Dataset Information

Laboratory assessment of SD Bioline HIV/Syphilis Duo Kit among pregnant women attending antenatal clinic Mayuge Health Center III, East central Uganda.

ABSTRACT: OBJECTIVE:Efforts to dual eradication of mother-to-child transmission of human immune deficiency virus (HIV) and syphilis have improved in the previous decades. This has however been hindered by limited validation studies. A cross-sectional study was conducted among adult pregnant women attending antenatal care clinic at Mayuge Health Center III. Two milliliters of venous blood were collected into Ethylene di-amine tetra acetic acid vacutainers, and tested for HIV and syphilis using the SD Bioline HIV/Syphilis Duo assay, and the national HIV and syphilis testing algorithm. Sensitivity and specificity were calculated for the Duo Kit against the gold standards within 95% confidence intervals. RESULTS:Three hundred and eighty-two (382) participants were enrolled. Their mean age was 25.8 years. The prevalence of HIV was 1.8% (95% confidence interval 1.23-2.41); while that of syphilis was 2.1% (95% confidence interval 1.81-2.54), and the dual infection was 0.52% (95% confidence interval 0.37-0.92). The sensitivity and specificity of the SD Bioline HIV/Syphilis Duo assay were all 100.0% (95% confidence interval 99.5 to 100.0 and 98.6 to 100.0, respectively). The performance of the SD Bioline HIV/Syphilis Duo Kit was optimal, reassuring its aptness for use, and favorable qualities to a limited resource setting.

SUBMITTER: Taremwa IM

PROVIDER: S-EPMC6482528 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Laboratory assessment of SD Bioline HIV/Syphilis Duo Kit among pregnant women attending antenatal clinic Mayuge Health Center III, East central Uganda.

Taremwa Ivan Mugisha IM Twelwanike Alupakusadi A Mwambi Bashir B Atuhairwe Christine C

BMC research notes 20190425 1

<h4>Objective</h4>Efforts to dual eradication of mother-to-child transmission of human immune deficiency virus (HIV) and syphilis have improved in the previous decades. This has however been hindered by limited validation studies. A cross-sectional study was conducted among adult pregnant women attending antenatal care clinic at Mayuge Health Center III. Two milliliters of venous blood were collected into Ethylene di-amine tetra acetic acid vacutainers, and tested for HIV and syphilis using the ...[more]

PMID: 31023349

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Project description: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.

Project description:BACKGROUND:Cervical cancer is almost entirely preventable through vaccination and screening, yet remains one of the 'gravest threats to women's lives' according to the World Health Organization. Specific high-risk subtypes of human papillomavirus (HR-HPV) are well-established as the primary cause of cervical cancer. Uganda has one of the highest cervical cancer incidence rates in the world (54.8 per 100,000) as a result of limited screening access and infrastructure. The integration of a self-collected cervical cancer screening program using HPV testing within existing community-based primary health care services could increase access to screening and reduce cervical cancer rates among Ugandan women. METHODS:Using a pragmatic, sequential, cluster randomized trial design; we will compare the effectiveness of two cervical cancer screening models for self-collected HPV testing: 1) community health worker recruitment (door-to-door); and 2) community health meetings. In Mayuge district, Uganda, 31 villages are randomized to one of two treatment arms. Due to the nature of this trial, blinding is not possible. Women are eligible to participate if they have no previous history of hysterectomy or treatment for cervical cancer or pre-cancer and are aged 25-49 years old. All participants receive an integrated package of cervical cancer screening and education. Samples are tested for HPV using GeneXpert point of care testing. All women who test positive for HR-HPV types are referred to a designated health centre for follow-up inspection by Visual Inspection with Acetic acid (VIA) and treatment with thermal ablation. The primary outcome for the trial is the number of women who attend follow-up for VIA screening at a designated Health Centre after a positive HR-HPV test out of all women screened per arm. Secondary outcomes include: cervical cancer screening knowledge; patient-reported experience measures for self-collected cervical cancer screening; and HPV incidence. DISCUSSION:Results from this study will inform the national scale-up of cervical cancer screening in Uganda, aligning with the World Health Organization's target of achieving cervical cancer elimination through the pillar of increased HPV screening coverage. TRIAL REGISTRATION:ISRCTN, ISRCTN12767014. Registered 14 May 2019, https://doi.org/10.1186/ISRCTN12767014; clinicaltrials.gov, NCT04000503; Registered 27 June 2019, https://clinicaltrials.gov/ct2/show/NCT04000503 PROTOCOL VERSION: January 8, 2020, version 1.

Project description:BACKGROUND:Screening for sexually transmitted infection (STI) especially HIV as early detection and treatment have been financially supported under the Thai Universal Coverage (UC) scheme since 2009 (THB140 for HIV). However, the implementation has not been evidence-based, strategic risk-based, nor economically evaluated whereas husbands who accompanied the pregnant women are likely to have a lower risk than those who did not come along. This study is aimed to determine the husband's willingness-to-pay (WTP) for his HIV and syphilis screening tests and potential factors affecting STI screenings at the antenatal care (ANC) clinic of a tertiary hospital in Thailand. METHODS:A pilot open-ended interview was conducted among 50 participants to estimate the mean and standard deviation of WTP prices for HIV and syphilis screening tests. A questionnaire was developed to obtain demographics, STI knowledge and screening history, as well as two contingent valuation methods (bidding and payment scale), using the mean WTP prices identified from the pilot study as a starting WTP with ¼SD step-up/down. The survey of 200 randomly selected husbands of pregnant women was conducted at King Chulalongkorn Memorial Hospital from April to June 2018. Descriptive statistics and logistic regression were used for data analysis. RESULTS:During the study period, 597 pregnant women received their first ANC. Of 368 accompanying husbands, 200 were enrolled in the study. Their median age was 31 (IQR 27-36) years old and 67% had a first child. Eighty-eight percent of the participants were willing to test for the STIs. Based on the bidding method, WTP prices for HIV and syphilis screening tests were US$14.5 (IQR 12.4-14.5) and US$9.7 (IQR 10-12), respectively. The payment scale method suggested approximately three-quarters of the WTP prices from the bidding method. CONCLUSIONS:The husbands who accompanied their pregnant wives to the ANC clinic showed positive behaviors according to the propitious selection theory. They tend to cooperate well with STI testing and are willing to pay at least two times the price of the STI screening tests. The financial support to promote STI screenings should be reconsidered to cover other groups with higher sexual behavior risks and less WTP.

Dataset Information

Laboratory assessment of SD Bioline HIV/Syphilis Duo Kit among pregnant women attending antenatal clinic Mayuge Health Center III, East central Uganda.

Publications

Laboratory assessment of SD Bioline HIV/Syphilis Duo Kit among pregnant women attending antenatal clinic Mayuge Health Center III, East central Uganda.

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