Hagen Frickmann1, Rebecca Hinz2, Sandra Rojak3, Insa Bonow4, Stefanie Ruben5, Christine Wegner6, Iris Zielke7, Ralf Matthias Hagen8, Egbert Tannich9. 1. Department of Microbiology and Hospital Hygiene, Tropical Microbiology and Entomology Unit, Bundeswehr Hospital Hamburg, Bernhard Nocht Str. 74, 20359 Hamburg, Germany; Institute for Medical Microbiology, Virology and Hygiene, University Medicine Rostock, Schillingallee 70, 18057 Rostock, Germany. Electronic address: Frickmann@bnitm.de. 2. Department of Microbiology and Hospital Hygiene, Tropical Microbiology and Entomology Unit, Bundeswehr Hospital Hamburg, Bernhard Nocht Str. 74, 20359 Hamburg, Germany. Electronic address: hinz@bnitm.de. 3. Department of Microbiology and Hospital Hygiene, Tropical Microbiology and Entomology Unit, Bundeswehr Hospital Hamburg, Bernhard Nocht Str. 74, 20359 Hamburg, Germany; Department of Infectious Diseases and Tropical Medicine, Bundeswehr Hospital Hamburg, Bernhard Nocht Str. 74, 20359 Hamburg, Germany. Electronic address: rojak@bnitm.de. 4. National Reference Centre for Tropical Pathogens, Bernhard Nocht Institute for Tropical Medicine, Bernhard Nocht Str. 74, 20359 Hamburg, Germany. Electronic address: ibonow@bnitm.de. 5. National Reference Centre for Tropical Pathogens, Bernhard Nocht Institute for Tropical Medicine, Bernhard Nocht Str. 74, 20359 Hamburg, Germany. Electronic address: ruben@bnitm.de. 6. National Reference Centre for Tropical Pathogens, Bernhard Nocht Institute for Tropical Medicine, Bernhard Nocht Str. 74, 20359 Hamburg, Germany. Electronic address: wegner@bnitm.de. 7. National Reference Centre for Tropical Pathogens, Bernhard Nocht Institute for Tropical Medicine, Bernhard Nocht Str. 74, 20359 Hamburg, Germany. Electronic address: zielke@bnitm.de. 8. Department of Preventive Medicine, Bundeswehr Medical Academy, Neuherbergstr. 11, 80937 Munich, Germany. Electronic address: hagen@bnitm.de. 9. National Reference Centre for Tropical Pathogens, Bernhard Nocht Institute for Tropical Medicine, Bernhard Nocht Str. 74, 20359 Hamburg, Germany. Electronic address: tannich@bnitm.de.
Abstract
BACKGROUND: We assessed a commercial loop-mediated amplification (LAMP) platform for its reliability as a screening tool for malaria parasite detection. METHODS: A total of 1000 blood samples from patients with suspected or confirmed malaria submitted to the German National Reference Center for Tropical Pathogens were subjected to LAMP using the Meridian illumigene Malaria platform. Results were compared with microscopy from thick and thin blood films in all cases. In case of discordant results between LAMP and microscopy (n = 60), confirmation testing was performed with real-time PCR. Persistence of circulating parasite DNA was analyzed by serial assessments of blood samples following malaria treatment. RESULTS: Out of 1000 blood samples analyzed, 238 were positive for malaria parasites according to microscopy (n = 181/1000) or PCR (additional n = 57/60). LAMP demonstrated sensitivity of 98.7% (235/238), specificity of 99.6% (759/762), positive predictive value (PPV) of 98.7% (235/238) and negative predictive value (NPV) of 99.6% (759/762), respectively. For first slides of patients with malaria and for follow-up slides, sensitivity values were 99.1% (106/107) and 98.5% (129/131), respectively. CONCLUSIONS: The performance of the Meridian illumigene Malaria platform is suitable for initial screening of patients suspected of clinical malaria.
BACKGROUND: We assessed a commercial loop-mediated amplification (LAMP) platform for its reliability as a screening tool for malaria parasite detection. METHODS: A total of 1000 blood samples from patients with suspected or confirmed malaria submitted to the German National Reference Center for Tropical Pathogens were subjected to LAMP using the Meridian illumigene Malaria platform. Results were compared with microscopy from thick and thin blood films in all cases. In case of discordant results between LAMP and microscopy (n = 60), confirmation testing was performed with real-time PCR. Persistence of circulating parasite DNA was analyzed by serial assessments of blood samples following malaria treatment. RESULTS: Out of 1000 blood samples analyzed, 238 were positive for malaria parasites according to microscopy (n = 181/1000) or PCR (additional n = 57/60). LAMP demonstrated sensitivity of 98.7% (235/238), specificity of 99.6% (759/762), positive predictive value (PPV) of 98.7% (235/238) and negative predictive value (NPV) of 99.6% (759/762), respectively. For first slides of patients with malaria and for follow-up slides, sensitivity values were 99.1% (106/107) and 98.5% (129/131), respectively. CONCLUSIONS: The performance of the Meridian illumigene Malaria platform is suitable for initial screening of patients suspected of clinical malaria.
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