Evaluation of the malaria rapid diagnostic test SDFK90: detection of both PfHRP2 and Pf-pLDH

Heutmekers, Marloes; Gillet, Philippe; Cnops, Lieselotte; Bottieau, Emmanuel; Esbroeck, Marjan Van; Maltha, Jessica; Jacobs, Jan

doi:10.1186/1475-2875-11-359

Cited by 20 publications

(19 citation statements)

References 28 publications

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“…The sensitivity of RDT for the diagnosis of malaria in the present study was 98.8% and the specificity was 91.5%. These figures were similar to those found in several other studies [8,[10][11][12][13], although in one study the sensitivity and specificity of RDTs compared with microscopy results were 85.3% and 59.8% respectively [7].…”

Section: Discussionsupporting

confidence: 89%

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Study on validity of a rapid diagnostic test kit versus light microscopy for malaria diagnosis in Ahmedabad city, India

Vyas¹,

Puwar²,

Patel³

et al. 2014

East Mediterr Health J

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Light microscopy of blood smears for diagnosis of malaria in the field has several limitations, notably delays in diagnosis. This study in Ahmedabad in Gujarat State, India, evaluated the diagnostic performance of a rapid diagnostic test for malaria (SD Bioline Malaria Ag P.f/Pan) versus blood smear examination as the gold standard. All fever cases presenting at 13 urban health centres were subjected to rapid diagnostic testing and thick and thin blood smears. A total of 677 cases with fever were examined; 135 (20.0%) tested positive by rapid diagnostic test and 86 (12.7%) by blood smear. The sensitivity of the rapid diagnostic test for malaria was 98.8%, specificity was 91.5%, positive predictive value 63.0% and negative predictive value 99.8%. For detection of Plasmodium falciparum the sensitivity of rapid diagnostic test was 100% and specificity was 97.3%. The results show the acceptability of the rapid test as an alternative to light microscopy in the field setting.

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Section: Discussionsupporting

confidence: 89%

“…However, for non-falciparum infections the test was 84.2% sensitive (95% CI: 72.1%-92.5%) and 96.5% specific (95% CI: 93.8%-98.2%) [12]. Overall sensitivity of the SDFK90 rapid test for the detection of P. falciparum was 98.5% and specificity was 98.8% [11].…”

Section: Discussionmentioning

confidence: 94%

Study on validity of a rapid diagnostic test kit versus light microscopy for malaria diagnosis in Ahmedabad city, India

Vyas¹,

Puwar²,

Patel³

et al. 2014

East Mediterr Health J

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“…Good performance was reported in previous evaluations [15,16]. SD90 was performed on EDTA blood samples according to the manufacturer’s instructions except for replacement of the transfer device by a micropipette.…”

Section: Methodsmentioning

confidence: 84%

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

Maltha

Guiraud

Lompo

et al. 2014

Malar J

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BackgroundIn most sub-Saharan African countries malaria rapid diagnostic tests (RDTs) are now used for the diagnosis of malaria. Most RDTs used detect Plasmodium falciparum histidine-rich protein-2 (PfHRP2), though P. falciparum-specific parasite lactate dehydrogenase (Pf-pLDH)-detecting RDTs may have advantages over PfHRP2-detecting RDTs. Only few data are available on the use of RDTs in severe illness and the present study compared Pf-pLDH to PfHRP2-detection.MethodsHospitalized children aged one month to 14 years presenting with fever or severe illness were included over one year. Venous blood samples were drawn for malaria diagnosis (microscopy and RDT), culture and complete blood count. Leftovers were stored at −80 °C and used for additional RDT analysis and PCR. An RDT targeting both PfHRP2 and Pf-pLDH was performed on all samples for direct comparison of diagnostic accuracy with microscopy as reference method. PCR was performed to explore false-positive RDT results.ResultsIn 376 of 694 (54.2%) included children, malaria was microscopically confirmed. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value were 100.0, 70.9, 69.4 and 100.0%, respectively for PfHRP2-detection and 98.7, 94.0, 91.6 and 99.1%, respectively for Pf-pLDH-detection. Specificity and PPV were significantly lower for PfHRP2-detection (p <0.001). For both detection antigens, specificity was lowest for children one to five years and in the rainy season. PPV for both antigens was highest in the rainy season, because of higher malaria prevalence. False positive PfHRP2 results were associated with prior anti-malarial treatment and positive PCR results (98/114 (86.0%) samples tested).ConclusionAmong children presenting with severe febrile illness in a seasonal hyperendemic malaria transmission area, the present study observed similar sensitivity but lower specificity and PPV of PfHRP2 compared to Pf-pLDH-detection. Further studies should assess the diagnostic accuracy and safety of an appropriate Pf-pLDH-detecting RDT in field settings and if satisfying, replacement of PfHRP2 by Pf-pLDH-detecting RDTs should be considered.

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“…13,14 Furthermore, similar patterns were also reported for other similar products, such as the CareStart Malaria HRP2/ pLDH (Pf/pan) Combo RDT, 30 and for a different, P. falciparumspecific SD Malaria Ag P.f (05FK90) product, which targets PfHRP2 and Pf-pLDH. 31 Among the samples that were diagnosed as P. falciparum-only infections by microscopy, there were P. falciparum mixed infections as detected by LDR-FMA; a number of them were P. falciparum-P. vivax mixed infections ( Table 2). Although the prevalence of those mixed infections was low, there was a noticeable difference in their P. falciparum parasitemia based on their RDT status.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, even when both PfHRP2 and pan bands (pLDH or aldolase) were positive, the intensity of the pan band was lower than that of the PfHRP2 band. 13,14,30,31 Both band intensities (visually scored, five categories) were correlated with parasite densities, with considerable overlap between categories. 13,14,30 Faint bands are often difficult to see and may be missed by health workers in reduced lighting conditions or with reduced visual acuity.…”

Section: Discussionmentioning

confidence: 99%

Plasmodium falciparum Parasitemia and Band Sensitivity of the SD Bioline Malaria Ag P.f/Pan Rapid Diagnostic Test in Madagascar

Mehlotra

Howes

Cramer

et al. 2019

The American Journal of Tropical Medicine and Hygiene

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Current malaria rapid diagnostic tests (RDTs) contain antibodies against Plasmodium falciparum-specific histidine-rich protein 2 (PfHRP2), Plasmodium lactate dehydrogenase (pLDH), and aldolase in various combinations. Low or high parasite densities/target antigen concentrations may influence the accuracy and sensitivity of PfHRP2-detecting RDTs. We analyzed the SD Bioline Malaria Ag P.f/Pan RDT performance in relation to P. falciparum parasitemia in Madagascar, where clinical Plasmodium vivax malaria exists alongside P. falciparum. Nine hundred sixty-three samples from patients seeking care for suspected malaria infection were analyzed by RDT, microscopy, and Plasmodium species-specific, ligase detection reaction-fluorescent microsphere assay (LDR-FMA). Plasmodium infection positivity by these diagnostics was 47.9%, 46.9%, and 58%, respectively. Plasmodium falciparum-only infections were predominant (microscopy, 45.7%; LDR-FMA, 52.3%). In all, 16.3% of P. falciparum, 70% of P. vivax, and all of Plasmodium malariae, Plasmodium ovale, and mixed-species infections were submicroscopic. In 423 P. falciparum mono-infections, confirmed by microscopy and LDR-FMA, the parasitemia in those who were positive for both the PfHRP2 and pan-pLDH test bands was significantly higher than that in those who were positive only for the PfHRP2 band (P < 0.0001). Plasmodium falciparum parasitemia in those that were detected as P. falciparum-only infections by microscopy but P. falciparum mixed infections by LDR-FMA also showed similar outcome by the RDT band positivity. In addition, we used varying parasitemia (3-0.0001%) of the laboratory-maintained 3D7 strain to validate this observation. A positive pLDH band in high P. falciparum-parasitemic individuals may complicate diagnosis and treatment, particularly when the microscopy is inconclusive for P. vivax, and the two infections require different treatments.

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Evaluation of the malaria rapid diagnostic test SDFK90: detection of both PfHRP2 and Pf-pLDH

Cited by 20 publications

References 28 publications

Study on validity of a rapid diagnostic test kit versus light microscopy for malaria diagnosis in Ahmedabad city, India

Study on validity of a rapid diagnostic test kit versus light microscopy for malaria diagnosis in Ahmedabad city, India

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

Plasmodium falciparum Parasitemia and Band Sensitivity of the SD Bioline Malaria Ag P.f/Pan Rapid Diagnostic Test in Madagascar

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