OraQuick Rapid HIV Test Label

The OraQuick Rapid Test is now being used where rapid results are considered important: Public hospitals, low-income pregnancy clinics, GBLT community centers, homeless services, prisons and low-income neighborhood health centers.

From the packet:

LIMITATIONS OF THE TEST

1. The OraQuick® Rapid HIV-1 Antibody Test must be used in accordance with the instructions in this package insert to obtain an accurate result.

2. Reading test results earlier than 20 minutes or later than 60 minutes may yield erroneous results.

3. This test is approved by FDA for use with fingerstick blood specimens only. Use of other types of specimens may not yield accurate results.

4. A Reactive result using the OraQuick® Rapid HIV-1 Antibody Test suggests the presence of anti-HIV-1 antibodies in the specimen. The OraQuick® Rapid HIV-1 Antibody Test is intended as an aid in the diagnosis of infection with HIV-1.

AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically.

  • ie – testing does not matter, AIDS is a diagnosis that is made without reference to HIV status

5. For a Reactive result, the intensity of the test line does not necessarily correlate with the titer of antibody in the specimen.

6. A Non-Reactive result does not preclude the possibility of exposure to HIV or infection with HIV. An antibody response to recent exposure may take several months to reach detectable levels.

  • Someone might take the totality of this list to mean – “We don’t know what this test measures or what it means.”
  • But medical practitioners are asked to take it as an absolute, for those who fit into the pre-determined “Risk Groups.”

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