This assay is optimized for the detection of HIV-1 groups M (subtypes A to H), N and O, but it may not detect all HIV-1 group N or O strains.

Diagnosis of HIV-1 infection should not rely solely upon a “Detected" result for HIV-1 DNA and/or RNA. Such a result should be considered in conjunction with patient’s clinical presentation, physical findings, and other diagnostic laboratory tests prior to establishing the diagnosis. An “Undetected" result indicates only the absence of HIV-1 DNA and RNA in the specimen tested and does not exclude the diagnosis of HIV-1 infection. “Undetected" results should be interpreted with caution, considering the patient's risk factors for HIV-1 infection, the analytical sensitivity of the assay, and the group of the infecting HIV-1 strain. Follow-up testing is recommended for high-risk patients with initially “Undetected" test results.