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The diagnostic sensitivity of dengue rapid test assays is significantly enhanced by using a combined antigen and antibody testing approach.
PLoS Negl Trop Dis. 2011 Jun; 5(6):e1199.PN

Abstract

BACKGROUND

Serological tests for IgM and IgG are routinely used in clinical laboratories for the rapid diagnosis of dengue and can differentiate between primary and secondary infections. Dengue virus non-structural protein 1 (NS1) has been identified as an early marker for acute dengue, and is typically present between days 1-9 post-onset of illness but following seroconversion it can be difficult to detect in serum.

AIMS

To evaluate the performance of a newly developed Panbio® Dengue Early Rapid test for NS1 and determine if it can improve diagnostic sensitivity when used in combination with a commercial IgM/IgG rapid test.

METHODOLOGY

The clinical performance of the Dengue Early Rapid was evaluated in a retrospective study in Vietnam with 198 acute laboratory-confirmed positive and 100 negative samples. The performance of the Dengue Early Rapid in combination with the IgM/IgG Rapid test was also evaluated in Malaysia with 263 laboratory-confirmed positive and 30 negative samples.

KEY RESULTS

In Vietnam the sensitivity and specificity of the test was 69.2% (95% CI: 62.8% to 75.6%) and 96% (95% CI: 92.2% to 99.8) respectively. In Malaysia the performance was similar with 68.9% sensitivity (95% CI: 61.8% to 76.1%) and 96.7% specificity (95% CI: 82.8% to 99.9%) compared to RT-PCR. Importantly, when the Dengue Early Rapid test was used in combination with the IgM/IgG test the sensitivity increased to 93.0%. When the two tests were compared at each day post-onset of illness there was clear differentiation between the antigen and antibody markers.

CONCLUSIONS

This study highlights that using dengue NS1 antigen detection in combination with anti-glycoprotein E IgM and IgG serology can significantly increase the sensitivity of acute dengue diagnosis and extends the possible window of detection to include very early acute samples and enhances the clinical utility of rapid immunochromatographic testing for dengue.

Authors+Show Affiliations

Research and Development, Alere, Brisbane, Australia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21713023

Citation

Fry, Scott R., et al. "The Diagnostic Sensitivity of Dengue Rapid Test Assays Is Significantly Enhanced By Using a Combined Antigen and Antibody Testing Approach." PLoS Neglected Tropical Diseases, vol. 5, no. 6, 2011, pp. e1199.
Fry SR, Meyer M, Semple MG, et al. The diagnostic sensitivity of dengue rapid test assays is significantly enhanced by using a combined antigen and antibody testing approach. PLoS Negl Trop Dis. 2011;5(6):e1199.
Fry, S. R., Meyer, M., Semple, M. G., Simmons, C. P., Sekaran, S. D., Huang, J. X., McElnea, C., Huang, C. Y., Valks, A., Young, P. R., & Cooper, M. A. (2011). The diagnostic sensitivity of dengue rapid test assays is significantly enhanced by using a combined antigen and antibody testing approach. PLoS Neglected Tropical Diseases, 5(6), e1199. https://doi.org/10.1371/journal.pntd.0001199
Fry SR, et al. The Diagnostic Sensitivity of Dengue Rapid Test Assays Is Significantly Enhanced By Using a Combined Antigen and Antibody Testing Approach. PLoS Negl Trop Dis. 2011;5(6):e1199. PubMed PMID: 21713023.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The diagnostic sensitivity of dengue rapid test assays is significantly enhanced by using a combined antigen and antibody testing approach. AU - Fry,Scott R, AU - Meyer,Michelle, AU - Semple,Matthew G, AU - Simmons,Cameron P, AU - Sekaran,Shamala Devi, AU - Huang,Johnny X, AU - McElnea,Catriona, AU - Huang,Chang-Yi, AU - Valks,Andrea, AU - Young,Paul R, AU - Cooper,Matthew A, Y1 - 2011/06/21/ PY - 2010/11/03/received PY - 2011/04/15/accepted PY - 2011/6/30/entrez PY - 2011/6/30/pubmed PY - 2011/10/19/medline SP - e1199 EP - e1199 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 5 IS - 6 N2 - BACKGROUND: Serological tests for IgM and IgG are routinely used in clinical laboratories for the rapid diagnosis of dengue and can differentiate between primary and secondary infections. Dengue virus non-structural protein 1 (NS1) has been identified as an early marker for acute dengue, and is typically present between days 1-9 post-onset of illness but following seroconversion it can be difficult to detect in serum. AIMS: To evaluate the performance of a newly developed Panbio® Dengue Early Rapid test for NS1 and determine if it can improve diagnostic sensitivity when used in combination with a commercial IgM/IgG rapid test. METHODOLOGY: The clinical performance of the Dengue Early Rapid was evaluated in a retrospective study in Vietnam with 198 acute laboratory-confirmed positive and 100 negative samples. The performance of the Dengue Early Rapid in combination with the IgM/IgG Rapid test was also evaluated in Malaysia with 263 laboratory-confirmed positive and 30 negative samples. KEY RESULTS: In Vietnam the sensitivity and specificity of the test was 69.2% (95% CI: 62.8% to 75.6%) and 96% (95% CI: 92.2% to 99.8) respectively. In Malaysia the performance was similar with 68.9% sensitivity (95% CI: 61.8% to 76.1%) and 96.7% specificity (95% CI: 82.8% to 99.9%) compared to RT-PCR. Importantly, when the Dengue Early Rapid test was used in combination with the IgM/IgG test the sensitivity increased to 93.0%. When the two tests were compared at each day post-onset of illness there was clear differentiation between the antigen and antibody markers. CONCLUSIONS: This study highlights that using dengue NS1 antigen detection in combination with anti-glycoprotein E IgM and IgG serology can significantly increase the sensitivity of acute dengue diagnosis and extends the possible window of detection to include very early acute samples and enhances the clinical utility of rapid immunochromatographic testing for dengue. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/21713023/The_diagnostic_sensitivity_of_dengue_rapid_test_assays_is_significantly_enhanced_by_using_a_combined_antigen_and_antibody_testing_approach_ L2 - https://dx.plos.org/10.1371/journal.pntd.0001199 DB - PRIME DP - Unbound Medicine ER -