National Association of Testing Authorities, Australia
Scope of Accreditation
Monash IVF Reproductive Pathology and Genetics Pty Ltd
Monash IVF Reproductive Pathology and Genetics Pty Ltd
Site
Monash IVF Clayton
Accreditation No.
20111
Site No.
23708
Date of Accreditation
16 Jun 2017
Contact
Availability
Services conditionally available to external clients
Supervision
S (Specialised)
Scope of Accreditation
Monash IVF Clayton
ISO 15189 (2012)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma; Serum | Anti-Mullerian hormone (AMH) |
| Chemical pathology - Tests for thyroid function | Plasma; Serum | Thyroxine (T4) - Free |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy | Plasma; Serum | Human chorionic gonadotropin (hCG) |
| Infertility and pregnancy tests including assisted reproductive technology - Infertility (including in-vitro fertilisation) related endocrinology | Plasma; Serum | Follicle stimulating hormone (FSH); Luteinising hormone (LH); Oestradiol; Progesterone; Prolactin; Testosterone; Thyroid stimulating hormone (TSH) |
| Infertility and pregnancy tests including assisted reproductive technology - Investigation of sperm | Semen | Sperm antibodies |
| Sperm chromatin integrity assay | ||
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) | Semen | pH |
| Colour; Viscosity; Volume | ||
| Agglutination; Aggregation; Motility | ||
| Morphology; Motility; Sperm number; Vitality | ||
| Morphology | ||
| Vitality | ||
| Sperm number | ||
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma; Serum | Hepatitis B virus surface antigen (HBs Ag); Hepatitis C virus (HCV); Human immunodeficiency virus (HIV); Rubella IgG antibody; Syphilis Treponema pallidum antibody |
| Molecular genetics - DNA extraction | Blood; Buccal swabs | DNA storage for future analyses; Viable DNA for sequencing and other molecular assays |
| Molecular genetics - Pre-implantation genetic testing | Blood; Buccal swabs; Extracted DNA; Trophectoderm | Nucleic acid analysis for specific variants |
| Chromosome copy number analysis; Chromosome structural rearrangements | ||
| Chromosome copy number analysis; Karyomapping for known single gene disorders | ||
| Molecular genetics/Cytogenetics - Bioinformatic analysis | DNA sequences; FASTQ files; TXT files; VCF files | Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation |
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.
20111
Site No.
23708
Print date
23 Apr 2024
END OF SCOPE
