title: Field and laboratory comparative evaluation of rapid malaria diagnostic tests versus traditional and molecular techniques in India.
abstract: BACKGROUND
  Malaria presents a diagnostic challenge in most tropical countries. Microscopy remains the gold standard for diagnosing malaria infections in clinical practice and research. However, microscopy is labour intensive, requires significant skills and time, which causes therapeutic delays. The objective of obtaining result quickly from the examination of blood samples from patients with suspected malaria is now made possible with the introduction of rapid malaria diagnostic tests (RDTs). Several RDTs are available, which are fast, reliable and simple to use and can detect Plasmodium falciparum and non-falciparum infections or both. A study was conducted in tribal areas of central India to measure the overall performance of several RDTs for diagnosis of P. falciparum and non-falciparum infections in comparison with traditional and molecular techniques. Such data will be used to guide procurement decisions of policy makers and programme managers.
  
  
  METHODS
  Five commercially available RDTs were tested simultaneously in field in parallel with peripheral blood smears in outbreak-affected areas. The evaluation is designed to provide comparative data on the performance of each RDT. In addition, molecular method i.e. polymerase chain reaction (PCR) was also carried out to compare all three methods.
  
  
  RESULTS
  A total of 372 patients with a clinical suspicion of malaria from Bajag Primary Health Centre (PHC) of district Dindori and Satanwada PHC of district Shivpuri attending the field clinics of Regional Medical Research Centre were included in the study. The analysis revealed that the First Response Malaria Antigen pLDH/HRP2 combo test was 94.7% sensitive (95% CI 89.5-97.7) and 69.9% specific (95% CI 63.6-75.6) for P. falciparum. However, for non-falciparum infections (Plasmodium vivax) the test was 84.2% sensitive (95% CI 72.1-92.5) and 96.5% specific (95% CI 93.8-98.2). The Parascreen represented a good alternative. All other RDTs were relatively less sensitive for both P. falciparum and non-falciparum infections.
  
  
  CONCLUSIONS
  The results in this study show comparative performance between microscopy, various RDTs and PCR. Despite some inherent limitation in the five RDTs tested, First Response clearly has an advantage over other RDTs. The results suggest that RDTs could play and will play an important role in malaria diagnosis.
authors.affiliation: Regional Medical Research Centre for Tribals ICMR, RMRCT Campus, Nagpur Road, Jabalpur 482003, Madhya Pradesh, India. neeru.singh@gmail.com
authors.forename: Neeru
authors.initials: N
authors.lastname: Singh
authors.forename: Man M
authors.initials: MM
authors.lastname: Shukla
authors.forename: Mohan K
authors.initials: MK
authors.lastname: Shukla
authors.forename: Rajiv K
authors.initials: RK
authors.lastname: Mehra
authors.forename: Shweta
authors.initials: S
authors.lastname: Sharma
authors.forename: Praveen K
authors.initials: PK
authors.lastname: Bharti
authors.forename: Mrigendra P
authors.initials: MP
authors.lastname: Singh
authors.forename: Ajay
authors.initials: A
authors.lastname: Singh
authors.forename: Arunachalam
authors.initials: A
authors.lastname: Gunasekar
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001800:Blood Specimen Collection; D002648:Child; D002675:Child, Preschool; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007194:India; D007223:Infant; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000469:parasitology; D016780:Malaria, Vivax / Q000175:diagnosis* / Q000469:parasitology; D008297:Male; D008853:Microscopy / Q000379:methods; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000302:isolation & purification*; D010966:Plasmodium vivax / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic