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PLoS One. 2019 Jan 28;14(1):e0211207. doi: 10.1371/journal.pone.0211207. eCollection 2019.

Accurate and reproducible enumeration of T-, B-, and NK lymphocytes using the BD FACSLyric 10-color system: A multisite clinical evaluation.

Author information

1
BD Biosciences, San Jose, CA, United States of America.
2
SYNLAB Unweltinstitut GmbH, Berlin, Germany.
3
Department of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, NC, United States of America.
4
Department of Pathology, University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA, United States of America.
5
Clinical Trial and Cellular Therapy Services, BloodCenter of Wisconsin, Milwaukee, WI, United States of America.
6
Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, Los Angeles, CA, United States of America.
7
BioCollections Inc., Miami, FL, United States of America.

Abstract

Clinical flow cytometry is a reliable methodology for whole blood cell phenotyping for different applications. The BD FACSLyric™ system comprises a flow cytometer available in different optical configurations, BD FACSuite™ Clinical software, and optional BD FACS™ Universal Loader. BD FACSuite Clinical software used with BD™ FC Beads and BD CS&T Beads enable universal setup for performance QC, instrument control, data acquisition/storage, online/offline data analysis, and instrument standardization. BD Biosciences sponsored the clinical evaluation of the BD FACSLyric 10-color configuration at seven clinical sites using delinked and de-identified blood specimens from HIV-infected and uninfected subjects to enumerate T-, B-, and NK-lymphocytes with the BD Multitest™ reagents (BD Multitest IMK kit and BD Multitest 6-color TBNK). Samples were analyzed on the BD FACSLyric system with BD FACSuite Clinical software, and on the BD FACSCanto™ II system with BD FACSCanto clinical software and BD FACS 7-Color Setup beads. For equivalency between methods, data (n = 362) were analyzed with Deming regression for absolute count and percentage of lymphocytes. Results gave R2 ≥0.98, with slope values ≥0.96, and slope ranges between 0.90-1.05. The percent (%) bias values were <10% for T- and NK cells and <15% for B- cells. The between-site (n = 4) total precision was tested for 5 days (2 runs/day), and gave %coefficient of variation below 10% for absolute cell counts. The stability claims were confirmed (n = 186) for the two BD Multitest reagents. The reference intervals were re-established in male and female adults (n = 134). The analysis by gender showed statistically significant differences for CD3+ and CD4+ T-cell counts and %CD4. In summary, the BD FACSLyric and the BD FACSCanto II systems generated comparable measurements of T-, B-, and NK-cells using BD Multitest assays.

Conflict of interest statement

We have the following interests. The studies were funded by BD Biosciences, the employer of Imelda Omana-Zapata, Kevin Judge, Beverly Lu and Kimberly Dean. Caren Mutschmann and Doreen Taufman are employed by SYNLAB Unweltinstitut GmbH and Nicole d’Empaire by BioCollections Inc. Maurice O’Gorman is a consultant for BD Biosciences. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

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