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EVALUATION OF A NEW RAPID IMMUNOCHROMATOGRAPHIC ASSAY FOR SERODIAGNOSIS OF ACUTE HEPATITIS E INFECTION

A rapid and reliable diagnostic assay for acute hepatitis E virus (HEV) infection is needed. We evaluated a rapid, immunochromatographic assay for IgM antibodies to HEV (ASSURE^TM HEV IgM Rapid Test) using acute-phase HEV samples (n = 200) from Indonesia and Nepal and convalescent-phase HEV samples (n = 70) from Nepal. Blood donors in Thailand (n = 100), individuals with hepatitis A (n = 80), hepatitis B (n = 45), and hepatitis C (n = 50) in Thailand and Nepal, acute-phase sera of individuals with Epstein-Barr virus infection (n = 20), and rheumatoid factor–positive blood (n = 26) served as negative controls. The assay had a sensitivity of 93% (95% confidence interval [CI] = 88.5–96.1%) and a specificity of 99.7% (95% CI = 98.3–100%). The positive and negative predictive values were 99.5% (95% CI = 97.1–100%) and 95.8% (95% CI = 93.1–97.7%), respectively. These results suggest that this assay is a sensitive and specific tool for the rapid diagnosis of acute HEV infection.

Received January 27, 2005. Accepted for publication May 19, 2005.

Acknowledgments: We thank Kittinun Hussem for excellent technical support, and the National Institute of Health Research and Development, the Indonesian Ministry of Health, and the Naval Medical Research Unit 2 for providing us with the HEV outbreak sera from Indonesia.

Financial support: This work was supported by the U.S. Army Medical Research and Materiel Command.

Disclaimer: The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or reflecting the views of the U.S. Department of the Army or the U.S. Department of Defense. The use of trade names is for identification only and does not constitute endorsement by the U.S. Government or the Government of the Kingdom of Thailand.

^* Address correspondence to Khin S. A. Myint, Armed Forces Research Institute of Medical Sciences, 315/6 Rajvithi Road, Bangkok 10400, Thailand. E-mail: myintk{at}afrims.org

Authors’ addresses: Khin S. A. Myint, Harald Noedl, and Mammen P. Mammen, Jr., Armed Forces Research Institute of Medical Sciences, 315/6 Rajvithi Road, Bangkok 10400, Thailand, Telephone: 66-2-644-4674, Fax: 66-2-644-4760, E-mails: myintk{at}afrims.org, harald.noedl{at}afrims.org, and mammenmp{at}afrims.org. Ming Guan, Hsiao Ying Chen, and Yang Lu, MP Biomedicals Asia Pacific Pte. Ltd. (formerly Genelabs Diagnostics), 85 Science Park Drive, #04-01, Singapore 118259, Telephone: 65-6775-0008, Fax: 65-6775-4536, E-mails: ming.guan{at}mpbio.com, hsiaoying.chen{at}mpbio.com, and yang.lu{at}mpbio.com. David Anderson, Select Vaccines, Suit 2, 233 High Street, Armadale, Victoria 3143, Australia, Telephone: 61-3-9824-8166, Fax: 61-3-9824-8161, E-mail: anderson{at}burnet.edu.au. Teresa Howard, The Macfarlane Burnet Institute, GPO Box 2284, Melbourne, Victoria 3004, Australia, Telephone: 61-3-9282-2128, Fax: 61-3-9282-2100, E-mail: toward{at}burnet.edu.au.

Reprint requests: Khin Saw Aye Myint, U.S. Army Medical Component–Armed Forces Research Institute of Medical Sciences, 315/6 Rajvithi Road, Bangkok 10400, Thailand.