This test detects human immunodeficiency virus type 1 (HIV-1) RNA from Group M, N, and O subtypes. A result of "Not Detected" does not rule out HIV-1 RNA concentrations below the limit of detection of the assay or the presence of inhibitors in the patient specimen. The diagnosis of HIV-1 infection should not be made solely on a single HIV-1 test result. Diagnosis requires repeat and confirmatory testing as recommended by the U.S. Health and Human Services Guidelines. Improper specimen handling can cause false negatives or contamination.