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The ligase chain reaction method detects more cases of pharyngeal N. gonorrhoeae infection than does culture.

Increased sensitivity of DNA amplification testing for the detection of pharyngeal gonorrhea in men who have sex with men. 
Page-Shafer K, Graves A, Kent C, Balls JE, Zapitz VM, Klausner JD. 

Clin Infect Dis. 2002;34:173-176.
 
Summary:

Question
What is the performance of the ligase chain reaction method compared to culture for the detection of pharyngeal N. gonorrhoeae infection in samples from men who have sex with men (MSM)?

Design
This study describes a direct comparison of a commercial ligase chain reaction assay with culture for the detection of N. gonorrhoeae in pharyngeal swabs.

Participants
Two hundred consecutively evaluated MSM presenting to a municipal STD clinic in San Francisco, CA, who reported a history of performing fellatio and no antibiotic use during the 2 weeks prior to sample collection were tested. The age range of participants was 18 to 61 years. All were asymptomatic for pharyngeal infection.

Description of Tests and Diagnostic Standard
Two pharyngeal swabs were obtained from the posterior pharynx of each patient. One swab was used for conventional culture on modified Thayer-Martin medium; the other was used for LCR testing (LCx, Abbott Laboratories, Abbott Park, IL). Specimens that were LCR positive and culture negative for N. gonorrhoeae were further tested at Abbott Laboratories using an LCR assay with probes for the N. gonorrhoeae pilin gene. The performance of each test was calculated based on a gold standard that defined samples positive by culture or, if culture negative and LCR positive, confirmed positive by pilin LCR as true positive samples.

Main Outcome Measures
The number of samples positive and negative for N. gonorrhoeae by each method, and the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each method as determined by the gold standard described above were calculated.

Main Results
The results of the LCR assay versus culture for the detection of N. gonorrhoeae in pharyngeal specimens obtained from MSM are shown in the table. N. gonorrhoeae was detected in 4.5% of the specimens by culture and in 11% by LCR. Additional testing by pilin gene LCR of the 14 LCR positive, culture negative specimens confirmed the presence of N. gonorrhoeae in 10 (71.4%). However, the culture positive, LCR negative specimen and the culture negative, LCR negative specimens were not retested by the pilin LCR. After analysis of these selected discrepant samples by pilin gene LCR, the sensitivity, specificity, PPV, and NPV of the LCR assay was 94.7%, 97.8%, 81.8%, and 98.9%, respectively. The sensitivity, specificity, PPV, and NPV of culture was 47.4%, 100%, 100%, and 94.8%, respectively.

Results of LCR versus culture
Culture result LCR assay result
Positive Negative Total
Positive 8 1 9
Negative 14 177 191
Total 22 178 200

Authors' Conclusions
By this discrepancy analysis, the sensitivity of the LCR for the diagnosis of infection was much higher than that of culture, but the specificity was lower.

Source of funding: National Institute of Dental and Craniofacial Research

For correspondence: Kimberly Page-Shafer, Center for AIDS Prevention Studies, University of California, San Francisco, 74 New Montgomery, Ste. 600, San Francisco, CA 94105. E-mail address: shafer@psg.ucsf.edu.

 

   

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