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Changes to Hepatitis C (HCV) RNA by PCR, Quantitative Result
The Microbiology Division will switch the current molecular platform, Abbott M2000, to the Abbott Alinity m for Hepatitis C virus (HCV) viral load testing. The assay is intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV infection, and to aid in the management of patients with known active HCV infection, including Sustained Virologic Response (SVR) determination.

The Alinity m HCV assay is not intended to be used in screening blood, plasma, serum, tissue donors for HCV.

Effective date: July 21, 2021

Methodology and reporting:
Alinity m is a fully integrated and automated molecular diagnostics analyzer that utilizes real-time PCR technology. The HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of HCV RNA, in human plasma or serum, from HCV antibody positive individuals.

Important considerations:
  • Please note that quantitative viral load values may vary between instruments. Therefore, if any of the tests above have been used to monitor the patient’s disease, it is recommended to re-establish baseline levels for these assays.
  • UCI will offer no charge re-baseline for a period of 90 days (July 21 – Oct. 21). If indicated, during this 90-day period, physicians must order the re-baseline as below:
  • If re-baseline is ordered, both tests (Abbott M2000 and Alinity m) will be reported.
Assay performance:
  • Analytical measurement range: 12 to 100,000,000 IU/mL (1.08 to 8.00 Log IU/mL)
  • Lower limit of quantification (LoQ): 12 IU/mL (1.08 Log IU/mL)
Clinical validation data:
  • Plasma samples covered a range of 2.39 – 9.69 log IU/mL. The Alinity m showed a mean bias of 0.117 log IU/mL (-0.18 log IU/mL to 0.50 log IU/mL).
  • Serum samples covered a range of 4.7 to 6.42 log IU/mL. The Alinity m showed a mean bias of 0.194 log IU/mL (0.02 log IU/mL to 0.32 log IU/mL).
  • The R2 for plasma and serum were 0.9488 and 0.9695 respectively indicating good linear correlation between methods.
  • Please take this into consideration when reviewing patient’s results.
New test code:
SHCVVL: Hepatitis C RNA, Quant Blood

Re-baseline test code:
SHECQT: Hepatitis C RNA, Quant Blood (RE-BASELINE ONLY, no charge)

Specimen Required:
Collect: 10.0mL of blood in PPT tube (pearl-top, EDTA)
Preparation: Separate plasma from cells within 6 hours of collection. Collect separate tubes dedicated for use on this test only.
Specimen required: 3.0 mL plasma
Minimum volume: 2.0 mL plasma. If re-baseline is requested, please submit minimum of 3.0 mL of plasma.

Stability (after separation from cells):
Ambient: Unacceptable
Refrigerated: 3 days
Frozen: 60 days (-70°C)

Turnaround time (TAT):
STAT: not available
Routine: 2-5 days

Rejection criteria:
Specimens that exceed stated stability, unlabeled/mislabeled/mismatched specimens, specimens submitted in leaking containers, non-sterile containers, heparinized specimens. Any blood specimens shared with other test requests.

A summary of all tests offered by our laboratory services can be found here:


Cassiana Bittencourt, MD
Division of Clinical Microbiology

Edwin S. Monuki, MD, PhD
Department of Pathology & Laboratory Medicine

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