Limitations of screening tests for the detection of Chlamydia trachomatis in asymptomatic adolescent and young adult women

Abstract

Objective: The purpose of this study was to examine the performance of different test types, specimen sources, and collection methods for screening of genital Chlamydia trachomatis infection in young women.

Study design: Asymptomatic women aged 16 to 25 years collected their own vaginal swabs and a first-voided urine specimen; a clinician collected urethral, vaginal, and endocervical swabs for culture and nucleic acid amplification tests, polymerase chain reaction and ligase chain reaction. A positive culture, 2 positive nucleic acid amplification tests, or 1 positive nucleic acid amplification test confirmed by a separate nested polymerase chain reaction comprised the criterion standard to define a C. trachomatis-infected woman.

Results: The prevalence of C. trachomatis was 22% (30/139 women). All 9 test results were available for 126 participants (91%). Sensitivities were comparable for polymerase chain reaction and ligase chain reaction (52%-63%), except for urine polymerase chain reaction (44%), and were lower for culture (22%-37%); specificities were 99% to 100%, except for urine ligase chain reaction (91%). Positive predictive values were >93%, except for urine ligase chain reaction (65%); negative predictive values were 83% to 91%. Combining nucleic acid amplification test results from 2 different specimens improved sensitivities without compromising specificity.

Conclusion: When C. trachomatis infection was defined by multiple tests from different specimen sources, the sensitivity of any 1 test from a single specimen source was lower than generally reported. The limitations of the use of a single test to identify C. trachomatis infection should be considered when test type, specimen source, and collection method for screening young women is being determined.