2001D-0044 Clinical Laboratory Improvement Amendments of 1988
FDA Comment Number : EC15
Submitter : Mr. Kevin Farrell Date & Time: 12/07/2005 09:12:48
Organization : California Office of AIDS
Category : State Government
Issue Areas/Comments
The letter is a comment on the Draft Guidance for CLIA Waiver Applications (Docket No. 2001D-0044).

The California Office of AIDS (COA), while strongly supportive of quality assurance in laboratory testing, believes that some provisions of the draft guidance would be detrimental to public health considerations and to HIV prevention in particular.

Specifically, we object to the proposed provision that any test for a reportable disease should not be considered to meet the waiver requirement for simplicity. Besides being illogical, this redefining of the ?simple? criterion for CLIA-waiver would result in dramatically decreased access to simple, rapid HIV testing devices, and subsequently decreased access to HIV testing and result delivery among populations at highest risk in California, as well as other parts of the United States. Effective surveillance must consist of both active and passive strategies, and must NOT become a barrier to the detection and prevention activities it is intended to support.

After a considerable investment of time and resources, California has established a rapid HIV testing program that successfully accesses populations at high risk for HIV infection. The implementation of this provision ? whether it reverses the current CLIA-waived status of existing simple rapid HIV tests or simply prevents subsequent tests from being granted waived status ? would negatively impact our efforts and perhaps negate the gains we?ve made at considerable cost.

COA also objects to certain provisions in the draft guidance that seem to have been formed with no consideration of the impact on diseases of relatively low prevalence. For example:

On page 26, a goal of 120 positive and 120 negative samples is specified for clinical study, with at least 90% consisting of actual patient samples. While it is noted that the overall sample size ?may well exceed 240,? nowhere is it noted that for a low-prevalence disease such as HIV, sample size may well exceed 6,000. (That is, in order to obtain 120 positive patient samples in settings with a prevalence of less than 2%, more than 6,000 samples would be needed.) This seems excessive and unreasonable.

Additional items such as the proposed requirement to include materials for confirmatory testing would pose an unnecessary burden and increase costs of testing for diseases of low prevalence such as HIV, and should be reconsidered in that light.

Thank you for the opportunity to comment on these draft guidelines. Please feel free to contact me if you wish to discuss any of these issues further.

Kevin Farrell
Chief, Education and Prevention Branch
California Office of AIDS