Premium
Evaluation of a dry format reagent alternative for CD4 T‐cell enumeration for the FACSCount system: A report on a Moroccan–Canadian study
Author(s) -
Bergeron Michèle,
Ding Tao,
Elharti Elmir,
Oumzil Hicham,
Soucy Nadia,
Harmouche Hicham,
Chaouch Saad,
Aouad Rajae EL,
Chabot Christian,
Mandy Francis
Publication year - 2010
Publication title -
cytometry part b: clinical cytometry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.646
H-Index - 61
eISSN - 1552-4957
pISSN - 1552-4949
DOI - 10.1002/cyto.b.20501
Subject(s) - reagent , enumeration , human immunodeficiency virus (hiv) , chemistry , computer science , chromatography , environmental science , mathematics , medicine , immunology , combinatorics
Background: Efforts to improve alternative CD4 T‐cell counting methods are critical to accelerate the implementation of HIV antiretroviral therapy in resources limited regions. Substituting liquid format reagents to eliminate cold‐chain transportation and refrigerated storage with dry format reagents contributes to higher efficiency supply management solution especially for laboratories at remote locations. ReaMetrix has developed dry format reagent kits compatible with the FACSCount system, a dedicated flow cytometer for T‐cell subset enumeration widely used in resource limited settings. A dual site collaborative study was designed to compare T‐cell subsets using both the new dry format ReaMetrix reagent and the original BD Biosciences liquid reagents. Method: A total of 167 HIV positive samples prepared with Rea T Count (ReaMetrix) and FACSCount (BD Biosciences) reagents were analyzed using FACSCount Systems. To compare both methods, Bland‐Altman, Pollock, Scott % similarity and correlation coefficient statistical analysis was applied. Immuno‐Trol served as an assay processing control and quality indicator of interlaboratory and intralaboratory variation. Results: The mean bias and limits of agreement for CD4 T‐cell measurements between Rea T Count and FACSCount reagents were −16 cells/μl (−4.6%) and −74 to +43, respectively. The correlation obtained was 0.988 with a similarity of 97.9%. Between laboratory variation data was very good with %CV below 10%. Conclusion: The introduction of dry reagents permits the elimination of cold‐chain transportation and the on‐site refrigerated storage without compromise to assay quality. The substitution of dry reagents facilitates easier supply management practice that will assure wider access to quality HIV treatment. © 2009 Clinical Cytometry Society