title: Utility of dengue NS1 antigen rapid diagnostic test for use in difficult to reach areas and its comparison with dengue NS1 ELISA and qRT-PCR.
abstract: The objective of this study was to demonstrate the utility of dengue virus (DENV) non structural protein 1 (NS1) based rapid diagnostic test (RDT) for use in tribal and difficult to reach areas for early dengue (DEN) diagnosis in acute phase patients and evaluate its sensitivity and specificity against DENV NS1 enzyme linked immune sorbent assay (ELISA) and real time reverse transcriptase polymerase chain reaction (qRT-PCR). The DENV NS1 RDT was used for preliminary diagnosis during outbreaks in difficult to reach rural and tribal areas. The diagnosis was confirmed by DENV NS1 ELISA in the laboratory. The samples were also tested and serotyped by qRT-PCR. The results were evaluated using statistical tests. The DENV NS1 RDT showed 99.2% sensitivity and 96.0% specificity when analyzed using DENV NS1 ELISA as standard. The specificity and sensitivity of the RDT when compared with qRT-PCR was 93.6% and 91.1%, respectively. The serotype specific evaluation showed more than 90% sensitivity and specificity for DENV-1, 2, and 3. The RDT proved a good diagnostic tool in difficult to reach rural and tribal areas. Further evaluation studies with different commercially available RDTs in different field conditions are essential, that will help clinicians and patients for treatment and programme managers for timely intervention.
authors.affiliation: National Institute for Research in Tribal Health (ICMR), Jabalpur, Madhya Pradesh, India.
authors.forename: Mohan K
authors.initials: MK
authors.lastname: Shukla
authors.affiliation: National Institute for Research in Tribal Health (ICMR), Jabalpur, Madhya Pradesh, India.
authors.forename: Neeru
authors.initials: N
authors.lastname: Singh
authors.affiliation: National Institute for Research in Tribal Health (ICMR), Jabalpur, Madhya Pradesh, India.
authors.forename: Ravendra K
authors.initials: RK
authors.lastname: Sharma
authors.affiliation: National Institute for Research in Tribal Health (ICMR), Jabalpur, Madhya Pradesh, India.
authors.forename: Pradip V
authors.identifier: 0000-0002-4767-6599
authors.initials: PV
authors.lastname: Barde
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D000956:Antigens, Viral / Q000097:blood*; D003715:Dengue / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D003716:Dengue Virus / Q000276:immunology / Q000302:isolation & purification*; D042241:Early Diagnosis; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007194:India / Q000453:epidemiology; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods; D019035:Rural Health Services; D012424:Rural Population; D012680:Sensitivity and Specificity; D065288:Serogroup; D017361:Viral Nonstructural Proteins / Q000097:blood* / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D000956:Antigens, Viral; C079340:NS1 protein, Dengue virus type 2; C546113:NS1 protein, Dengue virus type 3; C082515:NS1 protein, dengue-1 virus; D011933:Reagent Kits, Diagnostic; D017361:Viral Nonstructural Proteins
keywords: NS1 ELISA; NS1 rapid diagnostic test; dengue; qRT-PCR; rural and tribal areas