Clinic-based evaluation study of the diagnostic accuracy of a dual rapid test for the screening of HIV and syphilis in pregnant women in Nigeria

Olugbenga, Ijaodola; Oyelade, Taiwo A.; Laverty, Maura; Ngige, Evelyn; Anyaike, Chukwuma; Bakare, Rasheed; Ogunleye, Veronica O.; Maddox, Brandy L. Peterson; Newman, Daniel R.; Gliddon, Harriet D.; Ofondu, Eugenia; Nurse-Findlay, Stephen; Taylor, Melanie

doi:10.1371/journal.pone.0198698

Cited by 22 publications

(51 citation statements)

References 10 publications

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“…The positive percent agreement differed from that of Olugbenga et al . [ 21 ] but agreed with the negative percent agreement probably due to the four discordant results in this study. Besides, Olugbenga et al .…”

Section: Discussionsupporting

confidence: 85%

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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Section: Discussionsupporting

confidence: 85%

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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“…In the case of vector-borne diseases such as malaria and dengue, RDTs are also being implemented (6,7,37). Besides the HIV RDTs, the sensitivity and specificity of SD and WL for ChD are similar to or even higher than those of other RDTs used to diagnose other infections (27,(35)(36)(37)(38)(39)(40)(41).…”

Section: Downloaded Frommentioning

confidence: 99%

Rapid Diagnostic Tests for Trypanosoma cruzi Infection: Field Evaluation of Two Registered Kits in a Region of Endemicity and a Region of Nonendemicity in Argentina

et al. 2020

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Infection by Trypanosoma cruzi or Chagas Disease (ChD) affects around 7 million people in the Americas, most of which are unaware of their status due to lack of clinical manifestations and poor access to diagnosis. Rapid diagnostic tests (RDTs) are widely used for screening different infections (HIV, Hepatitis B, Syphilis), and their application for ChD would facilitate access to diagnosis, especially in remote areas where health services have scarce resources. We conducted a prospective intervention study during 2018 to evaluate in field two RDTs for ChD, authorized by the National Administration of Medicaments, Aliments, and Medical Technologies of Argentina (ANMAT), to in vitro diagnostic reactive; in endemic and non-endemic areas of Argentina. We recruited 607 volunteers older than 18 years in Salta province and City of Buenos Aires. The RDTs Ab Standard Diagnostics SD Bioline® (SD) and Check Chagas Wiener Lab® (WL) were performed in situ with whole blood sample, and confirmatory serology was done at a reference center. The rate of infection with T. cruzi was 17.8% (108/607). SD test showed a performance of 97.2% sensitivity (95%CI 93.5-100), 91.7% specificity (95%CI 96.2-99.2%), and WL test 93.4% sensitivity (95%CI 88.2-98.6%), 99.1% specificity (95%CI 91.9-100%). The sensitivity and specificity for the two RDTs tested were higher than previously reported. These results encourage the use of the tested RDTs in Salta province and to perform further field studies for the implementation of these RDTs in other epidemiological scenarios. This will be very important to improve access to diagnosis of Chagas and its clinical manage as a neglected disease, especially in remote areas with health access barriers.

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“…The sensitivity and specificity of non-laboratory staff correctly identifying cryptococcal antigen were 100% in both studies. Additionally, syphilis testing by non-laboratory staff using the dual HIV/syphilis rapid diagnostic test had an agreement of 0.666 (0.358–0.974) and a specificity of 99.9% (95% CI: 99.8–100%) compared to when compared to laboratory technicians [44]. Furthermore, nursing staff successfully tested external quality assurance panels using syphilis rapid tests with a sensitivity and specificity over 90% [16,47].…”

Section: Resultsmentioning

confidence: 99%

“…Point-of-care viral load testing was found to be easy, or very easy, to use by all non-laboratory staff, while 85% of questionnaire respondents indicated that point-of-care viral load testing was suitable or very suitable for non-laboratory staff [38]. Ninety percent of non-laboratory staff identified that a syphilis rapid diagnostic test was easy to use [16], while antenatal care staff scored the dual HIV/syphilis rapid diagnostic test 2.41 (out of 3) for ease of use and 2.27 (out of 3) for ease of interpretation [44].…”

Section: Resultsmentioning

confidence: 99%

Performance of non-laboratory staff for diagnostic testing and specimen collection in HIV programs: A systematic review and meta-analysis

Vojnov¹,

Taegtmeyer²,

Boeke³

et al. 2019

PLoS ONE

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Background In most high HIV burden countries, many HIV patients do not have reliable access to required diagnostic laboratory tests. Task shifting of clinical tasks to lower cadres of health care workers and lay counselors has been successful in scaling up treatment for HIV and may also be an effective strategy in expanding access to essential diagnostic testing. Methods We screened major electronic databases between 1 January 2005 to 26 August 2018 to identify studies assessing ease of use and accuracy of task shifting of HIV-related diagnostic testing and/or specimen collection to non-laboratory health staff. Two independent reviewers screened all titles and abstracts for studies that analyzed diagnostic accuracy, patient impact, ease-of-use, or cost-effectiveness. Studies were assessed for quality, bias, and applicability following the QUADAS-2 framework. We generated summary estimates using random-effects meta-analyses. Results We identified 42 relevant studies. Overall, point-of-care CD4 testing performed by non-laboratory staff had a mean bias of -54.44 (95% CI: -72.40 –-36.48) compared to conventional laboratory-based. Though studies were limited, the diagnostic accuracy of point-of-care alanine transaminase enzyme (ALT) and hemoglobin testing performed by non-laboratory staff was comparable to conventional laboratory-based testing by laboratory professionals. Point-of-care testing and/or specimen collection were generally found to be acceptable and easy to use for non-laboratory staff. Conclusions Task shifting of testing using point-of-care technologies to non-laboratory staff was comparable to laboratory professionals operating the same technology in the laboratory. Some variability was observed comparing the performance of point-of-care CD4 testing by non-laboratory staff to conventional laboratory-based technologies by laboratory professionals indicating potential lower performance was likely technological rather than operator caused. The benefits of task shifting of testing may outweigh any possible harms as task shifting allows for increased decentralization, access of specific diagnostics, and faster result delivery.

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Clinic-based evaluation study of the diagnostic accuracy of a dual rapid test for the screening of HIV and syphilis in pregnant women in Nigeria

Cited by 22 publications

References 10 publications

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

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

Rapid Diagnostic Tests for Trypanosoma cruzi Infection: Field Evaluation of Two Registered Kits in a Region of Endemicity and a Region of Nonendemicity in Argentina

Performance of non-laboratory staff for diagnostic testing and specimen collection in HIV programs: A systematic review and meta-analysis

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