Aptima® HCV Quant Dx Assay

    Confirmation of active HCV infection and monitoring HCV viral load on the fully automated Panther® system.

      Demand More from Your HCV NAAT

      The Aptima HCV Quant Dx assay detects and quantitates HCV RNA and is intended for use as an aid in:1

      • Diagnosis of active HCV infection following a positive HCV antibody test
      • Clinical management of patients infected with HCV

      The Aptima HCV Quant Dx Assay intended use is to:

      Confirm HCV Infection

      Detects and quantitates HCV RNA genotypes 1, 2, 3, 4, 5, and 6.

      Monitor Viral Load

      Provides industry-leading sensitivity in even the lowest-level HCV concentrations.

      HCV Treatment Is Evolving. Now HCV Testing Is Too.

      The Aptima HCV Quant Dx assay meets the 2021 American Association for the Study of Liver Diseases (AASLD) recommendations for an FDA-approved quantitative or qualitative nucleic acid test (LoD ≤25 IU/mL) to determine sustained virological response (SVR). It employs real-time transcription-mediated amplification (RT-TMA) technology on Hologic’s Panther® system—and gives you unparalleled performance across several essential parameters.2

        Performance by design

        The robust design of the Aptima HCV Quant Dx assay incorporates multiple primers and probes within a highly conserved region of HCV RNA (5’ UTR) to detect and quantitate across genotypes 1 – 6:1

        • Redundant target capture oligos for protection against mutations
        • Longer oligos for extra protection against single-base mismatches
        • Multiple amplification primers (T7 and non-T7) for broad genotype coverage

        Redefining sensitivity: Detect even the lowest-level concentrations of HCV across all major genotypes and quantify HCV for optimal treatment monitoring.

        1) Limit of Detection (LoD): The Aptima HCV Quant Dx assay can detect HCV RNA as low as 3.9 IU/mL in plasma samples and 3.4 IU/mL in serum samples.1

        2) The LoD has been thoroughly verified across HCV genotypes 1–6 with multiple replicates and multiple reagent lots.1

        3) Lower Limit of Quantitation (LLoQ): The Aptima HCV Quant Dx assay LLoQ has been thoroughly established and verified across all major genotypes (1–6).1

        Repeatable, reliable results.

        The Aptima HCV Quant Dx assay delivers high precision for reliable determination of viral load—and confidence to meet the demands of today’s challenging treatment landscape.1

        Claim

        Dx, Quant

        LoD

        3.9 IU/mL plasma
        3.4 IU/mL serum

        LLoQ

        10 IU/mL

        Methodology

        RT-TMA

        Verified Sample Types*

        Serum (SST, serum tubes)
        Plasma (EDTA, ACD, PPT)

        Your Virology IQ

         

        Test Your Virology Knowledge

        Take a quiz on current virology statistics and historic innovations.

        Get Started

        Question 1 of 2

        Today’s Hepatitis C treatments generally have cure rates of?

        • ×
        • ×
        ANSWER C: The WHO published that antiviral treatments cure more than 95% of patients with Hepatitis C infections.
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        Question 2 of 2

        What are the current CDC recommendations for regular HCV testing?

        • ×
        • ×
        ANSWER A: The CDC’s 2020 HCV testing guidelines are an augmentation—with reports and summaries—to previous recommendations published in 2008 and 2012. It currently recommends “1) hepatitis C screening at least once in a lifetime for all adults aged ≥18 years, except in settings where the prevalence of HCV infection is <0.1% and 2) hepatitis C screening for all pregnant women during each pregnancy, except in settings where the prevalence of HCV infection is <0.1%. The recommendation for HCV testing that remains unchanged is regardless of age or setting prevalence, all persons with risk factors should be tested for hepatitis C, with periodic testing while risk factors persist. Any person who requests hepatitis C testing should receive it, regardless of disclosure of risk, because many persons might be reluctant to disclose stigmatizing risks.”
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        You’re well on your way! Continue reading about the Virology assay suite.
        You’ll feel more informed and empowered when speaking with your healthcare provider.

        You’re well on your way! Continue reading about the Virology assay suite. You’ll feel more informed and empowered when speaking with your healthcare provider.

        Disclaimer:
        * For quantitative measurements: Tubes containing EDTA or Acid Citrate Dextrose (ACD) anticoagulants or Plasma Preparation Tubes (PPTs). For qualitative determination: Tubes containing EDTA or ACD anticoagulants, or PPTs, or Serum tubes, or Serum separator tubes (SSTs).

        References:
        1. Aptima HCV Quant Dx assay. US package insert AW-14498. Hologic, Inc.; 2018. 2. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed April 12, 2022. HIV-1 Quant Dx Assay. US package insert AW-18107-001. Hologic, Inc.;