Tennessee Rapid Testing Guidelines

Rapid HIV test technology promises to increase access to HIV testing among at-risk populations by reducing barriers associated with traditional methods of testing.

Additionally, almost all clients will receive their test results since they can be provided almost immediately.

On the basis of data submitted by the manufacturer for test approval, the sensitivity of rapid tests in the clinical studies was 99.6 percent.

While rapid tests are very reliable, confirmatory testing (Western Blot by serology or oral fluid) is required for all “preliminarily positive” rapid tests.

Increasing testing and notification will facilitate provision of medical and supportive services to HIV infected individuals earlier in the course of their infections.

Also, disease intervention activities such as partner notification can begin earlier.

While rapid testing may be an appropriate test for many people, some may not be prepared to deal with the possibility of test results in 20 minutes.

Provision should be made to offer those individuals an oral fluid test, when possible.

Use of Rapid Test Kits

The rapid HIV test uses oral fluid, finger stick whole blood, venipuncture whole blood, or plasma serum to identify the presence of HIV antibodies. The specimen is obtained through a finger stick, blood draw, or special oral swab. Any facility or entity that performs examinations on human specimens is considered a laboratory.

All laboratories must be certified under the Clinical Laboratory Improvements Amendments (CLIA) Program. CLIA requires all entities that perform even one test, including waived test on “. . . materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings,” to meet certain Federal requirements including stringent quality assurance measures. If an entity performs tests for these purposes they must register with the CLIA Program.

It is the responsibility of any entity performing rapid tests to establish an adequate quality assurance program to ensure the performance of the device. Failure to meet certain quality measures as set forth by the manufacturer renders the results unreliable. Applications for the CLIA waiver can be downloaded at www.cms.gov/clia.

All entities performing a rapid test must follow the Tennessee Medical Lab Board rule regarding the use of waived tests (Rule 1200-6-3. 16-17) . This rule requires that the screening be conducted under the supervision of a physician licensed in Tennessee.

Each screening location and notification to the Board’s administrative office will precede each event. The specifics of the screening activity must be recorded on the Waived Test Notification Form PH-3653, and forwarded to the above office. Individuals using this testing procedure must be screened for the ability to detect a change in color (Ishihara’s Platelet Test), because the test incorporates a change of color in interpreting results.

Documentation indicating such vision screening has been performed on individuals will be included with each exemption submitted to the board’s administrative office prior to their performing the tests. Agencies performing this test must be an official designee.

Any client whose rapid HIV test is preliminarily positive must receive a confirmatory test. The confirmatory test must be a Western Blot performed on either oral fluid or a blood sample. Any person with a preliminary positive rapid test and a negative or indeterminate confirmatory test should have follow-up testing within 30 days. The follow-up test should be on a blood specimen.

In a clinical setting, general consent to care is adequate as permission to test.

Training - HIV Counseling and Testing Certification

Any agency receiving funds from the Tennessee Department of Health for rapid HIV testing must have all staff that performs HIV rapid tests fully certified as an HIV Prevention Counselor. Training shall be provided by qualified trainers within each health region. For a list of trainers in your area contact HIV Prevention at 615-741-7500.

Any volunteers wishing to receive HIV testing certification MUST be sponsored by a recognized agency that has a relationship with the Tennessee Department of Health for HIV rapid testing. Counselors must comply with counseling messages set forth by the Department. Additionally, anyone performing the test must complete training on the use of the rapid HIV testing device conducted by a rapid testing sales representative.

Testing Considerations

Traditional outreach strategies may need to be modified due to the confidentiality concerns regarding rapid testing. The Health Insurance Portability and Accountability Act Privacy Rule, 2003 (HIPAA Privacy Rule, 2003) states that reasonable effort must be taken to protect the privacy of clients seeking medical services. It is essential to provide a private area to conduct rapid HIV testing.

Reporting

All entities within the State of Tennessee, who use the rapid HIV tests, are required to comply with all State of Tennessee HIV/AIDS disease-reporting requirements. Furthermore, rapid HIV tests are not to be used as a means of providing anonymous HIV testing. All of the required *demographic and locating information must be collected on each recipient of a rapid HIV test. ALL positive test results, including “preliminary positives” shall be forwarded to the local health department for reporting and case investigation purposes, in accordance with State of Tennessee statute, T.C.A. 68-10-101.

Regional and local public health departments should continue to work within CBO partnerships to assure these guidelines are met. A memorandum of agreement (MOA) between agencies should include these guidelines and should be signed off by all before testing begins.

*Required information includes name, race, sex, birth date, home/work address/phone, risk factor information and any additional information collected.