Diagnostic accuracy of an automated microscope solution (miLab™) in detecting malaria parasites in symptomatic patients at point-of-care in Sudan: a case–control study

• Published in: Malaria Journal
• Main Authors: Muzamil M. Abdel Hamid, Abdelrahim O. Mohamed, Fayad O. Mohammed, Arwa Elaagip, Sayed A. Mustafa, Tarig Elfaki, Waleed M. A. Jebreel, Musab M. Albsheer, Sabine Dittrich, Ewurama D. A. Owusu, Seda Yerlikaya
• Format: Article in Journal/Newspaper
• Language: English
• Published: BMC 2024
• Subjects: Automated microscope; Artificial intelligence; miLab™; Malaria; Sudan; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic
• Online Access: https://doi.org/10.1186/s12936-024-05029-3; https://doaj.org/article/dbfe8dfc1dba4aff909dfee472b4564a

Abstract Background Microscopic detection of malaria parasites is labour-intensive, time-consuming, and expertise-demanding. Moreover, the slide interpretation is highly dependent on the staining technique and the technician’s expertise. Therefore, there is a growing interest in next-generation, fully- or semi-integrated microscopes that can improve slide preparation and examination. This study aimed to evaluate the clinical performance of miLab™ (Noul Inc., Republic of Korea), a fully-integrated automated microscopy device for the detection of malaria parasites in symptomatic patients at point-of-care in Sudan. Methods This was a prospective, case–control diagnostic accuracy study conducted in primary health care facilities in rural Khartoum, Sudan in 2020. According to the outcomes of routine on-site microscopy testing, 100 malaria-positive and 90 malaria-negative patients who presented at the health facility and were 5 years of age or older were enrolled consecutively. All consenting patients underwent miLab™ testing and received a negative or suspected result. For the primary analysis, the suspected results were regarded as positive (automated mode). For the secondary analysis, the operator reviewed the suspected results and categorized them as either negative or positive (corrected mode). Nested polymerase chain reaction (PCR) was used as the reference standard, and expert light microscopy as the comparator. Results Out of the 190 patients, malaria diagnosis was confirmed by PCR in 112 and excluded in 78. The sensitivity of miLab™ was 91.1% (95% confidence interval [CI] 84.2–95.6%) and the specificity was 66.7% (95% Cl 55.1–67.7%) in the automated mode. The specificity increased to 96.2% (95% Cl 89.6–99.2%), with operator intervention in the corrected mode. Concordance of miLab with expert microscopy was substantial (kappa 0.65 [95% CI 0.54–0.76]) in the automated mode, but almost perfect (kappa 0.97 [95% CI 0.95–0.99]) in the corrected mode. A mean difference of 0.359 was found in the Bland–Altman analysis ...