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Abstract
Comparative data summary of the Efoora rapid HIV diagnostic test
D. Grosky1, R. Rubenstein2
Issues: A comparison of the Efoora HIV Rapid Test as compared to the Abbott Laboratories Enzyme Immunoassay (EIA).
Description: Using preclinical studies and a multicenter clinical trial, the accuracy, sensitivity and specificity of a rapid, lateral-flow immunochromatographic HIV-1 antibody detection device (Efoora HIV Rapid Test) was compared with an enzyme immunoassay (EIA) (Abbott Laboratories). Preclinical studies were performed using seroconversion, crossreaction and interference panels, archived clinical specimens and fresh whole bood. 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. Preclinical testing of seroconversion panels showed that antibodies were often detected earlier by the rapid test than by EIA. No significant interference or crossreactions 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 adults demonstrated sensitivity and specificity for the Efoora HIV Rapid Test of 99.8% (95% confidence interval [CI], 99.3 and 99.8%) 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.
Lessons learned: Thus, 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.
Recommendations: That the Efoora HIV Rapid Test is used in all settings and in all instances where currently the Aboott Laboratories enzyme immunoassay is used.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
WEPE0011
Suggested Citation
"D.Grosky, et al.
Comparative data summary of the Efoora rapid HIV diagnostic test.
:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
WEPE0011"
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