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 ( With the increasing availability of rapid tests for the detection of human immunodeficiency virus type 1 (HIV-1) antibodies, the screening of individuals for HIV infection is moving from laboratories to clinic-based settings (7). The early versions of these tests were neither easy to run nor particularly sensitive or specific (3, 19) Recent advances in the use of lateral-flow immunochromatographic strips and colloidal gold technology have allowed the development of rapid tests with very high sensitivity and specificity that are easy to run and can be used with whole blood (7,15). Rapid tests for the detection of antibodies to HIV in serum or plasma are commercially available and have been recently reviewed (7, 15).The potential public health benefits of rapid HIV testing are internationally recognized by the World Health Organization and in the United States by the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services, and the Food and Drug Administration (FDA) (15,20). There are at least four reasons to promote rapid HIV testing. First, a change in the paradigm of HIV counseling and testing would enhance a proactive role in HIV testing. According to the CDC client record database, only 25 to 43% of those patients who are ultimately determined to be positive and 33 to 48% of those who are negative return for their results if laboratory-based assays are performed. These rates have improved over the years (18) but are still unacceptably low. However, in clinical settings equipped with rapid HIV testing, patients can be present to observe the rapid testing, be informed of the result in Ͻ30 min, and be counseled immediately. Second, rapid HIV tests that can use whole-blood samples are much more efficient than enzyme immunoassay (EIA) testing in resource-limited settings where supplies (sterile needles, blood collection tubes, centrifuges, and electricity, etc.) are scarce and reporting mechanisms cumbersome (9, 21).

Development of an Immunochromatographic Strip for Serological Diagnosis of Porcine Hemagglutinating Encephalomyelitis Virus

“…36 Because of GICA's convenience and speed as well as its specificity, sensitivity, and the ability to use the test without instruments or with only a simple instrument, it is suitable for clinical diagnosis and drug testing purposes at any location. 4,5 Most proteins and antibodies can be easily coupled to colloidal gold particles. In the current study, rabbit anti-pig IgG was used with gold particles as a detector reagent.…”

“…A colloidal gold immunochromatographic assay (GICA) is a solid-phase immunoassay developed in the 1980s that combines the techniques of colloidal gold labeling, chromatographic analysis, immunodetection, and other methods 36 . Because of GICA's convenience and speed as well as its specificity, sensitivity, and the ability to use the test without instruments or with only a simple instrument, it is suitable for clinical diagnosis and drug testing purposes at any location 4,5 . Most proteins and antibodies can be easily coupled to colloidal gold particles.…”

Detection of Bacillus anthracis spores by super-paramagnetic lateral-flow immunoassays based on “Road Closure”

“…Since serological lateral-flow tests emerged in the 1980s, this technology has been widely applied in medical diagnostics (Arens et al, 2005;McMullan et al, 2012), biodefense (Hodge et al, 2013;Hong et al, 2010), food safety (Shephard, 2008) and other fields due to its fast-response, low cost and simplicity (Paek et al, 2000;Yetisen et al, 2013). This technology integrates thin layer chromatography with immunoreactions.…”