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Published on: September 24, 2010
Rapid confirmation of HIV infection
Niel T Constantine1, Fassil Ketema
1Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. constant@umbi.umd.edu
Insights
A new rapid confirmatory HIV assay provides accurate results in 5 minutes. This innovative test shows high concordance with standard methods, proving effective for HIV-1 infection confirmation.
Area of Science:
- Virology
- Immunology
- Diagnostic Assays
Background:
- Accurate and rapid human immunodeficiency virus (HIV) testing is crucial for timely clinical management and public health.
- Existing confirmatory methods can be time-consuming, limiting immediate clinical decision-making.
Purpose of the Study:
- To evaluate the performance and utility of a novel, prototype rapid confirmatory HIV assay.
- To assess its applicability in diverse clinical and public health testing scenarios.
Main Methods:
- The rapid assay's performance was evaluated using 849 blood samples (serum, plasma, whole blood, fingerstick).
- Included were HIV-1 Western blot (WB)-confirmed positive, negative, and indeterminate samples.
- Analytic sensitivity was assessed using HIV-1 seroconversion panels, with results compared to an FDA-licensed WB test.
Main Results:
- The rapid assay demonstrated 100% concordance with WB for confirmed HIV-1 positive samples.
- It achieved 92.3% concordance with WB for indeterminate results.
- Sensitivity in detecting recent seroconversion was comparable or superior to WB in 10 out of 13 panels, with excellent precision and reproducibility.
Conclusions:
- This rapid HIV confirmatory assay represents a significant advancement, offering proof of principle for accurate HIV-1 infection confirmation.
- Its speed and accuracy present considerable advantages for public health initiatives and clinical settings.
Objective:
To investigate the utility of a prototype rapid confirmatory HIV assay which offers specific results in 5 min and has applications in a variety of important testing situations.
Methods:
The performance of the rapid confirmatory assay was assessed with 849 blood samples, including serum, plasma, venipuncture whole blood, and peripheral blood collected via fingerstick. Included were over 700 HIV Western blot (WB)-confirmed antibody positive sera, and others which were classified as negative or indeterminate by WB. The analytic sensitivity of the rapid confirmatory assay was assessed using 13 HIV-1 seroconversion panels, and all results were compared to those of an FDA-licensed WB reference test.
Results:
The rapid test exhibited 100% concordance with the reference test when testing HIV-1 WB-confirmed positive samples, and 92.3% concordance with samples having WB-inconclusive results. The sensitivity for confirming recent seroconversion was as good, or better than, the FDA-licensed HIV-1 WB in 10/13 panels. The rapid assay performed accurately with whole blood collected from fingerstick, and exhibited excellent precision and reproducibility.
Conclusion:
We conclude that this rapid HIV confirmatory assay, the first of its kind, demonstrates proof of principle for the accurate confirmation of HIV-1 infection and offers important advantages in public health and clinical testing venues.
