TestPack Chlamydia, a new rapid assay for the direct detection of Chlamydia trachomatis.
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.
Coleman
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Infectious Disease and Immunology Research, Abbott Laboratories, Illinois 60064.
Varitek
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V
Mushahwar
I K
IK
Marchlewicz
B
B
Safford
J
J
Hansen
J
J
Kurpiewski
G
G
Grier
T
T
D000942:Antigens, Bacterial / Q000032:analysis*; D002584:Cervix Uteri / Q000382:microbiology*; D002690:Chlamydia Infections / Q000175:diagnosis*; D002692:Chlamydia trachomatis / Q000276:immunology / Q000302:isolation & purification*; D005260:Female; D006801:Humans; D008297:Male; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D002575:Uterine Cervicitis / Q000175:diagnosis*
D000942:Antigens, Bacterial; D011933:Reagent Kits, Diagnostic