Performance of two rapid diagnostic tests for malaria diagnosis at the China-Myanmar border area

Malaria diagnosis remains a concern in non-endemic countries, with rapid diagnosis being crucial to improve patients’ outcome. Rapid diagnostic tests have high sensitivity but they also have flaws and false-negative results that might jeopardize malaria diagnosis. Some false-negative results might relate to a prozone-like effect. The authors describe two patients with false-negative rapid diagnostic tests in which a prozone-like effect might have been involved. The authors highlight that these tests should not be used without accompanying light microscopy observation of blood films and discuss potential benefits of using rapid diagnostic tests with more than one specific antigen for Plasmodium falciparum.

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Expanding Access to Malaria Diagnosis through Retail Shops in Western Kenya: What Do Shop Workers Think?

Malaria Research and Treatment ◽

10.1155/2013/398143 ◽

2013 ◽

Vol 2013 ◽

pp. 1-9 ◽

Cited By ~ 3

Author(s):

Andria Rusk ◽

Catherine Goodman ◽

Violet Naanyu ◽

Beatrice Koech ◽

Andrew Obala ◽

...

Keyword(s):

Diagnostic Tests ◽

Diagnostic Testing ◽

Malaria Diagnosis ◽

Rapid Diagnostic Tests ◽

Presumptive Treatment ◽

Group Discussions ◽

Western Kenya ◽

Appropriate Treatment ◽

The Common ◽

Viable Approach

Background. The common symptoms of malaria reduce the specificity of clinical diagnosis. Presumptive treatment is conventional but can lead to overdiagnosis of malaria, delay of appropriate treatment, overprescription of antimalarials, and drug resistance. Routine use of diagnostic tests can address many of these concerns. Though treatment is often procured from retailers, there is low availability of rapid diagnostic tests for malaria (MRDTs), a simple, inexpensive, and accurate diagnostic solution. We know little about the challenges to expanding access to diagnostics through these outlets. Methods. To understand the perceptions of the benefits and challenges to selling rapid diagnostic tests for malaria, we conducted focus group discussions with antimalarial retailers who serve the residents of the Webuye Health and Demographic Surveillance Site in western Kenya. Results. Medicine retailers perceived MRDTs to be beneficial to their customers and businesses but also included cost, fear of the tests, risks of self-treatment, and regulatory concerns among the challenges to using and selling MRDTs. Conclusion. MRDTs represent a viable approach to increase access to malaria diagnostic testing. Medicine retailers are eager for MRDTs to be made available to them. However, certain challenges remain to implementation in retail outlets and should be addressed in advance.

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COMPARISON BETWEEN MICROSCOPY AND RAPID DIAGNOSTIC TESTS IN DIAGNOSIS OF MALARIA AT A TERTIARY CARE MEDICAL INSTITUTION IN UTTARAKHAND (A 3-YEAR STUDY)

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2018.v11i2.22141 ◽

2018 ◽

Vol 11 (2) ◽

pp. 94 ◽

Cited By ~ 2

Author(s):

Pratima Gupta ◽

Priyanka Gupta ◽

Shalinee Rao ◽

Neha Singh ◽

Deepjyoti Kalita

Keyword(s):

Predictive Value ◽

Diagnostic Tests ◽

Tertiary Care ◽

Screening Method ◽

Malaria Diagnosis ◽

Peripheral Blood Smear ◽

Rapid Diagnostic Tests ◽

Screening Methods ◽

Suitable Alternative ◽

Malaria Antigen

Objectives: Malaria is one of the most prevalent parasitic diseases all over the world including India. Although the microscopic study of stained peripheral blood smear (PBS) is a gold standard of malaria diagnosis due to some subjective errors, rapid diagnostic tests (RDTs) can be a suitable alternative. This study was conducted to estimate the prevalence and demographic details of malaria cases along with a comparison between the two most common screening methods: PBS and RDTs.Methods: Demographic profile, the prevalence of malaria in this region of Uttarakhand and evaluation of efficacy of RDT as a screening method was performed. Analysis of PBS microscopy for malaria parasites was performed and compared with immunochromatography based RDT over a duration of 3 years.Results: Out of total 2982 clinically suspected patients of malaria, 132 were found to be positive by either of the two methods. Prevalence of malaria was 4.4% in our study. Plasmodium vivax was the predominant species isolated (95%). Males outnumbered females with a ratio of 2.1:1. The most common age group affected was 30–49 years. Sensitivity and specificity of RDT was found to be 91.8% and 93.8%, respectively. Positive predictive value and negative predictive value were found to be 97.8% and 98.9%, respectively.Conclusion: We conclude that Uttarakhand is a low prevalence area for Malaria and the RDT based on malaria antigen (whole blood) method is as specific and sensitive as the traditional PBS microscopy. Thus, it can be used as an alternative to PBS microscopy.

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The diagnostic performance of rapid diagnostic tests and microscopy for malaria diagnosis in eastern Sudan using a nested polymerase chain reaction assay as a reference standard

Transactions of the Royal Society of Tropical Medicine and Hygiene ◽

10.1093/trstmh/trz069 ◽

2019 ◽

Vol 113 (11) ◽

pp. 701-705 ◽

Cited By ~ 2

Author(s):

Zakya A Abdalla ◽

NourElhouda A Rahma ◽

Elhashimi E Hassan ◽

Tajeldin M Abdallah ◽

Hadeel E Hamad ◽

...

Keyword(s):

Polymerase Chain Reaction ◽

Gold Standard ◽

Diagnostic Tests ◽

Diagnostic Performance ◽

Malaria Diagnosis ◽

Rapid Diagnostic Tests ◽

Chain Reaction ◽

Nested Polymerase Chain Reaction ◽

Polymerase Chain ◽

Eastern Sudan

Abstract Background Accurate diagnosis of malaria infection is essential for successful control and management of the disease. Both microscopy and rapid diagnostic tests (RDTs) are recommended for malaria diagnosis, however, RDTs are more commonly used. The aim of the current study was to assess the performance of microscopy and RDTs in the diagnosis of Plasmodium falciparum infection using a nested polymerase chain reaction (PCR) assay as the gold standard. Methods A cross-sectional study was carried out in Kassala Hospital, eastern Sudan. A total of 341 febrile participants of all ages were recruited. Blood specimens were collected and malaria testing was performed using an RDT (SD Bioline Malaria Ag Pf), microscopy and nested PCR. The sensitivity, specificity, positive and negative predictive values (PPV and NPV, respectively) of microscopy and the RDT were investigated. Results The prevalence of P. falciparum malaria infections in this study was 22.9%, 24.3% and 26.7% by PCR, microscopy and RDT, respectively. Compared with microscopy, the RDT had slightly higher sensitivity (80.7% vs 74.3%; p=0.442), equivalent specificity (89.3% vs 90.4%), a similar PPV (69.2% vs 69.8%) and a higher NPV (94.0% vs 92.2%). Conclusions The diagnostic performance of the RDT was better than that of microscopy in the diagnosis of P. falciparum malaria when nested PCR was used as the gold standard.

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Rapid Diagnostic Tests for Malaria Parasites

Clinical Microbiology Reviews ◽

10.1128/cmr.15.1.66-78.2002 ◽

2002 ◽

Vol 15 (1) ◽

pp. 66-78 ◽

Cited By ~ 681

Author(s):

Anthony Moody

Keyword(s):

Diagnostic Tests ◽

New Technology ◽

Malaria Diagnosis ◽

Cost Effective ◽

Rapid Diagnostic Tests ◽

World Health ◽

Diagnostic Challenge ◽

Population Movements ◽

Endemic Malaria ◽

Health Organization

SUMMARY Malaria presents a diagnostic challenge to laboratories in most countries. Endemic malaria, population movements, and travelers all contribute to presenting the laboratory with diagnostic problems for which it may have little expertise available. Drug resistance and genetic variation has altered many accepted morphological appearances of malaria species, and new technology has given an opportunity to review available procedures. Concurrently the World Health Organization has opened a dialogue with scientists, clinicians, and manufacturers on the realistic possibilities for developing accurate, sensitive, and cost-effective rapid diagnostic tests for malaria, capable of detecting 100 parasites/μl from all species and with a semiquantitative measurement for monitoring successful drug treatment. New technology has to be compared with an accepted Rgold standardS that makes comparisons of sensitivity and specificity between different methods. The majority of malaria is found in countries where cost-effectiveness is an important factor and ease of performance and training is a major consideration. Most new technology for malaria diagnosis incorporates immunochromatographic capture procedures, with conjugated monoclonal antibodies providing the indicator of infection. Preferred targeted antigens are those which are abundant in all asexual and sexual stages of the parasite and are currently centered on detection of HRP-2 from Plasmodium falciparum and parasite-specific lactate dehydrogenase or Plasmodium aldolase from the parasite glycolytic pathway found in all species. Clinical studies allow effective comparisons between different formats, and the reality of nonmicroscopic diagnoses of malaria is considered.

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A diagnostic performance evaluation of rapid diagnostic tests and microscopy for malaria diagnosis using nested polymerase chain reaction as reference standard in a tertiary hospital in Jos, Nigeria

Transactions of the Royal Society of Tropical Medicine and Hygiene ◽

10.1093/trstmh/try071 ◽

2018 ◽

Vol 112 (10) ◽

pp. 436-442 ◽

Cited By ~ 1

Author(s):

Okokon I Ita ◽

Akaninyene A Otu ◽

Kenneth Onyedibe ◽

Anthony A Iwuafor ◽

Edmund Banwat ◽

...

Keyword(s):

Polymerase Chain Reaction ◽

Diagnostic Tests ◽

Diagnostic Performance ◽

Malaria Diagnosis ◽

Tertiary Hospital ◽

Rapid Diagnostic Tests ◽

Reference Standard ◽

Chain Reaction ◽

Nested Polymerase Chain Reaction ◽

Polymerase Chain

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Low sensitivity of malaria rapid diagnostic tests stored at room temperature in the Brazilian Amazon Region

The Journal of Infection in Developing Countries ◽

10.3855/jidc.2564 ◽

2013 ◽

Vol 7 (03) ◽

pp. 243-252 ◽

Cited By ~ 5

Author(s):

Luciano T Gomes ◽

Mauro S Tada ◽

Tony H Katsuragawa ◽

Marinete M Povoa ◽

Giselle MR Viana ◽

...

Keyword(s):

Falciparum Malaria ◽

Diagnostic Tests ◽

Room Temperature ◽

Malaria Diagnosis ◽

Brazilian Amazon ◽

Rapid Diagnostic Tests ◽

Amazon Region ◽

Falciparum Infection ◽

Kappa Index ◽

Brazilian Amazon Region

Introduction: In remote areas of the Amazon Region, diagnosis of malaria by microscopy is practically impossible. This study aimed to evaluate the performance of two rapid diagnostic tests (RDTs) targeting different malaria antigens stored at room temperature in the Brazilian Amazon Region. Methodology: Performance of the OptiMal Pf/Pan test and ICT-Now Pf/Pan test was analyzed retrospectively in 1,627 and 1,602 blood samples, respectively. Tests were performed over a 15-month period. Kits were stored at room temperature in five community health centres located in the Brazilian Amazon Region. RDT results were compared with thick blood smear (TBS) results to determine sensitivity, specificity, and accuracy of the RDT. Results: The sensitivities of the OptiMal Pf/Pan test were 79.7% for Plasmodium falciparum malaria diagnosis and 85.7% for non-P. falciparum infections. The results showed a crude agreement of 88.5% for P. falciparum, and 88.3% for non-P. falciparum infections (Kappa index = 0.74 and 0.75, respectively). For the ICT-Now Pf/Pan test (CI 95%), the sensitivities were 87.9% for P. falciparum malaria diagnosis and 72.5% for non-P. falciparum infection. Crude agreement between the ICT-Now Pf/Pan test and TBS was 91.4% for P. falciparum and 79.7% for non-P. falciparum infection. The Kappa index was 0.81 and 0.59 for the final diagnosis of P. falciparum and non-P. falciparum, respectively. Higher levels of parasitaemia were associated with higher crude agreement between RDT and TBS. Conclusions: The sensitivities of RDTs stored at room temperature over a 15-month period and performed in field conditions were lower than those previously reported.

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

Malaria Journal ◽

10.1186/s12936-021-03923-8 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Daniel Getacher Feleke ◽

Yonas Alemu ◽

Nebiyou Yemanebirhane

Keyword(s):

Diagnostic Accuracy ◽

Diagnostic Tests ◽

Meta Analysis ◽

Malaria Diagnosis ◽

Rapid Diagnostic Tests ◽

Accurate Diagnosis ◽

Isothermal Amplification ◽

Test Method ◽

Loop Mediated Isothermal Amplification ◽

Good Diagnostic Accuracy

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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