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M94A3061.TXT
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1994-10-25
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Document 3061
DOCN M94A3061
TI Inter laboratory assessment of the FACSCount System.
DT 9412
AU Shiba A; Landay A; Ullery S; Webster K; Becton Dickinson Immunocytometry
Systems, San Jose, CA.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):162 (abstract no. PB0074). Unique
Identifier : AIDSLINE ICA10/94369514
AB The standard methodology for enumeration of T lymphocyte subsets
requires an absolute lymphocyte count from a hematology analyzer in
addition to lymphocyte subset percentages determined by flow cytometry.
A simple, precise, and inexpensive option to standard methodology would
allow greater access to quality absolute CD4 count determinations. The
FACSCount System is a complete system for the enumeration of absolute
CD4+, CD8+, and CD3+ T lymphocytes in whole blood. The single instrument
platform with dedicated software and reagents is easy to use and
designed to improve reproducibility within and across laboratories. This
study compared the system performance at two laboratories with minimum
level testing personnel for moderate versus high complexity tests as
defined under the Clinical Laboratory Improvement Amendments of 1988
(CLIA '88). Whole blood samples were analyzed in parallel with the
FACSCount System at two laboratories. The FACSCount operator at Lab 1
was a medical technologist trained in flow cytometry. The operator at
Lab 2 was a data entry clerk with a high school education. Samples were
also analyzed at Lab 1 with the standard methodology for absolute count
determinations to verify the accuracy of the FACSCount System.
Comparison of absolute T lymphocyte counts from Lab 2 with results from
Lab 1 are presented. Estimates of within sample precision at each site
are presented along with an analysis of the comparability of these
precision estimates across sites. Precision estimates are also used to
assess the inter laboratory variability of the FACSCount System. The
FACSCount System provided reproducible results across the two
laboratories.
DE Antigens, CD3/BLOOD CD4-CD8 Ratio Human Leukocyte
Count/*INSTRUMENTATION Observer Variation Predictive Value of Tests
Reproducibility of Results T-Lymphocyte Subsets/*IMMUNOLOGY T4
Lymphocytes/IMMUNOLOGY MEETING ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).