Evaluation of a rapid antigen detection test for Neisseria gonorrhoeae in urine sediment for diagnosis of gonococcal urethritis in males

Suzuki, Kuri; Matsumoto, Tetsuya; Murakami, Hiroatsu; Tateda, Kazuhiro; Ishii, Nobuhisa; Yamaguchi, Keizo

doi:10.1007/s10156-004-0322-6

Cited by 15 publications

(10 citation statements)

References 10 publications

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“…Table 2 summarises the extracted data from these studies. The POCTs evaluated included the GC Check (PATH, Seattle, Washington, USA),20 BioStar (GC OIA) (ThermoFisher/BioStar, Boulder, Colorado, USA),21 22 Binax NOW Gonorrhoea Test (Inverness),23 GeneXpert CT/NG (Cepheid, Sunnyvale, California, USA),24 ACON Duo25 and NG ACON Plate (ACON NG) (ACON Laboratories, San Diego, California, USA) 25. The ACON Duo, NG ACON, GC Check and Binax NOW are lateral flow immunochromatographic tests (ICTs); the BioStar is an optical immunoassay (OIA) tests; the GeneXpert CT/NG assay is based on NAAT (this test is referred to as a ‘near-patient NAAT’ hereafter because of the longer time to results than traditional POCTs).…”

Section: Resultsmentioning

confidence: 99%

Performance and operational characteristics of point-of-care tests for the diagnosis of urogenital gonococcal infections

Guy¹,

Causer

Klausner

et al. 2017

Sex Transm Infect

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background In 2012, there was an estimated 78 million new cases of gonorrhoea globally. Untreated infection may lead to reproductive and neonatal morbidity and facilitate HIV transmission. Diagnosis and treatment are a priority for control and prevention, yet use of point-of-care tests (POCTs) for Neisseria gonorrhoeae (NG) is limited. Objectives To review the performance and operational characteristics of NG POCTs for diagnosis of urogenital gonorrhoea. Methods We compiled and synthesised findings from two separate systematic reviews which included evaluations published until August 2015. results Six tests were included: five were immunochromatographic tests (ICTs) or optical immunoassay (OIAs) based on antigen detection; with 5-7 steps and results in 25-40 min, and one (GeneXpert CT/NG) was a 'near-patient test' based on nucleic acid amplification technique (NAAT); with three steps, electricity required, and results in 90 min. When compared with laboratory-based NAATs as the reference tests, sensitivities of ICT and OIA-based POCTs ranged from 12.5% to 70% when cervical/vaginal swabs were tested. Specificities ranged from 89% to 99.8%. The near-patient NAAT had sensitivities of >95% and specificities of >99.8% consistently across all specimen types (urine, cervical and vaginal swabs). conclusions Based on a limited number of evaluations, antigen detection POCTs for NG lacked sufficient sensitivity to be used for screening. A near-patient NAAT has acceptable performance, only involved a few steps, but needs electricity, a temperature-controlled environment and has a 90 min run time. To achieve wider scale up of NG POCTs, we need strong evidence of cost-effectiveness, which should inform guidelines and ultimately increase test development, demand and reduce costs.

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Section: Resultsmentioning

confidence: 99%

Performance and operational characteristics of point-of-care tests for the diagnosis of urogenital gonococcal infections

Guy¹,

Causer

Klausner

et al. 2017

Sex Transm Infect

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“…There were nine papers reporting LE dipsticks11 18–25 (table 1), three reporting ICT3 13 26 (table 2) and two studies reporting the use of microscopy27 28 (table 3). …”

Section: Resultsmentioning

confidence: 99%

Point-of-care tests for the diagnosis ofNeisseria gonorrhoeaeinfection: a systematic review of operational and performance characteristics

et al. 2012

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“…20 With their extremely high sensitivity and specificity, they are considered the gold standard for diagnosis 27 and good for different samples, such as cervical swabs from intrusive speculum examination or urine from the noninvasive route. 28 However, there are still some pitfalls in using these tools. They can cross-react with other Neisseria species and can be affected by specimen transport conditions.…”

Section: Naatsmentioning

confidence: 99%

Are we satisfied with the tools for the diagnosis of gonococcal infection in females?

Tsou

Chen

et al. 2011

Journal of the Chinese Medical Association

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Gonorrhea (Neisseria gonorrhoeae) is a common sexually transmitted infection in women, with a heavy burden on female and neonatal health, because sequelae occur, such as female infertility, ectopic pregnancy, neonatal ophthalmitis and infection, and chronic pelvic pain. Prompt and appropriate antibiotic treatment can cure infection and avoid complications. However, adequate treatment is not easy, because early and rapid identification of gonorrhea is interfered with by many factors, including the complicated mixed microflora of the vagina and cervix, non-user-friendly culture systems, and lack of immediate availability of results, even with a combination of subjective complaint and high clinical suspicion. A PubMed search was conducted using the major headings of "gonorrhoea and diagnostic tool" and "Neisseria gonorrhoeae and diagnostic tool", before the end of 2010. Recently available methods for the diagnosis of gonorrhea infection in women were included, including traditional tools and advanced technology. Traditional tools such as microscopic examination and microbial culture have been used broadly; unfortunately, they have relatively lower specificity or sensitivity, and most importantly, "see-and-treat" is impossible for these infected women. Advances in technology, such as antigen detection by immunoassay and nucleic acid amplification tests (NAATs), have achieved major progress in the diagnosis of gonorrhea, because of their accuracy, convenience and time-saving aspects. However, NAATs are expensive, making their acceptance impossible in developing countries. Detection of pathogens including N. gonorrheae using microarray chips is viewed as a possible solution, because it is a relatively rapid, easy, inexpensive and sensitive tool, which makes an "identify-and-treat" or point-of-care policy possible. A rapid and affordable tool with high sensitivity and specificity for detection of gonorrhea in developing countries is still not available at the time of writing. To make a point-of-care policy possible, advanced technology for aiding diagnosis of gonorrhea is encouraged and appreciated.

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Evaluation of a rapid antigen detection test for Neisseria gonorrhoeae in urine sediment for diagnosis of gonococcal urethritis in males

Cited by 15 publications

References 10 publications

Performance and operational characteristics of point-of-care tests for the diagnosis of urogenital gonococcal infections

Performance and operational characteristics of point-of-care tests for the diagnosis of urogenital gonococcal infections

Point-of-care tests for the diagnosis ofNeisseria gonorrhoeaeinfection: a systematic review of operational and performance characteristics

Are we satisfied with the tools for the diagnosis of gonococcal infection in females?

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