Aptima® HCV Quant Dx Assay

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Aptima® HCV Quant Dx Assay

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

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Overview

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.

The Latest on Aptima Virology

See More Virology Highlights

White House Initiative Aims to Finally Eliminate Hepatitis C Infection

The 2024 White House budget proposal includes a bold plan to eliminate Hepatitis C virus (HCV) in the United States within five years of implementation.

The Decline of HCV Genotyping and the Rise of Real-Time TMA

Patients no longer have to spend time and money on additional testing before getting the care they need.

The Case for NAAT in the HIV Algorithm

Researchers are calling for the CDC to update its guidelines to incorporate HIV testing that gives patients results as soon as possible.

See More Virology Highlights

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

Sophisticated Design

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

High Sensitivity

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

Precision

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

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Take a quiz on current virology statistics and historic innovations.

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Question 1 of 2

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

50% ×
80% ×
95% ✔

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

What are the current CDC recommendations for regular HCV testing?

One-time testing of all adults (18 years and older) and all pregnant women during every pregnancy, with regular testing for people with higher risk factors ✔
Testing of all adults (18 years or older) every two years, and once per year for people with higher risk factors ×
Yearly testing of all people aged 16 years or older, testing of all pregnant women during their first pregnancy, and testing during every pregnancy for women in higher-risk groups (e.g., those who inject drugs) ×

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.”

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.

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References