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Certain strains ofNeisseria subflava andNeisseria cinerea are known to produce false-positive results with the AMPLICORNeisseria gonorrhoeae PCR (Roche Diagnostic Systems, Branchburg, N.J.). The analytical sensitivity and analytical specificity of three PCR tests were assessed with 3 geographically diverseN. gonorrhoeae strains and 30 non-N. gonorrhoeae Neisseria spp. The sensitivities of the in-house nestedcppB gene and the 16S rRNA PCR methods were greater than that of the AMPLICORN. gonorrhoeae PCR with purified DNA from all 3N. gonorrhoeae strains. Six of 14 clinical strains ofN. subflava (1 from a vaginal swab, 5 from respiratory sites) produced false-positive AMPLICORN. gonorrhoeae PCR results and were negative by the two other PCR methods. When applied to 207 clinical specimens selected from a population with a high prevalence (∼9%) of infection, the results for 15 of 96 (15.6%) AMPLICOR-positive specimens and 14 of 17 (82.3%) AMPLICOR-equivocal specimens were not confirmed by the more sensitive nestedcppB PCR method. Only 2 of 94 (2.1%) of AMPLICORN. gonorrhoeae PCR-negative specimens from the same population tested positive by the nestedcppB method. These results suggest that for this population the AMPLICORN. gonorrhoeae PCR test is suitable as a screening test only and all positive results should be confirmed by a PCR method that is more specific and at least as sensitive. This study also illustrates that caution should be used when introducing commercially available nucleic acid amplification-based diagnostic tests into the regimens of tests used for populations not previously tested with these products.

Evaluation of AMPLICOR Neisseria gonorrhoeae PCR Using cppB Nested PCR and 16S rRNA PCR