External Quality Assessment of Reading and Interpretation of Malaria Rapid Diagnostic Tests among 1849 End-Users in the Democratic Republic of the Congo through Short Message Service (SMS)

The recent large outbreaks of Ebola virus disease (EVD) in West Africa and the Democratic Republic of the Congo (DRC) have highlighted the need for rapid diagnostic tests to control this disease. In this study, we clinically evaluated a previously developed immunochromatography-based kit, QuickNaviTM-Ebola. During the 2018 outbreaks in DRC, 928 blood samples from EVD-suspected cases were tested with QuickNaviTM-Ebola and the WHO-approved GeneXpert. The sensitivity and specificity of QuickNaviTM-Ebola, estimated by comparing it to GeneXpert-confirmed cases, were 85% (68/80) and 99.8% (846/848), respectively. These results indicate the practical reliability of QuickNaviTM-Ebola for point-of-care diagnosis of EVD.

Download Full-text

Analysis of false-negative rapid diagnostic tests for symptomatic malaria in the Democratic Republic of the Congo

Scientific Reports ◽

10.1038/s41598-021-85913-z ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Jonathan B. Parr ◽

Eddy Kieto ◽

Fernandine Phanzu ◽

Paul Mansiangi ◽

Kashamuka Mwandagalirwa ◽

...

Keyword(s):

Whole Genome Sequencing ◽

Genome Sequencing ◽

Diagnostic Tests ◽

Democratic Republic ◽

False Negative ◽

Rapid Diagnostic Tests ◽

Whole Genome ◽

Symptomatic Malaria ◽

Asymptomatic Children ◽

Republic Of The Congo

AbstractThe majority of Plasmodium falciparum malaria diagnoses in Africa are made using rapid diagnostic tests (RDTs) that detect histidine-rich protein 2. Increasing reports of false-negative RDT results due to parasites with deletions of the pfhrp2 and/or pfhrp3 genes (pfhrp2/3) raise concern about existing malaria diagnostic strategies. We previously identified pfhrp2-negative parasites among asymptomatic children in the Democratic Republic of the Congo (DRC), but their impact on diagnosis of symptomatic malaria is unknown. We performed a cross-sectional study of false-negative RDTs in symptomatic subjects in 2017. Parasites were characterized by microscopy; RDT; pfhrp2/3 genotyping and species-specific PCR assays; a bead-based immunoassay for Plasmodium antigens; and/or whole-genome sequencing. Among 3627 symptomatic subjects, 427 (11.8%) had RDT-/microscopy + results. Parasites from eight (0.2%) samples were initially classified as putative pfhrp2/3 deletions by PCR, but antigen testing and whole-genome sequencing confirmed the presence of intact genes. 56.8% of subjects had PCR-confirmed malaria. Non-falciparum co-infection with P. falciparum was common (13.2%). Agreement between PCR and HRP2-based RDTs was satisfactory (Cohen’s kappa = 0.66) and superior to microscopy (0.33). Symptomatic malaria due to pfhrp2/3-deleted P. falciparum was not observed. Ongoing HRP2-based RDT use is appropriate for the detection of falciparum malaria in the DRC.

Download Full-text

Field accuracy of HIV rapid diagnostic tests for blood donors screening, Bukavu, Eastern Democratic Republic of the Congo

The Journal of Infection in Developing Countries ◽

10.3855/jidc.9774 ◽

2018 ◽

Vol 12 (06) ◽

pp. 471-476

Author(s):

Théophile Mitima Kashosi ◽

Céléstin Bisangamo Kyambikwa ◽

Philémon Mbarabara Mulongo ◽

Jean Bisimwa Nachega

Keyword(s):

Diagnostic Tests ◽

Blood Donors ◽

Democratic Republic ◽

Point Of Care ◽

Kappa Statistic ◽

Rapid Diagnostic Tests ◽

Cohen’S Kappa ◽

Cohen's Kappa ◽

Republic Of The Congo ◽

Hiv 1

Introduction: Rapid diagnostic tests (RDTs) are widely used for point-of-care. point-of-care diagnosis of HIV infection in resource-limited settings. However, there are no data about their field diagnostic performance in Eastern Democratic Republic of the Congo (DRC), especially in the context of blood banks screening for transfusion safety purpose. Methodology: Blood specimens were collected from blood donors in Bukavu, Eastern DRC, from May the 1st to June the 30th, 2015, to evaluate the accuracy of Alere Determine HIV-1/2, Trinity Biotech Uni‑Gold HIV, and DoubleCheckGold Ultra HIV 1& 2 compared to the laboratory-based 4th generation ELISA apDia HIV Ag/Ab assay. Sensitivity, specificity, positive and negative predictive values, and related 95% confidence intervals were calculated using MedCalc statistical software version 15.1. Reliability was evaluated using Cohen’s Kappa Statistic, κ. Results: Among 312 participants who provided blood bags, 96/312 (30.7%) were female and the mean age (SD) was 31.7 years (± 8.1years). Sensitivity for the three tests was 57.1% (95% CI: 18.4-90.1). The specificity was 99.7% (95% CI: 18.4-90.1) for Alere Determine HIV 1/2, 100% (95% CI: 98.8-100.0) for Uni-Gold HIV, and (100% (95% CI: 98.8-100.0) for DoubleCheckGold Ultra HIV 1&2. Cohen’s Kappa Statistic showed moderate agreement between the 4th generation ELISA apDia HIV Ag/Ab and RDTs Alere Determine HIV 1/2 and Uni-Gold HIV (κ = 0.66; 95% CI: 0.55- 0.76) but good agreement for DoubleCheckGold Ultra HIV1&2 (κ = 0.72; 95% CI: 0.61 – 0.82). Conclusions: Compared to the laboratory-based ELISA apDia HIV Ag/Ab assay, the currently used 3rd generation HIV RDTs showed poor field accuracy results in a context of blood donors screening. These data support the need for 4th generation Ag-Ab RDTs in transfusion blood qualification.

Download Full-text