Aptima® HIV-1 Quant Dx Assay

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Aptima® HIV-1 Quant Dx Assay

Dual-claim assay to confirm HIV-1 infection and measure viral load.

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Overview

HIV-1 Detection and Viral Load Monitoring

With performance you can count on, the Aptima HIV-1 Quant Dx assay is a dual-claim assay that can be used to confirm HIV-1 infection and measure viral load for optimal patient management.¹ It offers reliable quantitation of HIV-1 RNA across a broad linear range, giving your lab excellent precision and sensitivity for HIV-1 detection and viral load monitoring.

The Aptima HIV-1 Quant Dx Assay intended use is to:

Confirm HIV Infection

Running on the Panther® system, Aptima HIV-1 Quant Dx accurately detects and monitors HIV-1 for reliable, repeatable results.

Monitor Viral Load

Industry-leading precision gives you confidence that any changes in viral load reflect clinical changes in the patient—not variations in the assay.

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Performance You Can Count On

Thoughtful assay design to guard against mutations.

Sophisticated Design

Robust assay design to guard against mutations

The Aptima HIV-1 Quant Dx assay design provides 3 levels of protection for confidence in assay performance despite drug selection pressures and growing genetic diversity:¹

Dual-target approach for built-in redundancy, with both targets chosen within highly conserved genomic regions of HIV-1 (LTR and pol) to ensure accurate quantitation
Sophisticated primer design to tolerate mutations
Redundant oligonucleotides for consistent performance

High Sensitivity

A highly sensitive assay for reliable quantitation of HIV-1 RNA.

The Aptima HIV-1 Quant Dx Assay ensures detection and quantitation across major groups and subtypes (M, N, O)

1) Limit of Detection (LoD): The Aptima HIV-1 Quant Dx assay can detect HIV-1 RNA as low as 12 copies/mL (3rd WHO International Standard) using a 0.5 mL sample.¹

2) Lower Limit of Quantitation (LLoQ): The Aptima HIV-1 Quant Dx assay reports viral load as low 30 copies/mL.¹

Precision

Precise results reduce repeat testing

The Aptima HIV-1 Quant Dx assay delivers high precision in quantitation, with a narrow coefficient of variation across the linear range—including in low-viremia samples—for results you can trust.¹

Claim

Dx & Quant

LoD

12 copies/mL in plasma
8.9 copies/mL in serum

LLoQ

30 copies/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

How many new cases of HIV were diagnosed in the United States in 2019?

Between 20,000 and 30,000 ×
Between 30,000 and 40,000 ✔
Between 40,000 and 50,000 ×

ANSWER B: According to the CDC’s HIV Basic Statistics page, 36,801 people received a new HIV diagnosis in the United States and dependent areas. “An estimated 1,189,700 people in the United States had HIV at the end of 2019, the most recent year for which this information is available,” the organization reports. “Of those people, about 87% knew they had HIV.”

What significant advances in virology earned the 2004 National Medal of Technology in Medicine?

Technology for simultaneous identification of HIV-1 and Hepatitis C in blood and organ donors ✔
Development of Efavirenz, the first FDA-approved non-nucleoside reverse transcriptase inhibitor (NNRTI) ×
Preliminary results from a trial demonstrating the utility of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) for PrEP in adults ×

ANSWER A: In 2004, the company Gen-Probe, founded in 1983 in San Diego, California, was presented with the National Medal of Technology by President George W. Bush “for the development and commercialization of new blood-testing technologies and systems for the direct detection of viral infections, including direct identification of West Nile Virus and simultaneous identification of HIV-1 and Hepatitis C virus in plasma of human blood and organ donors prior to transfusion.” Gen-Probe—and its pioneering technologies—was acquired by Hologic in 2012.

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