Field evaluation of the diagnostic performance of EasyScan GO: a digital malaria microscopy device based on machine-learning
Issued Date
2022-12-01
Resource Type
eISSN
14752875
Scopus ID
2-s2.0-85128011870
Pubmed ID
35413904
Journal Title
Malaria Journal
Volume
21
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Malaria Journal Vol.21 No.1 (2022)
Suggested Citation
Das D., Vongpromek R., Assawariyathipat T., Srinamon K., Kennon K., Stepniewska K., Ghose A., Sayeed A.A., Faiz M.A., Netto R.L.A., Siqueira A., Yerbanga S.R., Ouédraogo J.B., Callery J.J., Peto T.J., Tripura R., Koukouikila-Koussounda F., Ntoumi F., Ong’echa J.M., Ogutu B., Ghimire P., Marfurt J., Ley B., Seck A., Ndiaye M., Moodley B., Sun L.M., Archasuksan L., Proux S., Nsobya S.L., Rosenthal P.J., Horning M.P., McGuire S.K., Mehanian C., Burkot S., Delahunt C.B., Bachman C., Price R.N., Dondorp A.M., Chappuis F., Guérin P.J., Dhorda M. Field evaluation of the diagnostic performance of EasyScan GO: a digital malaria microscopy device based on machine-learning. Malaria Journal Vol.21 No.1 (2022). doi:10.1186/s12936-022-04146-1 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/84861
Title
Field evaluation of the diagnostic performance of EasyScan GO: a digital malaria microscopy device based on machine-learning
Author(s)
Das D.
Vongpromek R.
Assawariyathipat T.
Srinamon K.
Kennon K.
Stepniewska K.
Ghose A.
Sayeed A.A.
Faiz M.A.
Netto R.L.A.
Siqueira A.
Yerbanga S.R.
Ouédraogo J.B.
Callery J.J.
Peto T.J.
Tripura R.
Koukouikila-Koussounda F.
Ntoumi F.
Ong’echa J.M.
Ogutu B.
Ghimire P.
Marfurt J.
Ley B.
Seck A.
Ndiaye M.
Moodley B.
Sun L.M.
Archasuksan L.
Proux S.
Nsobya S.L.
Rosenthal P.J.
Horning M.P.
McGuire S.K.
Mehanian C.
Burkot S.
Delahunt C.B.
Bachman C.
Price R.N.
Dondorp A.M.
Chappuis F.
Guérin P.J.
Dhorda M.
Vongpromek R.
Assawariyathipat T.
Srinamon K.
Kennon K.
Stepniewska K.
Ghose A.
Sayeed A.A.
Faiz M.A.
Netto R.L.A.
Siqueira A.
Yerbanga S.R.
Ouédraogo J.B.
Callery J.J.
Peto T.J.
Tripura R.
Koukouikila-Koussounda F.
Ntoumi F.
Ong’echa J.M.
Ogutu B.
Ghimire P.
Marfurt J.
Ley B.
Seck A.
Ndiaye M.
Moodley B.
Sun L.M.
Archasuksan L.
Proux S.
Nsobya S.L.
Rosenthal P.J.
Horning M.P.
McGuire S.K.
Mehanian C.
Burkot S.
Delahunt C.B.
Bachman C.
Price R.N.
Dondorp A.M.
Chappuis F.
Guérin P.J.
Dhorda M.
Author's Affiliation
Infectious Diseases Data Observatory
WorldWide Antimalarial Resistance Network
Faculty of Tropical Medicine, Mahidol University
Makerere University College of Health Sciences
Mahidol Oxford Tropical Medicine Research Unit
Infectious Diseases Research Collaboration
Tribhuvan University
Universite Cheikh Anta Diop
Kenya Medical Research Institute
National Institute for Communicable Diseases
Fundacao Oswaldo Cruz
Menzies School of Health Research
University of California, San Francisco
L'Institut de Santé Globale, Genève
University of Oregon
Hôpitaux Universitaires de Genève
Nuffield Department of Medicine
Chittagong Medical College
Dev Care Foundation
Global Health Labs
Institut des Sciences et Techniques
Fondation Congolaise pour la Recherche Médicale (FCRM)
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
WorldWide Antimalarial Resistance Network
Faculty of Tropical Medicine, Mahidol University
Makerere University College of Health Sciences
Mahidol Oxford Tropical Medicine Research Unit
Infectious Diseases Research Collaboration
Tribhuvan University
Universite Cheikh Anta Diop
Kenya Medical Research Institute
National Institute for Communicable Diseases
Fundacao Oswaldo Cruz
Menzies School of Health Research
University of California, San Francisco
L'Institut de Santé Globale, Genève
University of Oregon
Hôpitaux Universitaires de Genève
Nuffield Department of Medicine
Chittagong Medical College
Dev Care Foundation
Global Health Labs
Institut des Sciences et Techniques
Fondation Congolaise pour la Recherche Médicale (FCRM)
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Other Contributor(s)
Abstract
Background: Microscopic examination of Giemsa-stained blood films remains the reference standard for malaria parasite detection and quantification, but is undermined by difficulties in ensuring high-quality manual reading and inter-reader reliability. Automated parasite detection and quantification may address this issue. Methods: A multi-centre, observational study was conducted during 2018 and 2019 at 11 sites to assess the performance of the EasyScan Go, a microscopy device employing machine-learning-based image analysis. Sensitivity, specificity, accuracy of species detection and parasite density estimation were assessed with expert microscopy as the reference. Intra- and inter-device reliability of the device was also evaluated by comparing results from repeat reads on the same and two different devices. This study has been reported in accordance with the Standards for Reporting Diagnostic accuracy studies (STARD) checklist. Results: In total, 2250 Giemsa-stained blood films were prepared and read independently by expert microscopists and the EasyScan Go device. The diagnostic sensitivity of EasyScan Go was 91.1% (95% CI 88.9–92.7), and specificity 75.6% (95% CI 73.1–78.0). With good quality slides sensitivity was similar (89.1%, 95%CI 86.2–91.5), but specificity increased to 85.1% (95%CI 82.6–87.4). Sensitivity increased with parasitaemia rising from 57% at < 200 parasite/µL, to ≥ 90% at > 200–200,000 parasite/µL. Species were identified accurately in 93% of Plasmodium falciparum samples (kappa = 0.76, 95% CI 0.69–0.83), and in 92% of Plasmodium vivax samples (kappa = 0.73, 95% CI 0.66–0.80). Parasite density estimates by the EasyScan Go were within ± 25% of the microscopic reference counts in 23% of slides. Conclusions: The performance of the EasyScan Go in parasite detection and species identification accuracy fulfil WHO-TDR Research Malaria Microscopy competence level 2 criteria. In terms of parasite quantification and false positive rate, it meets the level 4 WHO-TDR Research Malaria Microscopy criteria. All performance parameters were significantly affected by slide quality. Further software improvement is required to improve sensitivity at low parasitaemia and parasite density estimations. Trial registration ClinicalTrials.gov number NCT03512678.