Performance of a Commercial Polymerase ChainReaction Test for EndocervicalChlamydia trachomatisInfection in a University Hospital Population

[摘要] Objectives:To examine the accuracy of a commercial polymerase chain reaction (PCR) test (AmplicorCTR, Roche Diagnostic Systems, Branchburg NJ) for identification of endocervical chlamydialinfections through both laboratory evaluation and among a diverse teaching hospital patientpopulation.Methods:Testing of reliable threshold inocula and reproducibility were carried out using laboratorystock organisms. Paired endocervical samples from patients with a wide range of indicationswere tested by PCR and an established culture procedure, and discrepant pairs were furtheranalyzed to determine true results.Results:Laboratory evaluation suggested that one copy of target DNA from a viable organismconsistently yielded a positive result, and test reproducibility was very good, with an overall coefficientof variation of 15%. Compared to true results in 1,588 paired clinical samples from 1,489women with a 10% prevalence of infection, the PCR test and culture yielded respective sensitivitiesof 87.4% and 78.0%, and negative predictive values of 98.6% and 97.6%. Specificity and positivepredictive value for both tests were 100%. Cost per specimen was nearly identical at $18.84 and$18.88 respectively. Polymerase inhibitors and organisms lacking target DNA were not found infalse-negative PCR samples.Conclusion:This commercial PCR test is accurate, cost-competitive, and much faster than culturefor diagnosis of endocervical chlamydia infections in our population of intermediate prevalenceof chlamydial infection.

[学科分类] 妇产科学