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Journal of Clinical Microbiology, May 2005, p. 2399-2406, Vol. 43, No. 5
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.5.2399-2406.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Preclinical and Clinical Performance of the Efoora Test, a Rapid Test for Detection of Human Immunodeficiency Virus-Specific Antibodies

Max Q. Arens,^1* Linda M. Mundy,² Daniel Amsterdam,³ J. Tom Barrett,⁴ Dan Bigg,⁵ David Bruckner,⁶ Bruce Hanna,⁷ Harry Prince,⁸ Timothy Purington,⁹ Todd Hanna,⁷ Ross Hewitt,³ Carolyn Kalinka,³ Thomas Koppes,⁴ Sarz Maxwell,⁵ Ardis Moe,⁶ Mehmet Doymaz,⁶ Melinda Poulter,^6, Maryam Saber-Tehrani,⁸ Lorenzo Simard,⁹ Donna Wilkins-Carmody,⁹ John Vidaver,¹⁰ Cheryl Berger,¹¹ Alan H. Davis,^11, and Mortimer T. Alzona¹¹

Departments of Pediatrics,¹ Medicine, Washington University School of Medicine, St. Louis, Missouri,² Departments of Medicine and Microbiology, School of Medicine, University at Buffalo, Buffalo, New York,³ Howard Brown Health Center, Chicago, Illinois,⁴ Chicago Recovery Alliance, Chicago, Illinois,⁵ UCLA/UCLA CARE Center, Los Angeles, California,⁶ Bellevue Hospital, New York, New York,⁷ Focus Technologies, Inc., Cypress, California,⁸ Tapestry Health Systems, Inc., Northampton, Massachusetts,⁹ DM-STAT, Medford, Massachusetts,¹⁰ Efoora, Inc., Buffalo Grove, Illinois,¹¹

Received 16 July 2004/ Returned for modification 9 November 2004/ Accepted 17 January 2005

Barriers to effective diagnostic testing for human immunodeficiency virus type 1 (HIV-1) infection can be reduced with simple, reliable, and rapid detection methods. Our objective was to determine the accuracy, sensitivity, and specificity of a new rapid, lateral-flow immunochromatographic HIV-1 antibody detection device. Preclinical studies were performed using seroconversion, cross-reaction, and interference panels, archived clinical specimens, and fresh whole blood. In a multicenter, prospective clinical trial, a four-sample matrix of capillary (fingerstick) whole-blood specimens and venous whole blood, plasma, and serum was tested for HIV-1 antibodies with the Efoora HIV rapid test (Efoora Inc., Buffalo Grove, IL) and compared with an enzyme immunoassay (EIA) (Abbott Laboratories) licensed by the Food and Drug Administration. Western blot and nucleic acid test supplemental assays were employed to adjudicate discordant samples. Preclinical testing of seroconversion panels showed that antibodies were often detected earlier by the rapid test than by a reference EIA. No significant interference or cross-reactions were observed. Testing of 4,984 archived specimens yielded a sensitivity of 99.2% and a specificity of 99.7%. A prospective multicenter clinical study with 2,954 adult volunteers demonstrated sensitivity and specificity for the Efoora HIV rapid test of 99.8% (95% confidence interval [CI], 99.3 and 99.98%) and 99.0% (95% CI, 98.5 and 99.4%), respectively. Reactive rapid HIV-1 antibody detection was confirmed in 99.6% of those with a known HIV infection (n = 939), 5.2% of those in the high-risk group (n = 1,003), and 0.1% of those in the low-risk group (n = 1,012). For 21 (0.71%) patients, there was discordance between the results of the rapid test and the confirmatory EIA/Western blot tests. We conclude that the Efoora HIV rapid test is a simple, rapid assay for detection of HIV-1 antibodies, with high sensitivity and specificity compared to a standardized HIV-1 EIA.

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* Corresponding author. Mailing address: Department of Pediatrics, Washington University School of Medicine, One Children's Place, St. Louis, MO 63110. Phone: (314) 454-8035. Fax: (314) 454-8020. E-mail: arens{at}wustl.edu.

Present address: University of Virginia Health System, Department of Pathology, Charlottesville, Va.

Present address: Binax, Inc., Portland, Maine.

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Journal of Clinical Microbiology, May 2005, p. 2399-2406, Vol. 43, No. 5
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.5.2399-2406.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.