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Aptima HIV-1 Quant Dx Assay (CE-IVD)

The Aptima HIV-1 Quant Dx Assay is the first and only CE-IVD certified viral load assay with a dual claim for both diagnosis of HIV infection and monitoring of HIV-1 infected patients.
- Thoughtfully designed with multiple levels of protection against future HIV-1 mutations.
- Performs with excellent sensitivity and precision across a wide linear dynamic range.
- Offers convenience and efficiency with superior automation on the Panther system.

This assay is not available for sale in the US. Please contact your local sales representative for product availability.


The Aptima HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test for the detection and quantitation of HIV-1 RNA on the fully automated Panther system. It is intended for use as an aid in the diagnosis of HIV-1 infection, as a confirmation of HIV-1 infection, and as an aid in clinical management of patients infected with HIV-1. 

  • A dual target approach against highly conserved regions in the HIV genome, pol and LTR; a sophisticated primer design; and redundancy of oligonucleotides for protection against mutations.
  • Thorough verification of performance parameters such as LoD, LLoQ, and linearity across groups M, N and O with well-designed studies using the latest CLSI guidelines.
  • Excellent precision in quantitation of low viremia.

Diagnostic and confirmatory testing for HIV-1

Current detection of HIV-1 infection is primarily based on serologic testing for antibodies and/or p24 antigen by immunoassay. Although sensitivity of these tests have improved, there still exists a window period between the time of infection and the time of detection. The Aptima HIV-1 Quant Dx assay can detect HIV-1 RNA in plasma and serum an average of 5 days earlier than HIV p24 tests and over 10 days earlier than Anti-HIV 1/2 immunoassays.1 The detection of HIV-1 RNA in the plasma or serum of patients without antibodies is indicative of acute or primary HIV-1 infection; diagnosis of HIV-1 in acute patients can lead to increased treatment rates and decrease in transmission rates.2

Monitoring HIV-1 infected patients 

In conjunction with clinical presentation and other laboratory markers for disease prognosis in HIV-1 infected individuals, the Aptima HIV-1 Quant Dx assay may be used as an aid in monitoring the effect of antiretroviral treatment by measuring
changes in the concentration of HIV-1 RNA in plasma. When used as an aid in monitoring the effect of antiretroviral therapy, performance for quantitative results is established with plasma specimens only. Serum specimens may not be used for quantitative results. This assay is not intended for use in screening blood or plasma donors.


Excellent Sensitivity

The Aptima HIV-1 Quant Dx assay’s limit of detection in subtype B samples (3rd International WHO Standard) is 12 copies/mL. In other samples such as those from subtype F or Group N or Group O, the assay’s LOD is less than 9 copies/mL.

(All tables and figures in this section can be found in the Aptima HIV-1 Quant Dx package insert.)

Limit of Detection Using the 3rd Party HIV-1 WHO International Standard Limit of Detection Across HIV-1 Subtypes and Groups

Lower Limit of Quantitation

The Aptima HIV-1 Quant Dx assay’s lower limit of quantitation was established and verified using the strict CLSI guidelines. The LLoQ of the assay is set at the highest concentration of all subtypes tested: 30 copies/mL. In samples such as subtype B, F, CRF01_AE or Group N and O, the LLoQ is 15 copies/mL or less.

Verification of LLoQ by HIV-1 Subtype or Group

Linearity of the Aptima HIV-1 Quant Dx assay

Linearity Across the Dynamic Range

Linearity Across Groups and Subtypes


Reliable Quantitation

The Aptima HIV-1 Quant Dx assay offers precise quantitation across the linear range in addition to accurate quantitation.

Precision is maintained in samples with low-viremia with narrow CV of less than 10% in samples with 1.80 log copies/mL HIV-1.

Precision of the Aptima HIV-1 Quant Dx Assay

Diagnostic Performance

Diagnostic Agreement Between Aptima HIV-1 Quant Dx Assay and Comparator Assay

  1. CE_IVD Aptima HIV-1 Quant Dx package insert. San Diego, CA; Hologic, Inc., 2015.
  2. Metsch LRPereyra M, Messinger S, et al. HIV transmission risk behaviors among HIV-infected persons who are successfully linked to care. Clin Infect Dis 2008; 47:577–84.
CLSI Clinical and Laboratory Standards Institute
LLoQ Lower Limit of Quantitation
LoD Limit of Detection
LTR Long Terminal Repeat
pol Polymerase