Performance of SD Bioline Malaria Ag Pf/Pan rapid test in the diagnosis of malaria in South-Kivu, DR Congo

Kashosi, Théophile Mitima; Mutuga, Joseph Minani; Byadunia, Devotte Sifa; Mutendela, John Kivukuto; Basimike, Mulenda; Mubagwa, Kanigula

doi:10.11604/pamj.2017.27.216.11430

Cited by 20 publications

(14 citation statements)

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“…The sensitivity of both PfHRP2 and PfPLDH RDT increased by the level of parasite density based on microscopy. This finding agrees with the WHO recommendation [31] and is in line with a number of previous studies [43,46]. This study also showed lower sensitivity for both PfHRP2 and PfPLDH in comparison with qPCR from clinical samples.…”

Section: Discussionsupporting

confidence: 93%

Performance of PfHRP2 and PfPLDH Rapid Diagnostics Test for Diagnosis of Plasmodium falciparum in Assosa Zone, Northwest Ethiopia

Alemayehu¹,

López²,

Dieng³

et al. 2020

Preprint

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Background Malaria is a life-threatening infectious disease particularly due to Plasmodium falciparum (P.falciparum ). Plasmodium falciparum Histidine-Rich Protein 2 (PfHRP-2) and Plasmodium falciparum specific Lactate Dehydrogenase (PfPLDH) based rapid diagnostic test are commonly used for malaria diagnosis in malaria endemic countries where microscopic examination is scarce. However, there is limited information on the performance of malaria RDT in rural and semi urban area of Assosa zone, Northwest Ethiopia. Thus, the aim of this study is to determine the performance of PfHRP2 and PfPLDH RDT for diagnosis of falciparum malaria against microscopy as reference method. Methods Health-facility based cross-sectional study design was conducted in Assosa zone, Northwest Ethiopia from November to December 2018. A total of four hundred and six malaria-suspected participants attending Bambasi, Sherkole, Kurmuk and Assosa health-centers were tested. Finger-prick blood samples were collected for microscopy blood film preparation, RDTs and molecular diagnosis. Statistical analyses were performed using SPSS version 20. Results Of the total study participants, 26.4% (107/406) were microscope confirmed P. falciparum positive. Using PfHRP2 and PfPLDH RDT, 30.3% (123/406) and 24.1% (98/406) were positive for P. falciparum, respectively. The sensitivity of PfHRP2 and PfPLDH was 96% and 89%, respectively, against microscope. The corresponding specificity rates of PfHRP2 and PfPLDH were 93% and 99%, respectively. Similarly, positive predictive value (PPV) and negative predictive value of PfHRP2 and PfPLDH RDT were 84%, 97%, 99% and 96%, respectively. There was an agreement between RDTs (PfPLDH and PfHRP2) and reference microscopy method with a kappa value of 0.86 and 0.90, respectively. Compared to qPCR, the specificity of PfHRP2 (93%) and PfPLDH RDT (98%) were high, though the respective sensitivity of PfHRP2(77%) and PfPLDH RDT(70%) were low. Conclusion PfHRP2 and PfPLDH showed reasonable agreement in detecting P. falciparum infections. Hence, currently used national malaria RDT kit can be continue to be used in certain malaria endemic areas in Ethiopia. However, Continuous monitoring the performance of PfHRP-2 RDT associated with false negative results is important to consider an alternative malaria RDT like PfPLDH RDT to support control and elimination of malaria in Ethiopia

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Section: Discussionsupporting

confidence: 93%

Performance of PfHRP2 and PfPLDH Rapid Diagnostics Test for Diagnosis of Plasmodium falciparum in Assosa Zone, Northwest Ethiopia

Alemayehu¹,

López²,

Dieng³

et al. 2020

Preprint

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“…MR Box assay results collected in the field at the Kakuma refugee camp had reduced overall agreement (86 and 84% for measles and rubella, respectively) with laboratory results compared to tests conducted in the laboratory. Similar observations of diminished performance in field trials relative to that determined in the laboratory have been described previously (46). There are multiple potential reasons for this effect.…”

Section: Possupporting

confidence: 84%

A digital microfluidic system for serological immunoassays in remote settings

et al. 2018

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“…It is interesting to note that performance of some of the malaria RDTs including those evaluated in this study are comparable to using the microscope [ 7 ] despite their limitations in sensitivity and specificity [ 8 , 22 , 32 ]. One of such limitations is that some of the RDTs just as those evaluated in this study could have false positive rates >10% [ 1 , 18 , 21 ] and need to be looked at since such kits have increased possibility of giving false positive result.…”

Section: Discussionmentioning

confidence: 99%

“…The RDTs could be used for screening and diagnosis when there is the fear of reduced reliability of HRP2-detecting RDTs because of hrp2 gene deletion in some strains of malaria parasites [ 33 ]. This is on the assumption that parasites with hrp2 gene deletion are expected to produce pLDH which would be detected when the parasite is present considering the time of sample analysis [ 21 , 22 ]. However, the possibility of the RDTs being able to detect parasites with hrp2 gene deletion needs to be explored.…”

Section: Discussionmentioning

confidence: 99%

“…One of such parasite protein is the parasite Lactate Dehydrogenase (pLDH). It is believed that addition of pLDH to HRP2 in RDTs can improve their performance by identifying malaria parasites with hrp2-gene deletion [ 17 , 18 ], help to differentiate current from convalescent infections and even to possibly identify infections that persist as a result of treatment failure [ 18 , 21 , 22 ]. We evaluated the diagnostic accuracy of CareStart (HRP2), CareStart (HRP2-pLDH) and SD-Bioline (HRP2/pLDH) using light microscopy as “gold standard” in middle Ghana, Africa among hospital attendant participants.…”

Section: Introductionmentioning

confidence: 99%

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Assessing the performance of only HRP2 and HRP2 with pLDH based rapid diagnostic tests for the diagnosis of malaria in middle Ghana, Africa

et al. 2018

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BackgroundRapid diagnostic test (RDT) kits have been useful tools to screen for the presence of infection with malaria parasites. Despite the improvement, false results from RDTs present a greater challenge. The need for quality test kits is desirable. We evaluated the diagnostic accuracy of three malaria RDTs.MethodThe team consented and enrolled 754 participants from the two major public hospitals in Kintampo districts of Ghana from June 2014 to August 2014. Venous blood samples were obtained by trained personnel and samples were screened for malaria using CareStart and SD Bioline HRP2 and HRP2 with pLDH based RDTs with blood slides for malaria microscopy as “gold standard”. Geometric mean parasite densities were estimated and parasite densities were used to estimate the quantitative limits of the RDTs. The sensitivities, specificities and other performance criteria were calculated using statistical analytical software.ResultThe median age of participants was 21 (range 5–31) years. There were 28.6% (215/752) were males and 71.4% (537/752) were females. Comparing with microscopy, the sensitivity, specificity, positive predictive value, negative predictive value and the ROC were for CareStart (HRP2), 98.2%, 66.5%, 82.6%, 95.6%, 0.82; for CareStart (HRP2/pLDH) 98.2%, 66.5%, 82.6%, 95.6%, 0.82 and for SD-Bioline (HRP2/pLDH) RDTs 98.2%, 69.2%, 84.2%, 96.0%, 0.84 respectively. The performance for all the kits were acceptable at a cut-off of 25 or more parasites/μl of blood.ConclusionsThe diagnostic performance of the three malaria RDTs was acceptable, according to the World Health Organisation criteria, to detect densities ≥25 parasite/μl of blood. The RDTs with HRP2/pLDH targets were comparable to those with only HRP2 and could successfully substitute current and commonly used HRP2-based RDTs.

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Performance of SD Bioline Malaria Ag Pf/Pan rapid test in the diagnosis of malaria in South-Kivu, DR Congo

Cited by 20 publications

References 7 publications

Performance of PfHRP2 and PfPLDH Rapid Diagnostics Test for Diagnosis of Plasmodium falciparum in Assosa Zone, Northwest Ethiopia

Performance of PfHRP2 and PfPLDH Rapid Diagnostics Test for Diagnosis of Plasmodium falciparum in Assosa Zone, Northwest Ethiopia

A digital microfluidic system for serological immunoassays in remote settings

Assessing the performance of only HRP2 and HRP2 with pLDH based rapid diagnostic tests for the diagnosis of malaria in middle Ghana, Africa

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