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. 1989 Dec;27(12):2811-4.
doi: 10.1128/jcm.27.12.2811-2814.1989.

TestPack Chlamydia, a new rapid assay for the direct detection of Chlamydia trachomatis

P Coleman  1 , V Varitek, I K Mushahwar, B Marchlewicz, J Safford, J Hansen, G Kurpiewski, T Grier
Affiliations

TestPack Chlamydia, a new rapid assay for the direct detection of Chlamydia trachomatis

P Coleman et al. J Clin Microbiol. 1989 Dec.

Abstract

TestPack Chlamydia (Abbott Laboratories) is a rapid enzyme immunoassay for the direct antigen detection of Chlamydia trachomatis in endocervical specimens. The assay is self-contained, requires no specialized equipment, and yields results in less than 30 min. The clinical performance of TestPack Chlamydia versus chlamydial cell culture was evaluated with a total of 1,694 paired endocervical specimens. Discordant samples were further investigated by immunofluorescent staining and by Chlamydiazyme immunoassay, with confirmatory procedures. The sensitivity of TestPack Chlamydia with less-than-48-h-old specimens was 76.5%, while culture sensitivity was 86.7%. TestPack Chlamydia specificity was determined to be 99.5%. These results indicate that TestPack Chlamydia is an accurate test for chlamydial infection, with a positive predictive value of 96.2%. This assay is suitable for low-volume chlamydial testing in physician offices, clinics, and smaller laboratories.

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