CONTRIBUTI SCIENTIFICI – Scientific Papers
Volume:
Biochimica Clinica 2023; 47(2) 151-157
Pubblicato on-line:
February 21, 2023
DOI:
10.19186/BC_2023.011
Valutazione delle prestazioni analitiche di un sistema di Point Of Care Testing per l’esame emocromocitometrico
Analytical performance evaluation of a point of care testing system for the complete blood count
AUTORI
U.O.C. Patologia Clinica, Azienda Sanitaria Territoriale Pesaro-Urbino
ABSTRACT
Analytical performance evaluation of a point of care testing system for the complete blood count
Introduction: point of care testing (POCT) is an alternative near to the patient approach to laboratory testing that should generate results comparable to those obtained in laboratory. In our study, we estimated the concordance of the blood cell count carried out on Norma Icon-5 POCT analyzer with that performed in laboratory on an automated blood cell count analyzer (Sysmex XN1000), to evaluate the possible utilization of the POCT in the Emergency Department (ED).
Methods: Venous blood samples were collected in tubes containing K3EDTA anticoagulant from 40 patients admitted to the ED. The degree of concordance between POCT results of red blood cells (RBC), white blood cells (WBC), platelets (PLT) count and haemoglobin (Hb) concentration were evaluated.
Results: The POCT versus XN1000 bias was -2.44% (95%CI: -3.45 to -1.43), 0.61% (95%CI: -0.70 to 1.92), 1.22% (95%CI: 0.612 to 1.83) and -10.45% (95%CI: -12.33 to -8.67) for RBC, WBC, Hb and PLT respectively. Passing-Bablok regression equation was y=-0.015 (95%CI: -0.309 to 0.240) +0.976x (95%CI: 0.915 to 1.0435); y=-0.186 (95%CI: -0.404 to 0.012) + 1.038x (95%CI: 1.008 to 1.068); y=-1.889 (95%CI: -7.224 to 1.500) + 1.030x (95%CI: 1.000 to 1.069) and y=-12.098 (95%CI: -21.500 to -3.824) + 0.964x (95%CI: 0.924 to 1.000) for RBC, WBC, Hb and PLT respectively.
Conclusion: The blood cell counter POCT results were statistically concordant with those of the laboratory system only for WBC count, but showed a clinically acceptable bias also for RBC count and Hb concentration values. However, PLT showed an underestimation statistically significant and also exceeding the minimum clinical allowable bias. Therefore, the POCT blood cell counter can be used for clinical purpose only for RBC, WBC and Hb determination.
BIBLIOGRAFIA
- Coppolecchia P, Drago C, Rossi L, Colla R, Tozzoli R. PoCT e diagnostica decentrata. UPDATE 2016 Posizione SIPMeL del GdS Point of Care Testing 2016 Riv Ital Med Lab 2016;12:14-25
- Rampoldi E, Patrucco G, Casati M, Morelli B. Principi per l’implementazione e la gestione del point-of-care-testing (POCT): indicazioni essenziali 2021 doi: 10.19186/BC_2021.032
- Di Serio F, Trenti T, Carraro P. Raccomandazioni per l’implementazione e la gestione del “point-of-care testing” (POCT). Biochim Clin 2011;35:242-51.
- Paloma O, Pilar F-C, Buno A. POCT accreditation ISO 15189 and ISO 22870: making the point. eJIFCC 2021 Vol32 No2 pp131-139.
- Wiencek J, Nichols J. Issues in the practical implementation of POCT: overcoming challenges Expert Rev Mol Diagn. 2016;16:415-22.
- Dolci A, Giavarina D, Pasqualetti S, et al. Total laboratory automation: do stat tests still matter? Clin Biochem. 2017;50:605-11.
- Price CP, St John A. Eds. Point-of-care testing for managers and policymakers from rapid testing to better outcomes. Washington, AACC Press 2006.
- Florkowski C, Don-Wauchope A, Gimenez N, et al. Point-of-care testing (POCT) and evidence-based laboratory medicine (EBLM) –does it leverage any advantage in clinical decision making? Crit Rev Clin Lab Sci 2017;54:471-94.
- Buoro S, Pipitone S, Fanelli A, et al. Valutazione multicentrica dei conteggi cellulari ottenuti con 8 analizzatori ematologici automatici. Biochim Clin 2016;40:195-203.
- Birindelli S, Aloisio E, Carnevale A, Brando B, Dolci A, Panteghini M. Evaluation of long-term imprecision of automated complete blood cell count on the Sysmex XN-9000 system Clin Chem Lab Med 2017;28;55:e219-e222.
- Abbasi U, Chowdhury P, Subramaniam S, Jain P, Muthe N, Sheik F. A cartridge based point-of-care device for complete blood count. Sci Rep 2019;9:18583.
- Larsson A, Carlsson L, Karlsson B, Lipcsey M. Rapid testing of red blood cell parameters in primary care patients using HemoScreen point of care instrument. BMC Fam Pract 2019;20:77.
- Norma Instruments Zrt. Operator’s Manual For Icon-5; 2021.
- Sysmex Corporation. Instruction for Use XN-series (for XN system) 2nd ed. Kobe, Japan: Sysmex Corporation; 2011.
- Clinical Laboratory Standard Institute (CLSI). Measurement procedure comparison and bias estimation using patient samples: Approved guideline – 3rd ed. CLSI Document EP09-A3. CLSI Wayne, PA, 2013.
- Vidali e GdS SIBioC Statistica per il Laboratorio. Met Comp ver. 1.0
- Aarsand AK, Fernandez-Calle P, Webster C, et al. The EFLM Biological Variation Database. https://biologicalvariation.eu/ (ultimo accesso gennaio 2023).
- Vidali M, Tronchin M, Dittadi R. Protocollo per la comparazione di due metodi analitici di laboratorio. Biochim Clin 2016;40:129-42.
- Aloisio E, Panzeri A, Birindelli S, Dolci A, Panteghini M. Validazione per l’impiego clinico delle determinazioni di emoglobina ed ematocrito sull’emogasanalizzatore GEM Premier 4000. Biochim Clin 2017;41:189-91.
