title: Performance of a HRP-2/pLDH based rapid diagnostic test at the Bangladesh-India-Myanmar border areas for diagnosis of clinical malaria.
abstract: BACKGROUND
  The rapid diagnostic test (RDT) has been adopted in contemporary malaria control and management programmes around the world as it represents a fast and apt alternative for malaria diagnosis in a resource-limited setting. This study assessed the performance of a HRP-2/pLDH based RDT (Parascreen® Pan/Pf) in a laboratory setting utilizing clinical samples obtained from the field.
  
  
  METHODS
  Whole blood samples were obtained from febrile patients referred for malaria diagnosis by clinicians from two different Upazila Health Complexes (UHCs) located near the Bangladesh-India and Bangladesh-Myanmar border where malaria is endemic. RDT was performed on archived samples and sensitivity and specificity evaluated with expert microscopy (EM) and quantitative PCR (qPCR).
  
  
  RESULTS
  A total of 327 clinical samples were made available for the study, of which 153 were Plasmodium falciparum-positive and 54 were Plasmodium vivax-positive. In comparison with EM, for P. falciparum malaria, the RDT had sensitivity: 96.0% (95% CI, 91.2-98.3) and specificity: 98.2% (95% CI, 94.6-99.5) and for P. vivax, sensitivity: 90.7% (95% CI, 78.9-96.5) and specificity: 98.9% (95% CI, 96.5-99.7). Comparison with qPCR showed, for P. falciparum malaria, sensitivity: 95.4% (95% CI, 90.5-98.0) and specificity: 98.8% (95% CI, 95.4-99.7) and for P. vivax malaria, sensitivity: 89.0% (95% CI,77.0-95.4) and specificity: 98.8% (95% CI, 96.5-99.7). Sensitivity varied according to different parasitaemia for falciparum and vivax malaria diagnosis.
  
  
  CONCLUSIONS
  Parascreen® Pan/Pf Rapid test for malaria showed acceptable sensitivity and specificity in border belt endemic areas of Bangladesh when compared with EM and qPCR.
authors.forename: Rubayet
authors.initials: R
authors.lastname: Elahi
authors.forename: Abu Naser
authors.initials: AN
authors.lastname: Mohon
authors.forename: Wasif A
authors.initials: WA
authors.lastname: Khan
authors.forename: Rashidul
authors.initials: R
authors.lastname: Haque
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh. shafiul@icddrb.org.
authors.forename: Mohammad Shafiul
authors.initials: MS
authors.lastname: Alam
mesh_terms: D000913:Antibodies, Protozoan / Q000097:blood*; D000953:Antigens, Protozoan / Q000097:blood*; D001459:Bangladesh; D003955:Diagnostic Tests, Routine / Q000379:methods*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007194:India; D007770:L-Lactate Dehydrogenase / Q000097:blood*; D016778:Malaria, Falciparum / Q000175:diagnosis*; D016780:Malaria, Vivax / Q000175:diagnosis*; D002052:Myanmar; D019095:Point-of-Care Systems; D015800:Protozoan Proteins / Q000097:blood*; D012680:Sensitivity and Specificity
chemical_list: D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; C514457:HRP-2 antigen, Plasmodium falciparum; D015800:Protozoan Proteins; D007770:L-Lactate Dehydrogenase