In order to substantively address issues connected with the spread of HIV, HIV Rapid Testing is a CLIA-waived, single-use immune-assay that detects the virus in a blood specimen from a finger stick in 20 minutes. Cause for concern evolved on this issue, as there is no mechanism to provide proper oversight to assure the test provides accurate results.

To gather information on the topic area, staff participated in a CDC sponsored audio conference “Rapid Testing: Advances for HIV Prevention” in November 2004. The program addressed issues related to testing quality assurance programs and the training of health care providers.

In an effort to gather information about how the clinical laboratory has been impacted by the use and availability of waived rapid HIV tests, a 29-question survey was developed for online distribution to a pre-determined segment of ASCP membership.

E-mail addresses were on file for over 60% (18,314) of members with targeted job titles. It was from this database subset that our Information Services Department generated a random sample of 5,000 members. Selected members received a broadcast e-mail pre-survey notice in December 2004 and survey cover letter with a link to the survey on WebSurveyor in December 2004.

Surveys were requested to be completed in December 2004. The survey sample size was determined through consultation with a statistician from our Board of Registry. Based on the number of members with email addresses (18,314), a sample size of 376 responses was determined to be necessary for final analysis (95% confidence level). Of the 5,000 email addresses that received broadcast surveys, 402 (10.4%) were returned completed.

The following provides a summary of the survey results:

1. Although CLIA-waived rapid HIV testing devices have been available for nearly two years, our survey indicates that use in medical facilities is still mostly limited to the clinical laboratory. Only 4% or 17 of 402 stated that POC rapid HIV tests are being performed outside the clinical lab in their institution; 91% conduct HIV testing via alternate methods to POC rapid HIV testing; 33% of labs perform HIV ELISA; 58% send specimens to reference or affiliated lab for HIV testing.
2. Even when rapid HIV tests are performed point of care, this survey indicates laboratory staff performs many of the tests. The survey suggests the availability of rapid HIV tests capable of being performed point of care have had limited impact on clinical laboratories. The indications from this survey are that the majority of laboratories are successfully training their staff and performing these tests in the clinical lab setting. The survey results indicate very limited rapid HIV testing is being performed outside the clinical laboratory in hospitals/medical institution.
3. Devery Howerton, PhD of CDC collaborated with ASCP to review the survey data and determine next steps. It was determined that at this time, an educational intervention was not required for laboratory professionals.
   
   There was agreement that there is a possibility that the laboratory may become more involved in the quality assurance and training of the rapid test kit if testing is performed point of care, but at the time of discussion, it was determined that the necessity does not exist. There was also agreement to draft an article related to the survey results, which would include CDC recommendations. The article authored by Dr. Howerton and Ms. Kroc, “Report of a Survey of ASCP Members Concerning Point-of-Care Rapid Testing and the Clinical Laboratory,” was published in the August 2005 issue of Laboratory Medicine.