The US Food and Drug Administration (FDA) has granted approval for MedMira’s rapid HIV test, Reveal G4 Rapid HIV-1 antibody test.
Reveal G4 will be used to detect HIV antibodies in fingerstick and venipuncture whole blood, allowing laboratories and hospitals to replace the serum and plasma specimens in testing.
The firm applied for the FDA’s premarket approval of Reveal G4 in April.
The new HIV test uses the firm’s Rapid Vertical Flow technology to offer accurate results.
According to the firm, around 1.2 million people in the US are living with HIV and about 168,000 people are unaware of the infection.
Reveal G4 involves a three-step testing procedure, including the addition of specimen, processing with the InstantGold cap and reading the results.
MedMira CEO Hermes Chan said: "Reveal G4 delivers the same speed, performance, and quality that customers have come to know as hallmarks of our technology platform, and now we’ve added whole blood applications.
"This product is all about creating a rapid HIV testing solution that gives healthcare providers and their patients choices that make testing possible in any setting."
MedMira will distribute Reveal G4 in the US, through VWR International and Cardinal Health.
The company is also involved in developing a wide range of rapid tests for major infectious diseases.