Performance of rapid diagnostic tests, microscopy, loop-mediated isothermal amplification (LAMP) and PCR for malaria diagnosis in Ethiopia: a systematic review and meta-analysis

Abstract Background Rapid accurate diagnosis followed by effective treatment is very important for malaria control. Light microscopy remains the “golden standard” method for malaria diagnosis. Diagnostic test method must have sufficient level of accuracy for detecting malaria parasites. Therefore, this study aimed to investigate the diagnostic accuracy of rapid diagnostic tests (RDTs), microscopy, loop-mediated isothermal amplification (LAMP) and/or polymerase chain reaction (PCR) for the malaria diagnosis in Ethiopia. Methods Data bases such as PubMed, PubMed central, Science direct databases, Google scholar, and Scopus were searched from September to October, 2020 for studies assessing the diagnostic accuracy of RDTs, microscopy, LAMP and PCR methods for malaria diagnosis. Results A total of 29 studies published between 2001 and 2020 were analysed using review manager, Midas (Stata) and Meta-disc. The sensitivity and specificity of studies comparing RDT with microscopy varies from 79%–100% to 80%–100%, respectively. The sensitivity of LAMP (731 tests) was 100% and its specificity was varies from 85 to 99% when compared with microscopy and PCR. Considerable heterogeneity was observed between studies included in this meta-analysis. Meta-regression showed that blinding status and target antigens were the major sources of heterogeneity (P < 0.05). RDT had an excellent diagnostic accuracy (Area under the ROC Curve = 0.99) when compared with microscopy. Its specificity was quite good (93%–100%) except for one outlier (28%), but lower “sensitivity” was observed when PCR is a reference test. This indicates RDT had a good diagnostic accuracy (AUC = 0.83). Microscopy showed a very good diagnostic accuracy when compared with PCR. Conclusions The present study showed that microscopy and RDTs had high efficiency for diagnosing febrile malaria patients. The diagnostic accuracy of RDT was excellent when compared with microscopy. This indicates RDTs have acceptable sensitivities and specificities to be used in resource poor settings as an alternative for microscopy. In this study, LAMP showed an excellent sensitivities and specificities. Furthermore, the need of minimum equipment and relatively short time for obtaining results can made LAMP one of the best alternatives especially for accurate diagnosis of asymptomatic malaria.

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Systematic review and meta-analysis of diagnostic accuracy of loop-mediated isothermal amplification (LAMP) methods compared with microscopy, polymerase chain reaction and rapid diagnostic tests for malaria diagnosis

International Journal of Infectious Diseases ◽

10.1016/j.ijid.2020.07.009 ◽

2020 ◽

Vol 98 ◽

pp. 408-419 ◽

Cited By ~ 2

Author(s):

Stephane Picot ◽

Michel Cucherat ◽

Anne-Lise Bienvenu

Keyword(s):

Systematic Review ◽

Polymerase Chain Reaction ◽

Diagnostic Accuracy ◽

Diagnostic Tests ◽

Meta Analysis ◽

Malaria Diagnosis ◽

Rapid Diagnostic Tests ◽

Isothermal Amplification ◽

Chain Reaction ◽

Polymerase Chain

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Accuracy of an Immunochromatographic Diagnostic Test (ICT Malaria Combo Cassette Test) Compared to Microscopy among under Five-Year-Old Children when Diagnosing Malaria in Equatorial Guinea

Malaria Research and Treatment ◽

10.4061/2010/858427 ◽

2010 ◽

Vol 2010 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

José-Luis Portero ◽

Maria Rubio-Yuste ◽

Miguel Angel Descalzo ◽

Jose Raso ◽

Magdalena Lwanga ◽

...

Keyword(s):

Thin Films ◽

Diagnostic Accuracy ◽

Diagnostic Test ◽

Diagnostic Tests ◽

Malaria Diagnosis ◽

Cost Effective ◽

Rapid Diagnostic Tests ◽

Equatorial Guinea ◽

Immunochromatographic Test ◽

Under Five

Conventional malaria diagnosis based on microscopy raises serious difficulties in weak health systems. Cost-effective and sensitive rapid diagnostic tests have been recently proposed as alternatives to microscopy. In Equatorial Guinea, a study was conducted to assess the reliability of a rapid diagnostic test compared to microscopy. The study was designed in accordance with the directives of the Standards for Reporting Diagnostic Accuracy Initiative (STARD). Peripheral thick and thin films for the microscopy diagnosis and a rapid immunochromatographic test (ICT Malaria Combo Cassette Test) were performed on under five-year-old children with malaria suspicion. The ICT test detected Plasmodium spp. infection with a sensitivity of 81.5% and a specificity of 81.9% while P. falciparum diagnosis occurred with a sensitivity of 69.7% and a specificity of 73.7%. The sensitivity of the ICT test increased with higher parasitemias. The general results showed little concordance between the ICT test and microscopy (kappa = 0.28, se: 0.04). In Equatorial Guinea, the ICT Malaria Combo Cassette Test has proven to be an acceptable test to detect high P. falciparum parasitemias. However, the decrease of sensitivity at medium and low parasitemias hampers that ICT can replace properly performed microscopy at present in the diagnosis of malaria in children.

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Field Performances of Rapid Diagnostic Tests Detecting Human Plasmodium Species: A Systematic Review and Meta-Analysis in India, 1990–2020

Diagnostics ◽

10.3390/diagnostics11040590 ◽

2021 ◽

Vol 11 (4) ◽

pp. 590

Author(s):

Loick Pradel Kojom Foko ◽

Veena Pande ◽

Vineeta Singh

Keyword(s):

Systematic Review ◽

Diagnostic Tests ◽

Meta Analysis ◽

Plasmodium Species ◽

Negative Likelihood Ratio ◽

Malaria Diagnosis ◽

Performance Outcomes ◽

Rapid Diagnostic Tests ◽

Cross Sectional ◽

Malaria Rdts

Rapid diagnostic tests (RDTs) have become a mainstay of malaria diagnosis in endemic countries since their implementation in the 1990s. We conducted a 30-year systematic review and meta-analysis on malaria RDTs performance in India. Outcomes of interest were sensitivity (Se), specificity (Sp), positive/negative likelihood ratio (PLR/NLR), and diagnostic odd ratio (DOR). Among the 75 studies included, most of the studies were cross-sectional (65.3%), hospital-based (77.3%), and targeted febrile patients (90.6%). Nearly half of RDTs were designed for detecting Plasmodium falciparum only (47.5%) while the rest were for P. falciparum and P. vivax (11.9%), and P. falciparum/Pan-Plasmodium except for P. knowlesi (32.3%). When compared to light microscopy (gold standard), pooled estimates of performances were: Se = 97.0%, Sp = 96.0%, PLR = 22.4, NLR = 0.02 and DOR = 1080. In comparison to polymerase chain reaction, the RDTs showed Se = 89.0% and Sp = 99.0%. Performance outcomes (Se and Sp) were similar for RDT targeting P. falciparum only, but decreased for mixed and non-falciparum infections. Performances of malaria RDTs are still high India. However, there is a need for developing RDTs with regard to targeting minor malarial species, individuals carrying only mature gametocytes, and pfhrp2-deleted parasites.

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Field validation of a magneto-optical detection device (Gazelle) for portable point-of-care Plasmodium vivax diagnosis

PLoS ONE ◽

10.1371/journal.pone.0253232 ◽

2021 ◽

Vol 16 (6) ◽

pp. e0253232

Author(s):

Hugo O. Valdivia ◽

Priyaleela Thota ◽

Greys Braga ◽

Leonila Ricopa ◽

Keare Barazorda ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Sensitivity And Specificity ◽

Nested Pcr ◽

Diagnostic Tests ◽

Point Of Care ◽

Malaria Diagnosis ◽

Final Analysis ◽

Rapid Diagnostic Tests ◽

Field Validation ◽

Pcr Assay

A major challenge for malaria is the lack of tools for accurate and timely diagnosis in the field which are critical for case management and surveillance. Microscopy along with rapid diagnostic tests are the current mainstay for malaria diagnosis in most endemic regions. However, these methods present several limitations. This study assessed the accuracy of Gazelle, a novel rapid malaria diagnostic device, from samples collected from the Peruvian Amazon between 2019 and 2020. Diagnostic accuracy was compared against microscopy and two rapid diagnostic tests (SD Bioline and BinaxNOW) using 18ssr nested-PCR as reference test. In addition, a real-time PCR assay (PET-PCR) was used for parasite quantification. Out of 217 febrile patients enrolled and tested, 180 specimens (85 P. vivax and 95 negatives) were included in the final analysis. Using nested-PCR as the gold standard, the sensitivity and specificity of Gazelle was 88.2% and 97.9%, respectively. Using a cutoff of 200 parasites/μl, Gazelle’s sensitivity for samples with more than 200 p/uL was 98.67% (95%CI: 92.79% to 99.97%) whereas the sensitivity for samples lower than 200 p/uL (n = 10) was 12.5% (95%CI: 0.32% to 52.65%). Gazelle’s sensitivity and specificity were statistically similar to microscopy (sensitivity = 91.8, specificity = 100%, p = 0.983) and higher than both SD Bioline (sensitivity = 82.4, specificity = 100%, p = 0.016) and BinaxNOW (sensitivity = 71.8%, specificity = 97.9%, p = 0.002). The diagnostic accuracy of Gazelle for malaria detection in P. vivax infections was comparable to light microscopy and superior to both RDTs even in the presence of low parasitemia infections. The performance of Gazelle makes it a valuable tool for malaria diagnosis and active case detection that can be utilized in different malaria-endemic regions.

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