Alere Determine™ HIV-1/2
Evaluations
Independent Clinical Studies
Alere Determine™ HIV-1/2
Below are summaries of a number of independent clinical studies of the Alere Determine™ HIV-1/2 test. For more studies and links to papers please visit our Studies and Implementation map.
Evaluation of simple rapid HIV assays and development of national rapid HIV test algorithms in Dar es Salaam, Tanzania
Lyamuya, EF., Aboud, S., Urassa, WK., Sufi, J., Mbwana, J., Ndugulile, F., Massambu, C. 2009. Evaluation of simple rapid HIV assays and development of national rapid HIV test algorithms in Dar es Salaam, Tanzania. BMC Infectious Diseases 2009, 9:19
In this evaluation the performance of the Alere Determine™ HIV-1/2 test was assessed as part of a program to develop alternative HIV screening algorithms for the Ministry of Health and Social Welfare in Tanzania. In addition to the Alere Determine™ HIV-1/2 test, five other rapid tests were evaluated, including the SD Bioline™ HIV 1/2 3.0, First Response™ HIV Care 1-2.0, HIV 1/2 Stat-Pak™ Dipstick and the Uni-Gold™ HIV-1/2. The Inno-lia™ HIV I/II immunoblot assay was used as the confirmatory reference method.
The evaluation used whole blood samples collected from hospital patients, pregnant women, VCT attendees and blood donors within Dar es Salaam. A total of 1,649 samples were collected between June and September 2006; 1,433 were included in the final analysis. The HIV serostatus of the samples was unknown prior to the evaluation. 390 samples were confirmed as HIV-1 Ab positive and 1,042 were HIV negative.
On initial testing, the Alere Determine™ test had 100% sensitivity and 99.6% specificity. On repeat testing, specificity rose to 99.8%. The PPV was 99% and NPV 100%. A performance appraisal of the test by laboratory technologists deemed the test easy to use.
Based on a combination of factors including performance, price, storage, stability and ease of use, the evaluation concluded that a suitable confirmatory HIV testing strategy based on initial testing on either SD Bioline™ or Alere Determine™ HIV-1/2 followed by testing of reactive samples on Alere Determine™ or SD Bioline™ would give 100% sensitivity and 100% specificity.
Results for all tests are summarised in Table 1.
Performance of a rapid and simple HIV testing algorithm in a multicentre phase III microbicide clinical trial
Crucitti T., Taylor D., Beelaert G., Fransen K., Van Damme L. 2011. Performance of a rapid and simple HIV testing algorithm in a multicentre phase III microbicide clinical trial. Clin Vaccine Immunol. Sep;18(9):1480-5
In this evaluation a sequential HIV multi-test algorithm using simple and rapid assays was assessed among participants in a phase 3 vaginal microbicide effectiveness trial. Given that many of these trials take place in remote and rural areas where laboratory diagnostics are not readily available, it is necessary to have a reliable and fast method for diagnosis of HIV. Rapid, simple, point-of-care HIV tests present the best option for HIV diagnosis in these settings.
Women were recruited from five sites across Benin, India, South Africa and Uganda. In total 5,734 specimens were obtained from 1,398 women. HIV testing was performed on finger-price whole blood samples and tested in a serial procedure using Alere Determine™ HIV-1/2 as the first line screen. If a sample was reactive on the Alere Determine™ test, it was confirmed using the SD Bioline™ HIV-1/2 3.0. In the case of discrepant results, the Uni-Gold™ HIV test was used to determine the final outcome. Study participants were tested for HIV at 1,3,6,9 and 12 months after enrolment.
Using this algorithm 46 women tested positive. Further confirmatory testing was performed at the Institute of Tropical Medicine, Antwerp, Belgium. This confirmatory testing established 42 women as true HIV positive.
The sequential HIV testing algorithm using rapid and simple tests showed an initial sensitivity of 100% and specificity of 99.9%.
At one study site in Kampala, Uganda, a number of false-reactive results were obtained on the Alere Determine™ HIV-1/2 test. Following retraining on storage and handling of the strips and test procedure, the number of false-reactive results was reduced. Some did remain however and were likely caused by interfering blood substances.
The study demonstrates the effectiveness and accuracy of HIV testing algorithms using rapid and simple point-of-care tests. In the context of the microbicide trial, confirmation of positive results on a second specimen further enhanced the reliability of results and proved to be easily implementable.
