Acquired Immune Deficiency Syndrome (AIDS); AIDS (Acquired Immune Deficiency Syndrome); HIV (Human Immunodeficiency Virus); HIV-1 Detection; HIV-1 PCR; HIV-1 RNA; HIV-2 Detection; HIV-2 PCR; HIV-2 RNA
Diagnosis of HIV-1 and/or HIV-2 infection in individuals with indeterminate or inconclusive HIV serologic test results
Diagnosis of HIV-1 and/or HIV-2 infection in individuals with acute or early HIV-1 and/or HIV-2 infection
Diagnosis of HIV-1 and/or HIV-2 infection in infants under 18 months of age who are born to HIV-infected mothers
Ship specimen frozen on dry ice.
If shipment will be delayed for more than 24 hours, freeze plasma specimen at -20 to -80 degrees C until shipment on dry ice.
This test is not licensed by the US Food and Drug Administration as a screening test for HIV-1 infection in donors of blood, human cells, tissues, or tissue products.
A single "Undetected" result may not rule out the presence of HIV infection, if the plasma specimen is collected and tested too early after exposure (ie, less than 10 days from exposure) or if patient is infected with a rare HIV variant. Improperly storage or processing (ie, incorrect temperature) of the plasma specimen for transport to the testing laboratory may lead to falsely negative viral RNA result.
Currently, 2 types of HIV, HIV type 1 (HIV-1) and HIV type 2 (HIV-2), are known to infect humans. HIV-1 has been isolated from patients with AIDS or AIDS-related complex, and from asymptomatic infected individuals at high-risk for AIDS. Accounting for more than 99% of HIV infection in the world, HIV-1 is transmitted by sexual contact, by exposure to infected blood or blood products, from an infected pregnant woman to fetus in utero or during birth, or from an infected mother to infant via breast-feeding. HIV-2 has been isolated from infected patients in West Africa, and it appears to be endemic only in that region. However, HIV-2 also has been identified in individuals who have lived in West Africa or had sexual relations with individuals from that geographic region. HIV-2 is similar to HIV-1 in overall genomic structure and ability to cause AIDS, but viral load tends to lower in HIV-2 than HIV-1 infection.
An "Detected" result indicates that the presence of RNA of the specific virus in the plasma specimen tested, consistent with the presence of this viral infection. For example, a "Detected" result for HIV-1 RNA by this assay is indicative of HIV-1 infection in the tested individual. A follow-up plasma specimen should be collected from this individual to both verify the diagnosis and quantify the HIV RNA prior to initiation of antiviral therapy.
An "Undetected" result indicates that the assay was unable to detect RNA of the specific virus in the plasma specimen tested.
An "Inconclusive" result indicates that the presence or absence of viral RNA could not be determined with certainty after repeat testing in the laboratory, possibly due to presence of inhibitory substances in the plasma specimen tested. Collection of a new plasma for testing is recommended.