Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy

Zorzi, Antonella; Cordioli, Maddalena; Gios, Lorenzo; Bravo, Paola Del; Toskin, Igor; Peeling, Rosanna W.; Blondeel, Karel; Cornaglia, Giuseppe; Kiarie, James; Ballard, Ronald C.; Mirandola, Massimo

doi:10.1136/sextrans-2016-053065

Cited by 22 publications

(30 citation statements)

References 15 publications

(6 reference statements)

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“…Although many community-based settings focus mostly on HIV testing, syphilis testing should be routinely included in the context of high prevalence rates. Such expansion of testing could be established through rapid point-of-care testing technologies including combined HIV and syphilis testing methodologies once these have been thoroughly validated [ 65 – 67 ].…”

Section: Discussionmentioning

confidence: 99%

The resurgence of syphilis in high-income countries in the 2000s: a focus on Europe

et al. 2019

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Syphilis can cause severe complications and sequelae. Following a decrease in reported cases in European Union/European Economic Area (EU/EEA) and other high-income countries in the 1980s and 1990s as a result of the HIV epidemic and ensuing changes in sexual behaviour, trends started to increase in the 2000s in a number of EU/EEA Member States with higher rates among men and a large proportion of cases reported among men who have sex with men (MSM), particularly HIV-positive MSM. Trends in EU/EEA Member States vary however with some countries continuing to report decreases in the number of reported cases (mostly in the Eastern part of EU/EEA) whereas many Western European countries report increasing numbers of cases. Increasing rates among women, although still relatively low, have been observed in a number of countries leading to concerns around mother-to-child transmission of syphilis and congenital syphilis. Similar overall trends are observed in other high-income countries with the exception of Japan where rates among heterosexual men and women have been rising at alarming levels. Control of syphilis requires use of comprehensive, evidence-based strategies which take into account lessons learned from previous control efforts as well as consideration of biomedical interventions.

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Section: Discussionmentioning

confidence: 99%

The resurgence of syphilis in high-income countries in the 2000s: a focus on Europe

et al. 2019

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“…Due to the inconsistency in RPR values compared with the Duo test’s ability to detect antibodies, we think it would be appropriate to compare TPHA but not RPR results with the performance of the Duo test, as shown by Zorzi et al . This study documented that for Treponema pallidum particulate agglutination (TPPA) test titres >1 in 1280, the misclassification rate for the syphilis treponemal tests would be very low [ 32 ]. This finding is consistent with the treponemal antigen-based syphilis testing component of the Duo test.…”

Section: Discussionmentioning

confidence: 99%

Field evaluation of SD BIOLINE HIV/Syphilis Duo assay among pregnant women attending routine antenatal care in Juba, South Sudan

Lodiongo¹,

Bior²,

Dumo³

et al. 2018

PLoS ONE

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The SD BIOLINE HIV/Syphilis Duo assay is the first World Health Organization prequalified dual rapid diagnostic test for simultaneous detection of HIV and Treponema pallidum antibodies in human blood. Prior to introducing the test into antenatal clinics across South Sudan, a field evaluation of its clinical performance in diagnosing both HIV and syphilis in pregnant women was conducted. SD Bioline test performance on venous blood samples was compared with (i) Vironostika HIV1/2 Uniform II Ag/Ab reference standard and Alere Determine HIV 1/2 non-reference standard for HIV diagnosis, and (ii) Treponema pallidum hemagglutination reference standard and Rapid plasma reagin non-reference standard for syphilis. Sensitivity, specificity, positive predictive value (PPN), negative predictive value (NPV) and kappa (κ) value were calculated for each component against the reference standards within 95% confidence intervals (CIs); agreements between Determine HIV 1/2 and SD Bioline HIV tests were also calculated. Of 442 pregnant women recruited, eight (1.8%) were HIV positive, 22 (5.0%) had evidence of syphilis exposure; 14 (3.2%) had active infection. For HIV diagnosis, the sensitivity, specificity, PPV and NPV were 100% (95% CI: 63.1–100), 100% (95% CI: 99.2–100), 100% (95% CI: 63.1–100) and 100% (95% CI: 99.2–100) respectively with κ value of 1 (95% CI: 0.992–1.000). Overall agreement of the Duo HIV component and Determine test was 99.1% (95% CI: 0.977–0.998) with 66.7% (95% CI: 34.9–90.1) positive and 100% (95% CI: 0.992–1.000) negative percent agreements. For syphilis, the Duo assay sensitivity was 86.4% (95% CI: 65.1–97.1) and specificity 100% (95% CI: 99.1–100) with PPV 100% (95% CI: 82.4–100), NPV 99.2% (95% CI: 97.9–99.9) and κ value 0.92 (95% CI: 0.980–0.999). Our findings suggest the SD Bioline HIV/Syphilis Duo Assay could be suitable for HIV and syphilis testing in women attending antenatal services across South Sudan. Women with positive syphilis results should receive treatment immediately, whereas HIV positive women should undergo confirmatory testing following national HIV testing guidelines.

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“…A double reader method (reader 1reader 2 (R1-R2)) will be adopted for both tests to determine any variability in the interpretation of test results. 11 The MR (Chembio) will be read by R2 only. R1 and R2 will be blind to each other's results and to the clinical history of the patients.…”

Section: Specimen Collectionmentioning

confidence: 99%

“…Both operational characteristics of the test and human factors, such as the ability to follow properly the POCT procedures (eg, taking whole blood finger-prick specimens, correct timing of adding the buffer and reading the result and interpreting results accurately), can interfere with the performance of a POCT. 11 Evaluation of the performance of these dual tests in clinic-based settings and their acceptability to patients and HCPs is therefore a high priority. The need for standardised highquality evaluations of POCTs was identified by two WHO technical consultations as being critical for the development and global uptake of POCTs for STIs.…”

mentioning

confidence: 99%

Standardised protocol for a prospective cross-sectional multicentre clinic-based evaluation of two dual point-of-care tests for the screening of HIV and syphilis in men who have sex with men, sex workers and pregnant women

Cordioli¹,

Gios²,

Mirandola³

et al. 2020

BMJ Open

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IntroductionDual point-of-care tests (POCTs) for detecting antibodies to HIV and syphilis have been developed for use with venous whole blood, serum/plasma or finger-prick capillary whole blood. Several tests are commercially available showing encouraging performance compared with ‘gold-standard’ reference tests in laboratory-based studies. However, data on their performance in the field are limited. This prospective cross-sectional study will conduct a clinic-based evaluation to assess the performance characteristics and acceptability to end-users of two dual HIV/syphilis POCTs for the screening of HIV and syphilis among men who have sex with men (MSM), sex workers (SWs) and pregnant women (PW). This master protocol outlines the overall research approach that will be used in seven countries.Method and analysisMSM, SWs and PW presenting at clinic evaluation sites in high, low and middle-income countries will be enrolled. The (WHO preapproved) POCTs to be evaluated are SD Bioline HIV/Syphilis Duo (Abbott) and Dual Path Platform HIV-Syphilis Assay (Chembio). Finger-prick blood will be collected to perform POCTs and compared with laboratory results (venepuncture blood). Procedures will be carried out by trained healthcare staff and tests performed according to the manufacturers’ directions. Sample size was calculated based on local prevalence of HIV and syphilis. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid to late 2021.Ethics and disseminationThis core protocol was independently peer reviewed and approved by the Research Project Review Panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The protocol has been adapted to individual countries and approved by RP2, ERC and institutional review boards at each site. Results will be disseminated through peer-reviewed journals and relevant conferences.

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Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy

Cited by 22 publications

References 15 publications

The resurgence of syphilis in high-income countries in the 2000s: a focus on Europe

The resurgence of syphilis in high-income countries in the 2000s: a focus on Europe

Field evaluation of SD BIOLINE HIV/Syphilis Duo assay among pregnant women attending routine antenatal care in Juba, South Sudan

Standardised protocol for a prospective cross-sectional multicentre clinic-based evaluation of two dual point-of-care tests for the screening of HIV and syphilis in men who have sex with men, sex workers and pregnant women

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