From pH to glucose: Implementing a simple point‐of‐care method for platelet quality control

BACKGROUND AND OBJECTIVES: The 21st edition of the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guide recommends replacing pH measurement with glucose determination as a quality control (QC) parameter for platelet concentrates (PCs) stored in platelet additive solutions (PAS). However, simple, validated glucose measurement methods suitable for Blood Establishment (BE) laboratories are lacking. This study assessed the feasibility of using a point-of-care (POC) glucometer for glucose measurement in PAS-E-stored PCs. MATERIALS AND METHODS: Thirty PCs suspended in PAS-E were analysed on days 2 and 6 of storage using a POC glucometer (Accu-Chek Instant®, Roche) and a reference laboratory autoanalyser (AU5800, Beckman Coulter®). Method comparison was performed using paired statistical testing, categorical analysis at low glucose concentrations and correlation analysis as a descriptive measure of association. RESULTS: Glucose levels measured by the glucometer and the autoanalyser were comparable on day 6. The mean difference was 2.2 ± 5.5 mg/dL on day 2 (p = 0.033) and 0.4 ± 2.6 mg/dL on day 6 (p = 0.415). Although a strong linear association was observed between methods (r = 0.988; p < 0.001), correlation was not interpreted as evidence of analytical agreement. Classification of samples below the clinically relevant threshold of 10 mg/dL (≈0.56 mmol/L) did not differ significantly between methods. CONCLUSION: A POC provides reliable glucose measurements in PAS-E PCs, comparable to a standard autoanalyser. This simple, rapid and cost-effective approach may facilitate implementation of the new EDQM recommendation and improve QC efficiency in BE.