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Journal of Clinical Microbiology, February 1999, p. 386-390, Vol. 37, No. 2
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.
Evaluation of AMPLICOR Neisseria
gonorrhoeae PCR Using cppB Nested PCR and 16S
rRNA PCR
David J.
Farrell*
Microbiology Section, Queensland Health
Pathology Service Toowoomba Laboratory, Toowoomba, Queensland,
Australia 4350
Received 18 August 1998/Returned for modification 24 September
1998/Accepted 10 November 1998
Certain strains of Neisseria subflava and
Neisseria cinerea are known to produce false-positive
results with the AMPLICOR Neisseria gonorrhoeae PCR (Roche
Diagnostic Systems, Branchburg, N.J.). The analytical sensitivity and
analytical specificity of three PCR tests were assessed with 3 geographically diverse N. gonorrhoeae strains and 30 non-N. gonorrhoeae Neisseria spp. The sensitivities of the
in-house nested cppB gene and the 16S rRNA PCR methods were
greater than that of the AMPLICOR N. gonorrhoeae PCR with
purified DNA from all 3 N. gonorrhoeae strains. Six of 14 clinical strains of N. subflava (1 from a vaginal swab, 5 from respiratory sites) produced false-positive AMPLICOR N. 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
nested cppB PCR method. Only 2 of 94 (2.1%) of AMPLICOR
N. gonorrhoeae PCR-negative specimens from the same
population tested positive by the nested cppB method. These
results suggest that for this population the AMPLICOR N. 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.
*
Mailing address: Microbiology Section, Queensland
Health Pathology Service Toowoomba Laboratory, Toowoomba, Queensland,
Australia, 4350. Phone: 61 7 46316562. Fax: 61 7 46392279. E-mail:
David_Farrell{at}health.qld.gov.au.
Journal of Clinical Microbiology, February 1999, p. 386-390, Vol. 37, No. 2
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.
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