Guidance on the critical shortage of sodium citrate coagulation tubes for hemostasis testing
- PMID: 34455689
- PMCID: PMC9290683
- DOI: 10.1111/jth.15514
Guidance on the critical shortage of sodium citrate coagulation tubes for hemostasis testing
Abstract
Recent manufacturing problems and increased utilization has created a shortage of 3.2% sodium citrate blood collection tubes used for coagulation testing, causing stakeholders such as hospitals, clinics and laboratories, to find suitable alternatives. Considerations for in-house citrate blood collection tube preparations or purchasing commercial products from unknown manufacturing sources is of particular concern to laboratories that perform coagulation testing. It is well recognized that variability exists between citrate blood collection tube manufacturers, thereby making any transition to new blood collection methods more challenging than simply switching to a new source. This document provides provisional guidance for validating alternative sources of sodium citrate blood collection tubes (commercial or in-house preparations) prior to clinical implementation.
Keywords: 3.2% sodium citrate; D-dimer; PT/APTT; coagulation testing; fibrinogen; validation.
© 2021 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.
Conflict of interest statement
Authors state no conflicts of interest.
References
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- Sodium citrate blood specimen collection tube conservation strategies – Letter to health care and laboratory personnel. June 10, 2021. Food and Drug Administration. Silverspring, MD. www.fda.gov/medical‐devices/letters‐health‐care‐providers/sodium‐citrate.... Accessed August 31, 2021.
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- Blue top tube recommendations. June 15, 2021. College of American Pathologists. Northfield, IL. https://documents.cap.org/documents/cap‐blue‐top‐tubes‐recommendations.pdf. Accessed August 31, 2021.
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- Sodium citrate blood specimen collection tube conservation strategies – Letter to health care and laboratory personnel. United States Food & Drug Administration. July 22, 2021 Update. www.fda.gov/medical‐devices/letters‐health‐care‐providers/sodium‐citrate.... Accessed August 31, 2021.
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