Background:
The Microbiology Division will switch the current molecular platform, Abbott M2000, to the Abbott Alinity m System for Human Immunodeficiency Virus type 1 (HIV-1) RNA viral load testing.
The assay is intended for the quantification of HIV-1 RNA in human plasma for clinical management of HIV-1 infected individuals. Performance for quantitative results is not established with serum specimens.
The test may be used to monitor disease prognosis by measuring the baseline plasma HIV-1 RNA level and to assess the response to antiretroviral treatment by measuring changes in plasma HIV-1 RNA levels.
The Alinity m System HIV-1 RNA assay is not intended for use in screening blood, blood products, tissue, or organ donors for HIV-1 RNA.
Effective date: June 15, 2022
Methodology:
Alinity m System is a fully integrated and automated molecular diagnostics analyzer that utilizes realtime PCR technology. The HIV-1 RNA Viral Load by PCR is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay intended for use in the clinical management of HIV-1 infected individuals in conjunction with clinical presentation and other laboratory markers.
Reporting: Important considerations:
- Please note that quantitative viral load values may vary between instruments. Therefore, if any other test has been used to monitor the patient’s infection, it is recommended to re-establish baseline levels for the new assay.
- UCI will offer no charge to re-baseline for a period of 77 days (June 15 – August 31, 2022). If indicated, during this 77-day period, physicians can order at no cost, the re-baseline as shown below (Re-baseline test code: SHIVQT)
- If re-baseline is ordered, both tests (Abbott M2000 and Alinity m System) will be reported.
- Please take this information into consideration when reviewing patient’s results.
Assay performance:
- Analytical measurement range: 20 to 10,000,000 HIV-1 RNA copies/mL (1.30 to 7.00 Log copies/mL)
- Lower limit of quantification (LoQ): 20 HIV-1 RNA copies/mL (1.30 Log copies/mL)
Clinical validation data:
- Plasma samples covered a range of 1.41 – 5.65 log HIV-1 RNA copies/mL. The Alinity m System showed a mean bias of 0.219 log HIV-1 RNA copies/mL (-0.03 log copies/mL to 0.60 log copies/mL).
- The R2 for plasma was 0.9866 indicating good linear correlation between methods (Abbott M2000 versus the Abbott Alinity m System).
New test code:
SHIVVL: HIV-1 (Human Immunodeficiency Virus Type-1) RNA by RT-PCR, Viral Load
Re-baseline test code:
SHIVQT: HIV 1 RNA (Viral Load) by RT-PCR, Quantitative (Re-baseline included at no additional charge until Aug. 31, 2022)
Specimen required:
Collection: 10.0 mL of blood in a plasma preparation tube (PPT) (pearl-top tube, EDTA).
Collect separate tube dedicated for use on this test only.
Preparation: Separate plasma from cells within 6 hours of collection.
Specimen required: 3.0 mL of plasma.
Minimum volume: 2.0 mL of plasma.
If re-baseline test is requested, please submit a minimum of 3.0 mL of plasma/serum.
Stability (after plasma separation from cells):
Ambient temperature: Unacceptable
Refrigerated (4°C): 2 days
Frozen (-70°C): 60 days
Turnaround time (TAT):
STAT: Not available
Routine: 2-5 days
Rejection criteria:
Specimens that exceed stated stability time/temperature, unlabeled/mislabeled/ mismatched.
Specimens submitted in leaking containers, non-sterile containers and heparinized tubes.
Any blood specimen shared with other test requests.
A summary of all tests offered by our laboratory services can be found here:
http://www.pathology.uci.edu/services/index.asp
Sincerely,
Cassiana E. Bittencourt, MD.
Director
Division of Clinical Microbiology
Luis M. de la Maza, MD, PhD
Associate Director
Division of Clinical Microbiology
Edwin S. Monuki, MD, PhD
Chair
Department of Pathology & Laboratory Medicine
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