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Clinical and Diagnostic Laboratory Immunology, May 2005, p. 593-598, Vol. 12, No. 5
1071-412X/05/$08.00+0     doi:10.1128/CDLI.12.5.593-598.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Comparison of a New Immunochromatographic Test to Enzyme-Linked Immunosorbent Assay for Rapid Detection of Immunoglobulin M Antibodies to Hepatitis E Virus in Human Sera

Hsiao Ying Chen,1 Yang Lu,1 Teresa Howard,2,3 David Anderson,2,3 Priscilla Yiquan Fong,1 Wei-Ping Hu,1 Chee Poh Chia,1 and Ming Guan1*

Genelabs Diagnostics Pte. Ltd., Singapore, Republic of Singapore,1 Select Vaccines Ltd., Melbourne, Australia,2 Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, Australia3

Received 12 January 2005/ Returned for modification 16 February 2005/ Accepted 2 March 2005

An immunochromatographic test for rapid detection of IgM antibodies in patients with acute hepatitis E infection was developed utilizing the well-characterized recombinant protein EP2.1 and monoclonal antibody 4B2. The new rapid test based on a novel reverse-flow technology was able to generate a positive result within 2 to 3 min. Our study showed that this test was able to detect anti-HEV IgM antibodies in 96.7% of the patient samples tested (n = 151) while maintaining an excellent specificity of 98.6% with samples from various patient or healthy control groups (total n = 208). Furthermore, this rapid test gave a good specificity of 90.9% when tested with rheumatoid factor (RF)-positive sera (RF value of ≤850 IU/ml; n = 11) although a higher concentration of RF in samples might cause cross-reactivity. The new test has a good agreement of 97.2% with a kappa value of 0.943 when compared with a reference enzyme-linked immunosorbent assay. The positive predictive value and the negative predictive value for the rapid test thus reached 98.0 and 97.6%, respectively. This is the first rapid, point-of-care test for hepatitis E and will be especially useful for the diagnosis of acute hepatitis E virus infection in field and emergency settings and in resource-poor countries.

* Corresponding author. Mailing address: Genelabs Diagnostics Pte. Ltd., Product Development, 85 Science Park Drive 04-01, Singapore Science Park, Singapore 118259, Republic of Singapore. Phone: 65 677 50008. Fax: 65 677 54536. E-mail: guanming{at}mail.genelabs.com.sg.

Clinical and Diagnostic Laboratory Immunology, May 2005, p. 593-598, Vol. 12, No. 5
1071-412X/05/$08.00+0     doi:10.1128/CDLI.12.5.593-598.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.





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