Evaluation of the performance of HIV1 & 2 one-step selftest kit for detection of HIV infection in whole human blood, serum or plasma samples.

Abstract

Acquired immune deficiency syndrome (AIDS) is cause by Human Immunodeficiency
Virus (HIV). It is an enveloped RNA virus belonging to the family of retroviruses
responsible for destroying the human immune defence system. HIV antibody testing is
critical for the diagnosis and counselling of HIV-infected persons, monitoring of trends in
HIV prevalence, and evaluation of the effectiveness of HIV prevention programmes.
Serological tests to detect antibodies to HIV became available in 1985, and since then more
kits for this test are still being produced. A total of 500 positive and 500 negative samples
were screened for HIV antibodies using Genie II HIV 1 & 2(BIO-RAD; 3, Boulevard
Raymond Poincare 92430 MARNES LA COQUETTE- FRANCE) and SeroCard™ HIV 1
& 2 Rapid (Trinity Biotech PLC; IDA Business Park Bray Co. Wicklow Ireland.) and were
further confirmed using New Lav Blot 1 western blot kit (BIO-RAD; 3, Boulevard Raymond
Poincare 92430 MARNES LA COQUETTE- FRANCE). These samples were screened
using the HIV1 & 2 one-step self-test kit (Bremancos Diagnostics Inc. BDI with lot Number
0141503) to evaluate its performance. Whole blood, serum or plasma was used for the
evaluation. Sensitivity of 99.2% and specificity of 99.8% were observed from the three sets
of tests conducted while positive predictive value (PPV) of 0.99 and negative predictive
value (NPV) of 0.99 each were calculated. The HIV 1 & 2 one-step-self test kit compared
well with Genie II HIV1 & 2 kit and western blot kit for detecting HIV antibodies in patient\'s
samples. Whole blood, plasma or serum can be used for the screening and easy for self test.

Keywords: HIV; AIDS; Genie II HIV I &2; SeroCard™ HIV 1&2 Rapid; New Lav Blot 1; HIV1 & 2 one-step-self test.

JOPAT Vol. 12 2007: pp.51-55