Abstract
Background:
The quality performance and the comparability between results of pharmacies point-of-care-testing (POCT) and institutional laboratories have been evaluated.
Methods:
Eight pharmacies participated in the project: a capillary specimen collected by the pharmacist and, simultaneously, a lithium-heparin sample drawn by a physician of laboratory medicine for the pharmacy customers (n=106) were analyzed in the pharmacy and in the laboratory, respectively. Glucose, cholesterol, HDL-cholesterol, triglycerides, creatinine, uric acid, aspartate aminotransferase, alanine aminotransferase, were measured using: Reflotron, n=5; Samsung, n=1; Cardiocheck PA, n=1; Cholestech LDX, n=1 and Cobas 8000. The POCT analytical performance only (phase 2) were evaluated testing, in pharmacies and in the laboratory, the lithium heparin samples from a female drawn fasting daily in a week, and a control sample containing high concentrations of glucose, cholesterol and triglycerides.
Results:
For all parameters, except triglycerides, the slopes showed a satisfactory correlation. For triglycerides, a median value higher in POCT in comparison to the laboratory (1.627 mmol/L vs. 0.950 mmol/L) has been observed. The agreement in the subjects classification, demonstrates that for glucose, 70% of the subjects show concentrations below the POCT recommended level (5.8–6.1 mmol/L), while 56% are according to the laboratory limit (<5.6 mmol/L). Total cholesterol exhibits a similar trend while POCT triglycerides show a greater percentage of increased values (21% vs. 9%). The reduction in triglycerides bias (phase 2) suggests that differences between POCT and central laboratory is attributable to a pre-analytical problem.
Conclusions:
The results confirm the acceptable analytical performance of POCT pharmacies and specific criticisms in the pre- and post-analytical phases.
Acknowledgments:
This study has been carried out thanks to skillful cooperation of the following authors: Carrara Franco, Farmacia S. Domenico; Finato Matteo, Farmacia Cappellini; Manni Maria Daniela, Farmacia S. Croce; Lazzarin Angelo, Farmacia Lazzarin; Vaccato Bagilotto Alessandro, Farmacia Moderna; Vignes Nadia, Farmacia all’Angelo; Visco Laura, Farmacia San Giovanni; Ciato Sebastiano, Farmacia Ciato.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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