4Cyte Pathology Pty Ltd

Site

4Cyte Pathology Sydney

Accreditation No.

20341

Site No.

24317

Date of Accreditation

18 Jul 2018

Address

1 Lucknow Road
North Ryde, NSW 2113
Australia

4Cyte.com.au

Contact

Mr Mario Theocharous P: +61 0435659701

Availability

Services available to external clients

Supervision

GX (General)

Scope of Accreditation

ISO 15189 (2012)

Human Pathology

Medicare expiry date

04 Nov 2023

Last Activity Date

23 Apr 2021

Service Product Determinant
Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals Urine 3,4-Methylenedioxymethamphetamine (MDMA); Amphetamines; Benzodiazepines; Cannabis; Cocaine; Methadone metabolites; Opiates
Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring Serum Carbamazepine; Digoxin; Lithium; Phenytoin (dilantin); Valproate (valproic acid, epilim)
Chemical pathology - Detection and/or quantitation of tumour markers Serum Thyroglobulin
Prostate specific antigen (PSA); Prostate specific antigen (PSA) fractions and derived index
β2-Microglobulin (B2M)
CA125 antigen (CA125); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA); α-Fetoprotein (AFP)
Chemical pathology - Detection of faecal occult blood Faeces Blood
Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) Plasma Parathyroid hormone (PTH)
Adrenocorticotropic hormone (ACTH)
Serum C-peptide; Cortisol; Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Insulin; Luteinising hormone (LH); Oestradiol; Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone
Aldosterone; Renin
Androstenedione; Growth hormone; Insulin-like growth factor 1 (IGF-1, somatomedin C)
Chemical pathology - Diagnosis and management of diabetes mellitus Plasma Glycated haemoglobin (HbA1c)
Chemical pathology - Further investigation of cardiac function Serum Troponin I
Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia Serum HDL - Quantitation
Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies Plasma; Serum Glucose
Serum Alanine aminotransferase; Alkaline phosphatase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; C-reactive protein (CRP); Cholesterol - LDL; Cholesterol - Total; Creatine kinase; Lactate dehydrogenase (LDH); Lipase; Triglycerides; Urea; γ-Glutamyltransferase
Serum; Urine Albumin; Calcium - Total; Chloride; Creatinine; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Urate; Urea
Urine Microalbumin
Chemical pathology - Investigation for folate deficiency Serum Folate
Chemical pathology - Investigation of Helicobacter pylori colonisation or eradication Breath C14
Chemical pathology - Investigation of malabsorption - Quantitation of solid tissue enzymes Intestinal tissue Lactase; Maltase; Sucrase
Chemical pathology - Iron studies Serum Ferritin; Iron; Transferrin
Chemical pathology - Quantitation of precursor and intermediary metabolites Plasma Amino acids
Chemical pathology - Quantitation of vitamin B markers Serum Holotranscobalamin (active vitamin B12)
Chemical pathology - Quantitation of vitamins Serum Cobalamin (vitamin B12); Vitamin D
Chemical pathology - Tests for thyroid function Serum Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free
Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies Serum Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO)
Anti-thyroid stimulation immunoglobulin antibodies (TSI)
Immunopathology - Quantitative and/or qualitative investigation of proteins Faeces Calprotectin
Serum α1-Antitrypsin phenotype
Urine Detection of Bence Jones proteins
Infertility and pregnancy tests including assisted reproductive technology - Diagnosis or follow up of threatened abortion and/or diagnosis of ectopic pregnancy Serum Human chorionic gonadotropin (hCG) - Quantitative total

ISO 15189 (2012)

Human Pathology

Medicare expiry date

04 Nov 2023

Last Activity Date

23 Apr 2021

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 Human papilloma virus cytological examination; 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 Endometrial pipelle; Liquid based cytology specimens from cervix; Vaginal smears; Vault smears; Vulval 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 Urine Cytological examination; Review and reporting of cytology samples
Anatomical pathology - Cytopathology - Testing for the National Cervical Screening Program Liquid based cytology specimens from cervix; Liquid based cytology specimens from vaginal vault Human papilloma virus (HPV); Cytological examination; Review and reporting of cervical cytological material

ISO 15189 (2012)

Human Pathology

Medicare expiry date

04 Nov 2023

Last Activity Date

23 Apr 2021

Service Product Determinant
Haematology - Bone marrow examination Bone marrow; Trephine Examination of aspirated material; Histological examination
Haematology - Diagnosis of thalassemia Blood Examination of haemoglobin H (HbH); Haemoglobin A (HbA) - Quantitation; Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation; Haemoglobin H (HbH) inclusions
Haematology - Examination of blood films by special staining Blood Malaria
Haematology - Full blood examination Blood Morphology
Differential number; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); Mean platelet volume (MPV); Nucleated red blood cells (NRBC); Platelet count; Red blood cell distribution width (RDW); Red blood cell index or indices; Reticulocytes
Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) Plasma Protein C and protein S
Activated partial thromboplastin time (APTT); D-dimer; Fibrinogen; International normalised ratio (INR); Prothrombin time (PT); Thrombin time (TT)
Haematology - Investigation of haemoglobinopathy (excluding thalassemia) Blood Haemoglobin S (HbS) - Presence; Haemoglobin fraction (S, C, D, E) - Quantitation; Other abnormal haemoglobins
Haematology - Limited blood examination Blood Erythrocyte (RBC) sedimentation rate (ESR)
Microbiology - Parasitology - Detection of ova, cysts and parasites Blood Malaria

ISO 15189 (2012)

Human Pathology

Medicare expiry date

04 Nov 2023

Last Activity Date

23 Apr 2021

Service Product Determinant
Immunohaematology - Blood group antibody detection Plasma Duffy system; Kell system; M and N factors; Other blood group systems; Rh phenotypes
Immunohaematology - Blood grouping Blood; Plasma ABO; RhD
ABO; RhD
Immunohaematology - Identification and quantitation of blood group antibodies Plasma Antibody titration
Other blood group antibodies; Rh
Direct antiglobulin test (DAT, direct Coombs test)

ISO 15189 (2012)

Human Pathology

Medicare expiry date

04 Nov 2023

Last Activity Date

23 Apr 2021

Service Product Determinant
Chemical pathology - Further investigation of renal and/or hepatic function Serum Tryptase
Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) Blood CD16; CD19; CD3; CD4; CD56; CD8; Natural killer (NK) cells
Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies Serum Anti-cardiolipin antibodies (ACA); Anti-cyclic citrullinated peptide antibodies (CCP); Anti-deamidated gliadin antibodies; Anti-double stranded DNA antibodies (dsDNA); Anti-extractable nuclear antigen antibodies (ENA); Anti-gastric parietal cell antibodies (GPC/PCA); Anti-glomerular basement membrane antibodies (anti-GBM); Anti-intrinsic factor antibodies (IF); Anti-myeloperoxidase antibodies (MPO); Anti-proteinase 3 antibodies (PR3); Anti-tissue transglutaminase antibodies (tTG)
Rheumatoid factor
Anti-liver-kidney microsomes antibodies (LKM); Anti-mitochondrial antibodies (AMA, AMA M1, AMA M2); Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA); Anti-smooth muscle antibodies (SMA)
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential epidermal and animal protein allergens) Serum Animal mix; Cat dander; Dog dander; Guinea pig epithelium; Rabbit epithelium
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [egg and fowl] allergens) Serum Chicken; Egg; Egg white
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fish, shellfish and molluscs] allergens) Serum Codfish; Crab; Lobster; Prawn
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fruit and vegetable] allergens) Serum Banana; Fruit mix; Kiwi; Melon
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 Milk
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [miscellaneous] allergens) Serum Staple food mix
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [seeds, legumes and nuts] allergens) Serum Almond; Brazil nut; Coconut; Hazelnut; Nut panel; Oat; Peanut; Rice; Rye; Soy bean
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential grass pollen allergens) Serum Grass mix
Bermuda grass; Meadow fescue; Paspalum grass; Rye grass
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential microorganism allergens) Serum Alternaria alternata; Aspergillus fumigatus; Cladosporium herbarum; Mould mix
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential mite allergens) Serum Dermatophagoides pteronyssinus house dust mite
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential occupational allergens) Serum Latex
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential tree pollen allergens) Serum Acacia; Olive; Silver birch
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential venom allergens) Serum Bumblebee venom; Common wasp (yellow jacket) venom; European paper wasp venom
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential weed pollen allergens) Serum Plantain - English; Weed mix
Immunopathology - Quantitation of complement proteins Serum Complement components C3 and C4
Immunopathology - Quantitative and/or qualitative investigation of proteins Serum α1-Globulin; α2-Globulin; β-Globulin; γ-Globulin
Detection and amount of paraproteins; Immunoglobulin A (IgA) - Kappa; Immunoglobulin A (IgA) - Lambda; Immunoglobulin G (IgG) - Kappa; Immunoglobulin G (IgG) - Lambda; Immunoglobulin M (IgM) - Kappa; Immunoglobulin M (IgM) - Lambda; Monoclonal proteins; α1-Globulin; α2-Globulin; β-Globulin; γ-Globulin
Urine Detection of Bence Jones proteins
Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses Serum Total immunoglobulin E
Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M

ISO 15189 (2012)

Human Pathology

Medicare expiry date

04 Nov 2023

Last Activity Date

23 Apr 2021

Service Product Determinant
Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) Semen Agglutination; Colour; Morphology; Motility; Sperm number; Viscosity; Volume; pH
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; Biopsy specimens; Blood; Bronchoalveolar lavage; Bronchoalveolar washings; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Faeces; Fluids; General swabs; Genital swabs; Intra-uterine contraceptive device (IUCD); Nasal swabs; Operative specimens; Post-operative wounds; Pus; Respiratory specimens; Semen; Skin; Throat swabs; Tissues; Urine; Wound swabs Pathogenic identification and antibiotic susceptibility
Bacteria; Blood; Casts; Crystals; Cultured pathogens identification; Epithelial cells; Erythrocytes (red blood cells, RBC); Glucose; Haemoglobin (Hb); Ketones; Leucocytes (white blood cells, WBC); Proteins; pH
Aspirates; Biopsy specimens; Blood; Bronchoalveolar lavage; Bronchoalveolar washings; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Fluids; General swabs; Genital swabs; Nasal swabs; Operative specimens; Post-operative wounds; Pus; Respiratory specimens; Semen; Skin; Throat swabs; Tissues; Urine; Wound swabs Staphylococcus aureus
Blood Cultured pathogens identification
Blood; Faeces Salmonella spp.
Genital swabs Streptococcus group B screening
Serum Helicobacter pylori antigen
Synovial fluid Crystals
Urine Pathogenic identification and antibiotic susceptibility
Bacteria; Blood; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Glucose; Haemoglobin (Hb); Ketones; Leucocytes (white blood cells, WBC); Proteins; pH
Microbiology - Mycobacteriology - Tests for cell mediated immunity Blood Interferon-γ (IFN-γ) release assays; Latent tuberculosis
Microbiology - Mycology - Detection of dermatophytes and other fungi causing cutaneous disease Hair; Nails; Skin scrapings Dermatophyte identification
Microbiology - Mycology - Detection, isolation and identification of yeasts and fungal elements Aspirates; Blood; Bronchial lavage; Bronchial washings; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Fluids; Genital swabs; Hair; Nails; Nasal swabs; Ocular specimens; Operative specimens; Post-operative wounds; Respiratory swabs; Skin; Skin scrapings; Sputum; Throat swabs; Tissues; Urine; Wound swabs Fungi identification; Yeasts identification
Microbiology - Parasitology - Detection of ova, cysts and parasites Faeces; Rectal swabs Cryptosporidia; Cyclospora; Giardia spp.; Microsporidia; Schistosoma spp.; Strongyloides stercoralis; Cysts; Ova; Parasites; Worms
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation Faeces Helicobacter pylori
Plasma; Serum Bordetella pertussis IgA; Bordetella pertussis IgG; Epstein-Barr virus IgG antibody; Epstein-Barr virus IgM antibody; Epstein-Barr virus nuclear antigen; Herpes simplex virus type 1 antibody (anti-HSV1) - IgM; Herpes simplex virus type 2 antibody (anti-HSV2) - IgG; Herpes simplex virus type 2 antibody (anti-HSV2) - IgM; 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 IgG antibody; Parvovirus IgM antibody; Varicella zoster virus IgG antibody; Varicella zoster virus IgM antibody
Hepatitis A virus antibody (anti-HAV) - IgG; Hepatitis A virus antibody (anti-HAV) - IgM; Hepatitis B virus core antibody (anti-HBc) - IgM; Hepatitis B virus core antibody (anti-HBc) - Total; Hepatitis B virus envelope antibody (anti-HBe); Hepatitis B virus envelope antigen (HBe Ag); Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Hepatitis B virus surface antigen (HBs Ag) - Confirmatory; Hepatitis C virus antibody (anti-HCV); Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies; Human immunodeficiency virus type 1/2 (HIV-1/2) antigen; Rubella IgG antibody; Rubella IgM antibody; Syphilis Treponema pallidum antibody; Toxoplasma spp. IgG antibody; Toxoplasma spp. IgM antibody
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG antibody; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody
Serum Cytomegalovirus antibody (anti-CMV) IgG; Cytomegalovirus antibody (anti-CMV) IgM; Helicobacter pylori
Anti-streptolysin O (ASOT)

ISO 15189 (2012)

Human Pathology

Medicare expiry date

04 Nov 2023

Last Activity Date

23 Apr 2021

Service Product Determinant
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum Bordetella parapertussis; Bordetella pertussis; Chlamydophila pneumoniae; Legionella pneumophila; Mycoplasma pneumoniae
Cervical swabs; Liquid based cytology specimens; Urethral swabs; Urine; Vaginal swabs Chlamydia trachomatis; Mycoplasma genitalium; Mycoplasma hominis; Neisseria gonorrhoeae; Ureaplasma urealyticum
Faeces Aeromonas spp.; Campylobacter spp.; Clostridium difficile toxin B; Escherichia coli - Enteroinvasive (EIEC); Salmonella spp.; Shigella spp.; Vibrio spp.; Yersinia enterocolitica
Genital swabs; Liquid based cytology specimens Chlamydia trachomatis serovars L1, L2, L2a or L3 (LGV); Haemophilus ducreyi; Lymphogranuloma venereum; Treponema pallidum
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) Cervical swabs; Liquid based cytology specimens; Urethral swabs; Urine; Vaginal swabs Trichomonas vaginalis
Faeces Blastocystis hominis; Cryptosporidium spp.; Cyclospora cayetanensis; Dientamoeba fragilis; Entamoeba histolytica; Giardia lamblia
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV); Rhinovirus
Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs; Throat swabs Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Cervical specimen; Liquid based cytology specimens Human papilloma virus (HPV)
Faeces Adenovirus; Astrovirus; Norovirus G1; Norovirus G2; Rotavirus A; Sapovirus
Genital swabs; Liquid based cytology specimens Herpes simplex virus (HSV); Varicella zoster virus (VZV)
Nasopharyngeal swabs; Throat swabs Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Respiratory specimens Adenovirus; Enterovirus; Human metapneumovirus; Parainfluenza virus type 1/2/3/4

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