Abstract
BackgroundHuman immunodeficiency virus (HIV) Rapid diagnostic Test (RDT) kits are the preferred assays for HIV testing in many countries. Prevention of Mother-to-Child Transmission, Know Your Status Campaigns, Blood-Safety, Voluntary Counseling and Testing are major strategies adapted to control transmission of the virus and the pivot of these interventions is either screening or diagnosing individuals through testing. There are reports of inconsistent sensitivity and specificity with whole blood and serum samples collected from the same individual. Little is known about the diagnostic characteristics of First Response HIV-1-2 RDT kit, used as a single test kit in national HIV prevention and control programmes. The debate has always centered on choosing between whole blood and serum in a case where a single test kit that runs on only blood specimen will be used for testing. The variations in specificities and sensitivities with whole blood and serum samples imply that some individuals who might be true positives will be missed and elude care. This study determined the best blood-based specimen type (whole blood or serum) that improves performance of First Response HIV RDT kit in detecting HIV-specific antibodies.MethodsA hospital-based cross-sectional study was conducted on 280 HIV infected and non-infected patients from May 2015 to June 2015. Blood samples from each participant were separated into whole blood and serum, and tested on First Response HIV-1-2 kits (Premier Medical Corporation Ltd., Kachigam, India) using Electro-chemi-luminescence assay (ECLIA) as reference assay.ResultsFirst Response HIV-1-2 RDT kit showed 100 % sensitivity and 100 % specificity with whole blood specimen and 100 % sensitivity and 82.86 % specificity with serum specimen for the detection of HIV-1. The positive and negative predictive values were 100, 100 and 85.35, 82.86 % for whole blood and serum respectively.ConclusionWhole blood specimen(s) from an individual have higher specificity, positive and negative predictive values than serum. Whole blood is the primary specimen to use on First Response HIV-1-2 RDT kit when screening peripheral blood for HIV-1-specific antibodies.
Highlights
Human immunodeficiency virus (HIV) Rapid diagnostic Test (RDT) kits are the preferred assays for HIV testing in many countries
2 Out-Patient Department (OPD) and three prospective blood donor samples were positive for HIV-1 but they were excluded from the analysis
Using serum as test specimen on First Response HIV1-2 Rapid Diagnostic Test (RDT) kit increases the tendency of producing false positive results
Summary
Human immunodeficiency virus (HIV) Rapid diagnostic Test (RDT) kits are the preferred assays for HIV testing in many countries. This study determined the best blood-based specimen type (whole blood or serum) that improves performance of First Response HIV RDT kit in detecting HIV-specific antibodies. Technologies that allow the detection of very low levels of HIV nucleic acids (RNA or DNA), viral p24 antigens, and HIV-specific antibodies have been developed [1] In spite of these successes, laboratory assays in general are still imperfect, and some recent infections remain undetected [2]. RDT kits have the lowest detection ability, they remain the preferred assay for HIV testing in many countries This is because they require little expertise to use, run on little sample volumes, cheaper in cost and produce test results in 15 min [4]. The results were similar when the test specimen was either whole blood or serum
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