Evaluación de campo de la precisión diagnóstica de la prueba de diagnóstico rápido SD Bioline Malaria Antigen Pf/Pv® en Colombia

Mendoza, Nohora Marcela; Cucunubá, Zulma M.; Aponte, Samanda; González, Nohora E.; Bernal, Sindy Durley

doi:10.7705/biomedica.v33i4.1464

Cited by 13 publications

(9 citation statements)

References 21 publications

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“…On the other hand, a number of surveys regarding the evaluation of SD Bioline Malaria Ag Pf/Pan test against microscopy took place in endemic countries (Colombia, Korea, Myanmar). In Colombia, sensitivity, specificity, PPV and NPV for SD Bioline Pf/Pv test were estimated at 92%, 98.7%, 94.5% and 98.1%, respectively [ 18 ]. In Korea, sensitivity of RDT for P .…”

Section: Discussionmentioning

confidence: 99%

Field Application of SD Bioline Malaria Ag Pf/Pan Rapid Diagnostic Test for Malaria in Greece

et al. 2015

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Greece, a malaria-free country since 1974, has experienced re-emergence of Plasmodium vivax autochthonous malaria cases in some agriculture areas over the last three years. In early 2012, an integrated control programme (MALWEST Project) was launched in order to prevent re-establishment of the disease. In the context of this project, the rapid diagnostic tests (RDT) of SD Bioline Malaria Ag Pf/Pan that detects hrp-2 and pan-LDH antigens were used. The aim of this study was to assess the field application of the RDT for the P. vivax diagnosis in comparison to light microscopy and polymerase chain reaction (PCR). A total of 955 samples were tested with all three diagnostic tools. Agreement of RDT against microscopy and PCR for the diagnosis of P. vivax was satisfactory (K value: 0.849 and 0.976, respectively). The sensitivity, specificity and positive predictive value of RDT against PCR was 95.6% (95% C.I.: 84.8-99.3), 100% (95% C.I.: 99.6-100.0) and 100% (95% CI: 91.7-100.0) respectively, while the sensitivity, specificity and positive predictive value of RDT against microscopic examination was 97.4% (95% C.I.: 86.1-99.6), 99.4% (95% C.I.: 98.6-99.8) and 86.1% (95% CI: 72.1-94.7), respectively. Our results indicate that RDT performed satisfactory in a non-endemic country and therefore is recommended for malaria diagnosis, especially in areas where health professionals lack experience on light microscopy.

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Section: Discussionmentioning

confidence: 99%

Field Application of SD Bioline Malaria Ag Pf/Pan Rapid Diagnostic Test for Malaria in Greece

et al. 2015

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“… 69 Colombia also reported two P. falciparum isolates from clinically infected subjects; however, it was not possible to amplify exon 2 for both pfhrp2 and pfhrp3 . 70 In a recent survey in communities around Iquitos-Nauta road in the Peruvian Amazon region, it was difficult to find P. falciparum PfHRP2-positive individuals even though they were diagnosed positive by light microscopy and pLDH (D. Gamboa, A. Llanos, and J. M. Vinetz, unpublished data). Thus far, Guyana is the only country in South America where all P. falciparum isolates have been found to carry pfhrp2 ; therefore, to date, the performance of PfHRP2-based RDTs here has not yet been affected.…”

Section: Cross-icemr Comparisonmentioning

confidence: 99%

Malaria Diagnosis Across the International Centers of Excellence for Malaria Research: Platforms, Performance, and Standardization

Tamaki

Gamboa

Ndiaye

et al. 2015

The American Journal of Tropical Medicine and Hygiene

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Diagnosis is “the act of identifying a disease, illness, or problem by examining someone or something.” When an individual with acute fever presents for clinical attention, accurate diagnosis leading to specific, prompt treatment often saves lives. As applied to malaria, not only individual patient diagnosis is important but also assessing population-level malaria prevalence using appropriate diagnostic methods is essential for public health purposes. Similarly, identifying (diagnosing) fake antimalarial medications prevents the use of counterfeit drugs that can have disastrous effects. Therefore, accurate diagnosis in broad areas related to malaria is fundamental to improving health-care delivery, informing funding agencies of current malaria situations, and aiding in the prioritization of regional and national control efforts. The International Centers of Excellence for Malaria Research (ICEMR), supported by the U.S. National Institute of Allergy and Infectious Diseases, has collaborated on global efforts to improve malaria diagnostics by working to harmonize and systematize procedures across different regions where endemicity and financial resources vary. In this article, the different diagnostic methods used across each ICEMR are reviewed and challenges are discussed.

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“…Using mAbs, enzyme-linked immunosorbent assay (ELISA) method and fluorescence-linked immunosorbent assay (FLISA) have established significant diagnostic biomarkers [12,13]. Resulting devices for the diagnosis of malaria based on malaria-specific antigens, such as histidine-rich protein 2 (HRP2) and lactate dehydrogenase (LDH), have been developed as alternative diagnostics to microscopy and PCR [14]. …”

Section: Introductionmentioning

confidence: 99%

Performance of coumarin-derived dendrimer-based fluorescence-linked immunosorbent assay (FLISA) to detect malaria antigen

Yeo

Huong

Han

et al. 2014

Malar J

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BackgroundDue to limitation of conventional malaria diagnostics, including microscopy, polymerase chain reaction (PCR), and enzyme-linked immunosorbent assay (ELISA), alternative accurate diagnostics have been demanded for improvement of sensitivity and specificity.MethodsSerially diluted Plasmodium LDH antigens, Plasmodium falciparum-infected human red blood cells (RBC) derived from in vitro culture or patient’s samples were used for evaluation of the performance of fluorescence-linked immunosorbent assay (FLISA). Microscopic examination was used to determine parasite density and the performance of FLISA was compared to ELISA. Finally, sensitivity and specificity of FLISA was determined by human specimens infected with P. falciparum, Plasmodium vivax, Toxoplasma gondii, and amoebae.ResultsAs a result of FLISA, the fluorescent intensity was highly correlated with antigen amount and FLISA was more sensitive than ELISA. FLISA detected at least 0.01 ng/ml of pLDH antigen, which showed 1,000-fold higher sensitivity than ELISA. In vitro-cultured P. falciparum was detected up to 20 parasite number/μL in FLISA but 5120 parasite number/μLin sandwich ELISA. In vitro P. falciparum-infected RBC number was highly correlated with fluorescent intensity (R2 = 0.979), showing that FLISA was reliable for detection of P. falciparum and available for quantification of parasite numbers. Furthermore, eighteen patient samples infected with P. falciparum (n = 9) and P. vivax (n = 9) showed 100% of sensitivity (18/18). FLISA showed 96.3% of specificity (26/27) because one sample of patient blood infected with T. gondii gave a false positive reactivity among healthy donors (n = 9), T. gondii-infected patients (n = 9), and amoeba-infected patients (n = 9).ConclusionFLISA has a keen and high performance to detect malaria antigen, suggesting a potential assay as malaria immunodiagnostic.

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Evaluación de campo de la precisión diagnóstica de la prueba de diagnóstico rápido SD Bioline Malaria Antigen Pf/Pv® en Colombia

Cited by 13 publications

References 21 publications

Field Application of SD Bioline Malaria Ag Pf/Pan Rapid Diagnostic Test for Malaria in Greece

Field Application of SD Bioline Malaria Ag Pf/Pan Rapid Diagnostic Test for Malaria in Greece

Malaria Diagnosis Across the International Centers of Excellence for Malaria Research: Platforms, Performance, and Standardization

Performance of coumarin-derived dendrimer-based fluorescence-linked immunosorbent assay (FLISA) to detect malaria antigen

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