Reactivity of a dual amplified chlamydia immunoassay with different serovars of Chlamydia trachomatis

Okadome, Aya; Notomi, Takashi; Nomura, Sadahiro; Nagayama, Ariaki

doi:10.1258/0956462991914465

Cited by 7 publications

(6 citation statements)

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“…The detection limit of the PCE EIA for urethritis-associated serovars is about half that of the previous assay (21). It has been argued that even with the gain in sensitivity, it is still about 2 log above the detection limit of NAATs (28).…”

Section: Discussionmentioning

confidence: 96%

“…However, the high costs of NAATs have hindered their widespread use in countries such as the United Kingdom, although they have been shown in modeling studies to be cost-effective in the medium to long term (15,35). Enhanced antigen detection tests such as IDEIA PCE EIA (Dako, Ely, Cambridgeshire, United Kingdom), which includes an amplification step to improve sensitivity (6,21), have been suggested as alternative tests in the United Kingdom when NAATs are unavailable (7). Another way to improve sensitivity at a low cost is to use an EIA to screen all samples and to retest specimens with optical densities just below the cutoff point for a negative test (negative gray zone) by using a NAAT (7,15).…”

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confidence: 99%

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Enhanced Enzyme Immunoassay with Negative-Gray-Zone Testing Compared to a Single Nucleic Acid Amplification Technique for Community-Based Chlamydial Screening of Men

et al. 2005

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We evaluated a low-cost diagnostic strategy for detecting Chlamydia trachomatis in a low-prevalence population. We used an amplified enzyme immunoassay (EIA) with a reduced-cutoff "negative gray zone" to identify reactive specimens for confirmation by a nucleic acid amplification test. As part of the Chlamydia Screening Studies project, men provided a first-pass urine specimen, which they returned by post for testing. We tested 1,003 specimens by IDEIA PCE EIA (Dako) and Cobas PCR (Roche). There were 32 (3.2%) true positive specimens according to a combined standard using an algorithm requiring concordant results from at least two independent tests. All of these were positive by Cobas PCR and 24 were confirmed to be positive by PCE EIA, including 2 that gave results in the negative gray zone. There were 971 true negative specimens, 2 of which were positive by Cobas PCR and 19 of which were initially inhibitory for PCR. The relative sensitivity, specificity, positive predictive value, and negative predictive value of PCE EIA with PCR confirmation were 75.0% (95% confidence interval [CI], 56.6 to 88.5%), 100% (95% CI, 99.7 to 100%), 100% (95% CI, 88.3 to 100%), and 99.2% (95% CI, 98.4 to 99.6%), respectively. The corresponding values for Cobas PCR were 100% (95% CI, 89.1 to 100%), 99.8% (95% CI, 99.3 to 100%), 94.1% (95% CI, 76.9 to 98.2%), and 100% (95% CI, 99.6 to 100%), respectively, with 1.9% (19/1003) of the samples being initially indeterminate. When the prevalence of C. trachomatis is low, the use of an amplified EIA on urine specimens, with confirmation of results in the negative gray zone by use of a nucleic acid amplification technique, is not suitable for screening asymptomatic men. In addition, positive nucleic acid amplification test results should be confirmed and an inhibition control should be used.

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Section: Discussionmentioning

confidence: 96%

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confidence: 99%

Enhanced Enzyme Immunoassay with Negative-Gray-Zone Testing Compared to a Single Nucleic Acid Amplification Technique for Community-Based Chlamydial Screening of Men

et al. 2005

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“…42,43 At the time of undertaking the ClaSS project there was evidence that one enzyme immunoassay (EIA), the IDEIA PCE EIA (Dako, Ely, UK), could perform as well as NAATs on specimens taken in a clinical setting. 44 The testing strategy for the assay, which included an amplification step to improve sensitivity, 45,46 involved repeat testing of specimens where the optical density was just below the cut-off point for a negative test result (the negative grey zone) with a NAAT. 40 The principle was that low levels of chlamydial DNA, which were below the level of detection of an EIA, would be detected by a NAAT.…”

Section: Laboratory Diagnosis Of Chlamydia Trachomatismentioning

confidence: 99%

Epidemiological, social, diagnostic and economic evaluation of population screening for genital chlamydial infection

Low

McCarthy²,

Macleod³

et al. 2007

Health Technol Assess

134

179

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“…They are also considerably more expensive, and the costs might be prohibitive for large-scale screening programs. Chernesky recently commented that tests such as the IDEIA polymer conjugate-enhanced (PCE) enzyme immunoassay (EIA; Dako, Ely, Cambridgeshire, United Kingdom), which includes an amplification step to improve sensitivity (4,16,23,29), deserved more critical evaluation (4). Studies from Japan have found that the IDEIA test performed well when used with vulvovaginal swabs (29,30).…”

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confidence: 99%

Vulvovaginal-Swab or First-Catch Urine Specimen To Detect Chlamydia trachomatis in Women in a Community Setting?

et al. 2006

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Screening for chlamydia in women is widely recommended. We evaluated the performance of two nucleic acid amplification tests for detecting Chlamydia trachomatis in self-collected vulvovaginal-swab and first-catch urine specimens from women in a community setting and a strategy for optimizing the sensitivity of an amplified enzyme immunoassay on vulvovaginal-swab specimens. We tested 2,745 paired vulvovaginal-swab and urine specimens by PCR (Roche Cobas) or strand displacement amplification (SDA; Becton Dickinson). There were 146 women infected with chlamydia. The assays detected 97.3% (95% confidence interval [CI], 93.1 to 99.2%) of infected patients with vulvovaginal-swab specimens and 91.8% (86.1 to 95.7%) with urine specimens. We tested 2,749 vulvovaginal-swab specimens with both a nucleic acid amplification test and a polymer conjugateenhanced enzyme immunoassay with negative-gray-zone testing. The relative sensitivities obtained after retesting specimens in the negative gray zone were 74.3% (95% CI, 62.8 to 83.8%) with PCR and 58.3% (95% CI, 46.1 to 69.8%) with SDA. In community settings, both vulvovaginal-swab and first-catch urine specimens from women are suitable substrates for nucleic acid amplification tests, but enzyme immunoassays, even after negative-gray-zone testing, should not be used in screening programs.

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Reactivity of a dual amplified chlamydia immunoassay with different serovars of Chlamydia trachomatis

Cited by 7 publications

References 0 publications

Enhanced Enzyme Immunoassay with Negative-Gray-Zone Testing Compared to a Single Nucleic Acid Amplification Technique for Community-Based Chlamydial Screening of Men

Enhanced Enzyme Immunoassay with Negative-Gray-Zone Testing Compared to a Single Nucleic Acid Amplification Technique for Community-Based Chlamydial Screening of Men

Epidemiological, social, diagnostic and economic evaluation of population screening for genital chlamydial infection

Vulvovaginal-Swab or First-Catch Urine Specimen To Detect Chlamydia trachomatis in Women in a Community Setting?

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