Diagnostic accuracy of rapid tests for sexually transmitted infections in symptomatic women

Nuñez-Forero, L.; Moyano-Ariza, Luisa; Gaitán-Duarte, Hernando; Angel‐Müller, Edith; Ruíz-Parra, Ariel Iván; González, Patricia; Rodríguez, A Herrera; Tolosa, Jorge E.

doi:10.1136/sextrans-2014-051891

Cited by 36 publications

(41 citation statements)

References 20 publications

(26 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…There are a large number of reports in the literature describing rapid, point-of-care syphilis tests that detect antibodies to T and a lesser number for NT. A number of studies, including a metaanalysis describing 18 tests (10), have been published that describe the performance of rapid and point-ofcare syphilis tests to detect antibodies to T (2,5,6,7,9,(11)(12)(13)(14)(15)(16) and with multiplex tests that detect antibodies to T and to HIV simultaneously (16, 20-24, 28, 29). However, there is variation in the reported performance of these rapid tests, with sensitivities and specificities between 84% and 98%, and 94% and 98%, respectively; sensitivities when using whole blood samples are lower (7,10,15).…”

Section: Discussionmentioning

confidence: 99%

“…The purpose of this study was to validate the manufacturers' claims by evaluating 2 commercial rapid assays that detect infection by T. pallidum by assessing antibody reactivity to T and, for 1 assay, additionally to NT. There have been a number of studies that assess syphilis assays (2,5,6,7,(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24), but none have evaluated these 2 tests using the same panel of samples under the same laboratory conditions. These tests represent 2 of the several major rapid tests to detect specific antibodies to T. pallidum that are available in the world market.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Assessment of Two Rapid Assays for Diagnostic Capability to Accurately Identify Infection by Treponema pallidum

Constantine

Sill

Gudesblat

et al. 2017

The Journal of Applied Laboratory Medicine

View full text Add to dashboard Cite

Background: Rapid, point-of-care tests that accurately identify syphilis are gaining popularity and offer several advantages over classic tests. Methods: The SD Bioline Syphilis 3.0 and the Chembio DPP Syphilis Screen and Confirm Assay (CB) were assessed using 1283 samples that had been characterized by reference tests. The challenge samples included 5 commercial panels (seroconversion, mixed-titer), archived samples, fresh samples, and a dilution series. Both tests detect specific anti-treponemal antibodies, and the CB additionally detects antibodies to a non-treponemal (NT) component. The evaluation was used to determine performance indices and compare with those cited by the manufacturers. Results: When assessing reactivity to treponemal, the sensitivities for the 2 tests were 98.3% and 93.2%, with specificities of 100% and 99.4%, respectively. For both tests, precision, whole blood testing, and high-temperature testing produced perfect results, and there were no invalid results. Comparisons of 2 different lots of each test indicated excellent concordance (100% and 99.5%), and reproducibility was 100% and 98.0%, respectively. For the CB, the sensitivity for the NT component was between 65.3% and 80.9%, but increased to 98.5% with samples having a rapid plasma regain (RPR) titer of ≥8. The specificity for NT was found to be 100%, and the reading of results visually and when using a battery-operated reader indicated a concordance for all challenges of 95%-100%. Conclusions: Both rapid tests produced impressive results for the detection of antibodies to treponemal for all challenges and exceeded, met, or closely approached the performance characteristics as cited by the manufacturers. IMPACT STATEMENT The use of these rapid tests can assist patients in a variety of care venues, including in resource-limited countries, in physicians' offices so that positive patients are immediately connected to care, for pregnant women to improve infant morbidity, for transfusions to protect recipients, and for the timely treatment of syphilis. The information provided will inform potential users of the performance characteristics of the two tests being considered for adoption and provides a comparison with what the manufacturers state. The results contribute to the field by providing a comparative analysis of two tests that are used in many countries.

show abstract

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Assessment of Two Rapid Assays for Diagnostic Capability to Accurately Identify Infection by Treponema pallidum

Constantine

Sill

Gudesblat

et al. 2017

The Journal of Applied Laboratory Medicine

View full text Add to dashboard Cite

show abstract

“…When compared with laboratory-based NAATs as the reference tests, among the ICTs and OIAs, sensitivities ranged from 12.5% with the ACON Duo test25 to 100% with the BioStar test; however, this study only included 5 NG-positive men (of 52 men in total) 22Figure 1 highlights the range of sensitivities and CIs of those POCTs.…”

Section: Resultsmentioning

confidence: 87%

“…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

View full text Add to dashboard Cite

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.

show abstract

“…In screening populations, such as people at high risk of STIs or pregnant women, the RTs for syphilis were recommended. 12 The National Profile STD Surveillance summarizes that the national rate of syphilis cases reached an historic low in 2000 and 2001, but has increased almost every year since then. This increase was largely attributable to an increase among men, and among MSM.…”

Section: Discussionmentioning

confidence: 99%

Screening for Syphilis in Cases of Suspected Gonorrhea and Chlamydia Infections

Nibhanipudi

2017

The Journal of Emergency Medicine

View full text Add to dashboard Cite

Background. In all cases of suspected sexually transmitted infections (STIs), it has been routine practice to screen for syphilis with a blood sample. The incidence of syphilis seems to be lower than that of commonly screened STIs. Objective. The objective of our study was to determine whether it is cost-effective to screen for syphilis with serological testing in cases of suspected gonorrhea and chlamydia infections. Hypothesis. Our hypothesis is that it is not cost-effective to screen for syphilis in cases of presumed gonorrhea and chlamydia infections. Methods. Our study is a New York Medical College institutional review board-approved retrospective study. During the period January 2004 to August 12, 2006, the laboratory work of all patients tested for gonorrhea and chlamydia in our emergency department was reviewed. The charts were reviewed for the following tests: gonorrhea DNA probe, chlamydia DNA probe, and syphilis IgG (immunoglobulin G)/RPR (rapid plasma reagin). The results of these tests were obtained and analyzed. Results. The total number of patients screened for gonorrhea and chlamydia during this period was 196. Seventy-eight patients tested positive for gonorrhea and chlamydia. All these 78 patients, tested negative for syphilis. The overall prevalence of positivity for STIs was 39.8% (78/196). The prevalence of chlamydia alone was 85.9% (67/78) and gonorrhea alone was 7.69% (6/78). The prevalence of combined both chlamydia and gonorrhea was 6.4% (5/78). Statistics. We used online SILICO 2 × 4 Fisher exact test. By comparing positive and negative results of serology RPR, GC, and chlamydia trap, the resultant 2-tailed P value is <.0001, which is statistically significant. Conclusions. Per our study, the yield of syphilis testing was negligible. It may not be cost-effective to screen for syphilis in cases of STIs such as gonorrhea and chlamydia.

show abstract

Diagnostic accuracy of rapid tests for sexually transmitted infections in symptomatic women

Cited by 36 publications

References 20 publications

Assessment of Two Rapid Assays for Diagnostic Capability to Accurately Identify Infection by Treponema pallidum

Assessment of Two Rapid Assays for Diagnostic Capability to Accurately Identify Infection by Treponema pallidum

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

Screening for Syphilis in Cases of Suspected Gonorrhea and Chlamydia Infections

Contact Info

Product

Resources

About