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.
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Accreditation No.
19619
Site No.
25049
Print date
09 Oct 2024
END OF SCOPE