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Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia.

ABSTRACT: This cross-sectional study of 3212 pregnant women assessed the field performance, acceptability, and feasibility of two dual HIV/syphilis rapid diagnostic tests, the Chembio DPP HIV-syphilis Assay and the SD Bioline HIV/syphilis Duo in antenatal clinics. Sensitivity and specificity for HIV and syphilis were calculated compared to the rapid Determine HIV-1/2 with Uni-Gold to confirm positive results for HIV and the Treponema pallidum particle agglutination assay for syphilis. RPR titers ?1:4 were used to define active syphilis detection. Acceptability and feasibility were assessed using self-reported questionnaires. For Chembio, the HIV sensitivity was 90.6% (95%CI?=?87.4, 93.0) and specificity was 97.2% (95%CI?=?96.2, 97.8); syphilis sensitivity was 68.6% (95%CI?=?61.9, 74.6) and specificity was 98.5% (95%CI?=?97.8, 98.9). For SD Bioline, HIV sensitivity was 89.4% (95%CI?=?86.1, 92.0) and specificity was 96.3% (95%CI?=?95.3, 97.1); syphilis sensitivity was 66.2% (95%CI?=?59.4, 72.4) and specificity was 97.2% (95%CI?=?96.4, 97.9). Using the reference for active syphilis, syphilis sensitivity was 84.7% (95%CI?=?76.1, 90.6) for Chembio and 81.6% (95%CI?=?72.7, 88.1) for SD Bioline. Both rapid diagnostic tests were assessed as highly acceptable and feasible. In a field setting, the performance of both rapid diagnostic tests was comparable to other published field evaluations and each was rated highly acceptable and feasible. These findings can be used to guide further research and proposed scale up in antenatal clinic settings.

SUBMITTER: Kasaro MP

PROVIDER: S-EPMC6751556 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia.

Kasaro Margaret P MP Bosomprah Samuel S Taylor Melanie M MM Sindano Ntazana N Phiri Caroline C Tambatamba Bushimbwa B Malumo Sarai S Freeman Bethany B Chibwe Bertha B Laverty Maura M Owiredu Morkor N MN Newman Lori L Sikazwe Izukanji I

International journal of STD & AIDS 20181125 4

This cross-sectional study of 3212 pregnant women assessed the field performance, acceptability, and feasibility of two dual HIV/syphilis rapid diagnostic tests, the Chembio DPP HIV-syphilis Assay and the SD Bioline HIV/syphilis Duo in antenatal clinics. Sensitivity and specificity for HIV and syphilis were calculated compared to the rapid Determine HIV-1/2 with Uni-Gold to confirm positive results for HIV and the Treponema pallidum particle agglutination assay for syphilis. RPR titers ≥1:4 were ...[more]

PMID: 30472926

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Project description:BackgroundAnaemia and malaria are both major contributors to maternal and child mortality, and morbidity, with some of the worst outcomes occurring in sub-Saharan Africa. Point of care tests (POCT), if used appropriately, provide a simple, inexpensive form of diagnostic testing, as a reliable alternative when laboratory tests are not readily available. In such resource limited settings, clinical staff tend to rely on symptom-based diagnosis and presumptive treatment. This study uses qualitative methods to identify the current practice of POCT use for malaria and anaemia, to explore the enablers and barriers to effective implementation of these POCT, and to determine how relationships between each of the stakeholder groups may impact on POCT use.MethodsStaff (clinical and laboratory) and patients (pregnant women) at three antenatal care facilities within the Ashanti Region of Ghana participated in interviews and focus group discussions (FGDs). An initial coding framework was developed based on the pre-defined objectives of the study. Thematic analysis was used to identify subthemes and categories within each of the key themes.ResultsAt the time data were collected all three facilities used malaria POCT either as an adjunct to microscopy, or as their only form of malaria testing. Although all three facilities were familiar with haemoglobin colour scale (HCS), none of the facilities used them routinely. Clinical staff perceived symptom-based diagnosis was a quick way to diagnosis because access to POCT during consultations was unreliable, but recognized disadvantages associated with symptom-based diagnosis. Perceived advantages of malaria and anaemia POCT were user-friendliness, improved diagnosis and opportunity for patient engagement, as well as lower cost implication for patients. Perceived disadvantages included likelihood of missed diagnosis of mild anaemia, as well as likelihood of human error leading to in accurate diagnosis which could impact on patient trust. Poor communication and lack of trust between staff groups was also identified as a barrier to effective uptake of POCT.ConclusionsConsistent supply of POCT as well as staff training and staff and patient engagement, are fundamental to successful uptake of POCT for effective malaria and anaemia management.

Project description:Background An ultrasensitive malaria rapid diagnostic test (RDT) was recently developed for the improved detection of low-density Plasmodium falciparum infections. This study aimed to compare the diagnostic performance of the PfHRP2-based Abbott Malaria Ag P. falciparum ultrasensitive RDT (uRDT) to that of the conventional SD-Bioline Malaria Ag P. falciparum RDT (cRDT) when performed under field conditions. Methods Finger-prick blood samples were collected from adults and children in two cross-sectional surveys in May of 2017 in southern Mozambique. Using real-time quantitative PCR (RT-qPCR) as the reference method, the age-specific diagnostic performance indicators of the cRDT and uRDT were compared. The presence of histidine-rich protein 2 (HRP2) and Plasmodium lactate dehydrogenase (pLDH) antigens was evaluated in a subset from dried blood spots by a quantitative antigen assay. pfhrp2 and pfhrp3 gene deletions were assessed in samples positive by RT-qPCR and negative by both RDTs. Results Among the 4,396 participants with complete test results, the sensitivity of uRDTs (68.2; 95% CI 60.8 to 74.9) was marginally better than that of cRDTs (61.5; 95% CI 53.9 to 68.6) (p-value?=?0.004), while the specificities were similar (uRDT: 99.0 [95% CI 98.6 to 99.2], cRDT: 99.2 [95% CI 98.9 to 99.4], p-value?=?0.02). While the performance of both RDTs was lowest in???15-year-olds, driven by the higher prevalence of low parasite density infections in this group, the sensitivity of uRDTs was significantly higher in this age group (54.9, 95% CI 40.3 to 68.9) compared to the sensitivity of cRDTs (39.2, 95% CI 25.8 to 53.9) (p-value?=?0.008). Both RDTs detected P. falciparum infections at similar geometric mean parasite densities (112.9 parasites/?L for uRDTs and 145.5 parasites/?L for cRDTs). The presence of HRP2 antigen was similar among false positive (FP) samples of both tests (80.5% among uRDT-FPs and 84.4% among cRDT-FPs). Only one false negative sample was detected with a partial pfhrp2 deletion. Conclusion This study showed that the uRDTs developed by Abbott do not substantially outperform SD-Bioline Pf malaria RDTs in the community and are still not comparable to molecular methods to detect P. falciparum infections in this study setting.

Project description:BackgroundTo overcome the limitations of conventional malaria rapid diagnostic tests (cRDTs) in diagnosing malaria in patients with low parasitaemia, ultrasensitive malaria rapid diagnostic tests (uRDTs) have recently been developed, with promising results under laboratory conditions. The current study is the first meta-analysis comparing the overall sensitivity, and specificity of newly developed ultrasensitive Plasmodium falciparum malaria RDT (Alere™ Ultra-sensitive Malaria Ag P. falciparum RDT) with the cRDT conducted in the same field conditions.MethodsPubMed, EMBASE, Cochrane infectious diseases group specialized register, and African Journals Online (AJOL) were searched up to 20th April 2021. Studies with enough data to compute sensitivity and specificity of uRDT and cRDT were retrieved. A random-effect model for meta-analysis was used to obtain the pooled sensitivity and specificity.ResultsOverall, 15 data sets from 14 studies were included in the meta-analysis. The overall sensitivity of the Alere™ ultra-sensitive Malaria Ag P. falciparum RDT regardless of the reference test and the clinical presentation of participants, was 55.5% (95% confidence interval [CI]: 45.5; 65.0), while the sensitivity regardless of the reference test and the clinical presentation of participants, was 42.9% (95% CI: 31.5; 55.2) for the cRDT performed in the same field conditions. When PCR was used as reference test, the sensitivity of uRDT was 60.4% (95% CI: 50.8; 69.2), while the sensitivity was 49.4% (95% CI: 38.2; 60.6) for the cRDT. The pooled specificity of uRDT regardless of the reference test and the clinical presentation of participants was 98.6% (95% CI: 97.1; 99.4), and the pooled specificity of cRDT regardless of the reference test and the clinical presentation of participants was 99.3% (95% CI: 98.1; 99.7). When PCR was used as reference test the specificity of uRDT and cRDT was 97.5% (95% CI: 94.1; 98.9) and 98.2% (95% CI: 95.5; 99.3). Regardless of the reference test used, the sensitivity of Alere™ Ultra-sensitive Malaria Ag P. falciparum RDT in symptomatic patients was 72.1% (95%CI: 67.4; 76.4), while sensitivity of cRDT was 67.4% (95%CI: 57.6; 75.9).ConclusionFindings of the meta-analysis show that Alere™ Ultra-sensitive Malaria Ag P. falciparum RDT compared to cRDT performed in the same field conditions has higher sensitivity but lower specificity although the difference is not statistically significant.

Dataset Information

Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia.

Publications

Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia.

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