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Clinipath Pathology OSBORNE PARK LABORATORY \| ACCREDITATION NUMBER: 2619 \| SITE NUMBER: 2612 \|
Address Details: 310 Selby Street North OSBORNE PARK, WA 6017 AUSTRALIA Map www.clinipathpathology.com.au	Contact Details: Ms Gayle van Oss +61(08) 93714228	Availability: Services available to external clients Supervision: GX (General)

Attached Departments: * Anatomical Pathology * Chemical Pathology * Faecal Occult Blood Testing Laboratory * Haematology * Immunohaematology * Immunopathology * Microbiology * Molecular * Serology * Toxicology
Printable version Note: Not all of the columns of the scope of accreditation displayed include data. 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.

Anatomical Pathology

ISO 15189 (2012)
Human Pathology
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
Anatomical pathology - Cytopathology - Cervical cytological investigation for abnormalities, precancerous or cancerous changes or conditions	Liquid based cytology specimens from cervix;	Review and reporting of cervical cytological material;

	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;	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	Skin smears;	Cytological examination; Review and reporting of cytology samples;

		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; Cytological examination; Review and reporting of cervical cytological material;

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 - Gene probes using paraffin in-situ hybridisation techniques (chromogenic/silver)	Formalin fixed paraffin embedded tissue sections;	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 investigation	Frozen sections of fresh tissue;	Detection of antigenic targets - Various;

	Formalin fixed paraffin embedded tissue sections;	Detection of antigenic targets - Various;

Chemical Pathology

ISO 15189 (2012)
Human Pathology
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals	Plasma; Serum; Urine;	Alcohol;

	Urine;	6-Acetylmorphine; Alcohol; Barbiturates; Buprenorphine; Methadone; Oxycodone; Phencyclidine; Propoxyphene; Synthetic cannabis;

Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring	Serum;	Carbamazepine; Lithium; Phenytoin (dilantin); Theophylline; Valproate (valproic acid, epilim);

	Plasma; Serum;	Clozapine;

Chemical pathology - Detection and/or quantitation of tumour markers	Serum;	Prostate specific antigen (PSA); Prostate specific antigen (PSA) fractions and derived index;

		α-Fetoprotein (AFP); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); CA125 antigen (CA125); Carcinoembryonic antigen (CEA); Human chorionic gonadotropin (HCG);

	Plasma; Serum;	β2-Microglobulin (B2M);

Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests)	Plasma; Serum;	Adrenocorticotropic hormone (ACTH); Anti-Mullerian hormone (AMH); C-peptide; Growth hormone; Insulin;

		Insulin-like growth factor 1 (IGF-1, somatomedin C);

		Androstenedione;

		Cortisol; Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone - Free; Testosterone - Total;

Chemical pathology - Diagnosis and management of diabetes mellitus	Blood;	Glycated haemoglobin (HbA1c);

Chemical pathology - Further investigation of cardiac function	Plasma; Serum;	B-type natriuretic peptide (BNP); N-Terminal-pro b-type natriuretic peptide (NT-proBNP); Troponin I;

Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia	Plasma; Serum;	HDL - Quantitation;

Chemical pathology - Further investigation of renal and/or hepatic function	Plasma; Serum;	α1-Antitrypsin; Haptoglobins;

Chemical pathology - Investigation and determination of hepatic, cardiac, bone, lipid, renal, skeletal muscle and other profiles and metabolic studies	Plasma; Serum;	γ-Glutamyltransferase; Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Chloride; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; High sensitivity C-reactive protein (CRP); Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea;

	Plasma; Serum; Urine;	Osmolality;

	Other body fluids;	Amylase; Lactate dehydrogenase (LDH); Lipase; Protein - Total;

	Urine;	Amylase; Calcium - Total; Chloride; Creatinine; Glucose; Magnesium; Microalbumin; Phosphate; Potassium; Protein - Total; Sodium; Urate; Urea;

Chemical pathology - Investigation for folate deficiency	Plasma; Serum;	Folate; Red blood cell folate;

Chemical pathology - Investigation of Helicobacter pylori colonisation or eradication	Breath;	C13; C14;

Chemical pathology - Investigation of maternal markers to detect foetal abnormality	Serum;	Free β-Human chorionic gonadotropin (free β-HCG); Pregnancy associated plasma protein A (PAPP-A);

Chemical pathology - Iron studies	Plasma; Serum;	Ferritin; Iron; Transferrin;

Chemical pathology - Markers of bone metabolism	Serum;	n-Telopeptide (NTx);

Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen)	Blood;	Calcium - Ionised; Glucose; Lactate; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); pH; Potassium; Sodium;

Chemical pathology - Quantitation of precursor and intermediary metabolites	Plasma;	Amino acids;

Chemical pathology - Quantitation of vitamin B markers	Plasma; Serum;	Holotranscobalamin (active vitamin B12);

Chemical pathology - Quantitation of vitamins	Plasma; Serum;	25-Hydroxyvitamin D;

		Cobalamin (vitamin B12);

Chemical pathology - Tests for thyroid function	Plasma; Serum;	Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free;

Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy	Plasma; Serum; Urine;	Detection of human chorionic gonadotropin (hCG);

Infertility and pregnancy tests including assisted reproductive technology - Diagnosis or follow up of threatened abortion and/or diagnosis of ectopic pregnancy	Plasma; Serum; Urine;	Human chorionic gonadotropin (HCG) - Quantitative total;

Faecal Occult Blood Testing Laboratory

ISO 15189 (2012)
Human Pathology
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
Chemical pathology - Detection and/or quantitation of tumour markers - Testing for the National Bowel Cancer Screening Program	Faeces;	Blood;

Haematology

ISO 15189 (2012)
Human Pathology
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
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;	Malaria;

		Haemoglobin H;

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;

		Morphology;

Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests)	Plasma;	D-dimer;

		Activated partial thromboplastin time (APTT); Anti-thrombin III; D-dimer; Factor IX; Factor VIII; Factor XI; Factor XII; Factor XIII; Fibrinogen; International normalised ratio (INR); Lupus anticoagulant; Protein C and protein S; Prothrombin time (PT); Thrombin time (TT); Von Willebrand factor (vWF) activity - Ristocetin co-factor assay; Von Willebrand factor (vWF) antigen - Quantitation;

	Blood;	Platelet function (PFA);

Haematology - Investigation of haemoglobinopathy (excluding thalassemia)	Blood;	Other abnormal haemoglobins;

		Haemoglobin fraction (S, C, D, E) - Quantitation;

		Haemoglobin S (HbS) - Presence;

Haematology - Investigation of haemolysis	Serum;	Cold agglutinins;

Haematology - Limited blood examination	Blood;	Erythrocyte (RBC) sedimentation rate (ESR);

Immunopathology - Quantitative and/or qualitative investigation of proteins	Serum;	Cryofibrinogen; Cryoglobulins;

Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites)	Blood;	Plasmodium falciparum; Plasmodium knowlesi; Plasmodium malariae; Plasmodium ovale curtisi; Plasmodium ovale wallikeri; Plasmodium vivax;

Microbiology - Parasitology - Detection of ova, cysts and parasites	Blood;	Malaria;

Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation	Blood;	Infectious mononucleosis;

Immunohaematology

ISO 15189 (2012)
Human Pathology
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
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;	Direct antiglobulin test (DAT, direct Coombs test); Examination for blood group antibodies; Group checks of patient and donor;

Immunohaematology - Investigation of blood transfusion reactions	Blood products;	Antibodies;

Immunohaematology - Issue and release of blood and blood product for transfusion	Blood;	Issue and release of blood and blood products for transfusion;

Immunopathology

ISO 15189 (2012)
Human Pathology
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping)	Blood;	CD3; CD4; CD5; CD8; CD10; CD16; CD19; CD20; CD23; CD45; CD56; HLA-B27; HLA-DR antigen; Kappa light chains; Lambda light chains;

Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies	Serum;	Rheumatoid factor;

		Anti-β-2-glycoprotein 1 antibodies; Anti-cardiolipin antibodies (ACA); Anti-deamidated gliadin antibodies; Anti-double stranded DNA antibodies (dsDNA); Anti-myeloperoxidase antibodies (MPO); Anti-proteinase 3 antibodies (PR3); Anti-tissue transglutaminase antibodies (tTG);

		Anti-extractable nuclear antigen antibodies (ENA);

		Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO);

		Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA);

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential component testing (purified native and/or recombinant allergens))	Serum;	α-Lactalbumin - Milk; Ara h2 - Peanut; Omega-5-gliadin - Wheat;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential drug allergens)	Serum;	Amoxicilloyl group; Ampicilloyl group; Cefaclor; Penicilloyl G; Penicilloyl V;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential epidermal and animal protein allergens)	Serum;	Budgerigar feathers; Canary bird feathers; Cat epithelium; Chicken feathers; Dog dander; Dog epithelium; Duck feathers; Finch feathers; Goose feathers; Horse dander; Parakeet feathers; Parrot feathers; Rabbit epithelium; Sheep epithelium; Turkey feathers;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [additives] allergens)	Serum;	Cochineal extract (carmine red, E120);

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; Octopus; Oyster; Salmon; Scallop; Seafood mix; Shrimp; Squid; Tuna;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fruit and vegetable] allergens)	Serum;	Apple; Apricot; Aubergine (eggplant); Avocado; Banana; Blackberry; Blueberry; Broccoli; Cabbage; Carrot; Celery; Cherry; Cucumber; Date; Fig; Garlic; Grape; Grapefruit; Green olive; Kiwi; Lemon citrus; Lime citrus; Mango; Melon; Olive - Black, fresh; Onion; Orange citrus; Papaya; Passion fruit; Pear; Pineapple; Plum; Potato; Raspberry; Spinach; Strawberry; Sweet potato; Tomato; Watermelon;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [meat] allergens)	Serum;	Beef; Mutton; Pork;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [milk] allergens)	Serum;	Casein; Cheese - Cheddar type; Cow's whey; Goat milk; Milk;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [miscellaneous] allergens)	Serum;	Baker's yeast; Cacao; Chocolate; Coffee; Honey; Hop (fruit cone); Malt; Mushroom; Staple food mix;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [seeds, legumes and nuts] allergens)	Serum;	Almond; Barley; Brazil nut; Buck wheat; Cashew nut; Chick pea; Coconut; Gluten; Green bean; Hazelnut; Lentil; Lupin seed; Macadamia nut; Maize; Nut panel; Oat; Pea; Peanut; Pecan nut; Pinenut; Pistachio; Quinoa; Rapeseed; Rice; Rye; Sesame seed; Soy bean; Walnut; Wheat;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [spices] allergens)	Serum;	Black pepper; Caraway; Cardamon; Chilli pepper; Clove; Ginger; Lovage; Mace; Marjoram; Parsley; Tarragon; Thyme;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential grass pollen allergens)	Serum;	Bahia grass; Bermuda grass; Cultivated rye; Johnson grass; Rye grass; Timothy grass;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential insect allergens)	Serum;	Fire ant; German cockroach; Mosquito;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential microorganism allergens)	Serum;	Acremonium kiliense; Alternaria alternata; Alternaria tenius; Aspergillus flavus; Aspergillus fumigatus; Candida albicans; Cladosporium herbarum; Penicillium chrysogenum (formerly Penicillium notatum); Penicillium glabrum; Setomelanomma rostrata (Helminthosporium halodes); Fusarium verticillioides (Fusarium moniliforme); Mould mix;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential mite allergens)	Serum;	Dermatophagoides farinae house dust mite; Dermatophagoides pteronyssinus house dust mite;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential occupational allergens)	Serum;	Chloramine-T; Cotton seed; Formaldehyde/formalin; Hexamethylene diisocyanate (1,6-hexamethylene diisocyanate; 1,6-HDI); House dust; Latex; Methylene diphenyl diisocyanate (MDI, isocyanate MDI, diphenylmethane diisocyanate); Phthalic anhydride; Sunflower seed; Toluene-2,4-diisocyanate (2,4-TDI);

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential tree pollen allergens)	Serum;	Acacia; Eucalyptus; Melaleuca; Olive; White pine; Willow salix;

Immunopathology - Detection of immunoglobulin E specific antibodies (to potential venom allergens)	Serum;	Bee venom; Honey bee venom; Paper wasp venom;

Immunopathology - Quantitation of complement proteins	Plasma; Serum;	Complement components C3 and C4;

Immunopathology - Quantitative and/or qualitative investigation of proteins	Plasma; Serum;	Protein classes;

Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses	Serum;	Total immunoglobulin E;

		Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M;

Immunopathology - Single HLA antigen typing	Blood;	HLA-B27;

Microbiology

ISO 15189 (2012)
Human Pathology
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
Chemical pathology - Detection of faecal occult blood	Faeces;	Blood;

Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy)	Semen;	Volume;

		Motility; Sperm number;

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	Blood;	Bacteria; Pathogenic microorganisms;

	Aspirates; Biopsy specimens; Blood; Cerebrospinal fluid (CSF); Cervical swabs; Ear swabs; Eye swabs; Faeces; Fluids; Gastric biopsy; General swabs; Genital swabs; Human breast milk; Infusates; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Operative specimens; Plasma; Post-operative wounds; Pus; Rectal swabs; Respiratory specimens; Skin; Sputum; Superficial sites; Synovial fluid; Throat swabs; Tissues; Urethra; Urine; Vaginal swabs; Wound swabs;	Bacteria; Pathogenic microorganisms;

	Aspirates; Biopsy specimens; Blood; Cerebrospinal fluid (CSF); Cervical swabs; Ear swabs; Eye swabs; Faeces; Fluids; Gastric biopsy; General swabs; Genital swabs; Glass slide; Human breast milk; Infusates; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Operative specimens; Plasma; Post-operative wounds; Pus; Rectal swabs; Respiratory specimens; Skin; Sputum; Superficial sites; Synovial fluid; Throat swabs; Tissues; Urethra; Urine; Vaginal swabs; Wound swabs;	Bacteria; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC);

	Aspirates; Biopsy specimens; Blood; Cerebrospinal fluid (CSF); Cervical swabs; Cord tissue; Ear swabs; Eye swabs; Faeces; Fluids; Gastric biopsy; General swabs; Genital swabs; Glass slide; Human breast milk; Infusates; Isolates; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Operative specimens; Plasma; Post-operative wounds; Pus; Rectal swabs; Respiratory specimens; Serum; Skin; Sputum; Superficial sites; Synovial fluid; Throat swabs; Tissues; Urethra; Urine; Vaginal swabs; Wound swabs;	Antibiotic susceptibility; Bacteria; Pathogenic microorganisms;

	Aspirates; Bacterial isolates; Biopsy specimens; Blood; Cerebrospinal fluid (CSF); Cervical swabs; Ear swabs; Eye swabs; Faeces; Fluids; Gastric biopsy; General swabs; Genital swabs; Human breast milk; Infusates; Isolates; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Operative specimens; Post-operative wounds; Pus; Rectal swabs; Respiratory specimens; Serum; Skin; Sputum; Superficial sites; Synovial fluid; Throat swabs; Tissues; Urethra; Urine; Vaginal swabs; Wound swabs;	Bacteria; Pathogenic identification; Pathogenic microorganisms;

	Urine;	Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC);

Microbiology - Environmental investigations and/or infection control	Spore strips/capsules;	Bacterial growth - Sterility;

Microbiology - Mycology - Detection, isolation and identification of yeasts and fungal elements	Blood; General swabs; Hair; Nails; Skin scrapings;	Fungi identification; Yeasts identification;

		Fungi identification; Yeasts identification;

		Fungi identification; Yeasts identification;

Microbiology - Parasitology - Detection of ova, cysts and parasites	Faeces;	Cyclospora; Giardia spp.;

		Cysts; Ova; Parasites;

Microbiology - Virology - Detection of pathogenic viruses	Faeces;	Adenovirus; Rotavirus;

Molecular

ISO 15189 (2012)
Human Pathology
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria)	Faeces;	Clostridiodes difficile;

		Aeromonas spp.; Campylobacter spp.; Salmonella spp.; Shigella spp.; Yersinia enterocolitica; Escherichia coli - Enteroinvasive (EIEC);

	Dry swabs; Urine;	Neisseria gonorrhoeae;

		Chlamydia trachomatis; Neisseria gonorrhoeae;

Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites)	Faeces;	Blastocystis hominis; Cryptosporidium spp.; Dientamoeba fragilis; Entamoeba histolytica; Giardia intestinalis;

Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses)	Liquid based cytology specimens;	Human papilloma virus;

	Faeces;	Adenovirus F40; Adenovirus F41; Norovirus G1; Norovirus G2; Rotavirus;

	Nasal swabs; Nasopharyngeal swabs; Throat swabs;	Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

	Dry swabs;	Adenovirus; Herpes simplex virus (HSV); Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV); Rhinovirus; Varicella zoster virus;

Serology

ISO 15189 (2012)
Human Pathology
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation	Serum;	Barmah forest virus IgG antibody; Barmah forest virus IgM antibody; Ross River virus IgG antibody; Ross River virus IgM antibody;

		Hepatitis A virus antibody (anti-HAV) - IgG; Hepatitis A virus antibody (anti-HAV) - IgM; Rubella IgG antibody; Rubella IgM antibody; Syphilis Treponema pallidum antibody; Toxoplasma spp. IgG antibody; Toxoplasma spp. IgM antibody;

		Helicobacter pylori IgG antibody;

		Cytomegalovirus antibody (anti-CMV) - IgM; Epstein-Barr virus IgG antibody; Epstein-Barr virus IgM antibody; Epstein-Barr virus nuclear antigen; Hepatitis C virus (HCV); Herpes simplex type 1 antibody (anti-HSV1) - IgG; Herpes simplex virus type 2 antibody (anti-HSV2) - IgG; Measles IgG antibody; Measles IgM antibody; Mumps virus IgG antibody; Mumps virus IgM antibody; Parvovirus IgG antibody; Parvovirus IgM antibody; Varicella zoster virus IgG antibody; Varicella zoster virus IgM antibody;

		Syphilis Treponema pallidum antibody;

		Cytomegalovirus antibody (anti-CMV) - IgG; Cytomegalovirus antibody (anti-CMV) - IgM; Hepatitis B core antibody (anti-HBc) - Total; Hepatitis B virus core antibody (anti-HBc) - IgM; 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); Human immunodeficiency virus (HIV) subtype O;

	Plasma; Serum;	Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody;

Toxicology

ISO 15189 (2012)
Human Pathology
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals	Urine;	6-Acetylmorphine; Barbiturates; Buprenorphine; Methadone metabolites; Oxycodone; Phencyclidine; Propoxyphene; Synthetic cannabis;

ISO 15189 (2012)
Legal
| Last Activity Date: 01-Aug-2019 | Medicare Expiry Date: 05-Jan-2023 |

SERVICE	PRODUCT	DETERMINANT	TECHNIQUE	PROCEDURE	LIMITATION/RANGE
Medico legal drug testing AS 4760, section 2 Collection, storage, handling and dispatch	Oral fluid;	Handling and dispatch; Sample collection and storage;

Medico legal drug testing AS 4760, section 5 Confirmatory testing procedures	Oral fluid;	Δ-9-Tetrahydrocannabinol (THC-Δ9); 6-Acetylmorphine; Amphetamines; Benzoylecgonine (ecgonine benzoate); Cocaine; Codeine; Ecgonine methyl ester; Methylamphetamine; Methylenedioxyamphetamine; Methylenedioxymethylamphetamine; Morphine;

Medico legal drug testing AS/NZS 4308, appendix A On-site screening procedure	Urine;	Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Creatinine; Opiates; pH; Specific gravity;

Medico legal drug testing AS/NZS 4308, section 2 Specimen collection, storage, handling and dispatch	Urine;	Colour; Creatinine; pH; Temperature;

Medico legal drug testing AS/NZS 4308, section 3 General laboratory requirements	Urine;	General laboratory requirements as described in AS/NZS 4308;

Medico legal drug testing AS/NZS 4308, section 4 Laboratory screening procedures	Urine;	Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Creatinine; Opiates;

Medico legal drug testing AS/NZS 4308, section 5 Laboratory confirmatory procedures	Urine;	6-Acetylmorphine; 11-nor-δ-9-Tetrahydrocannabinol-9-carboxylic acid; Amphetamines; Codeine; Ephedrine; Methylamphetamine; Methylenedioxyamphetamine; Methylenedioxymethylamphetamine; Morphine; Phentermine; Pseudoephedrine (PSE);

		α-Hydroxyalprazolam; 7-Amino-clonazepam; 7-Amino-flunitrazepam; 7-Amino-nitrazepam; Amphetamines; Benzoylecgonine (ecgonine benzoate); Benzylpiperazine (BZP, 1-benzylpiperazine); Codeine; Diazepam; Ephedrine; Methylamphetamine; Methylenedioxyamphetamine; Methylenedioxymethylamphetamine; Morphine; Nordiazepam; Oxazepam; Phentermine; Pseudoephedrine (PSE); Temazepam;

Copyright © 2020 National Association of Testing Authorities, Australia . National Association of Testing Authorities, Australia. Sydney (Head Office) PO Box 7507, Silverwater, NSW, 2128. Contact us: 1800 621 666 (free call).

Clinipath Pathology

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