New HIV Test for Earlier Diagnosis

Enhanced screening that includes nucleic acid testing (NAT) is designed to identify HIV in people in the period following recent infection, which could help limit the spread of the disease.

Primary or acute HIV infection occurs in the period following infection when people have not yet developed detectable levels of HIV antibodies. During this window, infected people are significant contributors to the spread of HIV as they tend to have very high levels of the virus, are very infectious, but are not yet aware of their HIV status. A new screening assay provides for automatic nucleic acid testing (NAT) for HIV on antibody-negative samples utilizing a proprietary pooling method. The new assay was developed by Laboratory Corporation of America Holdings (LabCorp, Burlington, NC, USA) but has not yet been cleared by the U.S. Food and Drug Administration (FDA) for diagnosing HIV infection.

A one-year pilot study conducted by the University of North Carolina (Chapel Hill, USA) that involved combined antibody screening with HIV NAT and pooled samples showed that the method can be an effective way to identify primary HIV infection. In the study, researchers performed NAT in pools of 90 samples on more than 100,000 HIV serologically negative samples tested by the state, with a positivity rate of about one in 5,000 screened samples.

"Mounting data suggest that a significant proportion of HIV transmissions occur during this highly viremic, acute stage of infection,” said Myla Lai-Goldman, M.D., executive vice president, chief scientific officer, and medical director of LabCorp. "And, increased awareness of infection status combined with appropriate preventive counseling may significantly reduce the unknowing spread of infection.”





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