title: Preclinical and clinical performance of the Efoora test, a rapid test for detection of human immunodeficiency virus-specific antibodies.
abstract: 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.
authors.affiliation: Department of Pediatrics, Washington University School of Medicine, One Children's Place, St. Louis, MO 63110, USA. arens@wustl.edu
authors.forename: Max Q
authors.initials: MQ
authors.lastname: Arens
authors.forename: Linda M
authors.initials: LM
authors.lastname: Mundy
authors.forename: Daniel
authors.initials: D
authors.lastname: Amsterdam
authors.forename: J Tom
authors.initials: JT
authors.lastname: Barrett
authors.forename: Dan
authors.initials: D
authors.lastname: Bigg
authors.forename: David
authors.initials: D
authors.lastname: Bruckner
authors.forename: Bruce
authors.initials: B
authors.lastname: Hanna
authors.forename: Harry
authors.initials: H
authors.lastname: Prince
authors.forename: Timothy
authors.initials: T
authors.lastname: Purington
authors.forename: Todd
authors.initials: T
authors.lastname: Hanna
authors.forename: Ross
authors.initials: R
authors.lastname: Hewitt
authors.forename: Carolyn
authors.initials: C
authors.lastname: Kalinka
authors.forename: Thomas
authors.initials: T
authors.lastname: Koppes
authors.forename: Sarz
authors.initials: S
authors.lastname: Maxwell
authors.forename: Ardis
authors.initials: A
authors.lastname: Moe
authors.forename: Mehmet
authors.initials: M
authors.lastname: Doymaz
authors.forename: Melinda
authors.initials: M
authors.lastname: Poulter
authors.forename: Maryam
authors.initials: M
authors.lastname: Saber-Tehrani
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Simard
authors.forename: Donna
authors.initials: D
authors.lastname: Wilkins-Carmody
authors.forename: John
authors.initials: J
authors.lastname: Vidaver
authors.forename: Cheryl
authors.initials: C
authors.lastname: Berger
authors.forename: Alan H
authors.initials: AH
authors.lastname: Davis
authors.forename: Mortimer T
authors.initials: MT
authors.lastname: Alzona
mesh_terms: D015483:HIV Antibodies / Q000097:blood*; D006679:HIV Seropositivity / Q000097:blood / Q000175:diagnosis; D015497:HIV-1 / Q000276:immunology* / Q000302:isolation & purification*; D006801:Humans; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods
chemical_list: D015483:HIV Antibodies