Performance of a commercial polymerase chain reaction test for endocervical Chlamydia trachomatis infection in a university hospital population

✍ Scribed by C.H. Livengood III; K.A. Boggess; J.W. Wrenn; A.P. Murtha

• Publisher: Hindawi Publishing Corporation
• Year: 1998
• Tongue: English
• Weight: 185 KB
• Volume: 6
• Category: Article
• ISSN: 1064-7449
• DOI: 10.1002/(sici)1098-0997(1998)6:5<224::aid-idog7>3.0.co;2-9

✦ Synopsis

Objectives: To examine the accuracy of a commercial polymerase chain reaction (PCR) test (Amplicor CT R , Roche Diagnostic Systems, Branchburg NJ) for identification of endocervical chlamydial infections through both laboratory evaluation and among a diverse teaching hospital patient population.

Methods: Testing of reliable threshold inocula and reproducibility were carried out using laboratory stock organisms. Paired endocervical samples from patients with a wide range of indications were tested by PCR and an established culture procedure, and discrepant pairs were further analyzed to determine true results.

Results: Laboratory evaluation suggested that one copy of target DNA from a viable organism consistently yielded a positive result, and test reproducibility was very good, with an overall coefficient of variation of 15%. Compared to true results in 1,588 paired clinical samples from 1,489 women with a 10% prevalence of infection, the PCR test and culture yielded respective sensitivities of 87.4% and 78.0%, and negative predictive values of 98.6% and 97.6%. Specificity and positive predictive 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 in false-negative PCR samples.

Conclusion: This commercial PCR test is accurate, cost-competitive, and much faster than culture for diagnosis of endocervical chlamydia infections in our population of intermediate prevalence of chlamydial infection.