title: Evaluation of a pan-serotype point-of-care rapid diagnostic assay for accurate detection of acute dengue infection.
abstract: The catastrophic rise in dengue infections in India and globally has created a need for an accurate, validated low-cost rapid diagnostic test (RDT) for dengue. We prospectively evaluated the diagnostic performance of NS1/IgM RDT (dengue day 1) using 211 samples from a pediatric dengue cohort representing all 4 serotypes in southern India. The dengue-positive panel consisted of 179 dengue real-time polymerase chain reaction (RT-PCR) positive samples from symptomatic children. The dengue-negative panel consisted of 32 samples from dengue-negative febrile children and asymptomatic individuals that were negative for dengue RT-PCR/NS1 enzyme-linked immunosorbent assay/IgM/IgG. NS1/IgM RDT sensitivity was 89.4% and specificity was 93.8%. The NS1/IgM RDT showed high sensitivity throughout the acute phase of illness, in primary and secondary infections, in different severity groups, and detected all 4 dengue serotypes, including coinfections. This NS1/IgM RDT is a useful point-of-care assay for rapid and reliable diagnosis of acute dengue and an excellent surveillance tool in our battle against dengue.
authors.affiliation: Division of Infectious Diseases, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, 560034, India.
authors.forename: Rosario
authors.initials: R
authors.lastname: Vivek
authors.affiliation: Division of Infectious Diseases, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, 560034, India.
authors.forename: Syed Fazil
authors.initials: SF
authors.lastname: Ahamed
authors.affiliation: Division of Infectious Diseases, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, 560034, India.
authors.forename: Shalini
authors.initials: S
authors.lastname: Kotabagi
authors.affiliation: ICGEB-Emory Vaccine Centre, International Centre for Genetic Engineering and Biotechnology, Aruna Asaf Ali Marg, New Delhi, 110067, India.
authors.forename: Anmol
authors.initials: A
authors.lastname: Chandele
authors.affiliation: Mammalian Biology, Recombinant Gene Products Laboratory, Centre for Genetic Engineering and Biotechnology, Aruna Asaf Ali Marg, New Delhi, 110067, India.
authors.forename: Ira
authors.initials: I
authors.lastname: Khanna
authors.affiliation: Mammalian Biology, Recombinant Gene Products Laboratory, Centre for Genetic Engineering and Biotechnology, Aruna Asaf Ali Marg, New Delhi, 110067, India.
authors.forename: Navin
authors.initials: N
authors.lastname: Khanna
authors.affiliation: ICGEB-Emory Vaccine Centre, International Centre for Genetic Engineering and Biotechnology, Aruna Asaf Ali Marg, New Delhi, 110067, India.
authors.forename: Kaustuv
authors.initials: K
authors.lastname: Nayak
authors.affiliation: Department of Microbiology, St. John's Medical College Hospital, Bangalore, 560034, India.
authors.forename: Mary
authors.initials: M
authors.lastname: Dias
authors.affiliation: ICGEB-Emory Vaccine Centre, International Centre for Genetic Engineering and Biotechnology, Aruna Asaf Ali Marg, New Delhi, 110067, India; Department of Pediatrics, Emory University, 1760 Haygood Drive, Atlanta, GA, 30322, USA.
authors.forename: Murali-Krishna
authors.initials: MK
authors.lastname: Kaja
authors.affiliation: Division of Infectious Diseases, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, 560034, India; International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: ashet1@jhu.edu.
authors.forename: Anita
authors.initials: A
authors.lastname: Shet
mesh_terms: D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood*; D000956:Antigens, Viral / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D003141:Communicable Diseases / Q000175:diagnosis; D003715:Dengue / Q000175:diagnosis*; D003716:Dengue Virus / Q000235:genetics / Q000276:immunology; D003955:Diagnostic Tests, Routine / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D007075:Immunoglobulin M / Q000097:blood* / Q000276:immunology; D007194:India; D007223:Infant; D008297:Male; D019095:Point-of-Care Systems; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D017361:Viral Nonstructural Proteins / Q000235:genetics / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D000956:Antigens, Viral; D007075:Immunoglobulin M; C079340:NS1 protein, Dengue virus type 2; C546113:NS1 protein, Dengue virus type 3; C082515:NS1 protein, dengue-1 virus; D017361:Viral Nonstructural Proteins
keywords: Dengue; Diagnostics; Evaluation; NS1 protein; Rapid diagnostic test