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Multicenter study to evaluate the OptiMAL rapid malaria diagnostic test in US hospitals



Multicenter study to evaluate the OptiMAL rapid malaria diagnostic test in US hospitals



Abstracts of the Interscience Conference on Antimicrobial Agents & Chemotherapy 43: 186



Background: Conventional diagnosis of malaria is accomplished by microscopic examination of blood smears. Microscopy is labor intensive, time consuming and may yield ambiguous results. Additionally, patients with suspected malaria often present to hospital ERs during hours when minimal laboratory staff are available. This multicenter study evaluated a rapid malaria diagnostic test, the OptiMAL(R) in comparison with microscopy to determine the usefulness of the Optimal(R) as a tool to quickly diagnose malaria in U. S. hospitals. Methods: Patients symptomatic for malaria were recruited in six U.S. hospitals. A venous blood sample was tested for malaria by both microscopy and the OptiMAL(R). The OptiMAL(R) test is performed on a drop of blood and detects pLDH, an enzyme produced by actively metabolizing malaria parasites. If a patient has malaria, a series of red lines appear on the test strip. The test differentiates P. falciparum from non-P. falciparum infections. Results: 216 patients with suspected malaria were tested by both microscopy and OptiMAL(R). Results indicated that 43 (20%) of the specimens were positive for malaria by microscopy (32 P. falciparum, 11 non-P. falciparum) while 42 (19%) were positive by OptiMAL(R) (31 falciparum, 11 non-falciparum). The OptiMAL(R) test sensitivity was 98%; specificity was 100% with a positive and negative predictive value of 100% and 99% respectively. The accuracy of the test was 100%. Conclusion: Participating hospitals reported that the OptiMAL(R) test was easy to perform and results were clear and simple to interpret. The general consensus from the hospital physicians and laboratory personnel was that routine use of the OptiMAL(R) in hospital laboratories would facilitate diagnosis of malaria and improve patient care in emergency rooms.

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