Evaluation of Commercially Available Diagnostic Tests for the Detection of Dengue Virus NS1 Antigen and Anti-Dengue Virus IgM Antibody

Hunsperger, Elizabeth A.; Yoksan, Sutee; Buchy, Philippe; Nguyen, Vinh Chau; Sekaran, Shamala Devi; Enria, Delia A.; Vazquez, Susana; Cartozian, Elizabeth; Pelegrino, Jose L.; Artsob, Harvey; Guzman, Maria G.; Olliaro, Piero; Zwang, Julien; Guillerm, Martine; Kliks, Susie; Halstead, Scott; Peeling, Rosanna W.; Margolis, Harold S.
October 2014
PLoS Neglected Tropical Diseases;Oct2014, Vol. 8 Issue 10, p1
Academic Journal
Commercially available diagnostic test kits for detection of dengue virus (DENV) non-structural protein 1 (NS1) and anti-DENV IgM were evaluated for their sensitivity and specificity and other performance characteristics by a diagnostic laboratory network developed by World Health Organization (WHO), the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Pediatric Dengue Vaccine Initiative (PDVI). Each network laboratory contributed characterized serum specimens for the panels used in the evaluation. Microplate enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT formats) were represented by the kits. Each ELISA was evaluated by 2 laboratories and RDTs were evaluated by at least 3 laboratories. The reference tests for IgM anti-DENV were laboratory developed assays produced by the Armed Forces Research Institute for Medical Science (AFRIMS) and the Centers for Disease Control and Prevention (CDC), and the NS1 reference test was reverse transcriptase polymerase chain reaction (RT-PCR). Results were analyzed to determine sensitivity, specificity, inter-laboratory and inter-reader agreement, lot-to-lot variation and ease-of-use. NS1 ELISA sensitivity was 60–75% and specificity 71–80%; NS1 RDT sensitivity was 38–71% and specificity 76–80%; the IgM anti-DENV RDTs sensitivity was 30–96%, with a specificity of 86–92%, and IgM anti-DENV ELISA sensitivity was 96–98% and specificity 78–91%. NS1 tests were generally more sensitive in specimens from the acute phase of dengue and in primary DENV infection, whereas IgM anti-DENV tests were less sensitive in secondary DENV infections. The reproducibility of the NS1 RDTs ranged from 92-99% and the IgM anti-DENV RDTs from 88–94%.


Related Articles

  • Performance of commercial dengue NS1 ELISA and molecular analysis of NS1 gene of dengue viruses obtained during surveillance in Indonesia. ¿ Aryati; Trimarsanto, Hidayat; Yohan, Benediktus; Wardhani, Puspa; Fahri, Sukmal; Tedjo Sasmono, R. // BMC Infectious Diseases;2013, Vol. 13 Issue 1, p1 

    Background Early diagnosis of dengue infection is crucial for better management of the disease. Diagnostic tests based on the detection of dengue virus (DENV) Non Structural Protein 1 (NS1) antigen are commercially available with different sensitivities and specificities observed in various...

  • First Isolation of Dengue Virus from the 2010 Epidemic in Nepal. Pandey, Basu D.; Nabeshima, Takeshi; Pandey, Kishor; Rajendra, Saroj P.; Shah, Yogendra; Adhikari, Bal R.; Gupta, Govinda; Gautam, Ishan; Tun, Mya M. N.; Uchida, Reo; Shrestha, Mahendra; Kurane, Ichiro; Morita, Kouichi // Tropical Medicine & Health;2013, Vol. 41 Issue 3, p103 

    Dengue is an emerging disease in eNepal and was first observed as an outbreak in nine lowland districts in 2006. In 2010, however, a large epidemic of dengue occurred with 4,529 suspected and 917 serologicallyconfirmed cases and five deaths reported in government hospitals in Nepal. The...

  • LABORATORY DIAGNOSIS FOR DENGUE. Cordeiro, Marli Tenório // Revista do Instituto de Medicina Tropical de Sao Paulo;Sep/Oct2012 Supplement, pS10 

    The article offers information on the laboratory diagnosis of dengue. It mentions several laboratory criteria for the confirmation of medical cases including isolation and identification of dengue virus from blood sample, detection of viral RNA using reverse transcriptase polymerase chain...

  • Genomic analysis of two ORF2 segments of new porcine astrovirus isolates and their close relationship with human astroviruses. Ulloa, Juan Carlos; Gutiérrez, María Fernanda // Canadian Journal of Microbiology;Jul2010, Vol. 56 Issue 7, p569 

    Porcine astrovirus (PAstV) has been poorly studied and has been associated mainly with gastroenteritis. Computational analysis has revealed the close relationship of PAstV with astroviruses of humans (HAstV) and cats (FAstV). In this study, 105 and 171 stool specimens were collected from piglets...

  • Detection of dengue virus serotypes 1, 2 and 3 in selected regions of Kenya: 2011-2014. Konongoi, Limbaso; Ofula, Victor; Nyunja, Albert; Owaka, Samuel; Koka, Hellen; Makio, Albina; Koskei, Edith; Eyase, Fredrick; Langat, Daniel; Schoepp, Randal J.; Rossi, Cynthia Ann; Njeru, Ian; Coldren, Rodney; Sang, Rosemary // Virology Journal;11/4/2016, Vol. 13 Issue 1, p1 

    Background: Dengue fever, a mosquito-borne disease, is associated with illness of varying severity in countries in the tropics and sub tropics. Dengue cases continue to be detected more frequently and its geographic range continues to expand. We report the largest documented laboratory confirmed...

  • Virological surveillance for early warning of dengue epidemics in the State of Rio de Janeiro, Brazil. Macedo, Gleicy Amorim; de Araújo, Josélio Maria Galvão; Schatzmayr, Hermann Gonçalves; Costa, Filipe Anibal Carvalho; de Filippis, Ana Maria Bispo; Santos, Flávia Barreto dos; Nogueira, Rita Maria Ribeiro // Transactions of the Royal Society of Tropical Medicine & Hygiene;Mar2013, Vol. 107 Issue 3, p141 

    Background The state of Rio de Janeiro has been important since 1986 as a portal for the introduction of dengue virus (DENV) into Brazil and dissemination of the virus throughout the country. This study describes an active surveillance of DENV in the state of Rio de Janeiro from 2004 to 2008....

  • Dengue myocarditis in Singapore: two case reports. Marques, N.; Gan, V.; Leo, Y.-s. // Infection;Jun2013, Vol. 41 Issue 3, p709 

    The authors report two cases of complicated dengue viral infection with acute myocarditis involving young male adults, of which one was fatal. The first case presented with typical signs of myocardial disease: chest pain and diaphoresis with myocardial depression in the electrocardiograph. The...

  • Evaluation of the Diagnostic Accuracy of a New Dengue IgA Capture Assay (Platelia Dengue IgA Capture, Bio-Rad) for Dengue Infection Detection. De Decker, Sophie; Vray, Muriel; Sistek, Viridiana; Labeau, Bhety; Enfissi, Antoine; Rousset, Dominique; Matheus, Séverine // PLoS Neglected Tropical Diseases;Mar2015, Vol. 9 Issue 3, p1 

    Considering the short lifetime of IgA antibodies in serum and the key advantages of antibody detection ELISAs in terms of sensitivity and specificity, Bio-Rad has just developed a new ELISA test based on the detection of specific anti-dengue IgA. This study has been carried out to assess the...

  • Laboratory Surveillance of Dengue in Rio Grande do Sul, Brazil, from 2007 to 2013. Tumioto, Gabriela Luchiari; Gregianini, Tatiana Schäffer; Dambros, Bibiana Paula; Cestari, Beatriz Carneiro; Alves Nunes, Zenaida Marion; Veiga, Ana Beatriz Gorini // PLoS ONE;Aug2014, Vol. 9 Issue 8, p1 

    Background: According to official records, dengue was introduced in Brazil in the 80's; since then several epidemics have occurred. Meanwhile, in Rio Grande do Sul (RS, Southern Brazil) the first autochthonous case occurred only in 2007. Methodology and Principal Findings: In this study we...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics