|
In the 1960's and 1970's, many
investigators worldwide were engaged in the study of autoantibodies in the
systemic rheumatic diseases and it had been established that autoantibodies
could be very important in clinical medicine as immunodiagnostic markers
for certain disease conditions. At the same time, in the late 1970's,
some commercial organizations in the U.S., Europe and Japan were developing
immunodiagnostic kits for the detection of antinuclear antibodies and other
antibodies. In this milieu, much confusion was created because of
lack of standardized reference sera for these autoantibodies with the
result that detection of the autoantibodies with the use of
commercially-available immunodiagnostic kits as well as in the laboratories
of academic investigators was often inaccurate.
In
1980, there was a meeting between Dr. Eng M. Tan (then at the University of
Colorado School of Medicine), Dr. Frederic McDuffie (then Sr. Vice
President and Director of Medical Affairs at National Arthritis
Foundation) and Dr. J. Steven McDougal (Centers for Disease Control) to
address the need for establishing authenticated standardized reference sera
for antinuclear antibodies in the rheumatic diseases. The Arthritis
Foundation provided funding for the inaugural meetings of a group of
scientific investigators who formed a committee to devote to this
work. The CDC provided the resources to establish a laboratory for
coordinating the activities of the committee and for lyophilization of
serum samples and ultimately the distribution of these standardized samples
to laboratories in this country and abroad. Within two years of the
formation of the AF/CDC Reference Lab, five standardized reference sera for
a number of antinuclear antibodies had been established, including
standards for different patterns of nuclear immunofluorescence and antibodies
reacting with native DNA, Sm antigen, U1-RNP and SS-B/La.
In
1982, at the urging of Dr. Ephraim Engleman who was then President of the
International League Against Rheumatism (ILAR), the AF/CDC ANA
Standardization Committee was expanded to include international
participation. The standardization committee was recognized by
ILAR, the World Health Organization (WHO) and the International Union
of Immunological Societies (IUIS) and received support from these
organizations. The committee now included members who were from the
U.S., U.K., Germany, Austria, Denmark, Netherlands, Japan, Australia and
Canada. The work of this committee progressed rapidly and more
reference sera were added to the serum bank at CDC.
These
reference sera have been distributed without any charge to research
laboratories, diagnostic laboratories and commercial organizations
developing autoantibody diagnostic kits. A survey performed in 1997
showed that more than 28,000 vials of standard reference sera had been sent
out by the CDC up to that time.
Some
of the activities of this committee have included collaboration with
immunodiagnostic companies in the validation of commercially available
immunodiagnostic kits. These studies have been published in
peer-reviewed journals and have been useful in improving the accuracy of
these diagnostic kits used by hospital laboratories in clinical diagnosis.
|
|
