A Human Immunodeficiency Virus Screening Algorithm to Address the High Rate of False-Positive Results in Pregnant Women in Japan

Prenatal human immunodeficiency virus (HIV) testing is essential for the prevention of mother-to-child transmission. However, false-positive results of screening testing are a concern as they may cause unnecessary emotional stress to pregnant women waiting for confirmatory test results. In regions w...

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Published inPloS one Vol. 5; no. 2; p. e9382
Main Authors Shima-Sano, Takako, Yamada, Rika, Sekita, Kazuyo, Hankins, Raleigh W., Hori, Hiromasa, Seto, Hiroshi, Sudo, Koji, Kondo, Makiko, Kawahara, Kazuo, Tsukahara, Yuki, Inaba, Noriyuki, Kato, Shingo, Imai, Mitsunobu
Format Journal Article
LanguageEnglish
Published United States Public Library of Science 23.02.2010
Public Library of Science (PLoS)
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ISSN1932-6203
1932-6203
DOI10.1371/journal.pone.0009382

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Summary:Prenatal human immunodeficiency virus (HIV) testing is essential for the prevention of mother-to-child transmission. However, false-positive results of screening testing are a concern as they may cause unnecessary emotional stress to pregnant women waiting for confirmatory test results. In regions with an extremely low prevalence, the positive predictive values of screening are unacceptably low rate. Here, we propose a HIV screening algorithm consisting of serial two fourth-generation enzyme immunoassays to reduce the number of false-positive screening results. When 6461 pregnant women presenting to two maternity hospitals located in the Tokyo metropolitan area of Japan from September, 2004 to January, 2006 were tested using Enzygnost HIV Integral as a first screening test, 27 showed positive reactions. When these positive reaction samples were tested using VIDAS HIV DUO Quick as a second screening test, only one of them had a positive reaction, and the remaining 26 were nonreactive. Confirmatory Western blots and nucleic acid amplification test also showed that one was positive and the remaining 26 were negative; the subject who was positive with the confirmatory tests was identical to the subject who was positive with the second screening test. Thus, by adding the second screening test, the false-positive rate was improved from 0.4% to 0%, and the positive predictive value from 3.7% to 100%, compared with the single screening test. By applying our serial screening algorithm to HIV testing in maternity hospitals, many uninfected pregnant women would not need to receive confirmatory tests and be subjected to emotional turmoil while waiting for their confirmatory test results. This algorithm would be suitable for HIV testing of pregnant women living in low prevalence regions such as Japan.
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Conceived and designed the experiments: TSS KK SK MI. Performed the experiments: TSS KS KS MK. Analyzed the data: TSS RY YT NI SK MI. Contributed reagents/materials/analysis tools: TSS HH HS YT NI. Wrote the paper: TSS SK MI. Coordinated with the patients, physicians, laboratory stuffs and data analyzer: RWH.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0009382