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Updated: Jul 13, 2026
A Rapid, Multiplex Dual Reporter IgG and IgM SARS-CoV-2 Neutralization Assay for a Multiplexed Bead-Based Flow Analysis System
Published on: April 6, 2021
A comparative study on the performance of two commercial anti-dengue IgM assay kits
V Kumarasamy1, H Zuridah, A W Asmah Hani
1Makmal Kesihatan Awam Kebangsaan, Kementerian Kesihatan, Lot 1853, 47000 Sungai Buloh, Selangor, Malaysia.
Insights
A commercial rapid dengue test showed low sensitivity (49.3%) and specificity (62.6%) compared to ELISA. While convenient for rapid dengue diagnosis, caution is advised when interpreting results due to equivocal outcomes.
Area of Science:
- Medical Diagnostics
- Immunology
- Infectious Diseases
Background:
- Dengue fever is a significant global health concern.
- Accurate and rapid diagnostic tools are crucial for effective dengue management.
- Evaluating new diagnostic devices against established methods is essential.
Purpose of the Study:
- To assess the performance of a commercial rapid immunochromatographic dengue IgG/IgM assay.
- To compare the rapid test results with a dengue IgM-capture ELISA.
- To determine the sensitivity and specificity of the rapid dengue test.
Main Methods:
- Evaluation of a commercial rapid immunochromatographic dengue IgG/IgM assay.
- Comparison against a dengue IgM-capture ELISA as the gold standard.
- Testing of 239 serum samples from patients with suspected acute dengue illness.
Main Results:
- The rapid dengue test yielded 72 positive, 76 negative, and 91 equivocal results.
- The assay demonstrated a relative sensitivity of 49.3% and a relative specificity of 62.6%.
- Significant number of equivocal results were observed with the rapid test device.
Conclusions:
- The commercial rapid dengue IgG/IgM assay exhibits limited sensitivity and specificity.
- Equivocal results necessitate careful interpretation and potentially further confirmatory testing.
- While offering rapid testing advantages, the current rapid assay requires cautious use in dengue diagnosis.
Abstract:
The performance of a commercial rapid immunochromatographic dengue IgG/IgM assay device was evaluated against an in-place dengue IgM-capture ELISA in the National Public Health laboratory. Of the 239 serum samples from patients with clinical diagnosis of acute dengue illness, 140 and 99 samples were tested positive and negative respectively for anti-dengue IgM by the in-placed ELISA. Comparatively, 72 and 76 samples were tested positive and negative respectively, and 91 samples gave equivocal results by the rapid dengue test device. The rapid immunochromatographic assay device gave a relative sensitivity of 49.3% and a relative specificity of 62.6%. Though the rapid immunochromatographic assay device has the advantages of rapid testing which simultaneously detects both IgG and IgM and can also be performed with whole blood, serum or plasma, the user has to exercise extreme caution with the interpretation of the test result.
