National Association of Testing Authorities, Australia
Scope of Accreditation
Australian Clinical Labs
Site
Clayton Laboratory
Accreditation No.
3427
Site No.
3420
Date of Accreditation
10 Apr 1990
Contact
Mrs Margaret Anne Auld P: +61 (03) 95386767
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Anatomical Pathology
ISO 15189 (2012)
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Anatomical pathology - Cytopathology - Testing for the National Cervical Screening Program | Liquid based cytology specimens from cervix | Cytological examination; Review and reporting of cervical cytological material |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Formalin-fixed paraffin-embedded (FFPE) tissues; Fresh tissue; Frozen sections of fresh tissue | Detection of antigenic targets - Various |
ISO 15189 (2022)
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Anatomical pathology - Cytopathology - Cervical cytological investigation for abnormalities, precancerous or cancerous changes or conditions | Cervical smear; 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 | Vault 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 | Other body fluids; Urine | 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 - Cytopathology - Testing for the National Cervical Screening Program | Liquid based cytology specimens from cervix | Human papilloma virus (HPV) |
| 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 - Immediate frozen section diagnosis | Fresh tissue | Intra-operative consultation and examination of biopsy material |
Chemical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of calculus | Calculi | Ammonium; Calcium; Carbonate; Cystine; Magnesium; Oxalate; Phosphate; Uric acid |
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Blood | Ethanol |
| Blood; Plasma; Urine | Ethanol | |
| Urine | 6-Acetylmorphine; Barbiturates; Methadone | |
| Chemical pathology - Biogenic amines | Urine | 5-Hydroxyindoleacetic acid (5-HIAA); Adrenaline; Noradrenaline |
| Dopamine | ||
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Blood; Plasma | Paracetamol (acetaminophen) |
| Digoxin; Gentamicin (cidomycin, septopal, genticyn, garamycin); Tobramycin; Vancomycin | ||
| Lamotrigine | ||
| Carbamazepine; Lithium; Phenytoin (dilantin); Theophylline; Valproate (valproic acid, epilim) | ||
| Plasma; Serum | Keppra; Ubiquinone | |
| Clozapine; Olanzapine | ||
| Amiodarone; Ubiquinone | ||
| Chemical pathology - Detection and/or quantitation of tumour markers | Blood; Plasma | Human chorionic gonadotropin (hCG) |
| CA125 antigen (CA125); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA); Prostate specific antigen (PSA); Prostate specific antigen (PSA) fractions and derived index; α-Fetoprotein (AFP) | ||
| β2-Microglobulin (B2M) | ||
| Chemical pathology - Detection of faecal occult blood | Faeces | Blood |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Blood; Plasma | Growth hormone |
| Anti-Mullerian hormone (AMH) | ||
| Adrenocorticotropic hormone (ACTH); Androstenedione; Insulin-like growth factor 1 (IGF-1, somatomedin C) | ||
| Testosterone - Free | ||
| C-peptide; Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Insulin; Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone | ||
| Blood; Plasma; Urine | Cortisol | |
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood; Plasma | Glycated haemoglobin (HbA1c) |
| Fructosamine | ||
| Chemical pathology - Further investigation of cardiac function | Blood; Plasma | Creatine kinase MB (CKMB); Troponin |
| B-type natriuretic peptide (BNP) | ||
| Plasma; Serum | Troponin I | |
| Urine | Myoglobin | |
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Blood; Plasma | HDL - Quantitation |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Blood; Plasma | Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Carbon dioxide (CO2); Chloride; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; High sensitivity C-reactive protein (CRP); Lactate; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase |
| Angiotensin converting enzyme (ACE) | ||
| Blood; Urine | Osmolality | |
| Cerebrospinal fluid (CSF) | Glucose; Protein - Total | |
| Urine | Calcium - Total; Creatinine; Glucose; Magnesium; Microalbumin; Phosphate; Potassium; Protein - Total; Sodium; Urate; Urea | |
| Chemical pathology - Investigation for folate deficiency | Blood; Plasma | Folate; Red blood cell folate |
| Chemical pathology - Investigation of malabsorption | Faeces; Urine | Reducing substances |
| Chemical pathology - Investigation of maternal markers for pre-eclampsia | Plasma | Placental growth factor (PGF, PLGF) |
| Chemical pathology - Investigation of maternal markers to detect foetal abnormality | Blood; Plasma | Free β-human chorionic gonadotropin (free β-hCG); Placental growth factor (PGF, PLGF); Pregnancy associated plasma protein A (PAPP-A) |
| Chemical pathology - Iron studies | Blood; Plasma | Ferritin; Iron; Transferrin |
| Chemical pathology - Markers of bone metabolism | Blood; Plasma | β-Crosslaps (CTX) |
| Chemical pathology - Quantitation of precursor and intermediary metabolites | Blood; Plasma | β-Hydroxybutyrate |
| Homocysteine | ||
| Chemical pathology - Quantitation of vitamin B markers | Blood; Plasma | Holotranscobalamin (active vitamin B12) |
| Chemical pathology - Quantitation of vitamins | Blood; Plasma | Ascorbic acid (vitamin C) |
| Cobalamin (vitamin B12); Vitamin D | ||
| Ascorbic acid (vitamin C); Pyridoxine (vitamin B6, pyridoxal, pyridoxamine); Retinol (vitamin A); Thiamine (vitamin B1); Tocopherol (vitamin E) | ||
| Plasma; Serum | Pyridoxine (vitamin B6, pyridoxal, pyridoxamine); Thiamine (vitamin B1) | |
| Chemical pathology - Tests for thyroid function | Blood; Plasma | Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free |
| Chemical pathology - Trace element analysis | Blood | Manganese |
| Magnesium | ||
| Blood; Plasma | Selenium | |
| Blood; Serum; Urine | Chromium | |
| Copper | ||
| Blood; Urine | Arsenic; Cadmium | |
| Lead | ||
| Plasma; Serum | Aluminium | |
| Serum; Urine | Zinc | |
| Urine | Fluoride | |
| Cobalt; Nickel | ||
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis or follow up of threatened abortion and/or diagnosis of ectopic pregnancy | Plasma | Human chorionic gonadotropin (hCG) - Quantitative total |
Haematology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Haematology - Assessment of haemolysis or metabolic enzymes (red cell enzyme assays) | Blood; Plasma | Glucose-6-phosphate dehydrogenase (G6PD) |
| Haematology - Bone marrow examination | Bone marrow | Examination of aspirated material |
| Haematology - Examination of blood films by special staining | Blood | Malaria |
| Haematology - Foetal haemoglobin in maternal circulation | Blood | Detection and quantitation of foetal red cells |
| 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 distribution width (RDW); Red blood cell index or indices; Reticulocytes |
| Morphology | ||
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Blood; Plasma | Activated partial thromboplastin time (APTT); Anti-Xa - Apixaban; Anti-Xa - Rivaroxaban; Anti-Xa activity; Anti-thrombin III; D-dimer; Factor II; Factor IX; Factor V; Factor VII; Factor VIII; Factor X; Factor XI; Factor XII; Fibrinogen; International normalised ratio (INR); Lupus anticoagulant; Mixing studies - APTT; Protein C and protein S; Thrombin time (TT); Von Willebrand factor (vWF) |
| Plasma | Activated protein C (APC) resistance | |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Blood; Bone marrow; Disaggregated tissues specimen; Fresh tissue | CD10; CD103; CD117; CD11c; CD13; CD138; CD14; CD15; CD16; CD19; CD20; CD200; CD23; CD3; CD33; CD34; CD38; CD4; CD45; CD5; CD56; CD7; CD79a; CD8; FMC7; HLA-DR antigen; Kappa light chains; Lambda light chains; MPO |
| Immunopathology - Single HLA antigen typing | Blood | HLA-B27 |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood | Malaria |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Blood; Plasma | Infectious mononucleosis |
Immunopathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Plasma; Serum | Anti-deamidated gliadin IgG antibodies; Anti-tissue transglutaminase IgA antibodies (tTG) |
| Serum | Anti-Saccharomyces cerevisiae antibodies (ASCA); Anti-extractable nuclear antigen antibodies (ENA); Anti-gastric parietal cell antibodies (GPC/PCA); Anti-glomerular basement membrane antibodies (anti-GBM); Anti-glutamic acid decarboxylase antibodies (GAD); Anti-intrinsic factor antibodies (IF); Anti-islet cell antigen 2 antibodies; Anti-myeloperoxidase antibodies (MPO); Anti-nucleosome antibodies; Anti-proteinase 3 antibodies (PR3) | |
| Anti-cardiolipin IgG antibodies (ACA); Anti-cardiolipin IgM antibodies (ACA); Anti-cardiolipin antibodies (ACA); Anti-dense fine speckle 70 antibodies; Anti-β2-glycoprotein-I antibodies | ||
| Anti-thyroid stimulation immunoglobulin antibodies (TSI) | ||
| Anti-acetylcholine receptor antibodies (AChR) | ||
| Anti-actin antibodies (AAA) | ||
| Anti-extractable nuclear antigen antibodies (ENA); Anti-liver antibodies; Anti-myositis antibodies; Anti-scleroderma antibodies | ||
| Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO) | ||
| Anti-double stranded DNA antibodies (dsDNA) | ||
| Anti-skin antibodies | ||
| Anti-endomysial antibodies (EMA); Anti-liver antibodies; Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA) | ||
| Rheumatoid factor | ||
| Anti-zinc transporter protein 8 antibodies (ZNT8) | ||
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential drug allergens) | Serum | Amoxicilloyl group; Ampicilloyl group; Penicilloyl G; Penicilloyl V |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential epidermal and animal protein allergens) | Serum | Animal mix; Cat epithelium; Dog dander; Feather mix; Horse dander |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [egg and fowl] allergens) | Serum | Chicken; Egg; Egg white; Egg yolk |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fish, shellfish and molluscs] allergens) | Serum | Blue mussel; Codfish; Crab; Lobster; Oyster; Prawn; Salmon; Scallop; Seafood mix; Squid; Tuna; Whiting |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fruit and vegetable] allergens) | Serum | Avocado; Banana; Cauliflower; Fruit mix; Kiwi; Lemon citrus; Orange citrus; Pineapple; Potato; Strawberry; Tomato |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [meat] allergens) | Serum | Beef; Lamb; Meat mix; Pork |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [milk] allergens) | Serum | Cheese - Cheddar type; Cheese - Mould type; Milk |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [miscellaneous] allergens) | Serum | Baker's yeast; Chocolate; Coffee; Honey; Mushroom; Yeasts |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [seeds, legumes and nuts] allergens) | Serum | Almond; Barley; Brazil nut; Cashew nut; Cereal mix; Corn; Gluten; Hazelnut; Macadamia nut; Nut panel; Oat; Peanut; Pecan nut; Pinenut; Pistachio; Rice; Rye; Sesame seed; Soy bean; Walnut; Wheat |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [spices] allergens) | Serum | Chilli pepper; Curry |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential grass pollen allergens) | Serum | Bermuda grass; Brome grass; Grass mix; Johnson grass; Kentucky plane (June) grass; Meadow fescue; Paspalum grass; Perennial rye grass; Sweet vernal grass; Timothy grass; Velvet grass |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential insect allergens) | Serum | Cockroach; Mosquito |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential microorganism allergens) | Serum | Alternaria tenius; Aspergillus fumigatus; Candida albicans; Cladosporium herbarum; Penicillium chrysogenum (formerly Penicillium notatum); Pityrosporum orbiculare (Malassezia furfur); Mould mix |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential mite allergens) | Serum | Dermatophagoides farinae house dust mite; Dermatophagoides pteronyssinus house dust mite; House dust - Hollister-Stier; House dust mite mix |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential occupational allergens) | Serum | Hexamethylene diisocyanate (1,6-hexamethylene diisocyanate; 1,6-HDI); Latex; Toluene-2,4-diisocyanate (2,4-TDI) |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential tree pollen allergens) | Serum | Acacia; Australian pine; Eucalyptus; Italian/Mediterranean/funeral cypress; Olive; Silver birch; Sycamore; Tree mix; White pine |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential venom allergens) | Serum | Common wasp (yellow jacket) venom; European hornet venom; Honey bee venom; Paper wasp venom |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential weed pollen allergens) | Serum | Mugwort; Plantain - English; Weed mix |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Faeces | Calprotectin |
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Plasma | Total immunoglobulin E |
Microbiology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Infertility and pregnancy tests including assisted reproductive technology - Investigation of sperm | Semen; Serum | Sperm antibodies |
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) | Retrograde urine; Semen | Morphology; Motility; Sperm number |
| Semen | pH | |
| Morphology; Motility; Sperm number | ||
| Vitality | ||
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis for post vasectomy and/or examination of cervical mucus | Semen | Presence of spermatozoa |
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Aspirates; Blood; Cerebrospinal fluid (CSF); Faeces; General swabs; Sputum; Tissues; Urine | Antibiotic susceptibility; Bacteria; Pathogenic identification; Pathogenic identification and antibiotic susceptibility; Pathogenic microorganisms |
| Bacteria; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | ||
| Bacteria; Pathogenic microorganisms | ||
| Bacteria; Pathogenic identification; Pathogenic microorganisms | ||
| Blood | Bacteria; Pathogenic microorganisms | |
| Urine | Blood; Epithelial cells; Erythrocytes (red blood cells, RBC); Glucose; Ketones; Leucocytes (white blood cells, WBC); Nitrite; Proteins; Specific gravity | |
| Legionella antigen; Streptococcus pneumoniae antigen | ||
| Bacteria; Blood; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Glucose; Leucocytes (white blood cells, WBC); Proteins; Specific gravity; pH | ||
| Microbiology - Environmental investigations and/or infection control (Clinical non-human testing) | Blood transfusion bags; Gastrointestinal endoscopes | Bacterial growth - Sterility |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Faeces | Clostridioides difficile |
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Aspirates; Cerebrospinal fluid (CSF); Faeces; Other body fluids; Respiratory specimens; Sputum; Tissues; Urine | Mycobacteria detection |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Aspirates; Blood; Cerebrospinal fluid (CSF); Respiratory swabs; Sputum; Tissues; Urine | Isolation of yeasts and Aspergillus |
| Isolation of yeasts and Aspergillus | ||
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Cysts; Ova; Parasites |
Molecular Biology
ISO 15189 (2012)
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Molecular biology - Microbial genotyping | Liquid based cytology specimens | Human papilloma virus (HPV) |
ISO 15189 (2022)
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Dry swabs; Liquid based cytology specimens; Urine | Chlamydia trachomatis; Neisseria gonorrhoeae |
| Dry swabs; Nasopharyngeal aspirate | Bordetella parapertussis; Bordetella pertussis; Mycoplasma pneumoniae | |
| Dry swabs; Urine | Mycoplasma genitalium | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Dry swabs | Trichomonas vaginalis |
| Faeces | Cryptosporidium spp.; Entamoeba histolytica; Giardia intestinalis | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Bronchial washings; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) |
| Dry swabs | Herpes simplex virus (HSV); Varicella zoster virus (VZV) | |
| Dry swabs; Nasopharyngeal aspirate | Adenovirus; Enterovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3; Respiratory syncytial virus (RSV) A/B; Rhinovirus | |
| Adenovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV); Rhinovirus | ||
| Faeces | Adenovirus; Adenovirus F41; Enterovirus; Norovirus G1; Norovirus G2; Rotavirus A; Sapovirus | |
| Nasal swabs; Nasopharyngeal swabs; Sputum; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Plasma; Serum | Hepatitis C virus (HCV) viral RNA | |
| Microbiology - Molecular biology - Microbial genotyping | Plasma; Serum | Hepatitis C virus (HCV) subtypes |
| Microbiology - Molecular biology - Quantitation of microbial nucleic acids | Plasma; Serum | Hepatitis B virus (HBV) viral load; Hepatitis C virus (HCV) viral load |
| Human immunodeficiency virus (HIV) RNA viral load |
Molecular Genetics
ISO 15189 (2012)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Predictive genetic testing - Targeted genes | Formalin-fixed paraffin-embedded (FFPE) tissues | Nucleic acid analysis for specific variants (melanoma) |
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood; Bone marrow | BCR-ABL gene rearrangement; Qualitative calculation of p190 positive BCR::ABL1 transcripts; Quantitative calculation of p210 positive BCR::ABL1 transcripts |
| Blood; Buccal swabs | Thiopurine methyltransferase (TPMT) | |
| Molecular genetics - DNA extraction | Blood | DNA storage for future analyses; Purified PCR product; Viable DNA; Viable DNA for sequencing |
| Blood; Formalin-fixed paraffin-embedded (FFPE) tissues | DNA storage for future analyses; Purified PCR product; Viable DNA; Viable DNA for sequencing | |
| Blood; Plasma | DNA storage for future analyses; Purified PCR product; Viable DNA; Viable DNA for sequencing | |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood | JAK2 V617F mutation |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Blood | Fragile X; Spinal muscular atrophy |
| Coeliac disease | ||
| Factor V Leiden; Hereditary haemochromatosis; Methylenetetrahydrofolate reductase (MTHFR); Prothrombin variant | ||
| Gilberts disease | ||
| Blood; Buccal swabs | Cystic fibrosis | |
| Ashkenazi Jewish; Bloom syndrome; Canavan disease; Cystic fibrosis; Familial dysautonomia; Fanconi anaemia; Hexosaminidase A deficiency (Tay Sachs disease); Mucolipidosis IV; Niemann-Pick disease type C | ||
| Molecular genetics - Non-invasive prenatal (genetic) screening | Maternal blood; Maternal plasma | Aneuploidy for chromosomes X and Y; Trisomy 13, trisomy 18, trisomy 21 |
| Molecular genetics - Predictive genetic testing - Targeted genes | Formalin-fixed paraffin-embedded (FFPE) tissues | Polygenic risk score (PRS) - Breast cancer |
| Molecular genetics - RNA extraction | Formalin-fixed paraffin-embedded (FFPE) tissues | RNA storage for future analyses; Viable RNA |
| Molecular genetics - Screening for an unknown mutation - Targeted panels for non-inherited (somatic) DNA/RNA changes | Extracted DNA; Extracted RNA; Formalin-fixed paraffin-embedded (FFPE) tissues | Solid tumours |
| Molecular genetics/Cytogenetics - Bioinformatic analysis | DNA sequences; FASTQ files; RNA sequences; TXT files | Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation |
Serology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Mycobacteriology - Tests for cell mediated immunity | Blood | Latent tuberculosis |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Faeces | Helicobacter pylori |
| Plasma; Serum | Strongyloides spp. | |
| Hepatitis A virus (HAV); 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 surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Hepatitis C virus (HCV); Human immunodeficiency virus (HIV); Rubella IgG antibody; Syphilis Treponema pallidum antibody; Toxoplasma spp. IgG antibody; Toxoplasma spp. IgM antibody; Toxoplasma | ||
| Syphilis Treponema pallidum antibody | ||
| Cytomegalovirus (CMV); Helicobacter pylori | ||
| Mycoplasma pneumoniae IgG antibody; Mycoplasma pneumoniae IgM antibody; Varicella zoster virus (VZV) IgG antibody; Varicella zoster virus IgM antibody | ||
| Rubella IgM antibody | ||
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) antibody | ||
| Barmah forest virus IgG antibody; Barmah forest virus IgM antibody; Bordetella pertussis toxin A IgA; Bordetella pertussis toxin G IgA; Dengue virus IgG antibody; Dengue virus IgM antibody; Dengue virus NS1 antigen; Ross River virus IgG antibody; Ross River virus IgM antibody | ||
| Epstein-Barr virus IgM antibody; Hepatitis B virus envelope antibody (anti-HBe); Hepatitis B virus envelope antigen (HBe Ag); Hepatitis C virus (HCV); Herpes simplex virus type 2 antibody (anti-HSV2) - IgG; Herpes simplex type 1 antibody (anti-HSV1) - IgG; Measles IgG antibody; Measles IgM antibody; Mumps virus IgG antibody; Mumps virus IgM antibody; Mycoplasma pneumoniae IgG antibody; Mycoplasma pneumoniae IgM antibody; Parvovirus B19 IgG antibody; Parvovirus B19 IgM antibody; Varicella zoster virus IgM antibody | ||
| Serum | Syphilis Treponema pallidum antibody | |
| Fluorescent Treponemal antibody |
Toxicology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Urine | Buprenorphine; Ethylglucuronide (ETG); γ-Hydroxybutyrate (GHB) |
| Chemical pathology - Trace element analysis | Blood | Arsenic; Cadmium; Chromium; Lead; Manganese; Selenium |
| Plasma | Aluminium; Chromium; Copper; Selenium; Zinc | |
| Urine | Arsenic; Cadmium; Chromium; Cobalt; Copper; Lead; Nickel; Zinc |
ISO 15189 (2022)
Legal
Medicare expiry date
02 Apr 2026
Last Activity Date
18 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Medico legal drug testing AS/NZS 4308:2008, appendix A On-site screening procedure | Urine | Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Opiates |
| Medico legal drug testing AS/NZS 4308:2008, appendix A On-site screening procedure - Testing performed at client sites | Urine | Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Opiates |
| Medico legal drug testing AS/NZS 4308:2008, section 2 Specimen collection, storage, handling and dispatch | Urine | Colour; Creatinine; Temperature; pH |
| Medico legal drug testing AS/NZS 4308:2008, section 3 General laboratory requirements | Urine | General laboratory requirements as described in AS/NZS 4308 |
| Medico legal drug testing AS/NZS 4308:2008, section 4 Laboratory screening procedures | Urine | Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Creatinine; Opiates |
| Medico legal drug testing AS/NZS 4308:2008, section 5 Laboratory confirmatory procedures | Urine | 11-nor-δ-9-Tetrahydrocannabinol-9-carboxylic acid; 6-Acetylmorphine; 7-Amino-clonazepam; 7-Amino-flunitrazepam; 7-Amino-nitrazepam; Amphetamines; Benzoylecgonine (ecgonine benzoate); Codeine; Diazepam; Ecgonine methyl ester; Ephedrine; Methylamphetamine; Methylenedioxyamphetamine; Methylenedioxymethylamphetamine; Morphine; Nordiazepam; Oxazepam; Phentermine; Pseudoephedrine (PSE); Temazepam; α-Hydroxyalprazolam |
The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.
Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.
Accreditation No.
3427
Site No.
3420
Print date
29 Nov 2024
END OF SCOPE