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

Abstract

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.

Performance analysis of polymerase chain reaction in relation to rapid diagnostic test (RDT) kit (SD bio line malaria ag p.f (05fk50)) for malaria diagnosis

“…Similarly, it was reported [40] higher values of 87.6% (PPV) and 93.4% (NPV) as compared to 70.47% and 38.95% recorded in the present study. In the present study, an overall accuracy level of 0.53 was observed, this higher than 0.42 reported by previous research [45].…”

Comparison of Rapid Diagnostic Test, Microscopy, and Polymerase Chain Reaction for the Detection of Plasmodium falciparum Malaria in a Low-Transmission Area, Jazan Region, Southwestern Saudi Arabia

“…The accuracy of malaria diagnostics depends on several factors, including the level of malaria endemicity, parasite density, mutation or deletion of the gene encoding the HRP2/HRP3, format and type of the RDT product, and storage conditions [ 17 , 18 , 38 , 39 ]. Saudi Arabia has not yet eliminated malaria, and Jazan is currently the only region with a limited number of malaria transmission foci and autochthonous cases [ 25 ].…”

Field performance of Plasmodium falciparum lactate dehydrogenase rapid diagnostic tests during a large histidine-rich protein 2 deletion survey in Ethiopia

“…Both RDTs used during the survey are WHO prequalified and, therefore, should meet requirements for safety and quality ([ 17 ] and https://extranet.who.int/pqweb/vitro-diagnostics/vitro-diagnostics-lists ). However, the performance of malaria RDT is dependent on several factors in addition to parasite densities [ 18 ] such as reduced community level transmission intensities [ 19 ]; operator skill [ 20 , 21 ], correct transport and storage conditions [ 22 ] and a strong product lot quality monitoring program [ 21 ]. In spite of high performance of PfLDH detection RDTs reported by others [ 12 , 23 – 25 ], the lower sensitivity and specificity of LDH detection RDT reported in this study, 69% and 72% sensitivity against PCR and multiplex assay, respectively and 38% and 36% specificity against PCR multiplex, respectively, could be partly driven by samples with low parasitaemia below the detection threshold of the PfLDH RDT.…”