National Association of Testing Authorities, Australia
Scope of Accreditation
Genomic Diagnostics
Site
GD QLD – Healius Pathology Pty Ltd
Accreditation No.
19619
Site No.
25049
Date of Accreditation
01 Jun 2017
Contact
Dr Nicole Chia P: +61 (07) 31214660
Availability
Services available to external clients
Supervision
B (Branch)
Scope of Accreditation
GD QLD – Healius Pathology Pty Ltd
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Service | Product | Determinant |
---|---|---|
Cytogenetics - Detection of defined, balanced and/or unbalanced chromosomal abnormalities by in situ hybridisation techniques | Amniotic fluid; Blood; Bone marrow; Chorionic villus tissue; Other body fluids; Other tissues - Malignant; Other tissues - Non-malignant; Paraffin embedded tissue; Smears; Tissues | Chromosomal rearrangement; Cytogenetic analysis and reporting; Pathogenic copy number changes |
Cytogenetics - Karyotype detection of balanced and/or unbalanced chromosome abnormalities | Amniotic fluid; Blood; Bone marrow; Chorionic villus tissue; Other tissues - Malignant; Other tissues - Non-malignant | Constitutional genetic abnormalities; Pathogenic copy number changes |
Cytogenetics - Molecular karyotype (SNP microarray) detection of unbalanced chromosome abnormalities | Amniotic fluid; Blood; Bone marrow; Chorionic villus tissue; Other tissues - Malignant; Other tissues - Non-malignant | Cytogenetic analysis and reporting; Pathogenic copy number changes |
Immunopathology - Single HLA antigen typing | Blood | HLA-B27 |
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood | β-Thalassaemia |
Apolipoprotein E genotyping; Factor V Leiden; Haemochromatosis; Methylenetetrahydrofolate reductase (MTHFR); Prothrombin variant | ||
Y chromosome microdeletion | ||
α-Thalassaemia | ||
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genesPrimary bioinformatics only – wet lab and reporting done by GX lab (19619 22717). | Blood | Fragile X |
Molecular genetics - DNA extraction | Amniotic fluid; Blood; Bone marrow; Cerebrospinal fluid (CSF); Chorionic villus tissue; Cultured cells; Extracted DNA; Fibroblast cell pellets; Formalin-fixed paraffin-embedded (FFPE) tissues; Fresh tissue; Frozen tissue; Muscle; Pleural fluid; Products of conception (POC); Skin biopsy; Tissue biopsy; Tissues; Trephine | DNA storage for future analyses; Purified PCR product; Quantification of DNA; Viable DNA; Viable DNA for sequencing; Viable DNA for sequencing and other molecular assays |
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood; Bone marrow | JAK2 mutation analysis |
Quantitative calculation of p210 positive BCR::ABL1 transcripts | ||
Nucleophosmin 1 (NPM1) mutation | ||
FLT3-ITD (internal tandem duplication) mutation; FLT3-TKD (tyrosine kinase domain) mutation | ||
Qualitative calculation of p190 positive BCR::ABL1 transcripts | ||
B and T-cell gene rearrangement studies | ||
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; Fresh tissue; Tissues | Solid tumours |
Molecular genetics - RNA extraction | Blood; Bone marrow | Viable RNA for molecular diagnostics |
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.
19619
Site No.
25049
Print date
28 Nov 2024
END OF SCOPE