Queen Elizabeth Hospital

Site

Department of Pathology

Accreditation No.

14238

Site No.

14231

Date of Accreditation

26 Jun 2001

Address

Rm 202, Block M, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon
0
Hong Kong

www3.ha.org.hk/qeh/tch/healthcare-professionals/dept/path/index.htm

Contact

Ms Man-Yee Kwan P: 85 235066878

Availability

Services available to external clients

Supervision

Not Applicable

Scope of Accreditation

Withdrawn

Department of Pathology

ISO 15189 (2012)

  • This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.

Human Pathology

Withdrawn
Service Product Determinant
Anatomical pathology - Cytopathology - Cervical cytological investigation for abnormalities, precancerous or cancerous changes or conditions Liquid based cytology specimens from cervix Cytological examination; Review and reporting of cervical cytological material
Anatomical pathology - Cytopathology - Gynaecological (non-cervical) cytological investigation for abnormalities, precancerous or cancerous changes or conditions Vaginal tissue Cytological examination; Review and reporting of gynaecological (non-cervical tissue) cytological samples
Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of body fluids, exudates, washings and brushings from non-squamous mucosal sites for the detection of malignancy Cerebrospinal fluid (CSF); Other body fluids; Sputum; Urine; Washings or brushings from other sites Cytological examination; Review and reporting of cytology samples
Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of nipple discharge or smears from squamous mucosal sites for the detection of cancerous or precancerous changes Nipple discharge Cytological examination; Review and reporting of cytology samples
Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations on samples obtained via fine needle aspiration biopsy Fine needle aspirates (FNA) Cytological examination; Review and reporting of fine needle aspiration samples
Anatomical pathology - Tissue pathology - Coronial autopsy services Body; Body parts Autopsy service and reporting
Anatomical pathology - Tissue pathology - Examination of biopsy material Formalin fixed tissue; Fresh tissue Review and reporting of biopsy material to identify or exclude morphological abnormalities
Anatomical pathology - Tissue pathology - Examination of biopsy material by electron microscopy Formalin fixed tissue; Fresh tissue; Smears Review and reporting of biopsy material to identify or exclude ultra-structural morphological abnormalities
Anatomical pathology - Tissue pathology - Gene probes using paraffin fluorescence in-situ hybridisation (FISH) Formalin-fixed paraffin-embedded (FFPE) tissues Detection of nucleic acid targets - Various
Anatomical pathology - Tissue pathology - Gene probes using paraffin in-situ hybridisation techniques (chromogenic/silver) Formalin-fixed paraffin-embedded (FFPE) tissues Detection of nucleic acid targets - Various
Detection of nucleic acid targets - Various
Anatomical pathology - Tissue pathology - Immediate frozen section diagnosis Fresh tissue Intra-operative consultation and examination of biopsy material
Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation Formalin-fixed paraffin-embedded (FFPE) tissues Detection of antigenic targets - Various
Frozen tissue Detection of antigenic targets - Various
Anatomical pathology - Tissue pathology - Mortuary facilities Body; Body parts Assessment - Level 2 mortuary
Anatomical pathology - Tissue pathology - Non-coronial autopsy services Body; Body parts Autopsy service and reporting
Chemical pathology - Analysis of calculus Calculi Ammonium; Calcium; Cysteine; Magnesium; Oxalate; Phosphate; Uric acid
Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals Blood Cyanide
Urine 2-Ethyl-5-methyl-3,3-diphenylpyrrolidine (EMDP); 2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP); Ecgonine methyl ester
Methanol
Amphetamines; Buprenorphine; Caffeine; Cocaine; Fentanyl; Methadone; Methamphetamine; Morphine; Oxycodone; Phencyclidine; Propoxyphene; Salbutamol
Barbiturates; Benzodiazepines; Cannabis; Cocaine; Opiates
Paraquat
Chemical pathology - Biochemical genetic services - Amino acid quantitation Cerebrospinal fluid (CSF) Alanine; Glycine; Serine
Plasma; Urine Alanine; Alloisoleucine; Arginine; Arginosuccinic acid; Asparagine; Aspartic acid; Citrulline; Cystine; Glutamic acid; Glutamine; Glycine; Histidine; Homocysteine; Hydroxyproline; Isoleucine; Leucine; Lysine; Methionine; Ornithine; Phenylalanine; Phosphoethanolamine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine; α-Aminobutyric acid
Chemical pathology - Biochemical genetic services for the diagnosis of metabolic and enzymological disorders Urine 2,4-Dinitrophenylhydrazine (DNPH, Brady's reagent, Borche's reagent); Chyle; D-lactate; Ferric chloride; Indican; Mucopolysaccharides (MPS); Sulfite
Chemical pathology - Biogenic amines Plasma Metanephrine; Methoxytyramine; Normetanephrine
Urine 5-Hydroxyindoleacetic acid (5-HIAA); Adrenaline; Dopamine; Homovanillic acid (HVA); Metanephrine; Methoxytyramine; Noradrenaline; Normetanephrine; Vanillylmandelic acid (VMA)
Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring Blood Cyclosporin; Everolimus; Sirolimus; Tacrolimus
Serum Carbamazepine; Digoxin; Gentamicin (cidomycin, septopal, genticyn, garamycin); Phenobarbitone; Phenytoin (dilantin); Theophylline; Valproate (valproic acid, epilim); Vancomycin
Amikacin
Methotrexate
Lithium
Ethanol; Paracetamol (acetaminophen); Salicylate
Urine 1,4-Dibenzylpiperazine (DBZP); 3',4'-Methylenedioxy-α-pyrrolidinobutyrophenone (MDPBP ); 3,4-Methylenedioxy-N-ethylamphetamine (MDEA); 3,4-Methylenedioxyamphetamine (MDA); 3,4-Methylenedioxymethamphetamine (MDMA); 3,4-Methylenedioxypyrovalerone (MDPV); 3-Hydroxymorphinan; 3-Methoxymorphinan; 4-Diphenylmethoxy-1-methylpiperidine; 4-Hydroxy-3-methoxymethamphetamine (HMMA); 5-Flucytosine; 6β-Naltrexol; Acebutolol; Acepromazine; Acetazolamide; Acyclovir; Adrenalone; Alfentanil; Allopurinol; Alprazolam; Alprenolol; Amantadine; Ambroxol; Amiloride; Amiodarone; Amisulpride; Amitriptyline; Amlodipine; Amobarbital; Amoxapine; Amoxicillin; Antazoline; Apomorphine; Aripiprazole; Atenolol; Atomoxetine; Atropine; Azithromycin; Baclofen; Barbital; Benfluorex; Benzoylecgonine (ecgonine benzoate); Benzylpiperazine (BZP, 1-benzylpiperazine); Betamethasone; Betaxolol; Bisacodyl - Cathartic; Bisoprolol; Bromazepam; Bromhexine; Bromocriptine; Bromperidol; Brompheniramine; Buflomedil; Bufotenine; Bumetanide; Bupivacaine; Bupropion; Buspirone; Butoforme; Butorphanol; Captopril; Carbamazepine; Carbimazole; Carbinoxamine; Carvedilol; Cathinone (benzoylethanamine, β-keto-amphetamine); Cefotaxime; Cefuroxime; Celecoxib; Cetirizine; Chlordiazepoxide; Chloroquine; Chlorothiazide; Chlorpheniramine; Chlorpromazine; Chlorpropamide; Chlorprothixene; Cimetidine; Cinchonine; Ciproflocaxin; Citalopram; Clarithromycin; Clenbuterol; Clobazam; Clomipramine; Clonazepam; Clonidine; Clozapine; Cocaethylene; Codeine; Colchicine; Cotinine; Crimidine; Cyproheptadine; Dapsone; Dehydronifedipine (DHN); Dehydronifedipinic acid (DHNA); Desipramine; Dexamethasone; Dexchlorpheniramine; Dextromethorphan; Dextromoramide; Dextrorphan; Diazepam; Dibucaine (cinchocaine); Diclofenac; Dihydrocodeine (6α-hydrocodol); Diisopyramide; Diltiazem; Diphenhydramine; Dipyridamole; Domperidone; Donepezil; Dothiepin (dosulepin); Doxepin; Doxylamine; Duloxetine; Empagliflozin; Enalapril; Entacapone; Ephedrine; Ergine (LSA, d-lysergic acid amide); Ergotamine; Erythromycin; Escitalopram; Esomeprazole; Estazolam; Ethambutol; Etoricoxib; Famotidine; Felbamate; Fenfluramine; Fexofenadine; Finasteride; Flecainide; Flucloxacillin; Fluconazole; Flunitrazepam; Fluoxetine; Fluphenazine; Flurazepam; Fluvoxamine; Furosemide; Gabapentin; Glafenine; Glibenclamide; Gliclazide; Glimepiride; Glipizide; Guaifenesin; Haloperidol; Heroin; Hydrochlorothiazide; Hydrocodone; Hydromorphone; Hydroxychloroquine; Hydroxyzine; Hyoscine (scopolamine); Ibuprofen; Ifendopril; Imipramine; Indapamide; Indomethacin; Irbesartan; Isoniazid; Isoprenaline; Ketamine; Ketobemidone; Ketoconazole; Ketoprofen; Labetalol; Lacosamide; Lamotrigine; Lansoprazole; Laudanosine; Levamisole; Levetiracetam; Levofloxacin; Levomepromazine; Lidocaine; Lisinopril; Loperamide; Loratadine; Lorazepam; Lormetazepam; Losartan; Loxapine; Lysergic acid diethylamide (LSD, lysergide); Mannitol; Maprotiline; Mefenamic acid; Melitracen (flupentixol); Meloxicam; Memantine; Meperidine (pethidine); Mephedrone; Mepyramine; Metformin; Methaqualone; Methoxyphenamine (OMMA); Methylbenzodioxolylbutanamine (MBDB); Methyldopa; Methylhexanamine (dimethylamylamine); Methylphenidate; Metoclopramide; Metolazone; Metoprolol; Metronidazole; Mianserin; Midazolam; Minaprine; Mirtazapine; Misoprostol; Monoethylglycinexylidide (MEGX); N-Methylephedrine; Nadolol; Nalbuphine; Naloxone; Naltrexone; Naproxen; Nateglinide; Nicotine; Nifedipine; Nimetazepam; Nimodipine; Nitrazepam; Nortriptyline; Olanzapine; Omeprazole; Orphenadrine; Oxazepam; Oxazepam glucuronide; Oxcarbazepine; Oxybutynin; Oxymorphone; Paliperidone; Pantoprazole; Papaverine; Paracetamol (acetaminophen); Paroxetine; Pentazocine; Pericyazine; Perindopril; Perphenazine; Phenformin; Pheniramine; Phenobarbital; Phentermine; Phenylephrine; Phenylpropanolamine (PPA); Phenytoin (dilantin); Pholcodine; Pimozide; Pioglitazone; Piroxicam; Pizotifen; Posaconazole; Prazepam; Prazosin; Pregabalin; Primaquine; Procaine; Prochlorperazine; Profenamine (ethopropazine); Proguanil; Promethazine; Propafenone; Propranolol; Protriptyline; Pseudoephedrine (PSE); Pyrazinamide; Pyrimethamine; Quetiapine; Quinidine; Quinine; Ramipril; Ranitidine; Reboxetine; Repaglinide; Rifampicin; Risperidone; Rivastigmine; Rosiglitazone; Roxithromycin; Rufinamide; Secobarbital; Selegiline; Sertraline; Sibutramine; Sildenafil; Simvastatin; Sotalol; Spironolactone; Sufentanil; Sulfamethoxazole; Sulfasalazine; Sulindac; Sulpiride; Telmisartan; Temazepam; Tenoxicam; Terazosin; Terbutaline; Tetracaine; Tetrahydropalmatine; Tetrazepam; Thiopental; Thioridazine; Tiagabine; Tianeptine; Tiapride; Ticlopidine; Tiotixene (thiothixene); Tolazamide; Tolbutamide; Tolterodine; Topiramate; Tramadol; Trazodone; Triamterene; Triazolam; Trifluoperazine; Trifluoromethylphenylpiperazine (TFMPP); Trihexyphenidyl (benzhexol); Trimetazidine; Trimethoprim; Trimipramine; Valsartan; Venlafaxine; Verapamil; Vigabatrin; Voriconazole; Warfarin; Zaleplon; Ziprasidone; Zolpidem; Zonisamide; Zopiclone; Zuclopenthixol; m-Chlorophenylpiperazine (m-CPP); para-Methoxy-N-methylamphetamine; para-Methoxyamphetamine
Chemical pathology - Detection and/or quantitation of tumour markers Serum CA125 antigen (CA125); CA19-9 antigen (CA19-9); CYFRA 21-1; Carcinoembryonic antigen (CEA); Human chorionic gonadotropin (hCG); Prostate specific antigen (PSA); α-Fetoprotein (AFP)
Thyroglobulin
Chemical pathology - Detection of faecal occult blood Faeces Blood
Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) Blood Adrenocorticotropic hormone (ACTH)
Plasma Renin
Saliva Cortisol
Serum Calcitonin; Gastrin; Growth hormone
Aldosterone
Procalcitonin
Cortisol; Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Insulin; Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone; Testosterone - Free
11-Deoxycortisol; 17α-Hydroxyprogesterone; Androstenedione; Testosterone
Urine 11-oxo-Etiocholanolone; 11-oxo-Pregnanetriol; 11β-Hydroxyandrosterone; 11β-Hydroxyetiocholanolone; 16α-Hydroxydehydroepiandrosterone; 16α-Hydroxypregnenolone; 17α-Hydroxypregnenolone; 17β-Androstenediol; 3a,16a,20a Pregnanetriol; 3b,16a,20a Pregnanetriol; Allotetrahydrocorticosterone; Allotetrahydrocortisol; Androstenetriol; Androsterone; Cortisol; Dehydroepiandrosterone (DHEA); Etiocholanolone; Pregnanediol; Pregnanetriol; Tetrahydro-11-dehydrocorticosterone; Tetrahydro-11-deoxycortisol; Tetrahydrocorticosterone; Tetrahydrocortisol; Tetrahydrocortisone; α-Cortol; α-Cortolone; β-Cortol; β-Cortolone
Chemical pathology - Diagnosis and management of diabetes mellitus Urine Ketones
Chemical pathology - Further investigation of cardiac function Plasma Troponin
Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia Plasma HDL - Quantitation
Chemical pathology - Further investigation of renal and/or hepatic function Plasma; Urine Uric acid
Serum Alkaline phosphatase (ALP) isoenzymes
Indocyanine green clearance
Caeruloplasmin; Haptoglobins; α1-Antitrypsin
Chemical pathology - Haem related pigments and precursors (excluding porphyria) Cerebrospinal fluid (CSF) Xanthochromia
Faeces Stercobilinogen
Urine Haemoglobin (Hb); Myoglobin
Bilirubin
Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies Cerebrospinal fluid (CSF) Lactate; Protein - Total
Glucose
Muscle Adenosine triphosphate; NADH-tetrazolium reductase; Non-specific esterase; Phosphorylase; Succinic dehyrogenase
Other body fluids; Urine pH
Plasma Alanine aminotransferase; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Total; Calcium - Total; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; Lactate dehydrogenase (LDH); Phosphate; Protein - Total; Triglycerides; Urea; γ-Glutamyltransferase
Ammonia; Bilirubin - Any fractions; Creatinine; Lactate; Magnesium
Plasma; Urine Chloride; Potassium; Sodium
Osmolality
Pleural fluid pH
Rectal biopsy Acetylcholinesterase (RCAC)
Serum C-reactive protein (CRP); High sensitivity C-reactive protein (CRP)
Cholinesterase
Urine Urobilinogen
Albumin; Creatinine; Microalbumin; Protein - Total
Amylase; Calcium - Total; Creatinine; Phosphate; Urea
Creatinine; Lactate
Chemical pathology - Investigation for folate deficiency Serum Folate
Chemical pathology - Investigation of malabsorption Urine Reducing substances
Chemical pathology - Investigation of porphyria Urine Coproporphobilinogen; Uroporphobilinogen
Porphobilinogen (PBG)
Chemical pathology - Iron studies Serum Iron; Total iron-binding capacity (TIBC)
Ferritin
Chemical pathology - Markers of bone metabolism Serum Procollagen type 1 N-terminal propeptide (P1NP); β-Crosslaps (CTX)
Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) Blood Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Haemoglobin (Hb); Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); pH
Chemical pathology - Quantitation of precursor and intermediary metabolites Blood Pyruvate
Serum β-Hydroxybutyrate
Chemical pathology - Quantitation of vitamins Blood 25-Hydroxyvitamin D
Serum Cobalamin (vitamin B12)
Chemical pathology - Tests for thyroid function Serum Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free
Chemical pathology - Trace element analysis Blood Arsenic; Cadmium; Chromium; Cobalt; Lead; Manganese
Plasma Aluminium; Chromium; Cobalt; Manganese; Selenium; Vanadium
Serum Copper; Zinc
Urine Aluminium; Antimony; Arsenic; Cadmium; Copper; Nickel; Vanadium
Cytogenetics - Detection of defined, balanced and/or unbalanced chromosomal abnormalities by in-situ hybridisation techniques Blood; Bone marrow Cytogenetic analysis and reporting
Cytogenetics - Molecular karyotype (SNP microarray) detection of unbalanced chromosome abnormalities Bone marrow Cytogenetic analysis and reporting
Haematology - Assessment of haemolysis or metabolic enzymes (red cell enzyme assays) Blood Glucose-6-phosphate dehydrogenase (G6PD)
Haematology - Bone marrow examination Bone marrow Examination of aspirated material
Haematology - Diagnosis of thalassemia Blood Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation
Haematology - Examination of blood films by special staining Blood Haemoglobin H; Heinz bodies
Malaria
Acid phosphatase; Lipids/triglycerides; Myeloid differentiation; Myeloperoxidase; Non-specific esterase; Polysaccharides
Haematology - Foetal haemoglobin in maternal circulation Blood Detection and quantitation of foetal red cell antigens
Haematology - Full blood examination Blood Differential number; Morphology; Reticulocytes
Differential number; Erythrocyte count (red blood cell count, RBCC); Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); Platelet count; Red blood cell index or indices; Reticulocytes
Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) Plasma Activated partial thromboplastin time (APTT); Anti-thrombin III; Factor II; Factor IX; Factor V; Factor VII; Factor VIII; Factor X; Factor XI; Factor XII; Fibrinogen; Mixing studies - APTT; Protein C and protein S; Prothrombin time (PT); Thrombin time (TT)
D-dimer
Lupus anticoagulant
Haematology - Investigation of haemoglobinopathy (excluding thalassemia) Blood Haemoglobin instability
Haemoglobin S (HbS) - Presence
Other abnormal haemoglobins
Haemoglobin fraction (S, C, D, E) - Quantitation
Haematology - Investigation of haemolysis Blood Schumm’s test
Paroxysmal nocturnal haemoglobinuria (PNH) screen
Osmotic fragility
Cold agglutinins
Haematology - Limited blood examination Blood Erythrocyte (RBC) sedimentation rate (ESR)
Immunohaematology - Blood group antibody detection Blood Other blood group systems; Rh phenotypes
Immunohaematology - Blood grouping Blood ABO; RhD
Immunohaematology - Determination of compatibility of blood donor units Blood Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies
Immunohaematology - Identification and quantitation of blood group antibodies Blood Antibody titration
Red blood cell phenotyping
Other blood group antibodies; Rh
Antibody elution
Immunohaematology - Investigation of blood transfusion reactions Blood Direct antiglobulin test (DAT, direct Coombs test); Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies
Immunohaematology - Issue and release of blood and blood product for transfusion Blood Issue and release of blood and blood products for transfusion
Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) Blood; Bone marrow CD10; CD13; CD2; CD20; CD22; CD3; CD33; CD5; CD7; CD79a; Myeloperoxidase
Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies Serum Anti-cardiolipin antibodies (ACA); Anti-double stranded DNA antibodies (dsDNA); Anti-extractable nuclear antigen antibodies (ENA); Anti-myeloperoxidase antibodies (MPO); Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA); Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO)
Rheumatoid factor
Anti-gastric parietal cell antibodies (GPC/PCA); Anti-mitochondrial antibodies (AMA, AMA M1 and/or AMA M2); Anti-smooth muscle antibodies (SMA); Anti-striated muscle antibodies
Immunopathology - Quantitation of complement proteins Serum Complement components C3 and C4
Immunopathology - Quantitative and/or qualitative investigation of proteins Serum Detection and quantitation of free kappa and free lambda light chains
Cryoglobulins
Serum; Urine Protein classes
Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses Serum Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M
Microbiology - Bacteriology - Detection of pathogenic bacteria Blood Bacteria; Pathogenic microorganisms
Blood; Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Genital swabs; Nasal swabs; Rectal swabs; Respiratory specimens; Sputum; Throat swabs; Tissues; Urine; Vaginal swabs Bacteria; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC)
Bacteria; Pathogenic identification; Pathogenic microorganisms
Bacteria; Pathogenic identification; Pathogenic microorganisms
Antibiotic susceptibility; Bacteria; Pathogenic microorganisms
Bacteria; Pathogenic microorganisms
Cerebrospinal fluid (CSF); Fluids Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC)
Faeces Clostridioides difficile toxin; Clostridium difficile glutamate dehydrogenase
Urine Legionella antigen; Streptococcus pneumoniae antigen
Specific gravity
Glucose; Proteins
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) Faeces Clostridioides difficile
Nasal swabs Methicillin resistant Staphylococcus aureus (MRSA)
Nasopharyngeal aspirate; Sputum Chlamydophila pneumoniae; Mycoplasma pneumoniae
Sputum Legionella pneumophila
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) Blood; Cerebrospinal fluid (CSF) Human immunodeficiency virus type 1 (HIV-1) RNA
Hepatitis B virus (HBV) DNA
Liquid based cytology specimens Human papilloma virus (HPV)
Microbiology - Mycobacteriology - Detection and identification of mycobacteria Aspirates; Blood; Bone marrow; Bronchial washings; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Faeces; Gastric lavage; Other body fluids; Respiratory specimens; Skin swabs; Sputum; Tissues; Urine; Wound swabs Mycobacteria identification
Aspirates; Blood; Bone marrow; Bronchial washings; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Faeces; Gastric lavage; Other body fluids; Skin swabs; Sputum; Tissues; Urine; Wound swabs Mycobacteria identification
Microbiology - Mycobacteriology - Tests for antigen lymphocyte stimulation Blood Mycobacterial antigen lymphocyte stimulation
Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Genital swabs; Nails; Nasal swabs; Respiratory specimens; Respiratory swabs; Skin scrapings; Sputum; Throat swabs; Tissues; Urine; Vaginal swabs Fungi identification; Yeasts identification
Fungi identification; Yeasts identification
Cerebrospinal fluid (CSF); Serum Cryptococcus antigen
Hair; Nails; Skin scrapings Fungi identification; Yeasts identification
Isolates; Nails; Respiratory swabs; Skin scrapings; Sputum Fungi susceptibility; Yeast susceptibility
Microbiology - Parasitology - Detection of ova, cysts and parasites AspiratesLiver aspiration; duodenal aspiration; sigmoidoscopy specimens Cysts; Ova; Parasites
Blood Malaria
Corneal scrapings; Faeces Amoebae
Corneal scrapingsContact lens solution; contact lens Acanthamoeba spp.
Faeces Cryptosporidia
Cryptosporidia; Isospora spp.
Giardia spp.
Faeces; Urine Cysts; Ova; Parasites
Skin scrapings Scabies
Sputum Cysts; Ova; Parasites
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation Blood Infectious mononucleosis
Serum Syphilis Treponema pallidum antibody
Cytomegalovirus (CMV) IgG avidity; Cytomegalovirus antibody (anti-CMV) IgM; Hepatitis A virus antibody (anti-HAV) - IgM; Hepatitis B virus core antibody (anti-HBc) - IgM; Hepatitis B virus core antibody (anti-HBc) - Total; Hepatitis B virus envelope antibody (anti-HBe); Hepatitis B virus envelope antigen (HBe Ag); Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Human immunodeficiency virus (HIV); Measles IgG antibody; Mumps virus IgG antibody; Rubella IgG antibody; Rubella IgM antibody; Toxoplasma spp. IgM antibody; Varicella zoster virus (VZV) IgG antibody
Hepatitis C virus (HCV)
Hepatitis A virus antibody (anti-HAV) - IgG; Hepatitis B virus envelope antigen (HBe Ag); Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Hepatitis C virus (HCV); Human immunodeficiency virus (HIV); Syphilis Treponema pallidum antibody
Hepatitis E virus (HEV) IgM
Hepatitis D virus (HDV)
Hepatitis B virus surface antigen (HBs Ag); Hepatitis C virus (HCV); Human immunodeficiency virus (HIV)
Measles IgG antibody; Varicella zoster virus (VZV) IgG antibody
Anti-streptolysin O (ASOT)
Epstein-Barr virus viral capsid antigen
Brucella spp.
β-1,3-D-Glucan
Human immunodeficiency virus (HIV)
Syphilis Treponema pallidum antibody
Human immunodeficiency virus (HIV); Measles IgG antibody; Mumps virus IgG antibody; Varicella zoster virus (VZV) IgG antibody
Microbiology - Virology - Detection of pathogenic viruses Aspirates; Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs; Respiratory swabs and/or washings Adenovirus; Influenza A virus; Influenza B virus; Parainfluenza virus; Respiratory syncytial virus (RSV)
Faeces Rotavirus
Nasopharyngeal aspirate; Nasopharyngeal swabs Influenza A virus; Influenza B virus
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes Blood Blood borne tumours
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes Aspirates; Formalin-fixed paraffin-embedded (FFPE) tissues; Sputum EGFR mutation analysisEGFR
Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes Blood α-Thalassaemia
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes Blood; Bone marrow; Leucocytes (leukocytes) α-ThalassaemiaJAK2 mutation analysis
Anatomical Pathology

ISO 15189 (2012)

Human Pathology

Withdrawn
Service Product Determinant
Anatomical pathology - Cytopathology - Cervical cytological investigation for abnormalities, precancerous or cancerous changes or conditions Liquid based cytology specimens from cervix Cytological examination; Review and reporting of cervical cytological material
Anatomical pathology - Cytopathology - Gynaecological (non-cervical) cytological investigation for abnormalities, precancerous or cancerous changes or conditions Vaginal smears Cytological examination; Review and reporting of gynaecological (non-cervical tissue) cytological samples
Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of body fluids, exudates, washings and brushings from non-squamous mucosal sites for the detection of malignancy Cerebrospinal fluid (CSF); Other body fluids; Sputum; Urine; Washings or brushings from other sites Cytological examination; Review and reporting of cytology samples
Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations on samples obtained via fine needle aspiration biopsy Fine needle aspirates (FNA) Cytological examination; Review and reporting of fine needle aspiration samples
Anatomical pathology - Tissue pathology - Coronial autopsy services Body; Body parts Autopsy service and reporting
Anatomical pathology - Tissue pathology - Examination of biopsy material Formalin fixed tissue; Fresh tissue Review and reporting of biopsy material to identify or exclude morphological abnormalities
Anatomical pathology - Tissue pathology - Examination of biopsy material by electron microscopy Formalin fixed tissue; Fresh tissue Review and reporting of biopsy material to identify or exclude ultra-structural morphological abnormalities
Anatomical pathology - Tissue pathology - Gene probes using paraffin fluorescence in-situ hybridisation (FISH) Formalin-fixed paraffin-embedded (FFPE) tissues Detection of nucleic acid targets - Various
Anatomical pathology - Tissue pathology - Gene probes using paraffin in-situ hybridisation techniques (chromogenic/silver) Formalin-fixed paraffin-embedded (FFPE) tissues Detection of nucleic acid targets - Various
Detection of nucleic acid targets - Various
Anatomical pathology - Tissue pathology - Immediate frozen section diagnosis Fresh tissue Intra-operative consultation and examination of biopsy material
Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation Formalin-fixed paraffin-embedded (FFPE) tissues Detection of antigenic targets - Various
Frozen tissue Detection of antigenic targets - Various
Anatomical pathology - Tissue pathology - Immunohistochemical investigation Formalin-fixed paraffin-embedded (FFPE) tissues Detection of antigenic targets - Various
Frozen sections of fresh tissue Detection of antigenic targets - Various
Anatomical pathology - Tissue pathology - Mortuary facilities Body; Body parts Assessment - Level 2 mortuary
Anatomical pathology - Tissue pathology - Non-coronial autopsy services Body; Body parts Autopsy service and reporting
Anatomical pathology - Tissue pathology - Skeletal muscle enzyme histochemistry Frozen sections of skeletal muscle Detection of muscle enzyme targets
Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies Muscle Adenosine triphosphate; NADH-tetrazolium reductase; Non-specific esterase; Phosphorylase; Succinic dehyrogenase
Rectal biopsy Acetylcholinesterase (RCAC)
Chemical Pathology (Routine and Special)

ISO 15189 (2012)

Human Pathology

Withdrawn
Service Product Determinant
Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals Blood Cyanide
Urine Methanol; Paraquat
Amphetamines; Buprenorphine; Caffeine; Cocaine; Fentanyl; Methadone; Methamphetamine; Morphine; Oxycodone; Phencyclidine; Propoxyphene; Salbutamol
Paraquat
Benzodiazepines
2-Ethyl-5-methyl-3,3-diphenylpyrrolidine (EMDP); 2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP); Amphetamines; Buprenorphine; Caffeine; Cocaine; Ecgonine methyl ester; Fentanyl; Methadone; Methamphetamine; Morphine; Oxycodone; Phencyclidine; Propoxyphene; Salbutamol
Chemical pathology - Biochemical genetic services - Amino acid quantitation Cerebrospinal fluid (CSF) Alanine; Glycine; Serine
Plasma; Urine Alanine; Alloisoleucine; Arginine; Arginosuccinic acid; Asparagine; Aspartic acid; Citrulline; Cystine; Glutamic acid; Glutamine; Glycine; Histidine; Homocysteine; Hydroxyproline; Isoleucine; Leucine; Lysine; Methionine; Ornithine; Phenylalanine; Phosphoethanolamine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine; α-Aminobutyric acid
Chemical pathology - Biochemical genetic services for the diagnosis of metabolic and enzymological disorders Urine 2,4-Dinitrophenylhydrazine (DNPH, Brady's reagent, Borche's reagent); Chyle; D-lactate; Ferric chloride; Indican; Mucopolysaccharides (MPS); Sulfite
Chemical pathology - Biogenic amines Plasma Metanephrine; Methoxytyramine; Normetanephrine
Urine 5-Hydroxyindoleacetic acid (5-HIAA); Adrenaline; Dopamine; Homovanillic acid (HVA); Metanephrine; Methoxytyramine; Noradrenaline; Normetanephrine; Vanillylmandelic acid (VMA)
Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring Blood Cyclosporin; Everolimus; Sirolimus; Tacrolimus
Serum Methotrexate
Amikacin
Lithium
Carbamazepine; Digoxin; Gentamicin (cidomycin, septopal, genticyn, garamycin); Methotrexate; Phenobarbitone; Phenytoin (dilantin); Theophylline; Valproate (valproic acid, epilim); Vancomycin
Ethanol; Paracetamol (acetaminophen); Salicylate
Urine 1,4-Dibenzylpiperazine (DBZP); 3',4'-Methylenedioxy-α-pyrrolidinobutyrophenone (MDPBP ); 3,4-Methylenedioxy-N-ethylamphetamine (MDEA); 3,4-Methylenedioxyamphetamine (MDA); 3,4-Methylenedioxymethamphetamine (MDMA); 3,4-Methylenedioxypyrovalerone (MDPV); 3-Hydroxymorphinan; 3-Methoxymorphinan; 4-Diphenylmethoxy-1-methylpiperidine; 4-Hydroxy-3-methoxymethamphetamine (HMMA); 5-Flucytosine; 6β-Naltrexol; Acebutolol; Acepromazine; Acetazolamide; Acyclovir; Adrenalone; Alfentanil; Allopurinol; Alprazolam; Alprenolol; Amantadine; Ambroxol; Amiloride; Amiodarone; Amisulpride; Amitriptyline; Amlodipine; Amobarbital; Amoxapine; Amoxicillin; Antazoline; Apomorphine; Aripiprazole; Atenolol; Atomoxetine; Atropine; Azithromycin; Baclofen; Barbital; Benfluorex; Benzoylecgonine (ecgonine benzoate); Benzylpiperazine (BZP, 1-benzylpiperazine); Betamethasone; Betaxolol; Bisacodyl - Cathartic; Bisoprolol; Bromazepam; Bromhexine; Bromocriptine; Bromperidol; Brompheniramine; Buflomedil; Bufotenine; Bumetanide; Bupivacaine; Bupropion; Buspirone; Butoforme; Butorphanol; Captopril; Carbamazepine; Carbimazole; Carbinoxamine; Carvedilol; Cathinone (benzoylethanamine, β-keto-amphetamine); Cefotaxime; Cefuroxime; Celecoxib; Cetirizine; Chlordiazepoxide; Chloroquine; Chlorothiazide; Chlorpheniramine; Chlorpromazine; Chlorpropamide; Chlorprothixene; Cimetidine; Cinchonine; Ciproflocaxin; Citalopram; Clarithromycin; Clenbuterol; Clobazam; Clomipramine; Clonazepam; Clonidine; Clozapine; Cocaethylene; Codeine; Colchicine; Cotinine; Crimidine; Cyproheptadine; Dapsone; Dehydronifedipine (DHN); Dehydronifedipinic acid (DHNA); Desipramine; Dexamethasone; Dexchlorpheniramine; Dextromethorphan; Dextromoramide; Dextrorphan; Diazepam; Dibucaine (cinchocaine); Diclofenac; Dihydrocodeine (6α-hydrocodol); Diisopyramide; Diltiazem; Diphenhydramine; Dipyridamole; Domperidone; Donepezil; Dothiepin (dosulepin); Doxepin; Doxylamine; Duloxetine; Empagliflozin; Enalapril; Entacapone; Ephedrine; Ergine (LSA, d-lysergic acid amide); Ergotamine; Erythromycin; Escitalopram; Esomeprazole; Estazolam; Ethambutol; Etoricoxib; Famotidine; Felbamate; Fenfluramine; Fexofenadine; Finasteride; Flecainide; Flucloxacillin; Fluconazole; Flunitrazepam; Fluoxetine; Fluphenazine; Flurazepam; Fluvoxamine; Furosemide; Gabapentin; Glafenine; Glibenclamide; Gliclazide; Glimepiride; Glipizide; Guaifenesin; Haloperidol; Heroin; Hydrochlorothiazide; Hydrocodone; Hydromorphone; Hydroxychloroquine; Hydroxyzine; Hyoscine (scopolamine); Ibuprofen; Ifendopril; Imipramine; Indapamide; Indomethacin; Irbesartan; Isoniazid; Isoprenaline; Ketamine; Ketobemidone; Ketoconazole; Ketoprofen; Labetalol; Lacosamide; Lamotrigine; Lansoprazole; Laudanosine; Levamisole; Levetiracetam; Levofloxacin; Levomepromazine; Lidocaine; Lisinopril; Loperamide; Loratadine; Lorazepam; Lormetazepam; Losartan; Loxapine; Lysergic acid diethylamide (LSD, lysergide); Mannitol; Maprotiline; Mefenamic acid; Melitracen (flupentixol); Meloxicam; Memantine; Meperidine (pethidine); Mephedrone; Mepyramine; Metformin; Methaqualone; Methoxyphenamine (OMMA); Methylbenzodioxolylbutanamine (MBDB); Methyldopa; Methylhexanamine (dimethylamylamine); Methylphenidate; Metoclopramide; Metolazone; Metoprolol; Metronidazole; Mianserin; Midazolam; Minaprine; Mirtazapine; Misoprostol; Monoethylglycinexylidide (MEGX); N-Methylephedrine; Nadolol; Nalbuphine; Naloxone; Naltrexone; Naproxen; Nateglinide; Nicotine; Nifedipine; Nimetazepam; Nimodipine; Nitrazepam; Nortriptyline; Olanzapine; Omeprazole; Orphenadrine; Oxazepam; Oxazepam glucuronide; Oxcarbazepine; Oxybutynin; Oxymorphone; Paliperidone; Pantoprazole; Papaverine; Paracetamol (acetaminophen); Paroxetine; Pentazocine; Pericyazine; Perindopril; Perphenazine; Phenformin; Pheniramine; Phenobarbital; Phentermine; Phenylephrine; Phenylpropanolamine (PPA); Phenytoin (dilantin); Pholcodine; Pimozide; Pioglitazone; Piroxicam; Pizotifen; Posaconazole; Prazepam; Prazosin; Pregabalin; Primaquine; Procaine; Prochlorperazine; Profenamine (ethopropazine); Proguanil; Promethazine; Propafenone; Propranolol; Protriptyline; Pseudoephedrine (PSE); Pyrazinamide; Pyrimethamine; Quetiapine; Quinidine; Quinine; Ramipril; Ranitidine; Reboxetine; Repaglinide; Rifampicin; Risperidone; Rivastigmine; Rosiglitazone; Roxithromycin; Rufinamide; Secobarbital; Selegiline; Sertraline; Sibutramine; Sildenafil; Simvastatin; Sotalol; Spironolactone; Sufentanil; Sulfamethoxazole; Sulfasalazine; Sulindac; Sulpiride; Telmisartan; Temazepam; Tenoxicam; Terazosin; Terbutaline; Tetracaine; Tetrahydropalmatine; Tetrazepam; Thiopental; Thioridazine; Tiagabine; Tianeptine; Tiapride; Ticlopidine; Tiotixene (thiothixene); Tolazamide; Tolbutamide; Tolterodine; Topiramate; Tramadol; Trazodone; Triamterene; Triazolam; Trifluoperazine; Trifluoromethylphenylpiperazine (TFMPP); Trihexyphenidyl (benzhexol); Trimetazidine; Trimethoprim; Trimipramine; Valsartan; Venlafaxine; Verapamil; Vigabatrin; Voriconazole; Warfarin; Zaleplon; Ziprasidone; Zolpidem; Zonisamide; Zopiclone; Zuclopenthixol; m-Chlorophenylpiperazine (m-CPP); para-Methoxy-N-methylamphetamine; para-Methoxyamphetamine
Chemical pathology - Detection and/or quantitation of tumour markers Serum Thyroglobulin
CA125 antigen (CA125); CA19-9 antigen (CA19-9); CYFRA 21-1; Carcinoembryonic antigen (CEA); Human chorionic gonadotropin (hCG); Prostate specific antigen (PSA); Thyroglobulin; α-Fetoprotein (AFP)
Chemical pathology - Detection of faecal occult blood Faeces Blood
Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) Blood Adrenocorticotropic hormone (ACTH)
Plasma Renin
Saliva Cortisol; Cortisone
Serum Aldosterone
Gastrin
11-Deoxycortisol; 17α-Hydroxyprogesterone; 21-Deoxycortisol; Androstenedione; Cortisol; Testosterone
Calcitonin; Cortisol; Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Growth hormone; Insulin; Luteinising hormone (LH); Macroprolactin; Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone; Testosterone - Free
Urine 11-oxo-Etiocholanolone; 11-oxo-Pregnanetriol; 11β-Hydroxyandrosterone; 11β-Hydroxyetiocholanolone; 16α-Hydroxydehydroepiandrosterone; 16α-Hydroxypregnenolone; 17α-Hydroxypregnenolone; 17β-Androstenediol; 3a,16a,20a Pregnanetriol; 3b,16a,20a Pregnanetriol; Allotetrahydrocorticosterone; Allotetrahydrocortisol; Androstenetriol; Androsterone; Cortisol; Dehydroepiandrosterone (DHEA); Etiocholanolone; Pregnanediol; Pregnanetriol; Tetrahydro-11-dehydrocorticosterone; Tetrahydro-11-deoxycortisol; Tetrahydrocorticosterone; Tetrahydrocortisol; Tetrahydrocortisone; α-Cortol; α-Cortolone; β-Cortol; β-Cortolone
Cortisol
Chemical pathology - Diagnosis and management of diabetes mellitus Serum Fructosamine
Urine Ketones
Chemical pathology - Further investigation of cardiac function Plasma Troponin I
Chemical pathology - Further investigation of renal and/or hepatic function Serum Alkaline phosphatase (ALP) isoenzymes; Caeruloplasmin; Haptoglobins; α1-Antitrypsin
Indocyanine green clearance
Alkaline phosphatase (ALP) isoenzymes
Chemical pathology - Haem related pigments and precursors (excluding porphyria) Cerebrospinal fluid (CSF) Xanthochromia
Faeces Stercobilinogen
Plasma Plasma free haemoglobin
Urine Bilirubin; Haemoglobin (Hb); Myoglobin; Urobilinogen
Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies Cerebrospinal fluid (CSF) Glucose; Lactate; Protein - Total
Glucose
Other body fluids; Urine pH
Plasma Chloride; Potassium; Sodium
Alanine aminotransferase; Albumin; Alkaline phosphatase; Ammonia; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Total; Calcium - Total; Chloride; Cholesterol - HDL; Cholesterol - LDL; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; Lactate; Lactate dehydrogenase (LDH); Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urea; Uric acid; γ-Glutamyltransferase
Ammonia; Bilirubin - Any fractions; Creatinine; Lactate; Magnesium
Plasma; Urine Osmolality
Pleural fluid pH
Serum C-reactive protein (CRP); High sensitivity C-reactive protein (CRP)
Cholinesterase
Urine Amylase; Calcium - Total; Creatinine; Magnesium; Phosphate; Urea; Uric acid
Urobilinogen
Chloride; Creatinine; Microalbumin; Potassium; Protein - Total; Sodium
Lactate
Chemical pathology - Investigation for folate deficiency Serum Folate
Chemical pathology - Investigation of malabsorption Urine Reducing substances
Chemical pathology - Investigation of porphyria Urine Porphobilinogen (PBG)
Porphyrins - Total
Chemical pathology - Iron studies Serum Ferritin; Iron; Total iron-binding capacity (TIBC)
Ferritin
Chemical pathology - Markers of bone metabolism Serum Procollagen type 1 N-terminal propeptide (P1NP); β-Crosslaps (CTX)
Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) Blood Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Haemoglobin (Hb); Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); pH
Chemical pathology - Quantitation of precursor and intermediary metabolites Blood Pyruvate
Serum β-Hydroxybutyrate
Chemical pathology - Quantitation of vitamins Blood 25-Hydroxyvitamin D
Serum Cobalamin (vitamin B12)
Chemical pathology - Tests for thyroid function Serum Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free
Chemical pathology - Trace element analysis Blood Arsenic; Cadmium; Chromium; Cobalt; Lead; Manganese
Plasma Aluminium; Chromium; Cobalt; Manganese; Selenium; Vanadium
Serum Copper; Zinc
Urine Aluminium; Antimony; Arsenic; Cadmium; Copper; Nickel; Vanadium
Immunopathology - Quantitation of complement proteins Serum Complement components C3 and C4
Immunopathology - Quantitative and/or qualitative investigation of proteins Serum Detection and quantitation of free kappa and free lambda light chains
Cryoglobulins
Serum; Urine Protein classes
Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses Serum Immunoglobulin subclasses
Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M
Haematology

ISO 15189 (2012)

Human Pathology

Withdrawn
Service Product Determinant
Chemical pathology - Diagnosis and management of diabetes mellitus Blood Glycated haemoglobin (HbA1c)
Cytogenetics - Biodosimetry-dicentric analysis Blood Cytogenetic dosimetry test for individual radiation dose assessment in radiation emergencies
Cytogenetics - Detection of defined, balanced and/or unbalanced chromosomal abnormalities by in-situ hybridisation techniques Blood; Bone marrow Cytogenetic analysis and reporting
Cytogenetics - Molecular karyotype (SNP microarray) detection of unbalanced chromosome abnormalities Bone marrow Cytogenetic analysis and reporting
Haematology - Assessment of haemolysis or metabolic enzymes (red cell enzyme assays) Blood Glucose-6-phosphate dehydrogenase (G6PD)
Haematology - Bone marrow examination Bone marrow Examination of aspirated material
Haematology - Diagnosis of thalassemia Blood Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation
Haematology - Examination of blood films by special staining Blood Haemoglobin H; Heinz bodies
Acid phosphatase; Lipids/triglycerides; Myeloid differentiation; Myeloperoxidase; Non-specific esterase; Polysaccharides
Malaria
Haematology - Foetal haemoglobin in maternal circulation Blood Detection and quantitation of foetal red cell antigens
Haematology - Full blood examination Blood Differential number; Erythrocyte count (red blood cell count, RBCC); Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); Platelet count; Red blood cell index or indices; Reticulocytes
Differential number; Morphology; Reticulocytes
Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) Blood Platelet function (PFA)
Plasma Lupus anticoagulant
D-dimer
Activated partial thromboplastin time (APTT); Anti-thrombin III; Factor II; Factor IX; Factor V; Factor VII; Factor VIII; Factor X; Factor XI; Factor XII; Fibrinogen; Mixing studies - APTT; Protein C and protein S; Prothrombin time (PT); Thrombin time (TT)
Haematology - Investigation of haemoglobinopathy (excluding thalassemia) Blood Haemoglobin S (HbS) - Presence
Other abnormal haemoglobins
Haemoglobin instability
Haemoglobin fraction (S, C, D, E) - Quantitation
Haematology - Investigation of haemolysis Blood Schumm’s test
Hereditary spherocytosis; Paroxysmal nocturnal haemoglobinuria (PNH) screen
Osmotic fragility
Cold agglutinins
Haematology - Limited blood examination Blood Erythrocyte (RBC) sedimentation rate (ESR)
Immunohaematology - Blood group antibody detection Blood Other blood group systems; Rh phenotypes
Immunohaematology - Blood grouping Blood ABO; RhD
Immunohaematology - Determination of compatibility of blood donor units Blood Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies
Immunohaematology - Identification and quantitation of blood group antibodies Blood Antibody titration
Antibody elution
Direct antiglobulin test (DAT, direct Coombs test); Red blood cell phenotyping
Other blood group antibodies; Rh
Immunohaematology - Investigation of blood transfusion reactions Blood Direct antiglobulin test (DAT, direct Coombs test); Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies
Immunohaematology - Issue and release of blood and blood product for transfusion Blood Issue and release of blood and blood products for transfusion
Immunohaematology - Storage and distribution of blood and blood components Blood; Blood products Issue and release of blood and blood products for transfusion
Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) Blood; Bone marrow CD10; CD117; CD13; CD19; CD2; CD20; CD22; CD3; CD33; CD34; CD4; CD5; CD7; CD79a; CD8; Myeloperoxidase
Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies Serum Anti-cardiolipin antibodies (ACA); Anti-double stranded DNA antibodies (dsDNA); Anti-extractable nuclear antigen antibodies (ENA); Anti-myeloperoxidase antibodies (MPO); Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA); Anti-proteinase 3 antibodies (PR3); Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO)
Anti-gastric parietal cell antibodies (GPC/PCA); Anti-mitochondrial antibodies (AMA, AMA M1 and/or AMA M2); Anti-smooth muscle antibodies (SMA); Anti-striated muscle antibodies
Rheumatoid factor
Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) Semen Motility; Sperm number
Microbiology

ISO 15189 (2012)

Human Pathology

Withdrawn
Service Product Determinant
Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy Urine Human chorionic gonadotropin (hCG)
Microbiology - Bacteriology - Detection of pathogenic bacteria Blood Bacteria; Pathogenic microorganisms
Clostridioides difficile toxin
Blood; Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Genital swabs; Nasal swabs; Rectal swabs; Respiratory specimens; Sputum; Throat swabs; Tissues; Urine; Vaginal swabs Bacteria; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC)
Bacteria; Pathogenic identification; Pathogenic microorganisms
Antibiotic susceptibility; Bacteria; Pathogenic microorganisms
Bacteria; Pathogenic microorganisms
Bacteria; Pathogenic identification; Pathogenic microorganisms
Cerebrospinal fluid (CSF) Bacteria; Pathogenic microorganisms
Cerebrospinal fluid (CSF); Fluids Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC)
Urine Glucose; Proteins
Legionella antigen; Streptococcus pneumoniae antigen
Microbiology - Environmental investigations and/or infection control Dialysis waters; Waters Bacterial growth - Sterility; Detection and characterisation of organisms (including identification and typing)
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (mycobacteria) Respiratory specimens Mycobacterium tuberculosis complex; Mycobacterium rifampicin resistance rpoB
Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Genital swabs; Nails; Nasal swabs; Respiratory specimens; Respiratory swabs; Skin scrapings; Sputum; Throat swabs; Tissues; Urine; Vaginal swabs Fungi identification; Yeasts identification
Fungi identification; Yeasts identification
Cerebrospinal fluid (CSF); Serum Cryptococcus antigen
Hair; Nails; Skin scrapings Fungi identification; Yeasts identification
Isolates; Nails; Respiratory swabs; Skin scrapings; Sputum Fungi susceptibility; Yeast susceptibility
Microbiology - Parasitology - Detection of ova, cysts and parasites AspiratesLiver aspiration; duodenal aspiration; sigmoidoscopy specimens Cysts; Ova; Parasites
Blood Malaria
Corneal scrapings; Faeces Amoebae
Corneal scrapingsContact lens solution; contact lens Acanthamoeba spp.
Faeces Cryptosporidia; Isospora spp.
Giardia spp.
Microsporidia
Faeces; Urine Cysts; Ova; Parasites
Rectal swabs Worms
Skin scrapings Scabies
Sputum Cysts; Ova; Parasites
Urine Cysts; Ova; Parasites
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation Blood Infectious mononucleosis
Serum Cytomegalovirus (CMV) IgG avidity; Cytomegalovirus antibody (anti-CMV) IgM; Hepatitis A virus antibody (anti-HAV) - IgM; Hepatitis B virus core antibody (anti-HBc) - IgM; Hepatitis B virus core antibody (anti-HBc) - Total; Hepatitis B virus envelope antibody (anti-HBe); Hepatitis B virus envelope antigen (HBe Ag); Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Human immunodeficiency virus (HIV); Measles IgG antibody; Mumps virus IgG antibody; Rubella IgG antibody; Rubella IgM antibody; Toxoplasma spp. IgM antibody; Varicella zoster virus (VZV) IgG antibody
Brucella spp.
Hepatitis A virus antibody (anti-HAV) - IgG; Hepatitis B virus envelope antigen (HBe Ag); Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Hepatitis C virus (HCV); Human immunodeficiency virus (HIV); Syphilis Treponema pallidum antibody
Human immunodeficiency virus (HIV)
Epstein-Barr virus viral capsid antigen
Hepatitis E virus (HEV) IgM
Hepatitis B virus surface antigen (HBs Ag); Hepatitis C virus (HCV); Human immunodeficiency virus (HIV)
Syphilis Treponema pallidum antibody
Anti-streptolysin O (ASOT)
Measles IgG antibody; Varicella zoster virus (VZV) IgG antibody
Molecular Genetics

ISO 15189 (2012)

Human Pathology

Withdrawn
Service Product Determinant
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (mycobacteria) Aspirates; Respiratory specimens; Tissues Mycobacterium tuberculosis complex
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) Liquid based cytology specimens Human papilloma virus (HPV)
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes Blood Blood borne tumoursChronic myelogenous leukaemia
Blood borne tumours
Molecular genetics - DNA fragment size analysis Blood; Formalin-fixed paraffin-embedded (FFPE) tissues DNA fragment size determination
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes Aspirates; Formalin-fixed paraffin-embedded (FFPE) tissues; Sputum EGFR mutation analysisNon-small cell lung cancer (EGFR)
EGFR mutation analysis
Blood; cDNA EGFR mutation analysis
Formalin-fixed paraffin-embedded (FFPE) tissues Microsatellite instability analysis
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted panels for non-inherited (somatic) DNA/RNA changes Formalin-fixed paraffin-embedded (FFPE) tissues KRAS mutation analysis
Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes Blood; Bone marrow; Leucocytes (leukocytes) α-ThalassaemiaJAK2 mutation analysis
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes Blood; Bone marrow; Leucocytes (leukocytes) α-ThalassaemiaJAK2 mutation analysis

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