Analytical Evaluation of the Abbott RealTime CT/NG Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Swabs

Adamson, Paul C; Pandori, Mark; Doernberg, Sarah B; Komarow, Lauren; Sund, Zoë; Tran, Thien T.; Jensen, David Hebbelstrup; Tsalik, Ephraim L.; Deal, Carolyn D.; Chambers, Henry F.; Fowler, Vance G.; Evans, Scott; Patel, Robin; Klausner, Jeffrey D.

doi:10.1016/j.jmoldx.2020.03.004

Cited by 9 publications

(5 citation statements)

References 10 publications

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“…Abbott’s m2000 did not perform as well as the other two assays in this evaluation nor in the NIH study mentioned above where the PPA estimates were 83.0% (rectal CT), 84.0% (oropharyngeal CT), 88.3% (rectal GC), and 84.8% (oropharyngeal GC) ( 24 ). In our study, the use of a three-way comparison and the small number of oropharyngeal CT-positive results may have limited our power to detect a statistically significant difference in performance for detection of oropharyngeal CT.…”

Section: Discussionmentioning

confidence: 56%

Multicenter Comparison of Nucleic Acid Amplification Tests for the Diagnosis of Rectal and Oropharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae Infections

Pol

Chernesky

Gaydos³

et al. 2022

J Clin Microbiol

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Research using nucleic acid amplification tests (NAATs) have repeatedly found rectal and oropharyngeal infections with Chlamydia trachomatis and Neisseria gonorrhoeae to be common and potentially more difficult to treat than genital infections. Unfortunately, public health and patient care efforts have been hampered by the lack of FDA-cleared NAATs with claims for anorectal or oropharyngeal samples. At the time of the initiation of this study, no commercially available assays had these claims. We formed a novel partnership among academic institutions and diagnostic manufacturers to address this public health need. From May 2018 through August 2019 we recruited 1108 women, 1256 men and 26 transgender persons each of whom provided 3 anal and 3 oropharyngeal swab specimens. The 3 anal swabs were pooled into a single transport tube as were the 3 oropharyngeal swabs. The performance of each of three study assays was estimated by comparison to the composite result and relative to one another. Percent positivity for chlamydia was 5.9 and 1.2% from anal and oropharyngeal specimens, respectively compared to 4.2 and 4.1% for gonorrhea. Sensitivity for chlamydia detection ranged from 81.0-95.1% and 82.8-100% for anal and oropharyngeal specimens, respectively. Gonorrhea sensitivity ranged from 85.9-99.0% and 74.0-100% for anal and oropharyngeal samples, respectively. Specificity estimates were ≥ 98.9% for all assays, organisms and sample types. Although there was heterogeneity between sensitivity estimates, these assays offer better ability to detect extra genital infections than culture and potential solutions for providing appropriate sexual healthcare for populations in which these infections are of concern.

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Section: Discussionmentioning

confidence: 56%

Multicenter Comparison of Nucleic Acid Amplification Tests for the Diagnosis of Rectal and Oropharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae Infections

Pol

Chernesky

Gaydos³

et al. 2022

J Clin Microbiol

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“…Various laboratory diagnostic approaches have recently been used to test chlamydia and gonorrhea and have changed considerably (Uprety and Cardenas, 2019;Adamson et al, 2020;Adamson and Klausner, 2022) Amplification time optimization for the mLAMP-AuNPs-LFB assay Four LAMP reaction times were evaluated at 67°C: (A) 15 min, (B) 25 min, (C) 35 min, and (D) 45 min. AuNPs-LFBs 1-7 represent nucleic acid template levels 5.0×10 4 , 5.0×10 3 , 5.0×10 2 , 5.0×10 1 , 5.0×10 0 , and 5.0×10 -1 copies and negative control (DW), respectively.…”

Section: Discussionmentioning

confidence: 99%

“…al., Serologic tests are not recommended because they lack precision for identifying active infections (Centers for Disease Control and Prevention, 2014). Nucleic acid amplification tests (NAATs) are currently recommended for diagnosing C. trachomatis and N. gonorrhoeae infections due to their high specificity and sensitivity and ease of sample transport and storage(Adamson et al, 2020;Inoue et al, 2021).Inoue et al used multiplex PCR to simultaneously detect N. gonorrhoeae and C. trachomatis and identified 100 copies within…”

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confidence: 99%

Visual and rapid identification of Chlamydia trachomatis and Neisseria gonorrhoeae using multiplex loop-mediated isothermal amplification and a gold nanoparticle-based lateral flow biosensor

Chen

Zhou

Yuan³

et al. 2023

Front. Cell. Infect. Microbiol.

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Sexually transmitted chlamydia and gonorrhea infections caused by the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae remain a major public health concern worldwide, particularly in less developed nations. It is crucial to use a point of care (POC) diagnostic method that is quick, specific, sensitive, and user-friendly to treat and control these infections effectively. Here, a novel molecular diagnostic assay, combining multiplex loop-mediated isothermal amplification (mLAMP) with a visual gold nanoparticles-based lateral flow biosensor (AuNPs-LFB) was devised and used for highly specific, sensitive, rapid, visual, and easy identification of C. trachomatis and N. gonorrhoeae. Two unique independent primer pairs were successful designed against the ompA and orf1 genes of C. trachomatis and N. gonorrhoeae, respectively. The optimal mLAMP-AuNPs-LFB reaction conditions were determined to be 67°C for 35 min. The detection procedure, involving crude genomic DNA extraction (~5 min), LAMP amplification (35 min), and visual results interpretation (<2 min), can be completed within 45 min. Our assay has a detection limit of 50 copies per test, and we did not observe any cross-reactivity with any other bacteria in our testing. Hence, our mLAMP-AuNPs-LFB assay can potentially be used for POC testing to detect C. trachomatis and N. gonorrhoeae in clinical settings, particularly in underdeveloped regions.

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“…This included testing urine, anorectal, and oropharyngeal samples for NG and CT using Abbott RealTime CT/NG assay (Des Plaines, IL, USA), with demonstrated high diagnostic accuracy for those anatomical sites. [20,21] Participants could choose whether anorectal and oropharyngeal samples were selfcollected or provider-collected. Instructional diagrams developed for the study were provided to guide participants with self-collection using anorectal and oropharyngeal swabs, and the provision of urine samples.…”

Section: Clinical Procedures Sample Collection and Laboratory Testingmentioning

confidence: 99%

Anorectal gonorrhoea and chlamydia among transgender women in Brazil: prevalence and assessment of performance and cost of anorectal infection detection and management approaches

McCartney,

Luppi,

Silva

et al. 2023

Sex Transm Infect

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ObjectivesWe aimed to determine the prevalence of anorectalNeisseria gonorrhoeae(NG) andChlamydia trachomatis(CT) among transgender women in Brazil, and to assess the performance and costs of various approaches for the diagnosis and management of anorectal NG/CT.MethodsTransOdara was a multicentric, cross-sectional STI prevalence study among 1317 transgender women conducted in five capital cities representing all Brazilian regions. Participants aged>18 years were recruited using respondent-driven sampling (RDS), completed an interviewer-led questionnaire, offered an optional physical examination and given choice between self-collected or provider-collected samples for NG/CT testing. Performance and cost indicators of predetermined management algorithms based on the WHO recommendations for anorectal symptoms were calculated.ResultsScreening uptake was high (94.3%) and the estimated prevalence of anorectal NG, CT and NG and/or CT was 9.1%, 8.9% and 15.2%, respectively. Most detected anorectal NG/CT infections were asymptomatic (NG: 87.6%, CT: 88.9%), with a limited number of participants reporting any anorectal symptoms (9.1%). Of those who permitted anal examination, few had clinical signs of infection (13.6%). Sensitivity of the tested algorithms ranged from 1.4% to 5.1% (highest for treatment based on the reported anorectal discharge or ulcer and receptive anal intercourse (RAI) in the past 6 months) and specificity from 98.0% to 99.3% (highest for treatment based on the reported anorectal discharge with clinical confirmation or report of RAI). The estimated cost-per-true case of anorectal NG/CT infection treated varied from lowest providing treatment for anorectal discharge syndrome based on the reported RAI ($2.70–4.28), with algorithms including clinical examinations decreasing cost-effectiveness.ConclusionsHigh prevalence of mostly asymptomatic anorectal NG and CT was observed among Brazilian transgender women. Multi-site NG/CT screening should be offered to transgender women. Where diagnostic testing capacity is limited, syndromic management for those presenting with anorectal symptoms is recommended.

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Analytical Evaluation of the Abbott RealTime CT/NG Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Rectal and Pharyngeal Swabs

Cited by 9 publications

References 10 publications

Multicenter Comparison of Nucleic Acid Amplification Tests for the Diagnosis of Rectal and Oropharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae Infections

Multicenter Comparison of Nucleic Acid Amplification Tests for the Diagnosis of Rectal and Oropharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae Infections

Visual and rapid identification of Chlamydia trachomatis and Neisseria gonorrhoeae using multiplex loop-mediated isothermal amplification and a gold nanoparticle-based lateral flow biosensor

Anorectal gonorrhoea and chlamydia among transgender women in Brazil: prevalence and assessment of performance and cost of anorectal infection detection and management approaches

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