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 in1:

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

HCV Treatment Is Evolving.

Now HCV Testing Is Too.

The Aptima HCV Quant Dx assay meets the 2016 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)—and provides unparalleled performance across several essential parameters 2,*:

Redefining sensitivity: Detect even the lowest-level concentrations of HCV across all major genotypes.

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

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

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Rigorous establishment of LLoQ for performance in HCV treatment monitoring.

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

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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

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Wide linear range for accurate quantitation at every stage of HCV infection.

The Aptima HCV Quant Dx assay accurately quantifies HCV RNA from 10 to 100 million IU/mL, ensuring accurate performance at every stage of the disease, from diagnosis to SVR.1

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The linear range of the Aptima HCV Quant Dx assay has been established across HCV genotypes 1 – 6 in both plasma and serum samples.1

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Process low-volume samples with ease.1

  • Analyze as little as 240 μL with automated dilution factor using Hologic’s validated and fully automated sample dilution protocol.
  • Obtain neat result without additional calculation (software automatically accounts for dilution).
  • Test samples from patients for whom drawing large samples can be difficult.
  • Run multiple assays from 1 primary collection tube.

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 – 61:

  • 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.

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Ordering information.

*When comparing key performance parameters such as LLoQ and precision.
Aptima SAT tube needed.


  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. Accessed January 14, 2021.