Performance characteristics of a new rapid immunochromatographic test for the detection of antibodies to human immunodeficiency virus (HIV) types 1 and 2
Identifieur interne : 000B79 ( Main/Exploration ); précédent : 000B78; suivant : 000B80Performance characteristics of a new rapid immunochromatographic test for the detection of antibodies to human immunodeficiency virus (HIV) types 1 and 2
Auteurs : H. Syed Iqbal [Inde] ; P. Balakrishnan [Inde] ; K. G. Murugavel [Inde] ; Solomon Suniti [Inde]Source :
- Journal of Clinical Laboratory Analysis [ 0887-8013 ] ; 2008.
English descriptors
- KwdEn :
- Aids research, Algorithm, Anal, Assay, Biomed industries, Blot, Card test, Card test assay, Clin, Clin diagn, Clin microbiol, Comparative results, Different antigenic bases, Drug resistance mutations, Elisa, First response, Genetic systemstm, High sensitivity, Human virus, Human virus type, Indeterminate results, Initial screening, Laboratory infrastructure, Microbiol, Nations programme, Negative result, Performance characteristics, Positive specimens, Primary assay, Rapid assay, Rapid assays, Rapid detection, Rapid immunochromatographic test, Reference laboratories, Reliable results, Rural areas, Screening, Screening assays, Second assay, Seronegative specimens, Several advantages, Syed iqbal, Tamil nadu, Testing algorithm, Testing technologies, Voluntary counseling, Western blot, World health organization.
- Teeft :
- Aids research, Algorithm, Anal, Assay, Biomed industries, Blot, Card test, Card test assay, Clin, Clin diagn, Clin microbiol, Comparative results, Different antigenic bases, Drug resistance mutations, Elisa, First response, Genetic systemstm, High sensitivity, Human virus, Human virus type, Indeterminate results, Initial screening, Laboratory infrastructure, Microbiol, Nations programme, Negative result, Performance characteristics, Positive specimens, Primary assay, Rapid assay, Rapid assays, Rapid detection, Rapid immunochromatographic test, Reference laboratories, Reliable results, Rural areas, Screening, Screening assays, Second assay, Seronegative specimens, Several advantages, Syed iqbal, Tamil nadu, Testing algorithm, Testing technologies, Voluntary counseling, Western blot, World health organization.
Abstract
Diagnostic kits for the detection of human immunodeficiency virus (HIV) antibodies have reached an unprecedented number. But choice of an ideal, cost‐effective, and rapid test for HIV infection is of immense value for use in developing countries like India, where resources are limited. In this study we have evaluated the performance characteristics of the rapid immunochromatographic HIV test kit First Response HIV 1‐2.O. First, the laboratory archived 450 characterized plasma/serum specimens, which were tested on First Response HIV 1‐2.O. Second, a total of 134 consecutive voluntary counseling and testing (VCT) specimens were also tested and positive specimens were further confirmed with HIV TRI‐DOT. All these VCT specimens were cross‐checked with HIV double‐enzyme‐linked immunosorbent assay (ELISA) (Murex and Vironostika), and the results were matched. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and efficiency of First Response HIV 1‐2.O with the 450 characterized specimens was 100% for HIV‐1 with reference assay. The results in the VCT algorithm were correlating with double‐ELISA. In the HIV‐2 analysis, five HIV‐2‐positive specimens in First Response HIV 1‐2.O were found to be HIV‐2‐indeterminate on Western blot. HIV TRI‐DOT was unable to pick up two HIV‐2 Western blot–positive specimens. First Response HIV 1‐2.O has several advantages: low‐cost (U.S. $0.70); only 10 µL of specimen; involves only two steps; room temperature storage; ability to differentiate HIV‐1 and 2; and use of whole blood specimen. Hence this test kit could be suitable for initial screening in the HIV testing algorithm in resource‐limited settings. J. Clin. Lab. Anal. 22:178–185, 2008. © 2008 Wiley‐Liss, Inc.
Url:
DOI: 10.1002/jcla.20238
Affiliations:
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<term>Blot</term>
<term>Card test</term>
<term>Card test assay</term>
<term>Clin</term>
<term>Clin diagn</term>
<term>Clin microbiol</term>
<term>Comparative results</term>
<term>Different antigenic bases</term>
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<term>First response</term>
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<term>High sensitivity</term>
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<term>Human virus type</term>
<term>Indeterminate results</term>
<term>Initial screening</term>
<term>Laboratory infrastructure</term>
<term>Microbiol</term>
<term>Nations programme</term>
<term>Negative result</term>
<term>Performance characteristics</term>
<term>Positive specimens</term>
<term>Primary assay</term>
<term>Rapid assay</term>
<term>Rapid assays</term>
<term>Rapid detection</term>
<term>Rapid immunochromatographic test</term>
<term>Reference laboratories</term>
<term>Reliable results</term>
<term>Rural areas</term>
<term>Screening</term>
<term>Screening assays</term>
<term>Second assay</term>
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<term>Syed iqbal</term>
<term>Tamil nadu</term>
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<term>Voluntary counseling</term>
<term>Western blot</term>
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<term>Performance characteristics</term>
<term>Positive specimens</term>
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<term>Rapid assay</term>
<term>Rapid assays</term>
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<front><div type="abstract" xml:lang="en">Diagnostic kits for the detection of human immunodeficiency virus (HIV) antibodies have reached an unprecedented number. But choice of an ideal, cost‐effective, and rapid test for HIV infection is of immense value for use in developing countries like India, where resources are limited. In this study we have evaluated the performance characteristics of the rapid immunochromatographic HIV test kit First Response HIV 1‐2.O. First, the laboratory archived 450 characterized plasma/serum specimens, which were tested on First Response HIV 1‐2.O. Second, a total of 134 consecutive voluntary counseling and testing (VCT) specimens were also tested and positive specimens were further confirmed with HIV TRI‐DOT. All these VCT specimens were cross‐checked with HIV double‐enzyme‐linked immunosorbent assay (ELISA) (Murex and Vironostika), and the results were matched. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and efficiency of First Response HIV 1‐2.O with the 450 characterized specimens was 100% for HIV‐1 with reference assay. The results in the VCT algorithm were correlating with double‐ELISA. In the HIV‐2 analysis, five HIV‐2‐positive specimens in First Response HIV 1‐2.O were found to be HIV‐2‐indeterminate on Western blot. HIV TRI‐DOT was unable to pick up two HIV‐2 Western blot–positive specimens. First Response HIV 1‐2.O has several advantages: low‐cost (U.S. $0.70); only 10 µL of specimen; involves only two steps; room temperature storage; ability to differentiate HIV‐1 and 2; and use of whole blood specimen. Hence this test kit could be suitable for initial screening in the HIV testing algorithm in resource‐limited settings. J. Clin. Lab. Anal. 22:178–185, 2008. © 2008 Wiley‐Liss, Inc.</div>
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