TY - JOUR
T1 - A north American multilaboratory study of CD4 counts using flow cytometric panleukogating (PLG)
T2 - A NIAID-DAIDS immunology quality assessment program study
AU - Denny, Thomas N.
AU - Gelman, Rebecca
AU - Bergeron, Michele
AU - Landay, Alan
AU - Lam, Lee
AU - Louzao, Raul
AU - Mandy, Frank F.
AU - Schmitz, John
AU - Spira, Thomas
AU - Wilkening, Cindy
AU - Glencross, Deborah K.
PY - 2008
Y1 - 2008
N2 - Background: The global HIV/AIDS pandemic and guidelines for initiating anti-retroviral therapy (ART) and opportunistic infection prophylaxis demand affordable, reliable, and accurate CD4 testing. A simple innovative approach applicable to existing technology that has been successfully applied in resource-challenged settings, PanLeukogated CD4 (PLG), could offer solutions for cost saving and improved precision. Methods: Day-old whole blood from 99 HIV+ donors was simultaneously studied in five North-American laboratories to compare the performance of their predicate methods with the dual-platform PLG method. The predicate technology included varying 4-color CD45/CD3/CD4/CD8 protocols on different flow cytometers. Each laboratory also assayed eight replicate specimens of day-old blood from 10 to 14 local donors. Bias and precision of predicate and PLG methods was studied between- and within-participating laboratories. Results: Significantly (P < 0.0001) improved between-laboratory precision/coefficient of variation (CV%) was noted using the PLG method (overall median 9.3% vs. predicate median CV 13.1%). Within-laboratory precision was also significantly (P < 0.0001) better overall using PLG (median 4.6% vs. predicate median CV 6.2%) and in 3 of the 5 laboratories. PLG counts tended to be 11% smaller than predicate methods (P < 0.0001) for shipped (median of predicate - PLG = 31) and local specimens (median of predicate - PLG = 23), both overall and in 4 of 5 laboratories(median decreases of 4, 16, 20, and 21% in shipped specimens); the other laboratory had a median increase of 5%. Conclusion: Laboratories using predicate CD4 methods similar to those in this study could improve their between-laboratory and their within-laboratory precision, and reduce costs, by switching to the PLG method after adequate training, if a change (usually, a decrease) in CD4 counts is acceptable to their health Systems.
AB - Background: The global HIV/AIDS pandemic and guidelines for initiating anti-retroviral therapy (ART) and opportunistic infection prophylaxis demand affordable, reliable, and accurate CD4 testing. A simple innovative approach applicable to existing technology that has been successfully applied in resource-challenged settings, PanLeukogated CD4 (PLG), could offer solutions for cost saving and improved precision. Methods: Day-old whole blood from 99 HIV+ donors was simultaneously studied in five North-American laboratories to compare the performance of their predicate methods with the dual-platform PLG method. The predicate technology included varying 4-color CD45/CD3/CD4/CD8 protocols on different flow cytometers. Each laboratory also assayed eight replicate specimens of day-old blood from 10 to 14 local donors. Bias and precision of predicate and PLG methods was studied between- and within-participating laboratories. Results: Significantly (P < 0.0001) improved between-laboratory precision/coefficient of variation (CV%) was noted using the PLG method (overall median 9.3% vs. predicate median CV 13.1%). Within-laboratory precision was also significantly (P < 0.0001) better overall using PLG (median 4.6% vs. predicate median CV 6.2%) and in 3 of the 5 laboratories. PLG counts tended to be 11% smaller than predicate methods (P < 0.0001) for shipped (median of predicate - PLG = 31) and local specimens (median of predicate - PLG = 23), both overall and in 4 of 5 laboratories(median decreases of 4, 16, 20, and 21% in shipped specimens); the other laboratory had a median increase of 5%. Conclusion: Laboratories using predicate CD4 methods similar to those in this study could improve their between-laboratory and their within-laboratory precision, and reduce costs, by switching to the PLG method after adequate training, if a change (usually, a decrease) in CD4 counts is acceptable to their health Systems.
KW - CD4
KW - CD4 lymphocyte
KW - CD4 T cell
KW - Multisite evaluation
KW - Panleukogated
KW - PLG
UR - https://www.scopus.com/pages/publications/42449157087
UR - https://www.scopus.com/pages/publications/42449157087#tab=citedBy
U2 - 10.1002/cyto.b.20417
DO - 10.1002/cyto.b.20417
M3 - Article
C2 - 18351622
AN - SCOPUS:42449157087
SN - 1552-4949
VL - 74
SP - S52-S64
JO - Cytometry Part B - Clinical Cytometry
JF - Cytometry Part B - Clinical Cytometry
IS - SUPPL. 1
ER -