Background: There are currently no FDA-cleared assays with a dual-claim for both diagnosis and monitoring of HIV-1. The Aptima HIV-1 Quant Dx Assay on the Panther platform (Panther) is the first commercially available test that is CE-marked for both HIV-1 diagnosis and monitoring, but only FDA-cleared for HIV-1 monitoring.
Objective: To evaluate the Panther assay for use as a qualitative and quantitative HIV-1 assay in a pediatric population, including patients younger than 24 months old, and review its effect on laboratory efficiency and hands-on-time following its implementation.
Study Design: 100 patient specimens previously tested on the Abbott m2000 RealTime HIV-1 assay (RealTime) and 185 patient specimens previously tested on the Aptima HIV-1 RNA Qualitative Assay (RNA Qual) were tested on the Panther. Verification panels were used to establish precision and linearity. In addition, 268 samples from 134 patients under 24 months of age were also evaluated on the Panther.
Results: Overall agreement between the Panther and RealTime assays was 83 %. The mean difference between the two methods was 0.10 Log copies/mL. All Panther measurements were linear across the dynamic range (R = 0.999). The Panther and RNA Qual assays showed 100 % agreement. Implementation of the assay opened 600 sq. ft. of space, saved 0.4 FTE and reduced hands-on-time by 70 %.
Conclusions: The Panther assay is an excellent option for HIV-1 qualitative detection and quantitative testing in pediatric patients, including those under 24 months of age. HIV testing on one platform has opened up space in the clinical laboratory and reduced hands on testing time.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jcv.2020.104352 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Nucleic acid amplification testing using dried blood spots to confirm the diagnosis of HIV-1 in adults.
J Clin Virol
December 2024
Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Background: The WHO HIV testing algorithm for high prevalence populations recommends the use of three different serologic assays, though this approach may lead to diagnostic misclassification. The study objective was to compare dried blood spot (DBS)-based HIV-1 nucleic acid detection methods to determine their suitability to confirm the diagnosis of HIV-1 in adults generally with suppressed or low-level plasma HIV-1 RNA.
Methods: Four methods were evaluated: Cepheid Xpert HIV-1 Qual Assay (Xpert), Hologic Aptima HIV-1 Quant Dx assay (Aptima), Roche Cobas Ampliprep/Cobas TaqMan HIV-1 test, v.
Prevalence of sexually transmitted infections and associated risk factors among female sex workers in Guinea-Bissau.
Sex Transm Infect
October 2024
The Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
Article Synopsis
- * Researchers recruited 467 women between October 2014 and May 2019, finding a striking 46.7% prevalence rate of curable STIs, with asymptomatic cases being significant, and a high ciprofloxacin resistance rate of 84%.
- * Key risk factors for STIs included age and HIV-1 infection, while using female condoms appeared protective; the findings suggest a critical need for improved STI testing and treatment efforts among this population to curb transmission.
Evaluation of Xpert point-of-care assays for detection of HIV infection in persons using long-acting cabotegravir for pre-exposure prophylaxis.
Microbiol Spectr
July 2024
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Unlabelled: Detection of HIV infection may be challenging in persons using long-acting cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) due to viral suppression and reduced/delayed antibody production. We evaluated two point-of-care tests for detecting HIV infection in persons who received CAB-LA in the HPTN 083 trial. Samples were obtained from 12 participants who received CAB-LA and had delayed detection of HIV infection using HIV rapid tests and an antigen/antibody test (52 plasma samples; 18 dried blood spot [DBS] samples).
View Article and Find Full Text PDFEvaluation of the ELITechGroup solution for plasma HIV-1 RNA quantification.
J Clin Virol
August 2024
Univ Rouen Normandie, Univ de Caen, INSERM, DYNAMICURE UMR 1311, CHU Rouen, Department of Virology, National Reference Center of HIV, F-76000 Rouen, France. Electronic address:
Article Synopsis
- Many manufacturers have created new kits for quantifying plasma HIV-1 RNA, and a recent kit combining the ELITe InGenius® instrument with the HIV1 ELITe MGB® kit has been launched globally.
- The study aimed to compare the clinical performance of this new kit with Hologic's Aptima® HIV-1 Quant Dx kit using a variety of HIV-1 samples to assess linearity, specificity, and sensitivity.
- Results showed that the two kits had an overall agreement of 83.7%, with slight differences in detection rates, but both were effective for monitoring viral load in patients with different HIV-1 strains.
Virological characterization of HIV-1 RNA elements detected exclusively through the LTR region by the dual-target Aptima HIV-1 Quant Dx assay in a subset of positive patients.
J Clin Virol
October 2023
Laboratory of Virology, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, Rome, Italy. Electronic address:
Background: In a restricted subset of HIV patients with suppressed viral load (i.e., pol-undetected HIV-RNA), the Aptima HIV-1 Quant Dx Assay (Aptima), a dual-target (pol and LTR) and dual-probe test for viral load (VL) monitoring, can detect HIV-RNA exclusively through amplification of the LTR region.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!