Abstract
Objectives The current study was undertaken to compare the sensitivity, specificity, positive predictive value and negative predictive values of a dengue IgM rapid immunochromatography (ICT) assay with a dengue IgM capture ELISA for the detection of anti-dengue virus IgM in patients clinically suspected of having dengue fever (DF). Methods Blood samples (n=119) were collected from paediatric and adult patients suspected of having DF at Teaching Hospital, Peradeniya (THP) after 5 days of fever. The samples were analyzed for the presence of anti-dengue virus IgM using a commercial rapid dengue IgM ICT assay (Hexagon dengue, Human, Germany) and a commercial IgM capture ELISA (Panbio Diagnostics Inc, Australia) provided to THP by the Ministry of Health for the diagnosis of dengue fever. Results When tested using the rapid dengue IgM ICT assay, 80 blood samples were positive and 39 were negative for anti-dengue virus IgM. When tested using the dengue IgM ELISA, 100 sera were positive and 19 were negative for dengue IgM. Using the IgM capture ELISA as the comparator, the sensitivity and the specificity of the rapid assay were 79% and 94.7% respectively with a positive (PPV) and negative (NPV) predictive value of 98.8% and 46.2%. Conclusion In comparison with the results of the IgM capture ELISA, the low sensitivity and NPV for anti-dengue virus IgM detection by the rapid dengue IgM ICT assay was noted. The low sensitivity and NPV means that patients with DF will be missed when using this test. In contrast, the high specificity and PPV indicate that this rapid assay is able to detect true positives. Since preliminary screening of DF is carried out widely using these rapid tests, the strengths and limitations of this and other similar tests require validation before use in diagnostic laboratories DOI: http://dx.doi.org/10.4038/sljid.v4i2.5925 Sri Lankan Journal of Infectious Diseases 2014; Vol.4(2):77-82
Highlights
Dengue fever (DF) is a mosquito-borne viral infection transmitted through Aedes aegypti and Aedes albopictus.[1]
The low sensitivity and negative predictive value (NPV) means that patients with DF will be missed when using this test
The high specificity and positive predictive value (PPV) indicate that this rapid assay is able to detect true positives
Summary
Dengue fever (DF) is a mosquito-borne viral infection transmitted through Aedes aegypti and Aedes albopictus.[1] DF is caused by 4 distinct dengue virus (DENV) serotypes, namely DENV1, DENV2, DENV3 and DENV4.2. In Sri Lanka, the laboratory diagnosis of DF is mainly by the detection of anti-dengue virus IgM antibodies using rapid immunochromatographic (ICT) assays. NS1 and dengue antibody detection are the 2 main methods used in the diagnosis of dengue infections. NS1 detection is available in private sector laboratories, it is not available in government hospitals for routine use. Most government hospitals do not provide an antibody diagnostic service using ELISA based methods. Rapid immunochromatographic (ICT) assays are being widely used in both government and private sector laboratories to provide a rapid diagnostic service
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