Pe. Sax et al., POTENTIAL CLINICAL IMPLICATIONS OF INTERLABORATORY VARIABILITY IN CD4(-LYMPHOCYTE COUNTS OF PATIENTS INFECTED WITH HUMAN-IMMUNODEFICIENCY-VIRUS() T), Clinical infectious diseases, 21(5), 1995, pp. 1121-1125
The CD4(+) T-lymphocyte count is an important factor in the management
of patients infected with human immunodeficiency virus. Previous stud
ies have found significant variability among the counts determined by
different laboratories. We conducted a study of lymphocyte phenotyping
in four laboratories to assess this variability and its possible clin
ical implications. One laboratory was situated at the study site; the
other three were selected randomly from a total of 11 commercial and h
ospital laboratories available locally. Blood specimens were obtained
from 24 patients and were sent to the four laboratories for a complete
blood count and a lymphocyte subset analysis. Using the Kruskall-Wall
is test, we found that the laboratories' ranks of four individual comp
onents of the CD4 cell count differed significantly: total white blood
cell count (P < .0001), lymphocyte percentage (P = .003), lymphocyte
count (P = .002), and CD4 percentage (P = .0004). Of the 24 patients i
n this survey, 14 (58.3%) had CD4-count results with enough variation
to have led to conflicting treatment recommendations; three of the 24
patients fulfilled the revised Centers for Disease Control and Prevent
ion case definition of AIDS on the basis of results from some but not
all laboratories. In addition, the laboratories disagreed on whether C
D4 cell counts of nine patients (37.5%) had increased or decreased sin
ce the previous determination. We conclude that when strict thresholds
of CD4 cell counts are used as a basis for treatment recommendations
or for diagnosis of AIDS, interlaboratory variability may be sufficien
t to alter the decisions made.