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
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