Bio-Rad Laboratories has received FDA premarket approval for its Geenius HIV-1/HIV-2 supplemental assay. An alternative to the Western blot method and the company’s Multispot HIV-1/HIV-2 rapid test, the assay can differentiate circulating antibodies to human immunodeficiency virus (HIV) types 1 and 2 in whole blood, serum, and plasma.
Bio-Rad developers worked closely with representatives from the Centers for Disease Control and Prevention (CDC) to ensure the assay would align with the HIV testing algorithm that the agency recommended in June 2014.
“We are pleased to receive FDA premarket approval for what we consider to be a great improvement in HIV diagnostic testing,” says Patrice Deletoille, Bio-Rad vice president and general manager of the infectious disease division.
The Geenius assay involves a three-step procedure that produces results within 30 minutes. Clinicians dispense 15 ?l of whole blood or 5 ?l of serum or plasma into the cassette well, add two drops of buffer, wait 5 to 7 minutes, and then add another five drops of buffer into a second well. After 20 minutes, the user can insert the cassette into the Geenius reader for automatic reading and interpretation.
The reader interprets six individual HIV-1 and HIV-2 band results, displaying the results in a user-friendly graphical interface once the cassette is inserted. A unique 2-D barcode identifies each cassette and allows the result and patient ID to be recorded on a single document. The data can later be uploaded to a laboratory information system.
For more information, visit Bio-Rad Laboratories.