE5000 Malaria parasite examination by Thick and thin films Smear preparation and Giemsa staining (pH7.2) as documented in OPHROU007 Immunological detection Diamed OptiMal-IT Rapid Malaria Test kit Peripheral blood smear examination by Wright – Giemsa stain Slide prepared and stained by Sysmex SP1000i Method as documented in OPHROU004 Platelet Count (manual) by 1% ammonium oxalate Reticulocyte Count, automated Method as documented in OPHROU001 Sysmex XE5000 Reticulocyte Count (manual) by Brilliant Cresyl Blue stain Method as documented in OPHROU006 Registration No. HOKLAS 817P Page 21 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Haematology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Haematology (cont’d) Coagulation Citrate blood Coagulation studies including - Prothrombin Time (PT) Sysmex CA 8000 - Activated partial thromboplastin time Sysmex CA7000 (APTT) Sysmex CA1500 - Fibrinogen Prothrombin Time (PT) by manual method Citrate blood Activated partial thromboplastin time Method as documented in OPHCOA072 Method as documented in OPHCOA073 (APTT) by manual method D-Dimer by Immunological latex agglutination Factor VIII assay Dade DIMERTEST Latex Assay Sysmex CA7000 Sysmex CA1500 Factor IX assay Sysmex CA7000 Sysmex CA1500 Lupus Anti-coagulant detection by Dilute Russell’s Viper Venom Time Method as documented in OPHCOA075 (DRVVT) Mixing Study Method as documented in OPHCOA078 Thrombin Time, automated Sysmex CA1500 Special Haematology EDTA whole blood Haemoglobin A2 and F quantitation by High performance liquid chromatography Haemoglobin Electrophoresis BioRad Variant II HPLC analyzer Method as documented in OPHSPE031 & OPHSPE032 Haemoglobin A1c by High performance liquid chromatography Tosoh G7 analyzer Registration No. HOKLAS 817P Page 22 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Haematology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Haematology Special Haematology (cont’d) (cont’d) Serum Vitamin B12 assay by Immunoassay (Chemiluminescent label) Beckman Coulter Access 2 Immunoassay System Serum Folate assay by Immunoassay (Chemiluminescent label) EDTA whole blood Beckman Coulter Access 2 Immunoassay System Red Cell Folate assay by Immunoassay (Chemiluminescent label) Beckman Coulter Access 2 Immunoassay System Serum Monospot Test Meridian Bioscience Monospot Test EDTA marrow blood Bone Marrow Examination Method as documented in OPHSPE044 Aspirate, clot, trephine Specimen preparation and routine staining: Method as documented in : OPHSPE001, OPHSPE044 and OPHSPE015 Marrow smear by - May Grunwald – Giemsa stain - Perl’s Prussian Blue stain Peripheral blood smear by - May Grunwald – Giemsa stain Special stains: Method as documented in: OPHSPE011, OPHSPE013, OPHSPE014, OPHSPE016, OPSPE017 - Acid Phosphatase stain - Specific esterase of Naphthol AS-D Chloroacetate Esterase - Myeloperoxidase stain - Non specific Naphthyl Acetate Esterase EDTA whole blood or marrow blood Immunophenotyping for haematological disorder by Flow Cytometry Beckman Coulter FC500 Flow Cytometer Lymphocyte subsets for haematological disorder by Flow Cytometry Beckman Coulter FC500 Flow Cytometer Registration No. HOKLAS 817P Page 23 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Haematology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Immunology Autoantibodies Serum Anti Nuclear antibody by Immunoassay (Enzyme-based label) BioRad Evolis Twin Plus Automated EIA analyzer Indirect Immunofluorescence Test BioRad ANA Screening Test kit BioRad Kallestad™ Hep 2 cell ANA kit Anti - dsDNA antibody by Immunoassay (Enzyme-based label) BioRad EVOLIS Twin Plus system DIASTAT Anti-ds DNA kit Anti - microsomal antibody by Particle agglutination Serodia - AMC kit Anti - thyroglobulin antibody by Particle agglutination Serodia - ATG kit Immune cell function and enumeration EDTA whole blood Immunophenotyping for immunological disorder by Flow Cytometry Beckman Coulter FC500 Flow Cytometer Lymphocyte subsets for immunological disorder by Flow Cytometry Beckman Coulter FC500 Flow Cytometer Registration No. HOKLAS 817P Page 24 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Blood Bank : L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 DISCIPLINE 專科範疇 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Haematology Blood Bank Clotted blood or EDTA blood ABO and Rh (D) typing by Red cell agglutination AutoVue Innova Manual method as documented in OPBTSC241 Weak D Testing by Red cell agglutination Method as documented in OPBTSC245 Antibody screening by Using CAT Method as documented in OPBTSC261 Saline Indirect Antiglobulin Test Method as documented in OPBTSC262 Indirect Antiglobulin Test (IAT) AutoVue Innova Pretransfusion testing by - Pretransfusion testing for red cell Method as documented in OPBTSC223 transfusion and component requests - Pretransfusion testing for infants < 4 Method as documented in OPBTSC341 months of age Red cell phenotyping by Direct agglutination Method as documented in OPBTSC301 and OPBIMH241 IAT Method as documented in OPBIMH241 Crossmatch by Electronic crossmatch Method as documented in OPBTSC284 Immediate spin Method as documented in OPBTSC282 Saline Indirect antiglobulin test Method as documented in OPBTSC283 Prewarmed technique using IAT AutoVue Innova using method as documented in OPBTSC263 Antenatal screen Clotted blood or EDTA blood ABO and Rh(D) typing plus antibody investigation if required by Method as documented in OPBIMH341 Red cell agglutination Titration of Antibody by NICE Method Method as documented in OPBIMH403 Registration No. HOKLAS 817P Page 25 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Blood Bank : L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 DISCIPLINE 專科範疇 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Haematology (cont’d) Immunohaematology EDTA Blood Direct Antiglobulin Test (DAT) by Red cell agglutination Method as documented in OPBTSC222 Investigation Clotted blood or EDTA blood Antibody identification by Polyethylene Glycol-IAT Method as documented in OPBIMH261 and OPBIMH281 Two Stage Enzyme Technique Method as documented in OPBIMH261 and OPBIMH282 Lewis/P1 blood group substance Method as documented in OPBIMH261 and OPBIMH283 neutralization test IAT EDTA blood AutoVue Innova Antibody elution and identification by Chloroquine elution Method as documented in OPBIMH301 Acid Glycine/EDTA elution by Method as documented in OPBIMH305 ELU KIT PLUS elution system Clotted blood or EDTA blood Adsorption of Autoantibodies by Method as documented in OPBIMH312 ZZAP Technique EDTA blood Investigation of ABO Blood Group Anomaly Method as documented in OPBTSC242 Saliva Saliva testing for ABH substances EDTA blood Weak A or B subgroups by adsorption and elution Clotted blood or EDTA blood Transfusion Reaction Method as documented in OPBIMH231 Method as documented in OPBIMH232 Method as documented in OPBTSC441 Registration No. HOKLAS 817P Page 26 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Microbiology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Clinical Bacteriology Microbiology and Infection Culture and Sensitivity Test Enteric samples (including stool and rectal swab) Urine Culture and antimicrobial susceptibility tests for pathogens by Conventional method Method as documented in OPMSTO001, OPMAST001 Urine formed elements by Microscopic examination with fixed volume in microtitre plate Method as documented in OPMURI001 Culture and antimicrobial susceptibility tests for pathogens by Standard loop method Upper respiratory tract samples (including throat swab, nasal Method as documented in OPMURI001, OPMAST001 Culture and antimicrobial susceptibility tests for pathogens by Conventional method Method as documented in OPMSPU001, OPMAST001 swab etc.) Lower respiratory tract samples (including sputum, bronchial Microscopy for cell morphology and microorganisms by Gram Stain Method as documented in OPMMIS001A1 aspirate, tracheal aspirate etc.) Culture and antimicrobial susceptibility tests for pathogens by Conventional method Brochioalveolar lavage (BAL) and Protected bronchial brush Method as documented in OPMSPU001/01, OPMAST001/01 Microscopy for cell morphology and microorganisms by Gram Stain Method as documented in OPMMIS001A1 Culture (semi-quantitative) and antimicrobial susceptibility tests for pathogens by Conventional method Method as documented in OPMSPU001, OPMAST001 Registration No. HOKLAS 817P Page 27 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Microbiology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Clinical Bacteriology (cont’d) Microbiology and Culture and Sensitivity Infection (cont’d) Test (cont’d) Genital samples Microscopy for cell morphology and microorganisms by Gram Stain Method as documented in OPMMIS001A1 Culture and antimicrobial susceptibility test for pathogens by Conventional method Miscellaneous samples (including swab, pus, tissue, body fluids etc.) Microscopy for cell morphology and Method as documented in OPMMIS004, OPMAST001 Method as documented in OPMMIS001A1 microorganisms by Gram Stain Crystal (joint fluid only) by Wet smear Method as documented in OPMMIS001A3 Amoeba (liver abscess only) by Wet smear Method as documented in OPMMIS001 Culture and antimicrobial susceptibility tests for pathogens by Conventional method Eye swab, corneal scrapping and joint fluid Method as documented in OPMMIS001, OPMAST001 Microscopy for Microorganisms by Gram Stain Method as documented in OPMCSF002 (for Emergency Lab) Blood Culture and antimicrobial susceptibility tests for pathogens by Conventional method Broth culture Method as documented in OPMBLO001 and 002 BD BACTEC FX Registration No. HOKLAS 817P Page 28 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Microbiology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Clinical Bacteriology (cont’d) Microbiology and Culture and Sensitivity Infection (cont’d) Test (cont’d) CSF Microscopy for Method as documented in Cell count by Counting chamber OPMCSF001, OPMCSF002 (for Emergency Lab) Microorganisms by Gram Stain OPMMIS001A1, OPMCSF002 (for Emergency Lab) Encapsulated yeast by India Ink Stain OPMCSF001 Culture and antimicrobial susceptibility tests for pathogens by Conventional method Method as documented in OPMCSF001, OPMAST001, OPMCSF002 (for Emergency Lab) Antigen detection (Streptococcus Group B; Haemophilus influenzae type b; Streptococcus pneumoniae; Neisseria meningitidis Group A, B, C, Y, W135; E. coli K1) by Latex agglutination Wellcogen Bacterial Antigen detection kit Antigen detection of Cryptococcus neoformans by Latex agglutination Remel Cryptococcus Antigen Latex kit Serology for Bacteria (Antibody detection) Serum Brucella antibody by agglutination method Method as documented in OPMSER003 Rickettsial antibody by agglutination method (Weil Felix test) Method as documented in OPMSER003 Salmonella antibody by agglutination method (Widal test) Method as documented in OPMSER003 Detection of extracellular antigens of Group A Streptococcus by Rapid slide test Dade Behring RapiTex ASL Registration No. HOKLAS 817P Page 29 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Microbiology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Clinical Microbiology and Infection (cont’d) Bacteriology (cont’d) Syphilus serology Serum Reagin antibody in response to Treponemal infection by Rapid Plasma Reagin (RPR) BioMerieux RPR test kit Treponema pallidum antibody by - Immunoassay (Chemiluminescent label) Abbott Architect i2000 system Syphilis TP assay - Fluorescent treponemal antibody- Virgo IF FTA-ABS TEST kit absorption test (FTA-ABS) - Treponemal pallidum Passive Particle Agglutination test (TPPA) Fujirebio Inc. Treponema palladium Particle Agglutination (TPPA) test kit Parasitology Stool Microscopy for enteric parasites by Conventional method Method as documented in OPMPAR001 Microscopy for Amoeba by Direct smear and concentration method Method as documented in OPMPAR001, OPMPAR001A1 Microscopy for fecal protozoa by Iron Haematoxylin stain Method as documented in OPMPAR002 Gomori's Trichome stain Method as documented in OPMPAR003 Microscopy for Coccidia and Cyanobacterium - Like Bodies (e.g. Cryptosporidium and Isospora) by Modified Kinyoun’s acid fast stain Method as documented in OPMPAR004 Mycology All samples Microscopy for fungal filaments and yeasts by KOH with Calcofluor White procedure Method as documented in OPMFUN001 Microscopy for fungal filaments and yeasts by Gram Stain Method as documented in OPMFUN001 Culture for fungi by Conventional method Method as documented in OPMFUN001, 002 and 003 Mycobacteriology CSF and Miscellaneous samples Microscopy for acid fast bacilli (AFB) by Auramine O fluorescent stain Method as documented in OPMMTB001 Registration No. HOKLAS 817P Page 30 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Microbiology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Clinical Virology Microbiology and Serology for Virus Infection (cont’d) (Antibody detection) Serum Cytomegalovirus antibody (IgG) by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect CMV IgG reagent kit Hepatitis A virus antibody, IgM by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect HAVAb-IgM reagent kit Hepatitis B virus antibody Anti-HBs (quantitative) by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect Anti-HBs reagent kit Anti-HBc (Total) by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect Anti-HBc reagent kit Anti-HBc (IgM) by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect Anti-HBc IgM reagent kit Anti-HBe by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect Anti-HBe reagent kit Hepatitis C virus antibody by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect Anti-HCV reagent kit Human immunodeficiency virus I & II antibody and p24 antigen by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect HIV Ag/Ab Combo reagent kit Rubella virus antibody (IgG) by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect Rubella IgG reagent kit Varicella zoster virus antibody (IgG) by Immunoassay (Enzyme-based label) Vidas Automated Immunoassay system Registration No. HOKLAS 817P Page 31 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Microbiology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Clinical Virology Microbiology and Serology for Virus Infection (cont’d) (Antibody detection) Nasopharyngeal aspirate (NPA) Influenza A and B virus by Immunochromatographic test BD Influenza A & B EZ direct antigen test Respiratory syncytial virus by Immunochromatographic test Serum BD EZ RSV direct antigen test Hepatitis B virus antigen HBsAg by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect HBsAg Qualitative II reagent kit HBeAg by Immunoassay (Chemiluminescent label) Abbott Architect Automated Immunoassay system Architect HBeAg reagent kit Registration No. HOKLAS 817P Page 32 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Microbiology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Medical Genetics Molecular Genetics Plasma Hepatitis B Virus (HBV) – Detection by Real-Time Polymerase Chain Reaction (PCR), quantitative Nucleic acid extraction by Abott m2000sp system (Target region: S gene) Nucleic acid amplification and detection Abbott m2000rt Real-Time PCR analyzer HBV quantitative assay Skin swabs Methicillin-resistant Staphylococcus aureus (MRSA) – Detection by Real-Time Polymerase Chain Reaction (PCR), qualitative Nucleic acid extraction by Roche LightCycler Advanced Lysis Kit (Target region: SCCmec cassette integrated with Sta aur chromosome) Nucleic acid amplification and detection: Method as documented in OPMMOL014 Nasopharyngeal aspirates, nasopharyngeal Chlamydiophilia pneumoniae – Detection by Real-Time Polymerase Chain Reaction swabs, throat and nasal (PCR), qualitative combined swab (Target region: J38 genomic region ) Nucleic acid extraction by bioMérieux NucliSENS easyMAG Nucleic acid amplification and detection: Method as documented in OPMMOL013 Influenza A virus – Detection by Reverse Transcription and Real time Nucleic acid extraction by Polymerase Chain Reaction (PCR), bioMérieux NucliSENS easyMAG qualitative Qiagen QIAamp Viral RNA Mini Kit (Target region: M gene) Nucleic acid amplification and detection: Method as documented in OPMMOL03 Influenza A virus (H1 and H3 subtype) – Detection by Reverse Transcription and Real time Polymerase Chain Reaction (PCR), Nucleic acid extraction by bioMérieux NucliSENS easyMAG Qiagen QIAamp Viral RNA Mini Kit qualitative (Target region: HA gene) Nucleic acid amplification and detection: Method as documented in OPMMOL04 Registration No. HOKLAS 817P Page 33 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Microbiology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Medical Genetics Molecular Genetics (cont’d) (cont’d) Nasopharyngeal aspirates, nasopharyngeal Influenza A virus (H5 subtype) – Detection by Reverse Transcription and Real time Nucleic acid extraction by swabs, throat and nasal Polymerase Chain Reaction (PCR), bioMérieux NucliSENS easyMAG combined swab (cont’d) qualitative Qiagen QIAamp Viral RNA Mini Kit (Target region: HA gene) Nucleic acid amplification and detection: Method as documented in OPMMOL11 Influenza A virus (Swine H1 subtype) – Detection by Reverse Transcription and Real time Polymerase Chain Reaction (PCR), Nucleic acid extraction by bioMérieux NucliSENS easyMAG Qiagen QIAamp Viral RNA Mini Kit qualitative (Target region: HA gene) Nucleic acid amplification and detection: Method as documented in OPMMOL05 Influenza B virus – Detection by Reverse Transcription and Real time Polymerase Chain Reaction (PCR), Nucleic acid extraction by bioMérieux NucliSENS easyMAG qualitative (Target region: nucleoprotein gene) Nucleic acid amplification and detection: Method as documented in OPMMOL012 Mycoplasma pneumoniae – Detection by Real-Time Polymerase Chain Reaction (PCR), qualitative Nucleic acid extraction by bioMérieux NucliSENS easyMAG (Target region: P1 gene) Nucleic acid amplification and detection: Method as documented in OPMMOL010 Respiratory samples Mycobacterium tuberculosis – Detection by Real-Time Polymerase Chain Reaction (PCR), qualitative Nucleic acid extraction by Cobas Amplicor Respiratory Specimen Preparatory Kit (Target region: 16s rRNA) Nucleic acid amplification and detection: Roche TaqMan 48 Real-Time PCR analyzer Mycobacterium tuberculosis (MTB) assay Registration No. HOKLAS 817P Page 34 of 34 22 October 2014 Ref: 817P-27 817 MED Hospital Authority, United Christian Hospital, Department of Pathology 醫院管理局，基督教聯合醫院，病理部 Microbiology Laboratory: DISCIPLINE 專科範疇 L02, Blk. S, Dept. of Pathology, 130 Hip Wo Street, Kwun Tong, Kowloon 九龍觀塘協和街 130 號邵逸夫大樓二樓 TEST AREA OR SAMPLE TYPE 測試範圍或樣本種類 SPECIFIC EXAMINATION OR PROPERTY MEASURED 特定測試或量度的特性 METHOD OR TECHNIQUE USED 方法或應用技術 This laboratory is accredited for performing examinations and for providing clinical interpretation of examinations listed below. Medical Genetics Molecular Genetics (cont’d) (cont’d) Stool Toxigenic Clostridium difficile – Detection by Real-Time Polymerase Chain Reaction (PCR), qualitative Nucleic acid extraction by bioMérieux NucliSENS easyMAG (Target region: tdcC gene) Nucleic acid amplification and detection: Method as documented in OPMMOL009 Norovirus – Detection by Reverse Transcription and Real time Nucleic acid extraction by Polymerase Chain Reaction (PCR), bioMérieux NucliSENS easyMAG qualitative Qiagen QIAamp Viral RNA Mini Kit (Target region: VP1 Capsid gene) Nucleic acid amplification and detection: Method as documented in OPMMOL01 Rotavirus – Detection by Reverse Transcription and Real time Polymerase Chain Reaction (PCR) Nucleic acid extraction by bioMérieux NucliSENS easyMAG qualitative (Target region: VP1 gene) Nucleic acid amplification and detection: Method as documented in OPMMOL020 Urine, genital and eye swab Chlamydia trachomatis – Detection by Real-Time Polymerase Chain Reaction Nucleic acid extraction : (PCR), qualitative bioMérieux NucliSENS easyMAG (Target region: cryptic plasmid and Qiagen QIAamp Viral RNA Mini Kit chromosomal DNA) Nucleic acid amplification and detection: Roche Cobas TaqMan 48 Real-Time PCR analyzer Chlamydia trachomatis (CT) assay
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