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Registration No.

HOKLAS 805S
Page 1 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20

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 : Biomedical Scientist Director 醫務科學主管:


DIRECTOR Mrs Marianne LEUNG YANG Shih-ti
化驗所主管 梁楊世嫡女士
BS, MT(ASCP)(USA), MIBMS(UK)

AUTHORISED : Mrs Marianne LEUNG YANG Shih-ti


REPRESENTATIVE 梁楊世嫡女士
委任代表

ENQUIRY : Ms Countess TAM Chung-mei


查詢 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

CLIENTELE : Private physicians, medical centres, private and public hospitals and other medically-
服務對象 related 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

ACCREDITED TEST : Medical Testing 醫務化驗


CATEGORY
認可測試類別 Chemical Pathology 化學病理學
Clinical Microbiology and Infection 臨床微生物學及傳染病
Haematology 血液學
Immunology 免疫學
Medical Genetics (Molecular Genetics) 醫學遺傳學 (分子遺傳學)

SCOPE OF ACCREDITATION : Accredited activities are shown on the following pages


認可範圍 認可項目詳見後頁

* * * * * * * *
Registration No. HOKLAS 805S
Page 2 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 by
Immunoassay (Fluorescent label) Alere Triage MeterPro Tox Drug Screen
Immunochromatographic assay Biotest RightSign MultiDrug assay

Barbiturates by
Immunoassay (Fluorescent label) Alere Triage MeterPro Tox Drug Screen
Immunochromatographic assay Biotest RightSign MultiDrug assay

Benzodiazepines by
Immunoassay (Fluorescent label) Alere Triage MeterPro Tox Drug Screen
Immunochromatographic assay Biotest RightSign MultiDrug assay

Cannabinoids (THC) by
Immunoassay (Fluorescent label) Alere Triage MeterPro Tox Drug Screen
Immunochromatographic assay Biotest RightSign MultiDrug assay

Cocaine Metabolites by
Immunoassay (Fluorescent label) Alere Triage MeterPro Tox Drug Screen
Immunochromatographic assay Biotest RightSign MultiDrug assay

Methadone by
Immunoassay (Fluorescent label) Alere Triage MeterPro Tox Drug Screen
Immunochromatographic assay Biotest RightSign MultiDrug assay

Methamphetamines by
Immunoassay (Fluorescent label) Alere Triage MeterPro Tox Drug Screen
Immunochromatographic assay Biotest RightSign MultiDrug assay

Opiates by
Immunoassay (Fluorescent label) Alere Triage MeterPro Tox Drug Screen
Immunochromatographic assay Biotest RightSign MultiDrug assay

Phencyclidine (PCP) by
Immunoassay (Fluorescent label) Alere Triage MeterPro Tox Drug Screen
Immunochromatographic assay Biotest RightSign MultiDrug assay
Registration No. HOKLAS 805S
Page 3 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 General chemistry


Fluoride Plasma Glucose by
Spectrophotometry Ortho-Vitros Fusion 5.1 System GLU slides

Serum 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

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
Registration No. HOKLAS 805S
Page 4 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 General chemistry (cont’d)


(cont’d) Serum (cont’d) Cholesterol, LDL by
Immunoassay (colorimetric method) Ortho-Vitros Fusion 5.1 System dLDL reagent

Creatine Kinase (CK), Total by


Spectrophotometry 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

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
Registration No. HOKLAS 805S
Page 5 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 General chemistry (cont’d)


(cont’d) Serum (cont’d) Urea Nitrogen (BUN) by
Spectrophotometry Ortho-Vitros Fusion 5.1 System BUN slides

Uric acid
Spectrophotometry Ortho-Vitros Fusion 5.1 System URIC slides

Urine Albumin by
Immunoturbidimetry Ortho-Vitros Fusion 5.1System mALB reagents

Amylase by
Spectrophotometry Ortho-Vitros Fusion 5.1 System AMYL slides

Calcium by
Spectrophotometry Ortho-Vitros Fusion 5.1 System CA slides

Creatinine by
Spectrophotometry Ortho-Vitros Fusion 5.1 System CREA slides

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


Spectrophotometry Ortho-Vitros Fusion 5.1 System BUN slides

Uric acid by
Spectrophotometry Ortho-Vitros Fusion 5.1 System URIC slides
Registration No. HOKLAS 805S
Page 6 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 Hormones


(cont’d) Serum Cortisol by
Immunoassay (Fluorescent label) Abbott Architect i2000SR System Cortisol assay

Dehydroepiandrosterone Sulphate (DHEA-S) by


Immunoassay (Chemiluminescent label) 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) Siemens Immulite XPi System FSH assay

Growth Hormone (GH) by


Immunoassay (Chemiluminescent label) Siemens Immulite XPi System
Growth Hormone assay

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
Registration No. HOKLAS 805S
Page 7 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 Hormones (cont’d)


(cont’d) Serum (cont’d) 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

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 Bio-Rad D-10 Haemoglobin Testing System
Chromatography (HPLC) HbA1c assay

Serum 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 (Chemiluminescent label) DaiSorin Liason XL 25 OH Vitamin D Total 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
Registration No. HOKLAS 805S
Page 8 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 Therapeutic drug monitoring


(cont’d) (cont’d)
Serum (cont’d) Valproic Acid by
Immunoassay (Fluorescent label) Abbott Architect i2000SR System Valproic Acid
assay

Tumour markers
Serum Alpha-feto Protein (AFP) by
Immunoassay (Chemiluminescent label) Abbott Architect i2000SR System AFP assay

Beta-Human Chorionic Gonadotropin (β-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 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 Microscopy for Cell Morphology and
HVS, endocervical swab, Microorganisms by
urethral swab, etc) 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 Microscopy for Cell Morphology and


samples (including sputum, Microorganism by
bronchial aspirate, tracheal 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 Microscopy for Cell Morphology and


samples (including throat Microorganisms by
swab, nasal swab etc) 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 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 Culture and Antimicrobial Susceptibility Tests for
stool and rectal swab) 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 Microscopy for Cell Morphology and


(including eye, ear, skin Microorganisms by
swabs, etc) 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, Microscopy for Cell Morphology and


(including abscess pus or Microorganisms by
tissue, etc) Gram stain Manual method as documented in M015

Urine 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 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 Helicobacter pylori Antibody (IgG) by
(cont’d) 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 Aution Max AX4030 Urine Chemistry System

Urine Formed Elements by


Microscopic examination Method as documented in U001 using
Neubauer Chamber
Sysmex UF-1000i Urine Micro System
Registration No. HOKLAS 805S
Page 12 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 Serum Cytomegalovirus Antibody (IgG) by
(cont’d) 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

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 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 Bayer Advia 2120i Haematology System
- Haematocrit 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

Haematology –
Immunohaematology
Clotted blood or EDTA ABO and Rh(D) Typing by
whole blood Red Cell Agglutination Grifols WADiana 8XT System
Manual method as documented in H001
Registration No. HOKLAS 805S
Page 14 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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


(microbiology)
Cervical scraping and cervical Chlamydia trachomatis – detection by
aspirate, endocervical swab, Real-time Polymerase Chain Reaction, Nucleic acid extraction, amplification and
vaginal swab, male urethral qualitative detection by COBAS 4800 using cobas® 4800
swab and urine (Target region: cryptic plasmid and ompA gene) CT/NG assay

Neisseria gonorrhoeae – detection by


Real-time Polymerase Chain Reaction, Nucleic acid extraction, amplification and
qualitative detection by COBAS 4800 using cobas® 4800
(Target region: DR-9) CT/NG assay

Nasopharyngeal swab, Adenovirus – detection by


Washings and aspirates Real time Multiplex Polymerase Chain Nucleic acid extraction, amplification and
Reaction, qualitative detection by BioFire Diagnostics FilmArray
(Target region: Hexon gene) System – Respiratory Panel

Coronavirus – detection by
Real time Multiplex Polymerase Chain Nucleic acid extraction, amplification and
Reaction, qualitative detection by BioFire Diagnostics FilmArray
(Target region: Polyerase or nucleoprotein gene System – Respiratory Panel
of respective strains)

Human Metapneumovirus – detection by


Real time Multiplex Polymerase Chain Nucleic acid extraction, amplification and
Reaction, qualitative detection by BioFire Diagnostics FilmArray
(Target region: Nucleoprotein gene) System – Respiratory Panel

Influenza A virus – detection by


Real time Multiplex Polymerase Chain Nucleic acid extraction, amplification and
Reaction, qualitative detection by BioFire Diagnostics FilmArray
(Target region: HA, M and NS1 gene) System – Respiratory Panel

Influenza B virus – detection by


Real time Multiplex Polymerase Chain Nucleic acid extraction, amplification and
Reaction, qualitative detection by BioFire Diagnostics FilmArray
(Target region: HA gene) System – Respiratory Panel

Parainfluenza virus – detection by


Real time Multiplex Polymerase Chain Nucleic acid extraction, amplification and
Reaction, qualitative detection by BioFire Diagnostics FilmArray
(Target region: HA or fusion gene of respective) System – Respiratory Panel
sub-types)
Registration No. HOKLAS 805S
Page 16 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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
(cont’d) (microbiology) (cont’d)
Nasopharyngeal swab, Respiratory syncytial virus – detection by
Washings and aspirates (cont’d) Real time Multiplex Polymerase Chain Nucleic acid extraction, amplification and
Reaction, qualitative detection by BioFire Diagnostics FilmArray
(Target region: M gene) System – Respiratory Panel

Rhinovirus and/or Enterovirus – detection by


Real time Multiplex Polymerase Chain Nucleic acid extraction, amplification and
Reaction, qualitative detection by BioFire Diagnostics FilmArray
(Target region: 5’ UTR) System – Respiratory Panel
Registration No. HOKLAS 805S
Page 17 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
Kowloon Branch : 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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 18 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
Kowloon Branch : 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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 19 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20

PathLab Medical Laboratories Limited


栢立醫學化驗所有限公司
Central Branch : 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 室

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 20 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20

PathLab Medical Laboratories Limited


栢立醫學化驗所有限公司
Central Branch : 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 室

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 21 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
Causeway Bay Branch : 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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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 22 of 22
Issue Date: 29 August 2016
MED
805 Ref. HOKLAS805S-20
PathLab Medical Laboratories Limited
栢立醫學化驗所有限公司
Causeway Bay Branch : 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

DISCIPLINE TEST AREA SPECIFIC EXAMINATION OR METHOD


專科範疇 OR SAMPLE TYPE PROPERTY MEASURED 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

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