Evaluation of the Abbott LCx Assay for Detection of
            <i>Neisseria gonorrhoeae</i>
            in Endocervical Swab Specimens from Females

Kehl, Sue C.; Georgakas, Kristina; Swain, Geoffrey; Sedmak, Gerald V.; Gradus, Stephen; Singh, Ajmer; Foldy, Seth

doi:10.1128/jcm.36.12.3549-3551.1998

Cited by 28 publications

(7 citation statements)

References 11 publications

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“…The published LCx studies calculated performance as if only one specimen type from each patient had been tested by the LCx. Compared to COBAS AMPLICOR performance calculated on a per-specimen basis, the LCx exhibited very similar sensitivities for female endocervical swabs (3,4,10), male urethral swabs (3,4), and male urine (3). In contrast, LCx sensitivity was approximately 20% higher for female urine (16,20).…”

Section: Discussionmentioning

confidence: 99%

“…Another limitation of culturing is that it requires invasively collected endocervical or urethral swab specimens. Recent studies have shown that a nucleic acid amplification-based test can achieve high sensitivity and specificity for the detection of N. gonorrhoeae (4,8,10,12,16). This test can be performed on self-collected urine, vaginal, and vulval specimens (8,20; A. Stary and B. Hartman, Program Abstr.…”

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Multicenter Evaluation of AMPLICOR and Automated COBAS AMPLICOR CT/NG Tests for Neisseria gonorrhoeae

et al. 2000

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The fully automated COBAS AMPLICOR CT/NG and semiautomated AMPLICOR CT/NG tests were evaluated in a multicenter trial for their ability to detect Neisseria gonorrhoeae infections. Test performance compared to that of culturing was evaluated for 2,192 matched endocervical swab and urine specimens obtained from women and for 1,981 matched urethral swab and urine specimens obtained from men. Culture-negative, PCR-positive specimens that tested positive in a confirmatory PCR test for an alternative target sequence within theN. gonorrhoeae 16S rRNA gene were considered to be true positives. The overall prevalences of gonorrhea were 6.6% in women and 20.1% in men. The COBAS AMPLICOR and AMPLICOR formats yielded concordant results for 98.8% of the specimens and exhibited virtually identical sensitivities and specificities. The results that follow are for the COBAS AMPLICOR format. With the infected patient as the reference standard, the resolved sensitivities of PCR were 92.4% for endocervical swab specimens and 64.8% for female urine specimens. There were no significant differences in these rates between women with and without symptoms. Among symptomatic men, COBAS AMPLICOR sensitivities were 94.1% for urine and 98.1% for urethral swabs; for asymptomatic men, the results were 42.3 and 73.1%, respectively. In comparison, the sensitivities of culturing were 84.8% for endocervical specimens, 92.7% for symptomatic male urethral specimens, and only 46.2% for urethral specimens obtained from asymptomatic men. When PCR results were analyzed as if only a single test had been performed on a single specimen type, the resolved sensitivity was always higher. The resolved specificities of PCR were 99.5% for endocervical swab specimens, 99.8% for female urine specimens, 98.9% for male urethral swab specimens, and 99.9% for male urine specimens. The internal control revealed that 2.1% of specimens were inhibitory when initially tested. Nevertheless, valid results were obtained for 99.2% of specimens because 60.0% of the inhibitory specimens were not inhibitory when a second aliquot was tested. The COBAS AMPLICOR CT/NG test for N. gonorrhoeae exhibited high sensitivity and specificity with urethral swab and urine specimens from men and endocervical swab specimens from women and thus is well suited for diagnosing and screening for N. gonorrhoeae infection.

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Section: Discussionmentioning

confidence: 99%

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Multicenter Evaluation of AMPLICOR and Automated COBAS AMPLICOR CT/NG Tests for Neisseria gonorrhoeae

et al. 2000

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“…Nucleic acid amplification tests (NAATs), either in‐house or commercial assays, targeting N. gonorrhoeae have been shown to have varying degrees of specificity and sensitivity [6–11]. NAATs do not require viable bacteria, and can therefore circumvent the problems of specimen collection and transportation for this fragile organism, especially when specimens are collected in remote areas.…”

Section: Introductionmentioning

confidence: 99%

A comparison of three real-time PCR assays for the confirmation of Neisseria gonorrhoeae following detection of N. gonorrhoeae using Roche COBAS AMPLICOR

Chui

Chiu

Kakulphimp

et al. 2008

Clinical Microbiology and Infection

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Three different real-time PCR assays were evaluated as confirmatory tests for Neisseria gonorrhoeae after initial screening using the COBAS AMPLICOR Chlamydia trachomatis and N. gonorrhoeae duplex assay. The target genes used for the confirmation were the gyr, cppB and 16S rRNA genes. Analytical specificity was determined by testing 60 strains belonging to different bacterial species and/or serogroups. The primers chosen from the 16S rRNA gene for confirmation of N. gonorrhoeae were highly specific, showed no cross-reactivity with other bacteria included in the study, and had an analytical sensitivity of 1 CFU. Of 192 clinical specimens that were positive for N. gonorrhoeae according to the COBAS AMPLICOR assay, 42 were confirmed as positive using the 16S rRNA gene target, 26 were confirmed using the cppB target, and 30 were confirmed using the gyr target. It was concluded that the real-time PCR assay targeting the 16S rRNA gene is a useful confirmatory assay to complement the COBAS AMPLICOR screening test for N. gonorrhoeae.

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“…The assessment of new assays that have superior sensitivities compared with current test methods is challenging, as evidenced by the introduction of nucleic acid amplification tests for Neisseria gonorrhoeae and Chlamydia trachomatis [ 13 , 14 ]. The specificity of the PCR assay studied here was not in question as it was determined to be high in our validation studies with no cross-reactivity demonstrated with a wide variety of microorganisms that may be present in human respiratory specimens (data not shown).…”

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Pneumocystis PCR: It Is Time to Make PCR the Test of Choice

Doyle

Vogel

Procop

2017

Open Forum Infectious Diseases

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BackgroundThe testing strategy for Pneumocystis at the Cleveland Clinic changed from toluidine blue staining to polymerase chain reaction (PCR). We studied the differences in positivity rates for these assays and compared each with the detection of Pneumocystis in companion specimens by cytology and surgical pathology.MethodsWe reviewed the results of all Pneumocystis test orders 1 year before and 1 year after the implementation of a Pneumocystis-specific PCR. We also reviewed the corresponding cytology and surgical pathology results, if performed. Finally, we reviewed the medical records of patients with rare Pneumocystis detected by PCR in an effort to differentiate colonization vs true disease.ResultsToluidine blue staining and surgical pathology had similar sensitivities and negative predictive values, both of which were superior to cytology. There was a >4-fold increase in the annual detection of Pneumocystis by PCR compared with toluidine blue staining (toluidine blue staining: 11/1583 [0.69%] vs PCR: 44/1457 [3.0%]; chi-square P < .001). PCR detected 1 more case than surgical pathology and was far more sensitive than cytology. Chart review demonstrated that the vast majority of patients with rare Pneumocystis detected were immunosuppressed, had radiologic findings supportive of this infection, had no other pathogens detected, and were treated for pneumocystosis by the clinical team.ConclusionPCR was the most sensitive method for the detection of Pneumocystis and should be considered the diagnostic test of choice. Correlation with clinical and radiologic findings affords discrimination of early true disease from the far rarer instances of colonization.

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Evaluation of the Abbott LCx Assay for Detection of Neisseria gonorrhoeae in Endocervical Swab Specimens from Females

Cited by 28 publications

References 11 publications

Multicenter Evaluation of AMPLICOR and Automated COBAS AMPLICOR CT/NG Tests for Neisseria gonorrhoeae

Multicenter Evaluation of AMPLICOR and Automated COBAS AMPLICOR CT/NG Tests for Neisseria gonorrhoeae

A comparison of three real-time PCR assays for the confirmation of Neisseria gonorrhoeae following detection of N. gonorrhoeae using Roche COBAS AMPLICOR

Pneumocystis PCR: It Is Time to Make PCR the Test of Choice

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