Aptima® HIV-1 Quant Dx Assay
Diagnosis of active infection, high sensitivity and excellent precision for Human Immunodeficiency Virus 1 (HIV-1) viral load monitoring.1
Information for Healthcare Professionals
Overview
Documents
Reliable Quantitation1
Deliver reliable, repeatable results with a robust dual-target assay that accurately detects and monitors HIV-1. Running the Aptima HIV-1 Quant DX assay on the Panther® System combines assay performance and excellent automation for viral load monitoring--a combination that delivers sample-to-result within a single integrated instrument.1
High Accuracy & Precision
The Aptima HIV Quant Dx assay is highly accurate for HIV-1 across the dynamic range of the assay.1-2
Efficient Workflow & Flexible Processing
No need for aliquoting or manual sample transfer. PPT, ACD and EDTA tubes are all validated.1 You can run multiple tests from a single sample. No manual sample preparation with primary tube loading to maintain positive sample identification.
Random Access & Rapid Turnaround Time
No more batching. You can run different test orders from the same sample as they arrive at the laboratory. Rapid turnaround time with first results in just 2 hours, 41 minutes. Prioritises STAT results.3
Automated Analysis & Dilution Factor
Automated QC analysis with Levey-Jennings plots to track and trend controls. Low sample volume option (240 μL) with automated dilution factor. Enables application of an automatic dilution factor instead of manual calculations.3
Simplify & Scale the Future of Diagnostics
The Aptima HIV-1 Quant Dx Assay is part of the Hologic Molecular Scalable Solution, a portfolio combining a broad, high-performing assay menu with high-throughput automation. Designed to flexibly scale to meet your needs, from a single-patient result to population-level screening.
Excellent Sensitivity & High Precision
High assay precision provides confidence that any detected increases in viral load are due to clinical changes in patients, rather than assay variation.1,4
12 copies/mL
Limit of detection (LoD)*
30 copies/mL
Lower limit of quantitation (LLoQ)
30-10 million copies/mL
Linear range*
Demand More from Your HIV-1 Assay1
- Intended use: diagnosis of primary HIV-1 infection, confirmation of HIV-1 infection, HIV-1 viral load monitoring
- Technology: Real-time Transcription-mediated Amplification (TMA)
- Target region: pol/LTR
- Groups: M, N, O
- Sample Types: serum and plasma (qualitative), plasma (quantitative)
Insights
*Established using the 1st WHO International Standard.
- Aptima HIV-1 Quant Dx Assay [package insert] AW-11853-001. Rev.010 San Diego, CA; Hologic, Inc., 2021.
- Hopkins M, Hau S, Tiernan C, et.al. Comparative Performance of the New Aptima HIV-1 Quant Dx Assay With Three Commercial PCR-Based HIV-1 RNA Quantitation Assays. J Clin Virol. 2015;69:56-62.
- Panther / Panther Fusion Operators Manual. AW-26055-001 Rev. 001
- Nair SV, Kim HC, Fortunko J, et al. Aptima HIV-1 Quant Dx—a fully automated assay for both diagnosis and quantification of HIV-1. J Clin Virol. 2016;77:46-54.
Safety Data Sheets
Package Inserts
1434
Hologic BV, Da Vincilaan 5, 1930 Zaventem, Belgium.
Notified Body number wherever applicable