National Association of Testing Authorities, Australia
Scope of Accreditation
SA Pathology
Site
Frome Road Laboratory
Accreditation No.
2348
Site No.
2341
Date of Accreditation
08 Apr 1988
Contact
Mr Jason Graefling P: +61 (08) 82223137
Availability
Services available to external clients
Supervision
GY (General)
Scope of Accreditation
Anatomical Pathology
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Anatomical pathology - Cytopathology - Cervical cytological investigation for abnormalities, precancerous or cancerous changes or conditions | Cervical tissue | 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 | 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 | Anus smears; Lip smears; Mouth smears; Nipple discharge; Nose smears; Skin smears | 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); Cytological examination; Review and reporting of cervical cytological material |
| Anatomical pathology - Tissue pathology - Examination of biopsy material | Formalin-fixed tissue; Fresh tissue; Gluteraldehyde fixed tissueNerve only | Review and reporting of biopsy material to identify or exclude morphological abnormalities |
| Formalin-fixed tissue; Fresh tissueMuscle only | Review and reporting of biopsy material to identify or exclude morphological abnormalities | |
| Formalin-fixed tissue; Gluteraldehyde fixed tissue | Review and reporting of biopsy material to identify or exclude morphological abnormalities | |
| Anatomical pathology - Tissue pathology - Examination of biopsy material by electron microscopy | Gluteraldehyde tissue | Review and reporting of biopsy material to identify or exclude ultra-structural morphological abnormalities |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Frozen sections of fresh tissueMuscle only | Detection of antigenic targets - Various |
| Anatomical pathology - Tissue pathology - Skeletal muscle enzyme histochemistry | Frozen sections of skeletal muscle | Detection of muscle enzyme targets |
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) | Semen | Volume |
| Motility; Sperm number | ||
| Viscosity | ||
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis for post vasectomy and/or examination of cervical mucus | Semen | Presence of spermatozoa |
Complex Inherited Disorders
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - DNA sequencing | Blood | DNA sequence analysis |
| Molecular genetics/Cytogenetics - Bioinformatic analysis | DNA sequences | Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation |
Cytogenetics (Cancer) Laboratory
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Biochemical genetic services for the diagnosis of metabolic and enzymological disorders | Tissues | Tissue culture and long term storage |
| Cytogenetics - Detection of defined, balanced and/or unbalanced chromosomal abnormalities by in situ hybridisation techniques | Amniotic fluid; Blood; Bone marrow; Other body fluids; Tissues | Cytogenetic analysis and reporting |
| Cytogenetics - Karyotype detection of balanced and/or unbalanced chromosome abnormalities | Amniotic fluid; Blood; Other body fluids; Tissues | Cytogenetic analysis and reporting |
| Cytogenetics - Molecular karyotype (SNP microarray) detection of unbalanced chromosome abnormalities | Blood; Bone marrow; Tissues | Cytogenetic analysis and reporting |
| Cytogenetic analysis and reporting |
Drugs Unit
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Plasma; Serum | Fentanyl; Methadone; Morphine; Oxycodone |
| Urine | Ethylglucuronide (ETG); Ethylsulfate | |
| Chemical pathology - Biogenic amines | Plasma | Metanephrine |
| Urine | 4-Hydroxy-3-methoxymethamphetamine (HMMA); 5-Hydroxyindoleacetic acid (5-HIAA); Homovanillic acid (HVA) | |
| Catecholamines; Metanephrine | ||
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Plasma; Serum | 5-Flucytosine; Aripiprazole; Clozapine; Itraconazole; Olanzapine; Paliperidone; Posaconazole; Quetiapine; Risperidone; Voriconazole |
| 5-Flucytosine; 6-Mercaptopurine; 6-Thioguanine | ||
| Amiodarone; Aripiprazole; Flecainide; Lamotrigine; Levetiracetam; Mycophenolate; Paliperidone; Perhexiline; Risperidone | ||
| Serum | Itraconazole; Posaconazole; Voriconazole |
ISO 15189 (2012)
Legal
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Medico legal drug testing AS/NZS 4308:2008, section 2 Specimen collection, storage, handling and dispatchVarious Collection Centres | 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; 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); Benzylpiperazine (BZP, 1-benzylpiperazine); Buprenorphine; Codeine; Diazepam; Ecgonine methyl ester; Ephedrine; Methadone; Methylamphetamine; Methylenedioxyamphetamine; Methylenedioxymethylamphetamine; Morphine; Nordiazepam; Oxazepam; Phentermine; Pseudoephedrine (PSE); Temazepam; α-Hydroxyalprazolam |
| Medico legal drug testing AS/NZS 4760, section 3 General laboratory requirements | Oral fluid | General laboratory requirements as described in AS/NZS 4760 |
| Medico legal drug testing AS/NZS 4760, section 4 Laboratory screen testing | Oral fluid | Amphetamine type substances; Cocaine; Cocaine metabolites; Δ-9-Tetrahydrocannabinol (THC-Δ9) |
| Medico legal drug testing AS/NZS 4760, section 5 Laboratory confirmatory procedures | Oral fluid | 3,4-Methylenedioxyamphetamine (MDA); 3,4-Methylenedioxymethamphetamine (MDMA); 6-Acetylmorphine; Alprazolam; Amphetamines; Benzoylecgonine (ecgonine benzoate); Buprenorphine; Clonazepam; Cocaine; Codeine; Diazepam; Ecgonine methyl ester; Flunitrazepam; Lorazepam; Methadone; Methylamphetamine; Midazolam; Morphine; Nitrazepam; Nordiazepam; Oxazepam; Oxycodone; Temazepam; Δ-9-Tetrahydrocannabinol (THC-Δ9) |
Familial Cancer Laboratory
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Whole exome sequencing studies for inherited (germline) DNA/RNA changes | Blood | Acute myeloid leukaemia RUNX1; Bannayan-Riley-Ruvalcaba syndrome; Cowden syndrome (multiple hamartoma syndrome); Emberger syndrome; Familial adenomatous polyposis; Fanconi anaemia; Gastrointestinal stroma tumour; Hemangioblastoma; Hereditary diffuse gastric cancer; Immunodeficiency; Juvenile polyposis; Lynch syndrome; Macrocephaly PTEN gene mutation; Maturity onset diabetes of the young (MODY); Multiple endocrine neoplasia type 1 (MEN1); Multiple endocrine neoplasia type 2 (MEN2); Neurofibromatosis; PTEN hamartoma tumour syndrome (PHTS); Paragangliomas; Phaeochromocytoma; Primary cilary dyskenesis; Renal clear cell carcinoma; Retinoblastoma; Schwannomatosis; Von Hippel Lindau disease |
| Molecular genetics - Predictive genetic testing - Targeted panels for inherited (germline) DNA/RNA changes | Amniotic fluid; Blood; Buccal swabs; Chorionic villus | Acute myeloid leukaemia RUNX1; Bannayan-Riley-Ruvalcaba syndrome; Cowden syndrome (multiple hamartoma syndrome); Emberger syndrome; Familial adenomatous polyposis; Gastrointestinal stroma tumour; Hemangioblastoma; Hereditary diffuse gastric cancer; Lynch syndrome; Macrocephaly PTEN gene mutation; Multiple endocrine neoplasia type 1 (MEN1); Multiple endocrine neoplasia type 2 (MEN2); Neurofibromatosis; PTEN hamartoma tumour syndrome (PHTS); Paragangliomas; Phaeochromocytoma; Renal clear cell carcinoma; Retinoblastoma; Schwannomatosis; Von Hippel Lindau disease |
Immunology
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Further investigation of renal and/or hepatic function | Plasma; Serum | Tryptase |
| Serum | Alkaline phosphatase (ALP) isoenzymes | |
| α1-Antitrypsin phenotype | ||
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Cerebrospinal fluid (CSF) | Albumin |
| Plasma; Serum | C1 esterase inhibitor | |
| Haematology - Foetal haemoglobin in maternal circulation | Blood | Detection and quantitation of foetal red cell antigens; Presence of foetal red blood cells |
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Blood | HLA-DR1; HLA-DR4 |
| Blood; Bone marrow; Cerebrospinal fluid (CSF); Disaggregated tissues specimen; Fresh tissue; Lavage; Serous fluid | CD10; CD103; CD117; CD11b; CD11c; CD123; CD13; CD138; CD14; CD15; CD16; CD19; CD197; CD1a; CD2; CD20; CD21; CD22; CD23; CD235a; CD24; CD25; CD27; CD28; CD3; CD30; CD33; CD34; CD38; CD4; CD41; CD45; CD45RA; CD45RO; CD5; CD56; CD57; CD58; CD61; CD64; CD65; CD7; CD71; CD8; CD81; FMC7; HLA-DR antigen; Immunoglobulin G (IgG); Immunoglobulin M (IgM); Kappa light chains; Lambda light chains; T-cell receptor aβ (TCRab); T-cell receptor β (TCRb); T-cell receptor γδ (TCRgd) | |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Cerebrospinal fluid (CSF); Serum | Anti-AMPA-1; Anti-AMPA-2; Anti-CV2; Anti-Hu; Anti-Ma-2; Anti-N-methyl-D-aspartate receptor antibodies (NMDA); Anti-Ri; Anti-SOX1; Anti-Tr/DNER; Anti-Yo (anti-PCA1); Anti-Zic4; Anti-amphiphysin; Anti-aquaporin 4 antibodies (AQP4); Anti-contactin associated protein-like 2 (CASPR-2); Anti-gamma aminobutyric acid (GABA); Anti-glutamic acid decarboxylase 65 (GAD65); Anti-leucine rich glioma inactivated protein 1 antibodies (LGI 1); Anti-neuronal antibodies; Anti-recoverin; Anti-titin |
| Plasma; Serum | Anti-myeloperoxidase antibodies (MPO); Anti-proteinase 3 antibodies (PR3) | |
| Anti-gastric parietal cell antibodies (GPC/PCA); Anti-liver-kidney microsomes antibodies (LKM); Anti-mitochondrial antibodies (AMA, AMA M1 and/or AMA M2); Anti-smooth muscle antibodies (SMA) | ||
| Anti-intrinsic factor antibodies (IF) | ||
| Anti-cardiolipin antibodies (ACA); Anti-glomerular basement membrane antibodies (anti-GBM) | ||
| Anti-liver cytosol antibodies (LC-1); Anti-mitochondrial antibodies (AMA, AMA M1 and/or AMA M2); Anti-myositis antibodies; Anti-soluble liver antigen/liver-pancreas antibodies (SLA/LP) | ||
| Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA) | ||
| Anti-RNA polymerase III antibodies (ARA, RNAP) | ||
| Paraneoplastic neurologic syndrome antibodies | ||
| Anti-Purkinje cell antibodies (PCA2) | ||
| Anti-actin antibodies (AAA); Anti-phospholipase A2 receptor antibodies (PLA2R) | ||
| Anti-β2-glycoprotein-I antibodies | ||
| Serum | Anti-glutamic acid decarboxylase antibodies (GAD); Anti-islet cell antigen 2 antibodies | |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential component testing [purified native and/or recombinant allergens]) | Serum | Api m1 phospholipase A2 - Honey bee; Ara h2 - Peanut; Pol d5 - European paper wasp; Ves v5 - Common wasp; β-Lactoglobulin - Milk |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential drug allergens) | Serum | Amoxicilloyl group; Ampicilloyl group; Cefaclor; Morphine; Penicilloyl G; Penicilloyl V; Pholcodine; Protamine; Suxamethonium (succinylcholine) |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential epidermal and animal protein allergens) | Serum | Budgerigar droppings; Budgerigar feathers; Cat dander; Cow dander; Dog dander; Guinea pig epithelium; Horse dander; Mouse urine proteins; Rabbit epithelium; Rat epithelium; Rat urine proteins |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [additives] allergens) | Serum | Guar gum (E412) |
| 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; Pacific squid; Salmon; Scallop; Shrimp; Tuna |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fruit and vegetable] allergens) | Serum | Apple; Apricot; Avocado; Banana; Bromelain (MUXF); Garlic; Kiwi; Mandarin (tangerine, clementine, satsumas) citrus; Mango; Melon; Onion; Orange citrus; Peach; Pineapple; Potato; Strawberry; Tomato; Watermelon |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [meat] allergens) | Serum | Beef; Galactose-α-1,3-galactose; Mutton; Pork |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [milk] allergens) | Serum | Casein; Milk |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [miscellaneous] allergens) | Serum | Cacao; Chocolate; Omega-5-gliadin; Yeasts |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [seeds, legumes and nuts] allergens) | Serum | Almond; Barley; Brazil nut; Cashew nut; Hazelnut; Lentil; Lupin seed; Macadamia nut; Maize; 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; Mustard |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential grass pollen allergens) | Serum | Bahia grass; Bermuda grass; Brome grass; Couch grass; Cultivated wheat; Johnson grass; Profilin; Rye grass; Timothy grass; Velvet grass |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential insect allergens) | Serum | German cockroach; Mosquito |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential microorganism allergens) | Serum | Alternaria alternata; Aspergillus flavus; Aspergillus fumigatus; Aspergillus niger; Aspergillus terreus; Cladosporium herbarum; Malassezia spp.; Penicillium chrysogenum (formerly Penicillium notatum); Pityrosporum orbiculare (Malassezia furfur); Setomelanomma rostrata (Helminthosporium halodes); Trichophyton rubrum |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential mite allergens) | Serum | Blomia tropicalis house dust mite; Dermatophagoides farinae house dust mite; Dermatophagoides pteronyssinus house dust mite; Glycyphagus domesticus storage mite; Lepidoglyphus destructor storage mite; Tyrophagus putrescentiae storage mite |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential occupational allergens) | Serum | Chlorhexidine; Formaldehyde/formalin; Hexamethylene diisocyanate (1,6-hexamethylene diisocyanate; 1,6-HDI); Latex; α-Amylase |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential tree pollen allergens) | Serum | Acacia; Australian pine; Eucalyptus; Melaleuca; Olive; Plane tree; Silver birch; Wattle; White pine; Willow salix |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential venom allergens) | Serum | Bull ant - Myrmecia forficata; Bull ant - Myrmecia nigriceps; Bull ant - Myrmecia pyriformis; Common wasp (yellow jacket) venom; Honey bee venom; Jumper ant; Paper wasp venom |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential weed pollen allergens) | Serum | Chenopodium; Goosefoot; Lamb’s quarters; Plantain - English; Russian thistle; Saltwort (prickly); Sheep sorrel; Wall pellitory |
| Immunopathology - Quantitation of complement proteins | Serum | Alternative pathway haemolytic complement; Total haemolytic complement |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Cerebrospinal fluid (CSF) | Oligoclonal bands |
| Faeces | Calprotectin | |
| Other body fluids | β2-Transferrin | |
| Plasma; Serum | Characterisation of paraproteins; Detection and amount of paraproteins | |
| Detection and quantitation of free kappa and free lambda light chains | ||
| Characterisation of cryoglobulins; Cryofibrinogen; Cryoglobulins | ||
| Serum | Protein classes | |
| Urine | Detection of Bence Jones proteins | |
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Cerebrospinal fluid (CSF) | Total immunoglobulin G |
| Plasma; Serum | Total immunoglobulin E | |
| Total immunoglobulin G | ||
| Immunopathology - Single HLA antigen typing | Blood | HLA-B5701 |
| HLA-B27 | ||
| Microbiology - Mycobacteriology - Tests for antigen lymphocyte stimulation | Blood | Mycobacterial antigen lymphocyte stimulation |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Serum | Aspergillus fumigatus specific IgG; Anti-avian IgG - Budgerigar; Anti-avian IgG - Pigeon |
| Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes | Blood | Primary immune deficiency disease |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Blood | Primary immune deficiency disease |
| Molecular genetics - Screening for an unknown mutation - Targeted genes | Blood | Coeliac disease |
| Thiopurine methyltransferase (TPMT) genotyping |
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Plasma; Serum | Adalimumab; Infliximab |
Leukaemia Unit
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood; Bone marrow | CSF3R and SETBP1 mutation test; Leukaemic gene rearrangements; Quantitative calculation of p210 positive BCR::ABL1 transcripts |
Metabolic Laboratory
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of calculus | Calculi | Calcium; Magnesium; Oxalate; Phosphate |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Serum | Sulthiame |
| Chemical pathology - Detection and/or quantitation of tumour markers | Serum | Chromogranin A |
| Chemical pathology - Detection of faecal occult blood | Faeces | Blood |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma; Serum | Erythropoietin (EPO); Gastrin |
| Aldosterone; Renin | ||
| Serum | 17α-Hydroxyprogesterone | |
| Growth hormone; Insulin-like growth factor 1 (IGF-1, somatomedin C) | ||
| Urine | Cortisol | |
| Chemical pathology - Further investigation of renal and/or hepatic function | Faeces | α1-Antitrypsin |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Blood; Plasma | Cholinesterase |
| Serum | Angiotensin converting enzyme (ACE) | |
| Acid phosphatase | ||
| Chemical pathology - Investigation of malabsorption - Quantitation of solid tissue enzymes | Intestinal tissue | Lactase; Maltase; Sucrase |
| Chemical pathology - Investigation of porphyria | Blood; Plasma cells | Porphyrins - Total |
| Faeces; Urine | Porphyrin isomers; Porphyrins - Total | |
| Urine | Porphobilinogen (PBG); δ-Aminolevulinic acid (δ-ALA) | |
| Chemical pathology - Quantitation of precursor and intermediary metabolites | Urine | Oxalate |
| Chemical pathology - Quantitation of vitamins | Blood | Pyridoxine (vitamin B6, pyridoxal, pyridoxamine); Thiamine (vitamin B1)Shimadzu Nexera 8050 (ML update req'd) |
| Serum | Ascorbic acid (vitamin C) | |
| Carotenoids; Retinol (vitamin A); Tocopherol (vitamin E) | ||
| 25-Hydroxyvitamin D; Vitamin D C3-epimers (C-3-epi-35-hydroxyvitamin D) | ||
| 1,25-Dihydroxyvitamin D | ||
| Chemical pathology - Trace element analysis | Blood | Cadmium; Lead; Magnesium; Manganese; Mercury |
| Liver | Copper; Iron | |
| Plasma; Serum | Aluminium; Chromium; Cobalt; Copper; Magnesium; Selenium; Zinc | |
| Urine | Arsenic; Cadmium; Chromium; Cobalt; Copper; Iodine; Lead; Magnesium; Manganese; Mercury; Thallium; Zinc | |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Faeces | Pancreatic elastase |
Microbiology and Infectious Diseases
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Anatomical pathology - Cytopathology - Testing for the National Cervical Screening Program | Self-collected vaginal swabs | Human papilloma virus (HPV) |
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Isolates | Legionella spp. |
| Respiratory specimens | Legionella spp. | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Axilla swabs; Groin swabs; Nasal swabs; Wound swabs | Methicillin resistant Staphylococcus aureus (MRSA) |
| Blood; Cerebrospinal fluid (CSF); Fluids | Streptococcus pneumoniae | |
| Eye swabs; Genital swabs; Liquid based cytology specimens; Urine | Chlamydia trachomatis; Neisseria gonorrhoeae | |
| Faeces | Campylobacter spp.; Salmonella spp.; Shigella spp.; Shiga toxin | |
| Clostridioides difficile | ||
| Fluids | Kingella kingae | |
| Fluids; Nasopharyngeal aspirate; Nasopharyngeal swabs; Respiratory specimens; Sputum; Throat swabs; Tissues | Bordetella pertussis | |
| Genital swabs | Streptococcus agalactiae (Streptococcus group B) | |
| Genital swabs; Urine | Mycoplasma genitalium | |
| Nasopharyngeal aspirate; Nasopharyngeal swabs; Respiratory specimens; Sputum; Throat swabs | Mycoplasma pneumoniae | |
| Rectal swabs; Skin swabs; Ulcer; Urethral swabs | Treponema pallidum | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (fungi) | Bronchial washings; Bronchoalveolar lavage | Pneumocystis jirovecii |
| Hair; Nails; Skin scrapings | Fungi identification; Yeasts identification | |
| Isolates | Fungi identification; Yeasts identification | |
| Skin scrapings; Skin swabs | Candida auris | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (mycobacteria) | Bacterial isolates | Mycobacterium spp. |
| Bacterial isolates; Respiratory specimens | Mycobacterium tuberculosis; Mycobacterium rifampicin resistance rpoB | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Faeces | Cryptosporidium spp.; Entamoeba histolytica; Giardia intestinalis |
| Genital swabs; Urine | Trichomonas vaginalis | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Amniotic fluid; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Faeces; Plasma; Serum; Tissues; Urine | Cytomegalovirus (CMV) |
| Blood; Cerebrospinal fluid (CSF) | Human parechovirus | |
| Blood; Cerebrospinal fluid (CSF); Dry swabs; Faeces; Nasopharyngeal aspirate; Urine | Enterovirus | |
| Blood; Cerebrospinal fluid (CSF); Eye swabs; Genital swabs; Lip swabs; Mouth swabs; Skin swabs; Throat swabs; Vitreous specimens | Varicella zoster virus (VZV) | |
| Herpes simplex virus (HSV) | ||
| Blood; Cerebrospinal fluid (CSF); Plasma; Serum | Epstein-Barr virus | |
| Bronchoalveolar lavage; Nasopharyngeal aspirate; Respiratory specimens; Sputum | Middle Eastern respiratory syndrome coronavirus (MERS-CoV) | |
| Cerebrospinal fluid (CSF); Plasma; Serum; Urine | Polyoma virus | |
| Dry swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Respiratory specimens; Self-collected vaginal swabs; Sputum; Tissues | Human metapneumovirus; Influenza A virus; Influenza A virus H3; Influenza B virus; Influenza virus H1N1 - Swine; Parainfluenza virus type 1/2/3; Respiratory syncytial virus (RSV) A/B; Rhinovirus; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) - PCR, RT-PCR | |
| Eye swabs; Faeces; Nasopharyngeal aspirate; Nasopharyngeal swabs; Plasma; Respiratory specimens; Serum; Sputum; Tissues; Urine | Adenovirus | |
| Faeces | Adenovirus group F; Norovirus; Rotavirus | |
| Adenovirus group F; Norovirus; Rotavirus | ||
| Liquid based cytology specimens | Human papilloma virus (HPV) | |
| Nasal swabs; Nasopharyngeal and throat swab; Nasopharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Nasal swabs; Nasopharyngeal and throat swab; Nasopharyngeal swabs; Self-collected vaginal swabs; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Nasal swabs; Nasopharyngeal and throat swab; Nasopharyngeal swabs; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Nasal swabs; Nasopharyngeal swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV); Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) - PCR, RT-PCR | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasal swabs; Nasopharyngeal swabs; Throat swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV); Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) - PCR, RT-PCR | |
| Plasma | Human immunodeficiency virus type 1 (HIV-1) RNA | |
| Plasma; Serum | Hepatitis B virus (HBV) DNA | |
| Hepatitis C virus (HCV) viral RNA | ||
| Saliva; Throat swabs; Urine | Measles virus; Mumps virus | |
| Microbiology - Molecular biology - Microbial genotyping | Plasma | Human immunodeficiency virus type 1 (HIV-1) sequencing for drug resistance |
| Plasma; Serum | Hepatitis C virus (HCV) subtypes | |
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Blood; Bone marrow | Mycobacteria identification |
| Isolates | Mycobacteria identification | |
| Mycobacteria antibiotic susceptibility | ||
| Mycobacteria antibiotic susceptibility | ||
| Mycobacteria identification | ||
| Mycobacteria antibiotic susceptibility | ||
| Other body fluids; Respiratory specimens; Tissues | Mycobacteria identification | |
| Other body fluids; Respiratory specimens; Tissues; Urine | Mycobacteria identification; Other pathogenic bacteria to genus level or species level | |
| Mycobacteria identification | ||
| Urine | Mycobacteria identification | |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Blood | Fungi identification; Yeasts identification |
| Cerebrospinal fluid (CSF); Fluids; General swabs; Isolates; Nails; Respiratory specimens; Skin scrapings; Tissues | Fungi identification; Yeasts identification | |
| Cerebrospinal fluid (CSF); Fluids; General swabs; Nails; Respiratory specimens; Skin scrapings; Tissues | Fungi identification; Yeasts identification | |
| Isolates | Yeasts identification | |
| Yeast susceptibility | ||
| Fungi susceptibility; Yeast susceptibility | ||
| Fungi identification; Yeasts identification | ||
| Microbiology - Virology - Detection of pathogenic viruses | Nasal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) |
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Blood; Cerebrospinal fluid (CSF) | Neisseria meningitidis |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Cadaveric donor plasma; Plasma | Hepatitis B virus (HBV) DNA; Hepatitis C virus (HCV) viral RNA; Human immunodeficiency virus type 1 (HIV-1) Group M RNA; Human immunodeficiency virus type 1 (HIV-1) Group O RNA; Human immunodeficiency virus type 2 (HIV-2) RNA |
Microbiology and Infectious Diseases – Pathogen Genomics
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Molecular biology - Bioinformatic analysis | DNA sequences | Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Primary analysis - Quality analysis of primary FASTQ or FASTA file (including assembly and mapping of reads to identified references).; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation |
| Microbiology - Molecular biology - Microbial DNA and/or RNA extraction | Isolates; Nasopharyngeal swabs | DNA storage for future analyses; Purified PCR product; RNA storage for future analyses; Viable DNA; Viable DNA for sequencing; Viable DNA for whole genome sequencing; Viable RNA; Viable RNA for sequencing |
| Microbiology - Molecular biology - Microbial genotyping | Isolates | Drug resistance Mycobacterium tuberculosis; Drug resistance gamma-Proteobacteria; Vaccine reactivity Neisseria meningitidis; Vaccine reactivity Streptococcus pneumoniae |
| Isolates; Nasopharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) |
Molecular Genetics
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood | Autoimmune polyendocrinopathy syndrome type 1; Factor V Leiden; Factor XIII deficiency; Haemochromatosis; Haemophilia A; Haemophilia B; Haemophilia C; Prothrombin variant; Von Willebrand disorder; α-Thalassaemia; β-Thalassaemia |
| Molecular genetics - Estimation of risk of inheritance of an unknown mutation (Bayesian and linkage calculations) | Amniotic fluid; Blood; Chorionic villus | Angelman syndrome; Fragile X; Maternal cell contamination; Myotonic dystrophy; Prader-Willi syndrome; Spinal muscular atrophy; Uniparental disomy |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood | Copy number variation (CNV); Quantitation of donor and recipient bone marrow derived cells in a transplant recipient |
| 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 | Indels; Single nucleotide variants (SNVs) |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Whole exome sequencing for non-inherited (somatic) DNA/RNA changes | Blood | Fusion genes; Indels; Novel isoforms; Single nucleotide variants (SNVs) |
| Molecular genetics - Heterozygous loci determinations | Blood; Chorionic villus; Products of conception (POC); Tissues | Nucleic acid analysis for specific variants |
| Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes | Amniotic fluid; Blood; Chorionic villus | Angelman syndrome; Duchenne-Becker muscular dystrophy; Fragile X; Fragile XE mental retardation; Friedreich's ataxia (FRDA, FA); Incontinentia pigmenti; Kennedy's disease (spinal and bulbar muscular atrophy); Myotonic dystrophy; Prader-Willi syndrome; Spinal muscular atrophy; Spinocerebellar ataxia |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Amniotic fluid; Blood; Chorionic villus | Angelman syndrome; Duchenne-Becker muscular dystrophy; Fragile X; Fragile XE mental retardation; Friedreich's ataxia (FRDA, FA); Incontinentia pigmenti; Kennedy's disease (spinal and bulbar muscular atrophy); Myotonic dystrophy; Prader-Willi syndrome; Spinal muscular atrophy; Spinocerebellar ataxia |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted panels for inherited (germline) DNA/RNA changes | Blood | Copy number variation (CNV); Indels; Single nucleotide variants (SNVs) |
| Copy number variation (CNV); Indels; Single nucleotide variants (SNVs) | ||
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Whole exome sequencing studies for inherited (germline) DNA/RNA changes | Blood | Copy number variation (CNV); Indels; Single nucleotide variants (SNVs) |
| Copy number variation (CNV); Indels; Single nucleotide variants (SNVs) | ||
| Molecular genetics - Predictive genetic testing - Targeted panels for inherited (germline) DNA/RNA changes | Blood | Haemophilia A; Haemophilia B; Haemophilia C; α-Thalassaemia; β-Thalassaemia |
| Haemophilia A; Haemophilia B; Haemophilia C | ||
| Molecular genetics - Prenatal genetic testing (excluding non-invasive prenatal [genetic] screening) | Amniotic fluid; Blood; Chorionic villus | Angelman syndrome; Duchenne-Becker muscular dystrophy; Fragile X; Fragile XE mental retardation; Friedreich's ataxia (FRDA, FA); Incontinentia pigmenti; Kennedy's disease (spinal and bulbar muscular atrophy); Myotonic dystrophy; Prader-Willi syndrome; Spinal muscular atrophy; Spinocerebellar ataxia |
| Amniotic fluid; Chorionic villus tissue; Cultured amniotic fluid cells; Cultured chorionic villus cells | Haemophilia A; Haemophilia B; α-Thalassaemia; β-Thalassaemia | |
| Molecular genetics - Screening for an unknown mutation - Targeted genes | Blood | Familial Mediterranean fever; Prelingual deafness |
| Molecular genetics/Cytogenetics - Bioinformatic analysis | DNA sequences; RNA sequences | Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation |
Molecular Oncology
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood; Bone marrow; Formalin-fixed paraffin-embedded (FFPE) tissues | Blood borne tumours; Breast cancer; Solid tumours |
| Molecular genetics - Heterozygous loci determinations | Blood; Tissues | Blood borne tumours |
Sequencing Centre
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jan 2027
Last Activity Date
11 Nov 2024
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Molecular biology - Microbial DNA and/or RNA sequencing | Extracted DNA; Extracted RNA | Sequenced DNA utilising massively parallel sequencing technologies |
| Molecular genetics - DNA sequencing | Purified PCR product | DNA sequence analysis |
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.
2348
Site No.
2341
Print date
26 Nov 2024
END OF SCOPE