title: Diagnostic performance of CareStart™ malaria HRP2/pLDH (Pf/pan) combo test versus standard microscopy on falciparum and vivax malaria between China-Myanmar endemic borders.
abstract: BACKGROUND
  Rapid diagnostic test (RDT) is becoming an alternative way of establishing quickly the diagnosis of malaria infections, by detecting specific malaria antigens in suspected patients' blood between the China-Myanmar endemic borders areas, towards achieving the National Malaria Elimination programme by 2020. The objective of this study is to evaluate the performance of CareStart™ Malaria Pf/Pan RDT kit for the diagnosis of malaria infections in suspected patients. Blood examination by microscopy was taken as gold standard to evaluate CareStart™ kit's sensitivity, specificity and predictive value and corrected with PCR assay.
  
  
  RESULTS
  Overall 126 of 241 (52.28%) malaria cases were detected by microscopy compared to 115 of 241(47.72%) CareStart™ kit and 128 of 241 (53.11%) PCR corrected assay. CareStart™ kit's sensitivity and specificity for the diagnosis of malaria were 89.68% and 98.26% respectively, compared to standard microscopy, whereas the sensitivity and specificity for falciparum malaria were 88.52% and 98.26%, and for vivax malaria: 90.77% and 100%. The CareStart™ positive predictive values were 98.26% (93.88-99.52%, 95% CI) compared to 100% (96.77-100%, 95% CI) for PCR-corrected, and the negative predictive values of 89.68% (83.15-93.87%, 95% CI) were the same in microscopy as PCR-corrected. The diagnostic accuracy of CareStart™ kit versus microscopy and PCR were 93.78% (89.99-96.19%, 95% CI) and 94.61% (90.99-96.82%, 95% CI) respectively. The likelihood of diagnostic of malaria positive was almost similar between microscopy and CareStart™ kit, with an entropy reduction of 60.0% compared to a weak likelihood of misdiagnosis of 0.10 (0.09-0.12, 95% CI), with an entropy reduction of 36.01%.
  
  
  CONCLUSIONS
  The accuracy of CareStart™ kit is comparable to gold standard microscopy in these areas, it is easy to perform and suitable for cross-border diagnosis and monitoring of local or imported malaria patterns by any local health staff in endemic remotes.
authors.affiliation: National Institute of Parasitic Diseases, Chinese Center for Diseases Control and Prevention, WHO Collaborating Center on Malaria, Schisostomiasis and Filariasis, Shanghai, 200025, China. tambo0711@gmail.com.
authors.forename: Sun
authors.initials: S
authors.lastname: Xiaodong
authors.forename: Ernest
authors.initials: E
authors.lastname: Tambo
authors.forename: Wei
authors.initials: W
authors.lastname: Chun
authors.forename: Cheng
authors.initials: C
authors.lastname: Zhibin
authors.forename: Deng
authors.initials: D
authors.lastname: Yan
authors.forename: Wang
authors.initials: W
authors.lastname: Jian
authors.forename: Wang
authors.initials: W
authors.lastname: Jiazhi
authors.forename: Zhou
authors.initials: Z
authors.lastname: Xiaonong
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D002648:Child; D002675:Child, Preschool; D002681:China; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D016778:Malaria, Falciparum / Q000175:diagnosis*; D016780:Malaria, Vivax / Q000175:diagnosis*; D008297:Male; D008853:Microscopy / Q000379:methods; D008875:Middle Aged; D002052:Myanmar; D010274:Parasitology / Q000379:methods*; D012680:Sensitivity and Specificity; D055815:Young Adult