Novel Blood Collection Tubes Improve Sample Preservation in a Multicenter Study in Thailand.

Abstract

Background: Blood collection tubes (BCTs) are critical in vitro diagnostic devices used in clinical laboratory testing. Innomed tubes are novel BCTs coated with heparin and anti-glycolytic 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, aiming to assess their performance in glucose stability, hemolysis resistance, and biochemical interferences relevant to diabetes and non-communicable disease (NCD) monitoring. Methods: 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. Subsequently, samples were centrifuged at 3500 rpm for 5-10 min and analyzed immediately after separation, not exceeding 2 h from collection. Results: 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 3500 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. Conclusions: Innomed 1 and 2 BCTs maintain blood glucose stability for 8 h, ensuring accurate biochemical, HbA1c, thyroid, and tumor marker testing. Their hemolysis resistance supports diabetes screening and Non-Communicable Diseases (NCD) monitoring. thereby emphasizing their clinical relevance in chronic disease management.