Reproducibility of the Roche Amplicor Polymerase Chain Reaction Assay for Detection of Infection by Chlamydia trachomatis in Endocervical Specimens

Abstract
Several investigators have reported that the Roche AmplicorTM PCR assay for detection of infection by Chlamydia trachomatis in endocervical specimens (Roche Diagnostic Systems) has a sensitivity in the range of 89–97% (1)(2)(3)(4)(5)(6)(7)(8), although a few studies have found lower sensitivity, in the range of 64–86% (8)(9)(10). All of the referenced studies have reported a specificity of 99–100%. Recently, however, the reproducibility of the assay has been questioned by investigators who found that 13 of 35 cervical specimens that were tested and then retested with the assay showed great variability in absorbance values (11). Because there is a paucity of information available concerning the reproducibility of the Amplicor assay, we report herein data informative on the issue that were obtained at UMDNJ-University Hospital. The protocol for this study was approved by the Institutional Review Board of UMDNJ-New Jersey Medical School.

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