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Published on: July 22, 2012
Comparative evaluation of the WHO and DAKOPATTS enzyme-linked immunoassay kits for rotavirus detection
Insights
Two enzyme-linked immunosorbent assay kits were compared for rotavirus detection. The DAKO-ELISA kit demonstrated comparable sensitivity and specificity to the WHO-ELISA kit in diverse laboratory settings.
Area of Science:
- Virology
- Immunology
- Clinical Diagnostics
Background:
- Rotavirus is a leading cause of severe diarrheal disease in infants and young children globally.
- Accurate and accessible diagnostic tools are crucial for rotavirus surveillance and management, especially in resource-limited settings.
Purpose of the Study:
- To evaluate and compare the diagnostic performance of two enzyme-linked immunosorbent assay (ELISA) kits for rotavirus antigen detection in faecal samples.
- To assess the suitability of the DAKO-ELISA kit for use in developing countries.
Main Methods:
- Faecal samples from 1,163 children, including 66 newborns, were analyzed using both the WHO-ELISA kit and the DAKO-ELISA kit.
- The study involved parallel testing in laboratories across seven countries: Burma, Chile, India, Mexico, Pakistan, Sri Lanka, and the United Kingdom.
Main Results:
- The DAKO-ELISA kit showed an overall sensitivity of 97% and a specificity of 97% when compared to the WHO-ELISA kit.
- In individual laboratories, the DAKO-ELISA kit exhibited a sensitivity range of 90-100% and a specificity range of 85-100%.
- Specifically for newborn faecal samples, the DAKO-ELISA kit achieved 100% sensitivity and 98% specificity.
Conclusions:
- The DAKO-ELISA kit is a highly sensitive and specific diagnostic tool for detecting rotavirus antigen in faeces.
- The DAKO-ELISA kit performs comparably to the WHO-ELISA kit, making it a viable option for rotavirus diagnostics in developing countries.
Abstract:
Faeces obtained from 1,163 children (including 66 newborn babies) were analysed in parallel for the presence of rotavirus particles using two enzyme-linked immunosorbent assay kits. The kits had been formulated by the WHO Collaborating Centre for Reference and Research on Rotavirus (WHO-ELISA kit) and by DAKOPATTS (DAKO-ELISA kit) to be suitable for use in laboratories in developing countries. The kits were evaluated in laboratories in Burma, Chile, India, Mexico, Pakistan, Sri Lanka and the United Kingdom. Comparison of the results obtained with the two kits indicated that the DAKO-ELISA had an overall sensitivity of 97% and a specificity of 97% relative to the WHO-ELISA. In individual laboratories the DAKO-ELISA (K349) kit had a sensitivity in the range 90-100%, and a specificity of 85-100%. The kit showed a sensitivity of 100% and a specificity of 98% in assays on faeces obtained from newborn babies. We conclude that the DAKO-ELISA is as sensitive and specific as the WHO-ELISA for the detection of rotavirus antigen in faeces.

