Abstract
BackgroundIn up to one third of the hospitals in some rural areas of Africa, laboratory services in malaria diagnosis are limited to microscopy by thin film, as no capability to perform thick film exists (gold standard in terms of sensitivity for malaria diagnosis). A new rapid molecular malaria diagnostic test called Loop-mediated isothermal DNA amplification (LAMP) has been recently validated in clinical trials showing exceptional sensitivity and specificity features. It could be a reliable diagnostic tool to be implemented without special equipment or training.ObjectiveThe objective of this proof of concept study was to confirm the feasibility of using LAMP technique for diagnosis of malaria in a rural Ethiopian hospital with limited resources.Methodology/Principal FindingsThis study was carried out in Gambo General Hospital, West Arsi Province (Ethiopia), from November 1st to December 31st 2013. A total of 162 patients with a non-focal febrile syndrome were investigated. The diagnostic capability (sensitivity, specificity, positive predictive and negative predictive values) of rapid malaria tests and microscopy by thin film was evaluated in comparison with LAMP. Eleven (6.79%) out of the 162 patients with fever and suspected malaria, tested positive for LAMP, 3 (1.85%) for rapid malaria tests and none of the eleven cases was detected by thin film microscopy.Conclusions/SignificanceLAMP can be performed in basic rural laboratories without the need for specialized infrastructure and it may set a reliable tool for malaria control to detect a low level parasitemia.
Highlights
In many areas of Ethiopia, malaria laboratory diagnosis is still based on microscopy
Eleven out of the 162 patients with fever tested positive for Loop-mediated isothermal DNA amplification (LAMP), 3 for rapid malaria tests (RDTs)
McNemar’s test) and none was detected by thin film microscopy (p = 0.0094 McNemar’s test)
Summary
In many areas of Ethiopia, malaria laboratory diagnosis is still based on microscopy. Recent studies have shown that many clinical laboratories use only thin films [2] with low sensitivity and virtually no quality control on the results [3], which could affect both to sensitivity and specificity of the diagnostic test. These results could be even poorer when only thin films are prepared in recycled slides in laboratories without quality control and no periodical training for lab technicians[4]. It could be a reliable diagnostic tool to be implemented without special equipment or training
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