The Effect of Urine Testing in Evaluations of the Sensitivity of the Gen-Probe APTIMA??Combo 2 Assay on Endocervical Swabs for Chlamydia trachomatis and Neisseria gonorrhoeae

Moncada, Jeanne; Schachter, Julius; Hook, Edward W.; Ferrero, D; Gaydos, Charlotte A.; Quinn, Thomas C.; Willis, Dean; Weissfeld, Alice S.; Martín, David H.

doi:10.1097/01.olq.0000124611.73009.d5

Cited by 66 publications

(41 citation statements)

References 21 publications

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“…5,6,13 • NAATs are more sensitive than culture, offer testing on a wider range of specimen types and are less demanding in specimen quality, transportation and storage. [17][18][19][20][21][22][23][24][25] They show high sensitivity (>96%) in both symptomatic and asymptomatic infection, show equivalent sensitivity in urine and urethral swab specimens from men 23 and equivalent sensitivity in clinician-taken or self-taken vulvo-vaginal and endocervical swabs from women. 24 NAATs significantly outperform transported samples for culture and are the sample of choice for testing individuals who are asymptomatic.…”

Section: Diagnosismentioning

confidence: 99%

2012 European guideline on the diagnosis and treatment of gonorrhoea in adults

2013

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Gonorrhoea is a major public health concern globally. Of particularly grave concern is that resistance to the extended-spectrum cephalosporins has emerged during the most recent years. This guideline provides recommendations regarding the diagnosis and treatment of gonorrhoea in Europe. Compared to the outdated 2009 European gonorrhoea guideline, this 2012 European gonorrhoea guideline provides up-to-date guidance on, broader indications for testing and treatment of gonorrhoea; the introduction of dual antimicrobial therapy (ceftriaxone 500 mg and azithromycin 2 g) for uncomplicated gonorrhoea when the antimicrobial sensitivity is unknown; recommendation of test of cure in all gonorrhoea cases to ensure eradication of infection and identify emerging resistance; and recommendations to identify, verify and report failures with recommended treatment regimens. Optimisations of the testing, diagnostics, antimicrobial treatment and follow-up of gonorrhoea patients are crucial in controlling the emergent spread of cephalosporin-resistant and multidrug-resistant gonorrhoea.

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Section: Diagnosismentioning

confidence: 99%

2012 European guideline on the diagnosis and treatment of gonorrhoea in adults

2013

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“…This is because some infected patients may have one specimen positive only. 76 Differences in the analytical sensitivities of NAAT assays may also create complications for such evaluations. By using TMA technology to amplify rRNA, the Gen-Probe AC2 assay has in theory the potential to detect lower concentrations of N. gonorrhoeae because the copies of 16S rRNA will usually exceed that of DNA targets used by other commercial N. gonorrhoeae NAATs.…”

Section: Issues For Assay Validationmentioning

confidence: 99%

Nucleic Acid Amplification Testing for Neisseria gonorrhoeae

Whiley

Tapsall

Sloots

2006

The Journal of Molecular Diagnostics

177

163

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Nucleic acid amplification tests (NAATs) for the detection of Neisseria gonorrhoeae became available in the early 1990s. Although offering several advantages over traditional detection methods, N. gonorrhoeae NAATs do have some limitations. These include cost, risk of carryover contamination, inhibition, and inability to provide antibiotic resistance data. In addition, there are sequence-related limitations that are unique to N. gonorrhoeae NAATs. In particular, falsepositive results are a major consideration. These primarily stem from the frequent horizontal genetic exchange occurring within the Neisseria genus, leading to commensal Neisseria species acquiring N. gonorrhoeae genes. Furthermore, some N. gonorrhoeae subtypes may lack specific sequences targeted by a particular NAAT. Therefore, NAAT false-negative results because of sequence variation may occur in some gonococcal populations. Overall, the N. gonorrhoeae species continues to present a considerable challenge for molecular diagnostics. The need to evaluate N. gonorrhoeae NAATs before their use in any new patient population and to educate physicians on the limitations of these tests is emphasized in this review.

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“…However, recent studies showed that nucleic acid amplification-based N. gonorrhoeae tests (NAATs) are much more sensitive (1,2,4,6,7,10). The Roche COBAS AMPLICOR (CA) N. gonorrhoeae test is probably the most widely used amplification test for N. gonorrhoeae.…”

mentioning

confidence: 99%

Comparison of COBAS AMPLICOR Neisseria gonorrhoeae PCR, Including Confirmation with N. gonorrhoeae- Specific 16S rRNA PCR, with Traditional Culture

et al. 2005

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A total of 3,023 clinical specimens were tested for Neisseria gonorrhoeae by using COBAS AMPLICOR (CA) PCR and confirmation of positives by N. gonorrhoeae-specific 16S rRNA PCR. The sensitivity of CA plus 16S rRNA PCR was 98.8%, compared to 68.2% for culture. Confirmation of CA positives increased the positive predictive value from 54.8 to 96.6%.For the detection of Neisseria gonorrhoeae, culture is still used by many laboratories. However, recent studies showed that nucleic acid amplification-based N. gonorrhoeae tests (NAATs) are much more sensitive (1,2,4,6,7,10). The Roche COBAS AMPLICOR (CA) N. gonorrhoeae test is probably the most widely used amplification test for N. gonorrhoeae. It was shown that certain strains of N. subflava, N. cinerea, N. flavescens, N. lactamica, N. sicca, and Lactobacillus species may produce false-positive results with the CA N. gonorrhoeae test (3, 4, 5, 9, and Manual for COBAS AMPLICOR Neisseria gonorrhoeae PCR test, version 1.0, Roche Diagnostics) and some other N. gonorrhoeae NAATs (8). Therefore, it is clear that positive results obtained with the CA N. gonorrhoeae test should be confirmed by another test method (2,3,4,8,9). In the present study we evaluated the reliability of N. gonorrhoeae testing in a low-prevalence population, using the CA N. gonorrhoeae test as a screening assay and an N. gonorrhoeae-specific 16S rRNA PCR for confirmation.N. gonorrhoeae PCR and culture were performed on 3,023 specimens from nonselected patients (2,415 female and 608 male) obtained by visiting general practitioners (48%), general hospitals (32%), or venereal disease (VD) clinics (20%). The vast majority of the patients were symptomatic, and 75% of them were between 15 and 35 years of age. Over 95% of the specimens were urogenital swabs, and the remaining 5% were rectal, throat, or eye swabs. Swabs for PCR and culture were sent to the laboratory in 2-sucrose-phosphate medium and in charcoal transport medium, respectively. The CA N. gonorrhoeae PCR (Roche) was tested according to the manufacturer's instructions (Roche Diagnostics manual, version 1). A specimen was considered negative for N. gonorrhoeae if the optical density (OD) was Ͻ0.200 and the OD of the inhibition control (IC) was Ն0.200. The specimen was considered positive for N. gonorrhoeae if the OD was Ն0.200, regardless of the IC result. All specimens with an initial positive result were retested in the CA N. gonorrhoeae PCR, and the result of this repeat CA test was conclusive for the final interpretation of the CA N. gonorrhoeae test. For the 16S rRNA N. gonorrhoeae PCR test, new DNA extracts from the original clinical specimens were prepared. The 16S rRNA N. gonorrhoeae PCR test (Roche) was also performed according to the manufacturer's instructions (manual for Neisseria gonorrhoeae 16S rRNA PCR test, version 2, Roche Diagnostics) and included hybridization with an N. gonorrhoeae-specific probe added to microwell plates. Specimens repeatedly positive by CA N. gonorrhoeae PCR and positive by 16S rRNA N. gonorrhoeae PCR were con...

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The Effect of Urine Testing in Evaluations of the Sensitivity of the Gen-Probe APTIMA??Combo 2 Assay on Endocervical Swabs for Chlamydia trachomatis and Neisseria gonorrhoeae

Cited by 66 publications

References 21 publications

2012 European guideline on the diagnosis and treatment of gonorrhoea in adults

2012 European guideline on the diagnosis and treatment of gonorrhoea in adults

Nucleic Acid Amplification Testing for Neisseria gonorrhoeae

Comparison of COBAS AMPLICOR Neisseria gonorrhoeae PCR, Including Confirmation with N. gonorrhoeae- Specific 16S rRNA PCR, with Traditional Culture

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