Clinical evaluation of innomed vacuum blood collection tubes based on GP34-A validation and verification

Abstract

Blood collection tubes (BCTs) are critical in vitro diagnostic devices used in clinical laboratory testing. Innomed tubes are novel BCTs coated with heparin and antiglycolytic agents (Innomed 1) and clot activators combined with anti-glycolytic agents (Innomed 2). This study, we focus on the verification and multicenter validation of Innomed tubes. Two types of Innomed tubes were evaluated. The verification process, conducted in a reference laboratory, assessed biochemical interferences, glucose stability, and the potential for hemolysis due to centrifugation and blood collection techniques. The multicenter validation of biochemical interferences was carried out across five hospital laboratories. Glucose levels in Innomed 1 and 2 remained stable within 8% of up to 8 h post-collection. No hemolysis was observed under varying centrifugation times (at 3,500 rpm) and blood collection techniques, as confirmed through visual inspection and lactate dehydrogenase level determinations. Innomed tubes were suitable BCTs for glucose, HbA1c, thyroid stimulating hormone, free triiodothyronine, free thyroxin, triiodothyronine, carcinoembryonic antigen, and prostate-specific antigen, as well as for 19 routine biochemical assays. Innomed 1 and 2 BCTs maintain blood glucose stability for 8 hours, ensuring accurate biochemical, HbA1c, thyroid, and tumor marker testing. Their hemolysis resistance supports diabetes screening and NCD monitoring