Maria Gioia1, Giorgio Da Rin2, Barbara Manenti3, Sarah Birindelli4, Maria Laura Ciardelli5, Roberto Gentile5, Gianluca Beretta6, Giuseppe Lorusso6, Daniela Avino7, Anna Maria Di Fabio8, Francesco Dima9, Alessandra Fanelli10, Maria Lorubbio10, Sara Francione11, Galina Marincheva11, Alessandra Marini12, Angela Papa13, Elena Giannelli13, Rachele Pajola14, Andrea Panzeri4, Silvia Pipitone15, Anna Benegiamo15, Roberta Rolla16, Matteo Vidali16, Sabrina Buoro3. 1. Clinical Chemistry Laboratory, Abele Ajello Hospital, Mazara del Vallo, Italy. 2. Medicine Laboratory, IRCCS Ospedale Policlinico San Martino, Genova, Italy. 3. Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy. 4. Clinical Pathology Unit, ASST Fatebenefratelli-Sacco, Milan, Italy. 5. Clinical Chemistry Laboratory, Policlinico San Matteo-IRCCS, University of Pavia, Pavia, Italy. 6. Clinical Chemistry Laboratory, Policlinico San Pietro - Istituti Ospedalieri Bergamaschi, San Pietro, Italy. 7. Hematological diagnostic Laboratory, P. O. "A. Tortora", Pagani, Italy. 8. Clinical Chemistry Laboratory, Avezzano Civic Hospital, Avezzano, Italy. 9. Section of Clinical Biochemistry, University of Verona, Verona, Italy. 10. Laboratory Department, Azienda Ospedaliera Careggi, Florence, Italy. 11. Department of Clinical Chemistry and Microbiology, ASL Novara, Borgomanero, Italy. 12. Department of Clinical Chemistry, Versilia Hospital, Lido di Camaiore, Italy. 13. Laboratory Medicine, Fondazione G. Monasterio CNR Regione Toscana, Pisa, Italy. 14. Clinical Chemistry Laboratory, Ospedali Riuniti Padova Sud Schiavonia, Italy. 15. Clinical Chemistry and Hematology Laboratory, University Hospital of Parma, Parma, Italy. 16. Clinical Chemistry Laboratory, Department of Health Sciences, Maggiore Carità Hospital, University of Eastern Piedmont, Novara, Italy.
Abstract
INTRODUCTION: The correctness of the results of automated platelet analysis is still highly debated. The aim of this multicenter study, conducted according to international guidelines, was to verify the analytical performance of nine different types of hematology analyzers (HAs) in the automated platelet analysis. METHODS: Four hundred eighty-six peripheral blood samples (PB), collected in K3 EDTA tubes, were analyzed by ABX Pentra, ADVIA2120i, BC-6800, BC-6800 Plus, Cell-DYN Sapphire, DxH800, XE-2100, XE-5000, XN-20 with PLT-F App. Within-run imprecision and between-run imprecision were carried out using PB and material control, respectively. The carryover, low limit of quantification (LoQ), and the PB stability were evaluated. RESULTS: The carryover was absent for all HAs. The LoQ of PLT ranged between 2.0 (Cell-Dyn Sapphire) and 25.0 × 109 /L (ADVIA 2120i), while immature platelet fraction (IPF) ranged between 1.0 (XN-20) and 12.0 × 109 /L (XE-5000). The imprecision (%CV) increases as the platelet count decreases. No HAs showed desirable CVAPS for PLT counts less than 50.0 × 109 /L, with the exception of Cell-DYN Sapphire (CV 3.0% with PLT-O mean value of 26.7 × 109 /L), XN-20 (CV 2.4% with PLT-F mean value of 21.5 × 109 /L), and BC-6800 Plus (CV 1.9% with PLT-O mean value of 26.5 × 109 /L). The sample stability ranged between under two hours for MPV by ADVIA2120i and 8 hours for other PLT parameters and HAs. CONCLUSION: The findings of this study may provide useful information regarding carryover, precision, and stability of platelet counts and parameters, especially in thrombocytopenic samples. Moreover, the stability of sample for platelet analysis is conditioned by the HA and by temperature and storage time.
INTRODUCTION: The correctness of the results of automated platelet analysis is still highly debated. The aim of this multicenter study, conducted according to international guidelines, was to verify the analytical performance of nine different types of hematology analyzers (HAs) in the automated platelet analysis. METHODS: Four hundred eighty-six peripheral blood samples (PB), collected in K3 EDTA tubes, were analyzed by ABX Pentra, ADVIA2120i, BC-6800, BC-6800 Plus, Cell-DYN Sapphire, DxH800, XE-2100, XE-5000, XN-20 with PLT-F App. Within-run imprecision and between-run imprecision were carried out using PB and material control, respectively. The carryover, low limit of quantification (LoQ), and the PB stability were evaluated. RESULTS: The carryover was absent for all HAs. The LoQ of PLT ranged between 2.0 (Cell-Dyn Sapphire) and 25.0 × 109 /L (ADVIA 2120i), while immature platelet fraction (IPF) ranged between 1.0 (XN-20) and 12.0 × 109 /L (XE-5000). The imprecision (%CV) increases as the platelet count decreases. No HAs showed desirable CVAPS for PLT counts less than 50.0 × 109 /L, with the exception of Cell-DYN Sapphire (CV 3.0% with PLT-O mean value of 26.7 × 109 /L), XN-20 (CV 2.4% with PLT-F mean value of 21.5 × 109 /L), and BC-6800 Plus (CV 1.9% with PLT-O mean value of 26.5 × 109 /L). The sample stability ranged between under two hours for MPV by ADVIA2120i and 8 hours for other PLT parameters and HAs. CONCLUSION: The findings of this study may provide useful information regarding carryover, precision, and stability of platelet counts and parameters, especially in thrombocytopenic samples. Moreover, the stability of sample for platelet analysis is conditioned by the HA and by temperature and storage time.