Commercial Dengue Rapid Diagnostic Tests for Point-of-Care Application: Recent Evaluations and Future Needs?

Dengue fever, dengue haemorrhagic fever, and dengue shock syndrome (DF/DHF/DSS) are tropical diseases that cause significant humanitarian and economic hardship. It is estimated that more than 2.5 billion people are at risk of infection and more than 100 countries have endemic dengue virus transmission. Laboratory tests are essential to provide an accurate diagnosis of dengue virus infection so that appropriate treatment and patient management may be administered. In many dengue endemic settings, laboratory diagnostic resources are limited and simple rapid diagnostic tests (RDTs) provide opportunities for point-of-care diagnosis. This paper addresses current issues relating to the application of commercial dengue RDTs for the diagnosis of acute dengue virus infection, recent diagnostic evaluations, and identifies future needs.

[1]  R. Peeling,et al.  Point-of-care tests for diagnosing infections in the developing world. , 2010, Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases.

[2]  R. Césaire,et al.  Prospective evaluation of nonstructural 1 enzyme-linked immunosorbent assay and rapid immunochromatographic tests to detect dengue virus in patients with acute febrile illness. , 2011, Diagnostic microbiology and infectious disease.

[3]  Rosanna W. Peeling,et al.  Dengue: a continuing global threat , 2010, Nature Reviews Microbiology.

[4]  V. Deubel,et al.  Enzyme-Linked Immunosorbent Assay Specific to Dengue Virus Type 1 Nonstructural Protein NS1 Reveals Circulation of the Antigen in the Blood during the Acute Phase of Disease in Patients Experiencing Primary or Secondary Infections , 2002, Journal of Clinical Microbiology.

[5]  S. Sekaran,et al.  Development of ASSURE® Dengue IgA Rapid Test for the Detection of Anti-dengue IgA from Dengue Infected Patients , 2011, Journal of global infectious diseases.

[6]  S. Sekaran,et al.  Evaluation of a Commercial SD Dengue Virus NS1 Antigen Capture Enzyme-Linked Immunosorbent Assay Kit for Early Diagnosis of Dengue Virus Infection , 2010, Journal of Clinical Microbiology.

[7]  J. Farrar,et al.  Comparison of two dengue NS1 rapid tests for sensitivity, specificity and relationship to viraemia and antibody responses , 2010, BMC infectious diseases.

[8]  A. Nisalak,et al.  High circulating levels of the dengue virus nonstructural protein NS1 early in dengue illness correlate with the development of dengue hemorrhagic fever. , 2002, The Journal of infectious diseases.

[9]  P. Young,et al.  Production of dimer-specific and dengue virus group cross-reactive mouse monoclonal antibodies to the dengue 2 virus non-structural glycoprotein NS1. , 1991, The Journal of general virology.

[10]  A. Nisalak,et al.  Prospective Study To Determine Accuracy of Rapid Serological Assays for Diagnosis of Acute Dengue Virus Infection in Laos , 2007, Clinical and Vaccine Immunology.

[11]  Chew Theng Sang,et al.  Clinical Evaluation of a Rapid Immunochromatographic Test for the Diagnosis of Dengue Virus Infection , 1998, Clinical Diagnostic Laboratory Immunology.

[12]  P. Young,et al.  An Antigen Capture Enzyme-Linked Immunosorbent Assay Reveals High Levels of the Dengue Virus Protein NS1 in the Sera of Infected Patients , 2000, Journal of Clinical Microbiology.

[13]  S. Sekaran,et al.  The Diagnostic Sensitivity of Dengue Rapid Test Assays Is Significantly Enhanced by Using a Combined Antigen and Antibody Testing Approach , 2011, PLoS neglected tropical diseases.

[14]  Rosanna W. Peeling,et al.  Evaluation of Commercially Available Anti–Dengue Virus Immunoglobulin M Tests , 2009, Emerging infectious diseases.

[15]  M. Guzmán,et al.  Kinetics of antibodies in sera, saliva, and urine samples from adult patients with primary or secondary dengue 3 virus infections. , 2007, International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases.

[16]  H. Doerr,et al.  Rapid Diagnosis of Primary Dengue Fever by the Immunochromatographic Test and by Electron Microscopy – A Case Report , 1999, Infection.

[17]  J. Lepault,et al.  Dengue Virus Type 1 Nonstructural Glycoprotein NS1 Is Secreted from Mammalian Cells as a Soluble Hexamer in a Glycosylation-Dependent Fashion , 1999, Journal of Virology.

[18]  A. Osterhaus,et al.  Kinetics of Dengue Virus-Specific Serum Immunoglobulin Classes and Subclasses Correlate with Clinical Outcome of Infection , 2001, Journal of Clinical Microbiology.

[19]  I. Kurane,et al.  Specific IgM and IgG responses in primary and secondary dengue virus infections determined by enzyme-linked immunosorbent assay , 2005, Epidemiology and Infection.

[20]  Philippe Dussart,et al.  Evaluation of Two New Commercial Tests for the Diagnosis of Acute Dengue Virus Infection Using NS1 Antigen Detection in Human Serum , 2008, PLoS neglected tropical diseases.

[21]  Cameron P. Simmons,et al.  Diagnostic Accuracy of NS1 ELISA and Lateral Flow Rapid Tests for Dengue Sensitivity, Specificity and Relationship to Viraemia and Antibody Responses , 2009, PLoS neglected tropical diseases.

[22]  M. Guzmán,et al.  Dengue diagnosis, advances and challenges. , 2004, International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases.

[23]  Rosanna W Peeling,et al.  A guide for diagnostic evaluations , 2006, Nature Reviews Microbiology.

[24]  Albert D. M. E. Osterhaus,et al.  Detection of Immune-Complex-Dissociated Nonstructural-1 Antigen in Patients with Acute Dengue Virus Infections , 2003, Journal of Clinical Microbiology.

[25]  S. Sekaran,et al.  Evaluation of ASSURE® Dengue IgA Rapid Test using dengue-positive and dengue-negative samples. , 2010, Diagnostic microbiology and infectious disease.

[26]  A. Nisalak,et al.  An enzyme-linked immunosorbent assay to characterize dengue infections where dengue and Japanese encephalitis co-circulate. , 1989, The American journal of tropical medicine and hygiene.

[27]  P. Levett,et al.  Evaluation of Four Methods for Detection of Immunoglobulin M Antibodies to Dengue Virus , 1999, Clinical Diagnostic Laboratory Immunology.

[28]  V. Deubel,et al.  Clinical and Virological Factors Influencing the Performance of a NS1 Antigen-Capture Assay and Potential Use as a Marker of Dengue Disease Severity , 2011, PLoS neglected tropical diseases.

[29]  L. Ng,et al.  Evaluation of nonstructural 1 antigen assays for the diagnosis and surveillance of dengue in Singapore. , 2010, Vector borne and zoonotic diseases.

[30]  A. Nisalak,et al.  The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection. , 2006, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[31]  K. Chua,et al.  Performance of a commercial rapid dengue NS1 antigen immunochromatography test with reference to dengue NS1 antigen-capture ELISA. , 2009, Journal of virological methods.

[32]  D. Gubler,et al.  Viraemia in patients with naturally acquired dengue infection. , 1981, Bulletin of the World Health Organization.

[33]  A. Nisalak,et al.  Evaluation of the Panbio dengue virus nonstructural 1 antigen detection and immunoglobulin M antibody enzyme-linked immunosorbent assays for the diagnosis of acute dengue infections in Laos. , 2008, Diagnostic microbiology and infectious disease.

[34]  G. Comach,et al.  Evaluation of dengue NS1 antigen detection tests with acute sera from patients infected with dengue virus in Venezuela. , 2009, Diagnostic microbiology and infectious disease.

[35]  M. Guzmán,et al.  Diagnosis of Dengue Virus Infection by Detection of Specific Immunoglobulin M (IgM) and IgA Antibodies in Serum and Saliva , 2003, Clinical Diagnostic Laboratory Immunology.

[36]  S. Yoksan,et al.  Evaluation of dengue nonstructural protein 1 antigen strip for the rapid diagnosis of patients with dengue infection. , 2009, Diagnostic microbiology and infectious disease.

[37]  M. Moorthy,et al.  Evaluation of a rapid immunochromatographic device for the detection of IgM & IgG antibodies to dengue viruses (DENV) in a tertiary care hospital in south India. , 2009, Indian journal of medical microbiology.

[38]  D. Vaughn,et al.  Comparison of Two Rapid Diagnostic Assays for Detection of Immunoglobulin M Antibodies to Dengue Virus , 2000, Clinical Diagnostic Laboratory Immunology.

[39]  Ho‐Sheng Wu,et al.  Application of the Dengue Virus NS1 Antigen Rapid Test for On-Site Detection of Imported Dengue Cases at Airports , 2009, Clinical and Vaccine Immunology.

[40]  H. Schatzmayr,et al.  Comparison of Three Commercially Available Dengue NS1 Antigen Capture Assays for Acute Diagnosis of Dengue in Brazil , 2010, PLoS neglected tropical diseases.

[41]  H. Prince,et al.  Estimation of Dengue Virus IgM Persistence Using Regression Analysis , 2011, Clinical and Vaccine Immunology.

[42]  P. Newton,et al.  A systematic review and meta-analysis of the diagnostic accuracy of rapid immunochromatographic assays for the detection of dengue virus IgM antibodies during acute infection. , 2006, Transactions of the Royal Society of Tropical Medicine and Hygiene.

[43]  Kun Wen,et al.  Kinetics of non-structural protein 1, IgM and IgG antibodies in dengue type 1 primary infection , 2011, Virology Journal.

[44]  H. J. de Silva,et al.  Evaluation of Six Commercial Point-of-Care Tests for Diagnosis of Acute Dengue Infections: the Need for Combining NS1 Antigen and IgM/IgG Antibody Detection To Achieve Acceptable Levels of Accuracy , 2011, Clinical and Vaccine Immunology.

[45]  L. Villar,et al.  Comparison of the diagnostic accuracy of commercial NS1-based diagnostic tests for early dengue infection , 2010, Virology Journal.

[46]  P. D. de Vries,et al.  Evaluation of Two Rapid Immunochromatographic Assays for Diagnosis of Dengue among Vietnamese Febrile Patients , 2007, Clinical and Vaccine Immunology.

[47]  N. M. Dung,et al.  Evaluation of a Rapid Immunochromatographic Test for Diagnosis of Dengue Virus Infection , 1998, Journal of Clinical Microbiology.

[48]  A. Nisalak,et al.  Dengue viremia titer, antibody response pattern, and virus serotype correlate with disease severity. , 2000, The Journal of infectious diseases.

[49]  D. Gubler,et al.  Dengue and dengue hemorrhagic fever. , 2014 .