Public and Scientific Affairs Board
October 25, 2005
Mr. Donald W. Jehn
Center for Biologics
Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852
RE: Blood
Products Advisory Committee Meeting, November 3-4, 2005
Approaches to OTC home-use HIV test kits
Dear Mr. Jehn:
The American Society for
Microbiology (ASM) appreciates the opportunity to provide comments to the Blood
Products Advisory Committee (BPAC) for its consideration of “approaches to
over-the-counter (OTC) home-use HIV test kits” during its November 3, 2005
meeting. The ASM is the largest
scientific society dedicated to the advancement of the microbiological sciences
and their application for the common good.
The Society represents more than 42,000 individual members who work as
researchers, educators, clinicians, administrators and technical personnel in
academic, industry, government, clinical and public health laboratories and
institutions.
According to the Clinical Laboratory
Improvement Amendments (CLIA) of 1988, the criteria that waived tests must meet
include:
- They employ methodologies that are so simple and
accurate as to render the likelihood of erroneous results negligible.
- They pose no reasonable risk of harm to the
patient if the test is performed incorrectly.
Certain lateral flow
immunochromatography assays for HIV-1 antibodies have already been granted
waived status by the Food and Drug Administration (FDA). The FDA has recognized the inherent
difficulties in having non-trained individuals perform HIV testing by adding
stringent quality assurance requirements to the tests that are already waived. Since the same criteria can not be applied in
cases where an individual is performing the test themselves, the ASM believes strongly
that these tests should meet even stiffer criteria before they can be considered
for home use. These criteria should evaluate
the likelihood of erroneous interpretation of test results and the risk of harm
to patients if test results are interpreted incorrectly.
1752
N Street, NW • Washington, DC • 20036
tel:
202-342-3209 • fax: 202-942-9335 • email: publicaffairs@asmusa.org
Home HIV-1 antibody testing
will remove the responsibilities for assay results interpretation and patient
counseling from trained medical professionals.
Even if patients are advised to seek professional advice by the package
insert for the test, there will be financial disincentives for doing so. Such consequences cannot be justified in the
name of increased access to testing.
It is our contention that
erroneous or incorrect interpretation of HIV-1 antibody test results by lay
persons not only presents a reasonable risk of harm to patients, but presents a
significant risk of harm to society at large.
Falsely negative results interpretation generates a mistaken sense of
well-being that will delay the initiation of beneficial antiretroviral therapy for
patients and leads to preventable infection of others. Falsely positive results interpretation
unnecessarily distresses uninfected patients who will
certainly experience severe anxiety as well as financial and productivity loss,
secondary to the seeking of medical care. In a worst case scenario, they may
become severely depressed or suicidal.
Dr. Patricia Charache of the
Johns Hopkins Medical Institutions and representing the ASM, will elaborate on
these points, as well as several others during the public comment portion of
the BPAC Meeting.
Thank you for your
consideration of our comments.
Sincerely,
Joseph M. Campos, Ph.D.,
Chair
Committee on Laboratory
Practices
Public and Scientific Affairs
Board