2001D-0044 Clinical Laboratory Improvement Amendments of 1988
FDA Comment Number : EC14
Submitter : Ms. Teri Dowling Date & Time: 12/07/2005 09:12:35
Organization : San Francisco Department of Public Health
Category : Local Government
Issue Areas/Comments
On behalf of the SFDPH, HIV Prevention Section, we are writing to register concerns about the new draft guidance regarding FDA's current thinking about CLIA waiver applications. We encourage the FDA to consider the impact of the new guidance on rapid HIV testing programs.

There are two major reasons that the adoption of this draft guidance would preclude rapid HIV testing from use. The first and most obvious is that the guidance states that a simple test should not produce results that 'need to be reported to a public health department at the state or local level.' As HIV is a reportable disease, this would prohibit rapid HIV testing from becoming CLIA-waived.

Secondly, the guidance states that a simple test should provide 'instructions and materials for obtaining and shipping specimens for confirmation testing, in cases where such testing is clinically advisable.' As all rapid HIV tests are considered screening tests, requiring confirmation with a supplemental test that must be run in a suitable laboratory, this would complicate rapid HIV testing and hinder the approval of any test similar to those currently on the market.

Since May of 2003, rapid HIV testing has been an important part of HIV prevention in San Francisco. Unlike earlier testing technologies, rapid HIV tests provide almost instant results, therefore helping to ensure that people with HIV learn their status and prevent spreading the virus to others. Currently there are almost two dozen community-based agencies in SF that offer rapid HIV testing services, serving more than 10,000 individuals each year in sites as varied as health fairs, jails, family planning clinics, street outreach venues, methadone clinics, and even in people's homes.

The success of rapid HIV testing depends on the ability of community agencies such as these to perform point-of-care HIV tests for the clients with which they have built rapport. It is partially because of this good relationship that clients of rapid HIV testing have shown such a positive reaction to the technology. Furthermore, rapid testing provides the solution to a major drawback of HIV testing prior to now, which was the low rate of return for results. Those who would most benefit from learning their HIV status often did not return one week later for their diagnosis, and as such may have continued to unknowingly transmit the virus to those around them. With rapid testing, nearly 100% of those who have HIV learn their status once they choose to take the test.

Advancing HIV Prevention is the major HIV prevention initiative of the Centers for Disease Control and Prevention, released in 2003. This initiative consists of four key strategies, one of which is to implement new models for diagnosing HIV infections outside medical settings, mostly using rapid HIV testing. Another is to prevent new infections by working with persons diagnosed with HIV and their partners, one specific component of which is by offering rapid HIV testing to partners. Since the release of this initiative, health departments across the US have been working to integrate rapid HIV testing into their HIV prevention efforts in these ways. The success of these programs in San Francisco has been considerable, and the direct result is that more people with HIV have learned their status and gained the ability to make informed decisions to protect their health and the health of others. Having CLIA-waived rapid HIV tests are critical to the implementation and further development of this initiative.

We encourage you to rethink the recommendations contained in this guidance because of their impact to rapid HIV testing. Please, contact us at the SFDPH for questions regarding this matter at 415 554-9167 or by email at Teri.Dowling@sfdph.

Teri Dowling, MA, MPH
HIV Counseling and Testing Program Manager

Shelley Facente, MPH
Rapid HIV Testing Coordinator

Tracey Packer, MPH
Interim Director
HIV Prevention Section