title: Evaluation of the Parasight Platform for Malaria Diagnosis.
abstract: The World Health Organization estimates that nearly 500 million malaria tests are performed annually. While microscopy and rapid diagnostic tests (RDTs) are the main diagnostic approaches, no single method is inexpensive, rapid, and highly accurate. Two recent studies from our group have demonstrated a prototype computer vision platform that meets those needs. Here we present the results from two clinical studies on the commercially available version of this technology, the Sight Diagnostics Parasight platform, which provides malaria diagnosis, species identification, and parasite quantification. We conducted a multisite trial in Chennai, India (Apollo Hospital [n= 205]), and Nairobi, Kenya (Aga Khan University Hospital [n= 263]), in which we compared the device to microscopy, RDTs, and PCR. For identification of malaria, the device performed similarly well in both contexts (sensitivity of 99% and specificity of 100% at the Indian site and sensitivity of 99.3% and specificity of 98.9% at the Kenyan site, compared to PCR). For species identification, the device correctly identified 100% of samples withPlasmodium vivaxand 100% of samples withPlasmodium falciparumin India and 100% of samples withP. vivaxand 96.1% of samples withP. falciparumin Kenya, compared to PCR. Lastly, comparisons of the device parasite counts with those of trained microscopists produced average Pearson correlation coefficients of 0.84 at the Indian site and 0.85 at the Kenyan site.
authors.affiliation: Sight Diagnostics Ltd., Jerusalem, Israel.
authors.forename: Yochay
authors.initials: Y
authors.lastname: Eshel
authors.affiliation: Sight Diagnostics Ltd., Jerusalem, Israel.
authors.forename: Arnon
authors.initials: A
authors.lastname: Houri-Yafin
authors.affiliation: Sight Diagnostics Ltd., Jerusalem, Israel.
authors.forename: Hagai
authors.initials: H
authors.lastname: Benkuzari
authors.affiliation: Sight Diagnostics Ltd., Jerusalem, Israel.
authors.forename: Natalie
authors.initials: N
authors.lastname: Lezmy
authors.affiliation: Department of Pathology, Apollo Hospital, Chennai, India.
authors.forename: Mamta
authors.initials: M
authors.lastname: Soni
authors.affiliation: Department of Pathology, Apollo Hospital, Chennai, India.
authors.forename: Malini
authors.initials: M
authors.lastname: Charles
authors.affiliation: Apollo Research and Innovations, Apollo Hospital, Chennai, India.
authors.forename: Jayanthi
authors.initials: J
authors.lastname: Swaminathan
authors.affiliation: Apollo Research and Innovations, Apollo Hospital, Chennai, India.
authors.forename: Hilda
authors.initials: H
authors.lastname: Solomon
authors.affiliation: Department of Pathology, Apollo Hospital, Chennai, India.
authors.forename: Pavithra
authors.initials: P
authors.lastname: Sampathkumar
authors.affiliation: Department of Pathology, Aga Khan University Hospital, Nairobi, Kenya.
authors.forename: Zul
authors.initials: Z
authors.lastname: Premji
authors.affiliation: Department of Pathology, Aga Khan University Hospital, Nairobi, Kenya.
authors.forename: Caroline
authors.initials: C
authors.lastname: Mbithi
authors.affiliation: Department of Pathology, Aga Khan University Hospital, Nairobi, Kenya.
authors.forename: Zaitun
authors.initials: Z
authors.lastname: Nneka
authors.affiliation: Department of Pathology, Aga Khan University Hospital, Nairobi, Kenya.
authors.forename: Simon
authors.initials: S
authors.lastname: Onsongo
authors.affiliation: Department of Pathology, Aga Khan University Hospital, Nairobi, Kenya.
authors.forename: Daniel
authors.initials: D
authors.lastname: Maina
authors.affiliation: Sight Diagnostics Ltd., Jerusalem, Israel.
authors.forename: Sarah
authors.initials: S
authors.lastname: Levy-Schreier
authors.affiliation: Sight Diagnostics Ltd., Jerusalem, Israel.
authors.forename: Caitlin Lee
authors.initials: CL
authors.lastname: Cohen
authors.affiliation: Sight Diagnostics Ltd., Jerusalem, Israel.
authors.forename: Dan
authors.initials: D
authors.lastname: Gluck
authors.affiliation: Sight Diagnostics Ltd., Jerusalem, Israel.
authors.forename: Joseph Joel
authors.initials: JJ
authors.lastname: Pollak
authors.affiliation: Sight Diagnostics Ltd., Jerusalem, Israel seth@sightdx.com.
authors.forename: Seth J
authors.initials: SJ
authors.lastname: Salpeter
mesh_terms: D003955:Diagnostic Tests, Routine / Q000379:methods*; D006801:Humans; D007194:India; D007630:Kenya; D016778:Malaria, Falciparum / Q000175:diagnosis*; D016780:Malaria, Vivax / Q000175:diagnosis*; D059208:Parasite Load / Q000379:methods; D010963:Plasmodium falciparum / Q000145:classification / Q000302:isolation & purification*; D010966:Plasmodium vivax / Q000145:classification / Q000302:isolation & purification*; D011446:Prospective Studies; D012680:Sensitivity and Specificity
keywords: computer vision; diagnosis; machine learning; malaria