Background:
The Microbiology Division will switch the current molecular platform, Abbott M2000, to the Abbott Alinity m System for Hepatitis B virus (HBV) DNA viral load testing.
The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing antiviral therapy.
The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment.
The Alinity m System HBV assay is not intended to be used in screening blood, blood products, tissue, or cellular and tissue-based products.
This assay is not approved by FDA as a diagnostic test to confirm the presence of an HBV infection.
Effective date: June 15, 2022
Methodology:
The Alinity m System is a fully integrated and automated molecular diagnostics analyzer that utilizes real-time PCR technology. The HBV test is an in vitro polymerase chain reaction (PCR) assay for the quantitation of HBV DNA in human plasma or serum.
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 this assay.
- UCI will offer no charge re-baseline testing for a period of 77 days (June 15 – August 31, 2022). If indicated, during this 77-day period, physicians can order the re-baseline as shown below (Rebaseline test code: SHEBQT).
- 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: 10 to 1,000,000,000 HBV DNA IU/mL (1.00 to 9.00 Log IU/mL)
- Lower limit of quantification (LoQ): 10 HBV DNA IU/mL (1.00 Log IU/mL)
Clinical validation data:
- Plasma samples covered a range of 1.28 – 8.51 log HBV DNA IU/mL. The Alinity m System showed a mean bias of 0.085 log IU/mL (-0.38 log UI/mL to 0.68 log IU/mL).
- Serum samples covered a range of 1.18 to 6.92 log HBV DNA IU/mL. The Alinity m System showed a mean bias of 0.390 log IU/mL (0.06 log UI/mL to 0.78 log IU/mL).
- The R2 for plasma and serum were 0.9901 and 0.9957 respectively indicating good linear correlation between the Abbott M2000 versus the Abbott Alinity m System.
New test code:
SHBVVL: Hepatitis B DNA by PCR, Viral Load.
Re-baseline test code:
SHEBQT: Hepatitis B DNA by PCR, Quantitative Blood (Re-baseline included at no additional charge until Aug. 31, 2022).
Specimen required:
Preferred specimen: 10.0 mL of blood in a plasma preparation tube (PPT) (pearl-top tube, EDTA).
For serum, collect 10 ml of blood in a serum separator tube (SST) (gold top tube).
Collect separate tubes dedicated for use on this test only.
Preparation: Separate plasma/serum from cells within 6 hours of collection.
Specimen required: 3.0 mL of plasma/serum.
Minimum volume: 2.0 mL of plasma/serum.
If re-baseline test is requested, please submit a minimum of 3.0 mL of plasma/serum.
Stability (after plasma/serum separation from cells):
Ambient temperature: Unacceptable
Refrigerated (4°C): 3 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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