Clinical information
Diagnostic Utility:
This is the qualitative detection of nucleic acids of Hepatitis B virus (HBV), Hepatitis C virus (HCV), and Human Immunodeficiency virus (HIV-1/2), and its determination is useful in:
- Identification of individuals with active infection by any of the three viruses.
- Transfusion of blood components.
- Transplantation of progenitor cells, umbilical cord blood cells, solid organs, and tissues.
Method:
Amplification by transcription (TMA).
Reference Values
Possible results are: Reactive and Non-Reactive.
Diagnostic Algorithm:
In case of a Reactive result of the multiplex screening test for Hepatitis C RNA, HIV-1/HIV-2 RNA, Hepatitis B DNA (TMA), discriminatory assays for HBV, HCV, and HIV can be performed to identify the specific virus/viruses:
| Code | Test Name | Can it be requested separately? | Is it always done? |
|---|---|---|---|
| 0260 | HBV, DNA (TMA). Discriminatory test | Yes | No (*) |
| 0261 | HBV, RNA (TMA). Discriminatory test | Yes | No (*) |
| 0262 | HIV, RNA (TMA). Discriminatory test | Yes | No (*) |
(*) Upon request
Response Time:
Maximum 2 working days
Specimen information
Sample: Plasma and/or serum from living and/or deceased individuals.
Tube: Aliquots of 1-5 mL, plasma tubes with EDTA, ACD, heparin or sodium acetate as an anticoagulant and/or serum tubes without gel separator.
Minimum essential volume: 1 ml
Stability:
- At room temperature: 3 days for samples from living individuals and 1 day for deceased samples.
- Refrigerated at 2-8 °C: 13 days for samples from living individuals and 8 days for deceased samples.
- Sample frozen at or below -20°C: 10 years
Transport instructions: Preferably at room temperature and/or refrigerated if it is whole blood tubes, and frozen if it is serum and/or plasma aliquots.
Reason for rejection: Highly hemolyzed sample.
Administrative information
BST Code: 0200
Test Description: Hepatitis C RNA, HIV-1 / HIV-2 RNA, Hepatitis B DNA (TMA). Screening
Synonyms: NAT
Section: Transfusion Safety Laboratory
BST Rate: Check the updated rates here.
Profiles:
Not applicable.
References
- Procleix Ultrio Elite assay package insert, 503049 Rev. 002
Quality
BST holds ISO 9001, ISO 14001, and OSHAS 18001 quality certifications, as well as the European Excellence 500+ seal. BST is accredited by CAT, JACIE-FACT, FACT-NETCORD, and EFI, and complies with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines.