Head-to-head comparison of accuracy of a rapid point-of-care HIV test with oral versus whole-blood specimens: a systematic review and meta-analysis
The Lancet Infectious DiseasesPublished 29 January 2012
Nitika Pant Pai, Bhairavi Balram, Sushmita Shivkumar, Jorge Martínez-Cajas, Christiane Claessens, Gilles Lambert
Citations169
SJR quartileQ1
SJR score5.45
SNIP5.66
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TL;DR
Although Oraquick had a high PPV in high-prevalence settings in oral specimens, the slightly lower sensitivity and PPVs in low-preValence settingsIn oral specimens should be carefully reviewed when planning worldwide expanded initiatives with this popular test.
Abstract
Although Oraquick had a high PPV in high-prevalence settings in oral specimens, the slightly lower sensitivity and PPV in low-prevalence settings in oral specimens should be carefully reviewed when planning worldwide expanded initiatives with this popular test.
Keywords
Immunology and MicrobiologyMedicine
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