Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 seroprevalence survey.

BACKGROUND: Accurate antibody tests are essential to monitor the SARS-CoV-2 pandemic. Lateral flow immunoassays (LFIAs) can deliver testing at scale. However, reported performance varies, and sensitivity analyses have generally been conducted on serum from hospitalised patients. For use in community testing, evaluation of finger-prick self-tests, in non-hospitalised individuals, is required. METHODS: Sensitivity analysis was conducted on 276 non-hospitalised participants. All had tested positive for SARS-CoV-2 by reverse transcription PCR and were ≥21 days from symptom onset. In phase I, we evaluated five LFIAs in clinic (with finger prick) and laboratory (with blood and sera) in comparison to (1) PCR-confirmed infection and (2) presence of SARS-CoV-2 antibodies on two 'in-house' ELISAs. Specificity analysis was performed on 500 prepandemic sera. In phase II, six additional LFIAs were assessed with serum. FINDINGS: 95% (95% CI 92.2% to 97.3%) of the infected cohort had detectable antibodies on at least one ELISA. LFIA sensitivity was variable, but significantly inferior to ELISA in 8 out of 11 assessed. Of LFIAs assessed in both clinic and laboratory, finger-prick self-test sensitivity varied from 21% to 92% versus PCR-confirmed cases and from 22% to 96% versus composite ELISA positives. Concordance between finger-prick and serum testing was at best moderate (kappa 0.56) and, at worst, slight (kappa 0.13). All LFIAs had high specificity (97.2%-99.8%). INTERPRETATION: LFIA sensitivity and sample concordance is variable, highlighting the importance of evaluations in setting of intended use. This rigorous approach to LFIA evaluation identified a test with high specificity (98.6% (95%CI 97.1% to 99.4%)), moderate sensitivity (84.4% with finger prick (95% CI 70.5% to 93.5%)) and moderate concordance, suitable for seroprevalence surveys.

Evaluating the impact of an intervention to increase uptake of modern contraceptives among adolescent girls (15-19 years) in Nigeria, Ethiopia and Tanzania: the Adolescents 360 quasi-experimental study protocol.

INTRODUCTION: Nigeria, Ethiopia and Tanzania have some of the highest teenage pregnancy rates and lowest rates of modern contraceptive use among adolescents. The transdisciplinary Adolescents 360 (A360) initiative being rolled out across these three countries uses human-centred design to create context-specific multicomponent interventions with the aim of increasing voluntary modern contraceptive use among girls aged 15-19 years. METHODS: The primary objective of the outcome evaluation is to assess the impact of A360 on the modern contraceptive prevalence rate (mCPR) among sexually active girls aged 15-19 years. A360 targets different subpopulations of adolescent girls in the three countries. In Northern Nigeria and Ethiopia, the study population is married girls aged 15-19 years. In Southern Nigeria, the study population is unmarried girls aged 15-19 years. In Tanzania, both married and unmarried girls aged 15-19 years will be included in the study. In all settings, we will use a prepopulation and postpopulation-based cross-sectional survey design. In Nigeria, the study design will also include a comparison group. A one-stage sampling design will be used in Nigeria and Ethiopia. A two-stage sampling design will be used in Tanzania. Questionnaires will be administered face-to-face by female interviewers aged between 18 and 26 years. Study outcomes will be assessed before the start of A360 implementation in late 2017 and approximately 24 months after implementation in late 2019. ETHICS AND DISSEMINATION: Findings of this study will be widely disseminated through workshops, conference presentations, reports, briefings, factsheets and academic publications.