Laboratory performance in HTLV-I/II analysis.
BACKGROUND
Since 1989, the CDC's Model Performance Evaluation Program has shipped samples to voluntary participant laboratories that test for HTLV antibodies. Each laboratory tests the well-characterized samples, reports the results, and provides information about its testing practices. The data from 15 performance survey periods are reported here.


METHODS
Multiple logistic regression was used to analyze all data from 15 survey periods from 1989 through 1996.


RESULTS
The mean analytic sensitivity for EIA was 99.2 percent per survey period (range, 96-100%), the mean analytic specificity was 97.8 percent (75.6-100%), and the overall accuracy was 88.8 percent (63.8-100%). The mean analytic sensitivity for Western blot was 88.8 percent (75.6-100%); the mean analytic specificity was 95.7 percent (86.7-100%), and the overall accuracy was 91.1 percent (78.1-100%).


CONCLUSIONS
Statistical analyses suggested associations between performance and both the retroviral serologic status of the sample and the analytical testing method. Western blot accuracy was associated with weekly testing volume. In early survey periods, performance problems were noted in the analysis of samples from donors with concomitant HTLV and HIV infections and those from donors who were positive for HTLV-II. Technological developments in test methods, such as the addition of recombinant antigens, appeared to have improved the laboratory performance of specific testing methods.
Williams
L O
LO
Public Health Practice Program Office, Division of Laboratory Systems, CDC, Atlanta, Georgia 30341, USA. lowl@cdc.gov
Blumer
S O
SO
Schalla
W O
WO
Robinson
P H
PH
Handsfield
J H
JH
Fehd
R J
RJ
Hancock
J S
JS
Lipman
H B
HB
Hearn
T L
TL
D015153:Blotting, Western; D019411:Clinical Laboratory Techniques / Q000592:standards; D015480:Deltaretrovirus Antibodies / Q000097:blood*; D005069:Evaluation Studies as Topic; D006801:Humans; D007124:Immunoenzyme Techniques; D016015:Logistic Models; D012680:Sensitivity and Specificity
D015480:Deltaretrovirus Antibodies