Abstract
Preanalytical quality control of blood samples is critical for tests of coagulation function and coagulation factor activity. Preanalytical storage time and temperature are the main variables. We investigated the effects of preanalytical frozen storage time and temperature on activated partial thromboplastin time (APTT), fibrinogen (Fbg), prothrombin time (PT)/international normalized ratio (INR), thrombin time (TT), factor VIII activity (FVIII:C), and factor IX activity (FIX:C) in frozen plasma. Samples (n = 144) were randomly and equally divided into four groups (storage at −80 °C or −20 °C) and analysed by CS5100 or CA7000 coagulation analysers. Baseline values and results after storage for 15 days, 1 month, 3 months, 6 months, and 1 year were measured after thawing. Mean percent changes and scatter plots were used to determine clinically relevant differences. The stabilities of coagulation tests and coagulation factor activities measured by the CS5100 system were consistent with those measured by the CA7000 system. At −80 °C, assessment samples of PT/INR, Fbg, and TT can be safely stored for 1 year, APTT for 6 months, and FVIII:C and FIX:C for 1 month. At −20 °C, samples of Fbg and TT can be stored for 1 year, PT/INR and FIX:C for 1 month, and APTT and FVIII:C for 15 days.
Highlights
Preanalytical quality control of blood samples includes steps that can interfere with the measurement of coagulation function and coagulation factor activity[1]
We demonstrated that prothrombin time (PT)/international normalized ratio (INR), thrombin time (TT), and Fbg can be safely stored for ≤24 h at 4 °C and 25 °C in fresh separated plasma, activated partial thromboplastin time (APTT) for ≤12 h at 4 °C and ≤8 h at 25 °C, and factor VIII activity (FVIII):C for ≤2 h and factor IX activity (FIX):C for ≤4 h at 4 °C and 25 °C
The mean changes of Fbg and TT were less than 10% for all time points and the mean percent change of FIX:C was less than 10% after sample storage for 1 month, regardless of storage temperature
Summary
Preanalytical quality control of blood samples includes steps that can interfere with the measurement of coagulation function and coagulation factor activity[1]. Our preliminary tests established the storage times and optimal temperatures for screening coagulation tests (activated partial thromboplastin time (APTT), fibrinogen (Fbg), prothrombin time/international normalized ratio (PT/INR), thrombin time (TT)) and D-dimers in asymptomatic individuals and hepatitis B patients, and those of FVIII:C and FIX:C in asymptomatic individuals, using whole blood samples and aliquoted fresh plasma[5,10,11]. Using fresh plasma samples that were immediately centrifuged after collection before being aliquoted and frozen, we aimed to investigate whether storage temperature (−20 °C or −80 °C) and time affected coagulation function and coagulation factor activity, and whether any changes caused by delayed analysis resulted in clinically relevant differences. We measured APTT, Fbg, PT/INR, TT, FVIII:C, and FIX:C in both fresh samples and frozen samples stored at −20 °C or –80 °C for 15 days, 1 month, 3 months, 6 months, and 1 year using Sysmex CS5100 and CA7000 coagulation analysers
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