Variability of reporting and lack of adherence to consensus guidelines in human T-lymphocyte immunophenotyping reports: results of a case series.
Percentages and absolute counts of CD4+ lymphocytes, as determined by T-lymphocyte immunophenotyping (TLI), are prognostic, as well as diagnostic, of the course of human immunodeficiency virus type 1 infections and are important indicators for initiating Pneumocystis carinii pneumonia prophylaxis and antiretroviral therapy. In December 1990, we requested that a nonrandom sample of 17 laboratories provide us with typical reports of their TLI results from an immunodeficient patient and from a patient whose TLI results were within the laboratory's normal reference ranges. We also searched published literature and documents proposed by professional organizations for recommendations regarding T-lymphocyte testing and reporting. This article compares guidelines for reporting TLI results, as proposed by the National Committee for Clinical Laboratory Standards in Document H42-P, with samples of reports obtained in our case series. Most reports follow some, but not all, of the proposed guidelines. A majority of the laboratories provided interpretations of the results in their reports. We found considerable variation in normal reference ranges. We describe this variation in detail for the CD4+ T-lymphocyte counts and CD4+ T-lymphocyte percentages. This article describes some of the TLI result report forms currently being used and identifies important quality issues in this rapidly expanding area of clinical laboratory testing.
Laboratory Assurance Program, Graduate School of Public Health, College of Health and Human Services, San Diego State University, CA 92182-0405.
K M
KM
Peddecord
A S
AS
Benenson
L K
LK
Hofherr
D P
DP
Francis
R S
RS
Garfein
G D
GD
Cross
W O
WO
Schalla
D005568:Forms and Records Control; D006801:Humans; D016130:Immunophenotyping / Q000592:standards*; D007958:Leukocyte Count; D008499:Medical Records / Q000592:standards*; D012016:Reference Values; D016176:T-Lymphocyte Subsets / Q000166:cytology; D009626:Terminology as Topic