Evaluation of an enzymatic<i>Chlamydia trachomatis</i>point-of-care rapid assay in Rwanda: the BioChekSwab Rapid Test: Table 1

Baetselier, Irith De; Mwambarangwe, Lambert; Cuylaerts, Vicky; Musengamana, Viateur; Agaba, Stephen; Kestelyn, Evelyne; Wijgert, Janneke van de; Crucitti, Tania

doi:10.1136/sextrans-2015-052202

Cited by 5 publications

(2 citation statements)

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“…The argument that it would be helpful in settings without advanced diagnostic facilities, for example in some developing countries, 24 took a severe blow by the finding of extreme insensitivity by manufacture-independent groups testing in resource poor settings. 25,26 Insensitive non-molecular tests have been a continuing blight, as seen by the poor performance of the BioChekSwab rapid test, 27 apparently an updated version of the HandiLab-C test. This raises the point that from the 1990s to the present time, some failed (insensitive) tests have been presented by manufacturers under another guise, providing fresh hope to users and patients.…”

Section: Chlamydia Trachomatismentioning

confidence: 99%

Diagnosis of some genital-tract infections: part 1. An historical perspective

Taylor‐Robinson

Pallecaros

Horner³

2017

Int J STD AIDS

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Making a prompt and accurate diagnosis of genital tract infections is the key to instituting appropriate treatment and the linchpin of sexually transmitted infection control. We present a brief history, not covering syphilis, of diagnostic events for each of six bacteria and one protozoan from the time of discovery up to the molecular revolution. The latter is touched upon but its impact will form the substance of a further presentation. Here, hindsight is helpful in understanding the way in which progress was made over 135 years, often when microbiology, not even seen as a distinct discipline, had a difficult time in providing what was required in terms of dependable diagnostic techniques. Gram-staining, growth on artificial media, growth in cultured cells, enzyme immunoassays, metabolic and immunofluorescence tests have all had their place and some still do despite the avalanche of the molecular era. Serology to determine the existence of organism-specific antibodies has been important in managing syphilis, but has only sometimes been helpful in supporting a diagnosis for other infections and has rarely been the primary deciding factor.

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Section: Chlamydia Trachomatismentioning

confidence: 99%

Diagnosis of some genital-tract infections: part 1. An historical perspective

Taylor‐Robinson

Pallecaros

Horner³

2017

Int J STD AIDS

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“…This editorial reflects on the worryingly poor performance of the BioChekSwab test in Rwanda, described by De Baetselier9 Testing is the theme of several other papers including a comparison of urine vs penile swabs for HPV 10…”

mentioning

confidence: 99%

Highlights from this issue

Cassell¹

2016

Sex Transm Infect

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Evaluation of the ‘Colli-Pee’, a first-void urine collection device for self-sampling at home for the detection of sexually transmitted infections, versus a routine clinic-based urine collection in a one-to-one comparison study design: efficacy and acceptability among MSM in Belgium

et al. 2019

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ObjectivesPre-exposure prophylaxis (PrEP) users are screened bi-annual for sexually transmitted infections (STIs). A novel device, called the Colli-Pee, collects first-void urine in a standardised way and the collector tube can be easily delivered by regular post to a certified laboratory. The aim of the study was a one-to-one comparison between the STI test results obtained with the urine collected in the clinic, versus urine collected at home in a real-life setting by Men who have Sex with Men (MSM) in Belgium. The user-friendliness and acceptability of the Colli-Pee device by the users was also evaluated.DesignA single-site nested substudy in a prospective PrEP demonstration project (Be-PrEP-ared) among MSM in Belgium.ParticipantsA total of 473 home-based samples from 213 MSM were received with a mean age of 38.5 years.InterventionsParticipants were requested to collect a urine sample at home using the Colli-Pee device and to send it to the laboratory via regular mail.Primary and secondary outcome measuresThe presence ofChlamydia trachomatis(CT), Neisseria gonorrhoeae(NG), Mycoplasma genitalium(MG) andTrichomonas vaginalis(TV) was determined using molecular amplification assays. Agreement between test results of samples collected at the clinic and collected at home were evaluated using Cohen’s kappa statistic.Results: TV was not detected. A very good to almost perfect agreement was found for CT, NG and MG of κ=0.75, 0.87 and 0.85, respectively. Using the Colli-Pee device only one low positive CT and two MG infections were missed, however, three additional CT, two NG and six MG infections were detected.ConclusionsThe Colli-Pee device is a feasible and convenient way to collect urine at home for STI testing. This may be particularly relevant for populations that need frequent STI testing, such as PrEP users and patients who prefer home-sampling.Trial registration numberNCT02552914; Pre-results.

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Evaluation of an enzymaticChlamydia trachomatispoint-of-care rapid assay in Rwanda: the BioChekSwab Rapid Test: Table 1

Abstract: The BioChekSwab Rapid Test, although ISO13485 certified and Conformitée Européenne (CE) labelled, lacked any sensitivity in our setting.

Cited by 5 publications

References 6 publications

Diagnosis of some genital-tract infections: part 1. An historical perspective

Diagnosis of some genital-tract infections: part 1. An historical perspective

Highlights from this issue

Evaluation of the ‘Colli-Pee’, a first-void urine collection device for self-sampling at home for the detection of sexually transmitted infections, versus a routine clinic-based urine collection in a one-to-one comparison study design: efficacy and acceptability among MSM in Belgium

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