Rapid diagnostic tests for diagnosing uncomplicated<i>P. falciparum</i>malaria in endemic countries

Abba, Katharine; Deeks, Jonathan J; Olliaro, Piero; Naing, Cho‐Min; Jackson, Sally; Takwoingi, Yemisi; Donegan, Sarah; Garner, Paul

doi:10.1002/14651858.cd008122.pub2

Cited by 189 publications

(207 citation statements)

References 284 publications

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“…Studies with multiple sites under the same study protocol were pooled directly as one single study in the meta-analysis. With regard to studies that evaluated multiple LED-FM systems on the same group of participants, we included data from only one LED-FM system for the meta-analysis in order to avoid bias caused by counting the same subjects more than once [12]. The LED-FM system most commonly used among our included studies in the meta-analysis was selected to minimise heterogeneity between studies.…”

Section: Discussionmentioning

confidence: 99%

Light-emitting diode fluorescence microscopy for tuberculosis diagnosis: a meta-analysis

Chang

Page²,

Bonnet³

2015

Eur Respir J

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Light-emitting diode fluorescence microscopy (LED-FM) is recommended by the World Health Organization to replace conventional Ziehl-Neelsen microscopy for pulmonary tuberculosis diagnosis. Uptake of LED-FM has been slow. One reason is its reported loss of specificity compared with Ziehl-Neelsen microscopy. We aimed to determine the diagnostic accuracy of LED-FM for tuberculosis detection and explore potential factors that might affect its performance.A comprehensive search strategy based on pre-specified criteria was employed to identify eligible studies between January 1, 2000 and April 1, 2014 in 11 databases. Standardised study selection, data extraction and quality assessment were conducted. Pooled sensitivity and specificity of LED-FM using culture as the reference standard were estimated through meta-analyses using a bivariate random-effects model. Investigation of heterogeneity was performed by subgroup analyses.We identified 12 unique studies, half of which were from peripheral healthcare facilities. LED-FM achieved a pooled sensitivity of 66.9% (95% CI 60.5-72.7%) and pooled specificity of 96.8% (95% CI 93.1-98.6%). A pooled sensitivity of 53.0% (95% CI 42.8-63.0%) and pooled specificity of 96.1% (95% CI 86.0-99.0%) were obtained by LED-FM among HIV-infected patients. Study methodology factors and differences in the LED-FM procedure or device could also affect the performance.LED-FM specificity is high and should not be a barrier to device introduction, particularly among peripheral healthcare settings where this technology is meant to be used. Sensitivity is reduced in HIVinfected patients. @ERSpublications Meta-analysis showed high performance of LED fluorescence microscopy in diagnosing pulmonary TB http://ow.ly/U3dxd

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Section: Discussionmentioning

confidence: 99%

Light-emitting diode fluorescence microscopy for tuberculosis diagnosis: a meta-analysis

Chang

Page²,

Bonnet³

2015

Eur Respir J

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“…The development of rapid diagnostic tests (RDTs) has aided diagnosis of malaria in resource-poor settings, but these tests have limited capability for species identification, as they were originally designed to distinguish P. falciparum from other Plasmodium species that cause disease in humans. Numerous studies have demonstrated the utility of RDTs, which have sensitivity and specificity comparable to those of microscopy while offering rapid diagnosis, in Africa and Asia (1,16). The performance of RDTs in areas of low malaria prevalence is less well investigated.…”

Section: T He Accurate Diagnosis Of Malaria By Microscopy In the Unitedmentioning

confidence: 99%

Performance of BinaxNOW for Diagnosis of Malaria in a U.S. Hospital

et al. 2012

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Microscopic diagnosis and species identification of Plasmodium in areas of nonendemicity provide a robust method for malaria diagnosis but are technically challenging. A prospective study was conducted to measure the performance of BinaxNOW compared to microscopy (the gold standard) in a U.S. teaching hospital. Overall, BinaxNOW was 84.2% sensitive and 99.8% specific. Excluding patients on antimalarial therapy, the sensitivity was 92.9%. Importantly, BinaxNOW initially misclassified a case of Plasmodium falciparum malaria as non-falciparum. These results support the judicious use of BinaxNOW in screening of individuals suspected of having malaria in areas of nonendemicity. T he accurate diagnosis of malaria by microscopy in the UnitedStates is complicated by a number of factors, including lack of experienced technologists, variable methodology and quality of smears, and partial morphological overlap between Plasmodium falciparum and other Plasmodium species (12,14). Although the incidence of malaria in returned febrile travelers is approximately 21%, only 1,300 cases were reported in the United States in 2008, in comparison to 243 million cases worldwide during the same period (15,19,20). The development of rapid diagnostic tests (RDTs) has aided diagnosis of malaria in resource-poor settings, but these tests have limited capability for species identification, as they were originally designed to distinguish P. falciparum from other Plasmodium species that cause disease in humans. Numerous studies have demonstrated the utility of RDTs, which have sensitivity and specificity comparable to those of microscopy while offering rapid diagnosis, in Africa and Asia (1, 16). The performance of RDTs in areas of low malaria prevalence is less well investigated. Studies in France have demonstrated 96% sensitivity, 99% specificity, and high negative predictive values (NPV) with certain RDTs but conclude that microscopy is necessary for definitive confirmation (3, 4). A similar study in the United States demonstrated 99% overall sensitivity and 99.6% NPV for the diagnosis of malaria with the BinaxNOW Malaria test; sensitivity for P. falciparum was 100% (17). BinaxNOW Malaria, the only U.S. Food and Drug Administration-approved RDT for malaria, qualitatively detects both the histidine-rich protein 2 (HRP-2), specific to P. falciparum, and aldolase, a panmalarial antigen found in all Plasmodium species (11).Here, we report on the performance of the BinaxNOW in a major U.S. academic medical center, describe a unique case of misidentification of P. falciparum by BinaxNOW, and discuss the advantages and disadvantages of using BinaxNOW as a screening tool in the United States. MATERIALS AND METHODSFrom July 2008 to March 2012, 484 BinaxNOW Malaria tests, on 407 unique patients, were performed concurrently with thin and thick blood smears in the Stanford Hospital Clinical Hematology Laboratory on consecutive blood samples from patients with suspected malaria. For each sample, one thick and two thin smears were prepared from venous ED...

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“…1,2 For diagnosing malaria, the microscopic detection of Plasmodium in thick blood films remains the gold standard, although reliable rapid diagnostic tests are increasingly available. 3 In addition, microscopic examination of stained blood films also enables the detection of other pathogens, including Trypanosoma brucei ssp., some of which cause human African trypanosomiasis. Half of all people at risk of African trypanosomiasis live in the Democratic Republic of the Congo, where almost 80% of all reported cases have occurred.…”

Section: Introductionmentioning

confidence: 99%

External quality assessment of Giemsa-stained blood film microscopy for the diagnosis of malaria and sleeping sickness in the Democratic Republic of the Congo

Mukadi

Gillet

Lukuka

et al. 2013

Bull. World Health Organ.

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Rapid diagnostic tests for diagnosing uncomplicatedP. falciparummalaria in endemic countries

Cited by 189 publications

References 284 publications

Light-emitting diode fluorescence microscopy for tuberculosis diagnosis: a meta-analysis

Light-emitting diode fluorescence microscopy for tuberculosis diagnosis: a meta-analysis

Performance of BinaxNOW for Diagnosis of Malaria in a U.S. Hospital

External quality assessment of Giemsa-stained blood film microscopy for the diagnosis of malaria and sleeping sickness in the Democratic Republic of the Congo

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