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MCRNA
61554
for the clinical management of patients. DNA-based assays are now available for the identification of
Chlamydia trachomatis. However, these assays are currently not approved for use on all specimen types.
The MicroTrak assay is an antibody-based method and is approved for use on rectal or nasopharyngeal
specimens.
Useful For: Detecting Chlamydia trachomatis in symptomatic or high-risk, asymptomatic females, and
in symptomatic males Detecting all 15 serotypes of Chlamydia trachomatis in endocervical, male urethral,
conjunctival, rectal, and nasopharyngeal specimens
Interpretation: This assay is positive in approximately 90% of infected cases when adequate specimen
is submitted. The sensitivity is reduced when the specimen demonstrates few columnar/cuboidal cells.
Reference Values:
None seen
Clinical References: 1. Groseclose SL, Zaidi AA, DeLisle SJ, et al: Estimated incidence and
prevalence of genital Chlamydia trachomatis infections in the United States, 1996. Sex Transmit Dis
1999;26:339-344 2. Guaschino S, De Seta F: Update on Chlamydia trachomatis. Ann NY Acad Sci
2000;900:293-300
Chlamydia trachomatis, Miscellaneous Sites, by Nucleic Acid
Amplification (GEN-PROBE)
Clinical Information: Chlamydia is caused by the obligate intracellular bacterium Chlamydia
trachomatis and is the most prevalent sexually transmitted bacterial infection in the United States.(1,2) In
2010, 1.3 million documented cases were reported to the CDC.(2) Given that 3 out of 4 infected women
and 1 out of 2 infected men will be asymptomatic initially, the actual prevalence of disease is thought to
be much greater than reported. The organism causes genitourinary infections in women and men and may
be associated with dysuria and vaginal, urethral, or rectal discharge. In women, complications include
pelvic inflammatory disease, salpingitis, and infertility. Approximately 25% to 30% of women who
develop acute salpingitis become infertile.(2) Complications among men are rare, but include epididymitis
and sterility. Rarely, genital chlamydial infection can cause arthritis with associated skin lesions and
ocular inflammation (Reiter syndrome). Chlamydia trachomatis can be transmitted from the mother
during delivery and is associated with conjunctivitis and pneumonia. Finally, Chlamydia trachomatis may
cause hepatitis and pharyngitis in adults. Once detected, the infection is easily treated by a short course of
antibiotic therapy. Annual Chlamydia screening is now recommended for all sexually active women age
25 years and younger, and for older women with risk factors for infection, such as a new sex partner or
multiple sex partners. The CDC also recommends that all pregnant women be given a screening test for
Chlamydia infection.(2) Repeat testing for test-of-cure is not recommended after treatment with a
standard treatment regimen unless patient compliance is in question, reinfection is suspected, or the
patient's symptoms persist. Repeat testing of pregnant women, 3 weeks after completion of therapy, is
also recommended to ensure therapeutic cure.(2) Culture was previously considered to be the gold
standard test for diagnosis of Chlamydia trachomatis infection.(2) However, organisms are labile in vitro,
and precise specimen collection, transportation, and processing conditions are required to maintain
organism viability, which is necessary for successful culturing. In comparison, nucleic acid amplification
testing (NAAT) provides superior sensitivity and specificity and is now the recommended method for
diagnosis in most cases.(3-5) Immunoassays and nonamplification DNA tests are also available for
Chlamydia trachomatis detection, but these methods are significantly less sensitive and less specific than
NAAT.(2) Improved screening rates and increased sensitivity of NAAT testing have resulted in an
increased number of accurately diagnosed cases.(2) Early identification of infection enables sexual
partners to seek testing and treatment as soon as possible and reduces the risk of disease spread. Prompt
treatment reduces the risk of infertility in women.
Useful For: Detection of Chlamydia trachomatis
Interpretation: A positive result indicates the presence of rRNA Chlamydia trachomatis. This assay
does detect plasmid-free variants of Chlamydia trachomatis. A negative result indicates that rRNA for
Chlamydia trachomatis was not detected in the specimen. The predictive value of an assay depends on the
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