Diagnostic Accuracy of CareStart™ Malaria HRP2 and SD Bioline Pf/PAN for Malaria in Febrile Outpatients in Varying Malaria Transmission Settings in Cameroon

Background: There was an increase in the number of malaria cases in Cameroon in 2018 that could reflect changes in provider practice, despite effective interventions. In this study, we assessed the diagnostic performance of two malaria rapid diagnostic tests (mRDTs) for diagnostic confirmation of suspected cases of malaria in public and private health facilities in two malaria transmission settings in Cameroon. Methods: We evaluated the diagnostic performance of CareStart pf and SD Bioline Pf/PAN mRDT and compared these parameters by RDT type and transmission setting. Nested PCR and blood film microscopy were used as references. The chi square test was used for independent sample comparisons, while the McNemar’s test was used to test for the dependence of categorical data in paired sample testing. A p < 0.05 was considered significant in all comparisons. The R (v.4.0.2) software was used for analyses. Results: A total of 1126 participants consented for the study in the four sites. The diagnostic accuracy of the CareStart Pf mRDT was 0.93.6% (0.911–0.961) in Yaoundé, 0.930% (0.90–0.960) in Ngounso, 0.84% (0.794–0.891) in St Vincent Catholic Hospital Dschang and 0.407 (0.345–0.468) in Dschang district hospital. For SD Bioline Pf/PAN the accuracy was 0.759 (0.738–0.846) for St Vincent Catholic Hospital Dschang and 0.426 (0.372–0.496) for the Dschang district hospital. The accuracy was slightly lower in each case but not statistically different when PCR was considered as the reference. The likelihood ratios of the positive and negative tests were high in the high transmission settings of Yaoundé (10.99 (6.24–19.35)) and Ngounso (14.40 (7.89–26.28)) compared to the low transmission settings of Dschang (0.71 (0.37–1.37)) and St Vincent Catholic hospital (7.37 (4.32−12.59)). There was a high degree of agreement between the tests in Yaoundé (Cohen’s Kappa: 0.85 ± 0.05 (0.7–0.95)) and Ngounso (Cohen’s Kappa: 0.86 ± 0.05 (0.74, 0.97)) and moderate agreement in St Vincent hospital Dschang (k: 0.58 ± 0.06 (0.44–0.71)) and poor agreement in the District Hospital Dschang (Cohen’s Kappa: −0.11 ± 0.05 (−0.21–0.01)). The diagnostic indicators of the SD Bioline Pf/PAN were slightly better than for CareStart Pf mRDT in St Vincent Catholic hospital Dschang, irrespective of the reference test. Conclusions: Publicly procured malaria rapid diagnostic tests in Cameroon have maintained high accuracy (91–94%) in the clinical diagnosis of malaria in high malaria transmission regions of Cameroon, although they failed to reach WHO standards. We observed an exception in the low transmission region of Dschang, West region, where the accuracy tended to be lower and variable between facilities located in this town. These results underscore the importance of the routine monitoring of the quality and performance of malaria RDTs in diverse settings in malaria endemic areas.

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Monitoring the threatened utility of malaria rapid diagnostic tests by novel high-throughput detection of Plasmodium falciparum hrp2 and hrp3 deletions: A cross-sectional, diagnostic accuracy study

EBioMedicine ◽

10.1016/j.ebiom.2019.10.048 ◽

2019 ◽

Vol 50 ◽

pp. 14-22 ◽

Cited By ~ 4

Author(s):

Andrea Kreidenweiss ◽

Franziska Trauner ◽

Miriam Rodi ◽

Erik Koehne ◽

Jana Held ◽

...

Keyword(s):

Plasmodium Falciparum ◽

Diagnostic Accuracy ◽

High Throughput ◽

Diagnostic Tests ◽

Rapid Diagnostic Tests ◽

Diagnostic Accuracy Study ◽

Cross Sectional ◽

Malaria Rapid Diagnostic Tests ◽

Accuracy Study ◽

High Throughput Detection

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Accuracy of Pf HRP2 versus Pf-pLDH antigen detection by malaria rapid diagnostic tests in hospitalized children in a seasonal hyperendemic malaria transmission area in Burkina Faso

Malaria Journal ◽

10.1186/1475-2875-13-20 ◽

2014 ◽

Vol 13 (1) ◽

Cited By ~ 21

Author(s):

Jessica Maltha ◽

Issa Guiraud ◽

Palpouguini Lompo ◽

Bérenger Kaboré ◽

Philippe Gillet ◽

...

Keyword(s):

Burkina Faso ◽

Malaria Transmission ◽

Diagnostic Tests ◽

Rapid Diagnostic Tests ◽

Antigen Detection ◽

Hospitalized Children ◽

Malaria Rapid Diagnostic Tests ◽

Transmission Area

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Appropriate targeting of artemisinin‐based combination therapy by community health workers using malaria rapid diagnostic tests: findings from randomized trials in two contrasting areas of high and low malaria transmission in south‐western Uganda

Tropical Medicine & International Health ◽

10.1111/tmi.12748 ◽

2016 ◽

Vol 21 (9) ◽

pp. 1157-1170 ◽

Cited By ~ 15

Author(s):

Richard Ndyomugyenyi ◽

Pascal Magnussen ◽

Sham Lal ◽

Kristian Hansen ◽

Siân E. Clarke

Keyword(s):

Combination Therapy ◽

Community Health ◽

Malaria Transmission ◽

Diagnostic Tests ◽

Randomized Trials ◽

Health Workers ◽

Rapid Diagnostic Tests ◽

Malaria Rapid Diagnostic Tests ◽

Western Uganda ◽

Low Malaria Transmission

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Performance and time to become negative after treatment of three malaria rapid diagnostic tests in low and high malaria transmission settings

Malaria Journal ◽

10.1186/s12936-016-1529-6 ◽

2016 ◽

Vol 15 (1) ◽

Cited By ~ 31

Author(s):

Francesco Grandesso ◽

Carolyn Nabasumba ◽

Dan Nyehangane ◽

Anne-Laure Page ◽

Mathieu Bastard ◽

...

Keyword(s):

Malaria Transmission ◽

Diagnostic Tests ◽

Rapid Diagnostic Tests ◽

Malaria Rapid Diagnostic Tests

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False-negative malaria rapid diagnostic tests in Rwanda: impact of Plasmodium falciparum isolates lacking hrp2 and declining malaria transmission

Malaria Journal ◽

10.1186/s12936-017-1768-1 ◽

2017 ◽

Vol 16 (1) ◽

Cited By ~ 53

Author(s):

Christina T. Kozycki ◽

Noella Umulisa ◽

Stephen Rulisa ◽

Emil I. Mwikarago ◽

Jean Pierre Musabyimana ◽

...

Keyword(s):

Plasmodium Falciparum ◽

Malaria Transmission ◽

Diagnostic Tests ◽

False Negative ◽

Rapid Diagnostic Tests ◽

Malaria Rapid Diagnostic Tests

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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.

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Field evaluation of diagnostic performance of malaria rapid diagnostic tests in western Kenya

Malaria Journal ◽

10.1186/s12936-016-1508-y ◽

2016 ◽

Vol 15 (1) ◽

Cited By ~ 30

Author(s):

Elizabeth W. Wanja ◽

Nickline Kuya ◽

Collins Moranga ◽

Mark Hickman ◽

Jacob D. Johnson ◽

...

Keyword(s):

Diagnostic Tests ◽

Diagnostic Performance ◽

Field Evaluation ◽

Rapid Diagnostic Tests ◽

Western Kenya ◽

Malaria Rapid Diagnostic Tests

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Diagnostic accuracy of SARS-CoV-2 rapid antigen detection testing in symptomatic and asymptomatic children in the clinical setting

Journal of Clinical Microbiology ◽

10.1128/jcm.00991-21 ◽

2021 ◽

Author(s):

Arnaud G. L’Huillier ◽

Matthieu Lacour ◽

Debora Sadiku ◽

Mehdi A. Gadiri ◽

Loraine De Siebenthal ◽

...

Keyword(s):

Viral Load ◽

Diagnostic Accuracy ◽

Diagnostic Tests ◽

Diagnostic Performance ◽

Rapid Test ◽

Rapid Diagnostic Tests ◽

Rt Pcr ◽

Test Device ◽

Asymptomatic Children ◽

Post Onset

Background. Antigen-based rapid diagnostic tests (RDTs) are used in children despite the lack of data. We evaluated the diagnostic performance of the Panbio TM -COVID-19 Ag Rapid Test Device (P-RDT) in children. Methods. Symptomatic and asymptomatic participants 0-16yo had two NPS for both RT-PCR and P-RDT Results. 822 participants completed the study, of which 533 (64.9%) were symptomatic. Among the 119 (14.5%) RT-PCR-positive patients, the P-RDT sensitivity was 0.66 (95%CI 0.57-0.74). Mean viral load (VL) was higher among P-RDT-positive than negative ones (p<0.001). Sensitivity was 0.91 in specimens with VL>1.0E6 IU/mL (95%CI 0.83-0.99), and decreased to 0.75 (95%CI 0.66-0.83) for specimens >1.0E3 IU/mL. Among symptomatic participants, the P-RDT displayed a sensitivity of 0.73 (95%CI 0.64-0.82), which peaked at 1.00 at 2 days post-onset of symptoms (DPOS; 95%CI 1.00-1.00), then decreased to 0.56 (95%CI 0.23-0.88) at 5 DPOS. There was a trend towards lower P-RDT sensitivity in symptomatic children <12 years (0.62 [95%CI 0.45-0.78]) versus ≥12 years (0.80 [95%CI 0.69-0.91]; p=0.09). In asymptomatic participants, the P-RDT displayed a sensitivity of 0.43 (95%CI 0.26-0.61). Specificity was 1.00 in symptomatic and asymptomatic children (95%CI 0.99-1.00). Conclusion . The overall respective 73% and 43% sensitivities of P-RDT in symptomatic and asymptomatic children was below the 80% cut-off recommended by the WHO. We observed a correlation between VL and P-RDT sensitivity as well as variation of sensitivity according to DPOS, a major determinant of VL. These data highlight the limitations of RDTs in children, with the potential exception in early symptomatic children ≥12yrs.

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