A Laboratory-Based Evaluation of Four Rapid Point-of-Care Tests for Syphilis

Causer, Louise; Kaldor, John; Fairley, Christopher K.; Donovan, Basil; Karapanagiotidis, Theo; Leslie, David; Robertson, Peter; McNulty, Anna; Anderson, David A.; Wand, Handan; Conway, Damian P.; Denham, Ian; Ryan, Claire; Guy, Rebecca

doi:10.1371/journal.pone.0091504

Cited by 39 publications

(29 citation statements)

References 31 publications

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“…Results consistent with those found in the present study (100.0%) were reported by Lien et al 16 Hernández-Trejo et al 17 and Siedner et al 18 Other authors reported low sensitivity values when using finger-prick, whole blood samples as 88.0%,18 91.8%,19 85.7%20 and 97.3% 21. A multicentre clinic-based study performed by Mabey et al 22 also found low sensitivity in Tanzania (59.6%), Brazil (88.5%), China (81.9%) and Haiti (72.5%) 22…”

Section: Discussionsupporting

confidence: 93%

Evaluation of seven rapid tests for syphilis available in Brazil using defibrinated plasma panels

et al. 2017

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Objectives In 2012, the WHO estimated that 6 million new cases of syphilis per year would occur worldwide, including 937 000 in Brazil. Early diagnosis and treatment of syphilis are essential to reduce morbidity and prevent transmission. The availability of rapid tests (RTs) for this diagnosis means that testing can be performed more quickly, as a point-of-care test, even in non-laboratory environments and requires only simple technical training to antibodies detection. The objective of this study was to evaluate the performance and operational aspects of seven commercially available RTs for syphilis in Brazil. Methods Seven rapid treponemal tests were evaluated for sensitivity, specificity, accuracy and Kappa value, according to a panel composed of 493 members. The operational performance of the assay was also determined for these tests. results The seven RTs showed sensitivity ranging from 94.5% to 100% when compared with the reference tests and specificity of between 91.5% and 100%. All the RTs evaluated presented good operational performance, and only one failed to present the minimum specificity as defined by Brazil's Ministry of Health. conclusion All the tests presented good operational performance, and the professionals who performed them considered them to be easy to use and interpret. This evaluation is important for making informed choices of tests to be used in the Brazilian Unified Health System. IntrOductIOnSyphilis constitutes a major public health problem. In 2012, the WHO estimated that six million new cases of syphilis per year would occur worldwide.

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Section: Discussionsupporting

confidence: 93%

Evaluation of seven rapid tests for syphilis available in Brazil using defibrinated plasma panels

et al. 2017

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“…The independent variables included gender (male or female), age (16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35), 36-45 and 46-65 years), education level (complete or incomplete primary or secondary school), residence region (from the seven major geographical regions of the state: Florianópolis, Extremo Oeste, Meio Oeste, Planalto Norte, Sul, Vale do Itajaí and Planalto Serrano) and previous blood donation status (never, within previous 12 months or more than 12 months ago). This model allowed for an estimation of the syphilis infection probability among those donors who did not return for follow-up testing, despite a reactive screening test result.…”

Section: Methodsmentioning

confidence: 99%

“…False-negative test results are more likely to occur with treponemal tests compared with VDRL tests in the early phase (2-3 weeks) of infection, whereas the opposite is true for the later stages of infection 29 . Most non-treponemal tests are less sensitive in patients with primary syphilis than in those with secondary syphilis 30 . Both false-positive and false-negative test results may bias the prevalence estimates; however, they are often diffi cult to quantify in blood bank settings.…”

Section: Ethical Considerationsmentioning

confidence: 99%

Syphilis seroprevalence estimates of Santa Catarina blood donors in 2010

Baião

Kupek

Petry³

2014

Rev. Soc. Bras. Med. Trop.

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Introduction: Knowledge of blood donor characteristics is essential to better guide clinical and serological screening for hemotherapy. The objective of this study was to determine the syphilis seroprevalence and the associated factors of blood donors in the State of Santa Catarina, Brazil. Methods: This population-based study from the State of Santa Catarina used information obtained from blood donation records. We analyzed 83,396 blood donor records generated from donors who were considered eligible to donate between January and August 2010. The aim of the study was to estimate the syphilis seroprevalence and its relationship with educational level, age, gender, geographical region and having donated blood in the past 12 months. We used descriptive analyses and a Poisson regression to calculate the prevalence ratios for the variables of interest. Results: We found a 0.14% overall seroprevalence and signifi cant differences among the following: fi rst-time blood donors (0.19%) versus repeat donors (0.03% to 0.08%); low educational levels (0.30%) versus medium and high educational levels (0.08% to 0.19%); and donors who did not report their residence (0.88%) or age (6.94%) versus those who did. Increased syphilis seroprevalence was also signifi cantly associated with increased age. Conclusion: High syphilis seroprevalence was associated with lower educational level, age, fi rst-time donation and the failure to provide age or residence information.

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“…The meta-analysis found that the Determine rapid test (Abbott Diagnostics, United Kingdom) using a serum sample had the best sensitivity (92.03%; 95% confidence interval [CI], 87.2% to 95.8%) and that Syphicheck (Qualpro, India) had the best specificity (99.4%; 95% CI, 98.9% to 99.8%). An Australian laboratory-based study of four syphilis POCT using stored sera reported that the Determine test had the highest overall sensitivity, with significantly higher test sensitivities among high-RPR-titer (RPR Ն 1:8) tests (61). POCT results were compared to treponemal immunoassay reference test results.…”

Section: Poctmentioning

confidence: 99%

Recent Trends in the Serologic Diagnosis of Syphilis

Morshed

Singh

2014

Clin. Vaccine Immunol.

163

156

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bComplexities in the diagnosis of syphilis continue to challenge clinicians. While direct tests (e.g., microscopy or PCR) are helpful in early syphilis, the mainstay of diagnosis remains serologic tests. The traditional algorithm using a nontreponemal test (NTT) followed by a treponemal test (TT) remains the standard in many parts of the world. More recently, the ability to automate the TT has led to the increasingly widespread use of reverse algorithms using treponemal enzyme immunoassays (EIAs). Rapid, point-of-care TTs are in widespread use in developing countries because of low cost, ease of use, and reasonable performance. However, none of the current diagnostic algorithms are able to distinguish current from previously treated infections. In addition, the reversal of traditional syphilis algorithms has led to uncertainty in the clinical management of patients. The interpretation of syphilis tests is further complicated by the lack of a reliable gold standard for syphilis diagnostics, and the newer tests can result in false-positive reactions similar to those seen with older tests. Little progress has been made in the area of serologic diagnostics for congenital syphilis, which requires assessment of maternal treatment and serologic response as well as clinical and laboratory investigation of the neonate for appropriate management. The diagnosis of neurosyphilis continues to require the collection of cerebrospinal fluid for a combination of NTT and TT, and, while newer treponemal EIAs look promising, more studies are needed to confirm their utility. This article reviews current tests and discusses current controversies in syphilis diagnosis, with a focus on serologic tests.

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A Laboratory-Based Evaluation of Four Rapid Point-of-Care Tests for Syphilis

Cited by 39 publications

References 31 publications

Evaluation of seven rapid tests for syphilis available in Brazil using defibrinated plasma panels

Evaluation of seven rapid tests for syphilis available in Brazil using defibrinated plasma panels

Syphilis seroprevalence estimates of Santa Catarina blood donors in 2010

Recent Trends in the Serologic Diagnosis of Syphilis

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