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Letter to Providers

April 3, 2009

Dear Colleague:

This letter provides a review of guidance for provision of preliminary positive screening results generated by conventional enzyme immunoassay (EIA)/chemiluminescent immunoassay (CIA) HIV screening tests. In some situations, it is important for individuals getting routine HIV antibody testing to learn of their potential infection prior to completion of confirmatory testing. Preliminary positive results, together with appropriate counseling, can support changes in risk behaviors and can initiate steps to link confirmed HIV-infected persons to care.

The provision of preliminary positive screening results generated by conventional EIA/CIA HIV screening tests offers a mechanism for patients to learn of their potential HIV infection when use of a rapid HIV test is not an option. As with rapid testing, care must be taken to provide appropriate counseling. The Departments' direct experience with rapid testing and its work to promote and encourage use of rapid technology statewide provides a solid foundation for counseling guidance (see below). The established messages and follow-up procedures for HIV rapid testing are effective, work well and would also be appropriate for the provision of preliminary positive screening results. Similarly, assuring follow-up for the provision of the confirmatory result is a priority.

Regulations and Procedures: New York State (NYS) regulations, specifically Subpart 58-8.4 (Attachment I) authorizes a clinical laboratory to report a preliminary finding of HIV infection pursuant to a written request of a physician or other person legally authorized to receive the test result. The laboratory report must clearly state that the finding is preliminary, that results of confirmatory testing will follow and that the confirmed results must be considered in making a diagnosis related to HIV infection. The rule for reporting of preliminary positive results does not apply to HIV test results provided to blood, tissue or organ donors or consenting next of kin, which must be confirmed prior to reporting. Attachment II contains a letter to clinical laboratories reviewing guidance for provision of preliminary positive results. For instructions on how to obtain a preliminary positive result, you should contact your laboratory.

Settings Appropriate for Release of Preliminary Positive Results: Since 1999, release of preliminary positive results of HIV testing in the labor, delivery and newborn setting has made antiretroviral therapy possible when it is most likely to prevent transmission. Other circumstances which might warrant provision of a preliminary positive finding from a conventional HIV antibody screening test include:

  1. Hospital inpatients that may be discharged prior to completion of confirmatory testing.
  2. Persons with recent exposure and those who may be lost to follow-up.
  3. Patients whose follow-up is fragile or uncertain or who are likely to be lost to follow-up (e.g., persons who are homeless, unstably housed or without telephones).
  4. Prison and jail inmates likely to be released prior to completion of confirmatory testing.
  5. Individuals who have had occupational exposures.
  6. Individuals with travel or other plans who will note be available to receive their confirmed result in a timely manner.

In short, provision of preliminary positive results may be appropriate to avert a missed opportunity for individuals to learn of their potential HIV infection. Standing orders for release of preliminary positive results, together with policies and procedures for provision of confirmed results, may be appropriate in specific settings (e.g., hospital inpatient and other units using conventional testing, high volume clinics, correctional facilities).

Counseling Messages: Individuals receiving preliminary positive results should receive appropriate counseling, the details of which reflect an assessment of client risk factors. Counseling messages are similar to those appropriate for a person with a reactive rapid HIV test (Attachment III).

We hope that this information is helpful in caring for individuals who may not otherwise learn of their possible HIV infection. Additional information about HIV testing, including information for providers and for consumers, is available on the NYS Department of Health website.

Sincerely,

Humberto Cruz
Directory, AIDS Institute