NEW YORK – The US Food and Drug Administration announced Thursday that it has granted Emergency Use Authorization to sodium citrate blood collection tubes from Becton Dickinson.
Sodium citrate collection tubes have been in high demand in the US as they are used to measure disorders in blood clotting, also called coagulopathies, that can occur in cases of COVID-19.
The EUA is specifically for BD Vacutainer Plus Citrate Plasma Tubes that are manufactured at BD's UK manufacturing site.
The BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) are sterile, plastic, evacuated tubes containing 0.109 molar sodium citrate as an anticoagulant intended to prevent whole blood from clotting before analysis, according to the FDA's EUA letter. A blood sample in the tube can subsequently be centrifuged and the plasma portion analyzed for coagulation parameters to detect clotting time disorders, the agency said.
The BD tubes are now authorized for emergency use in healthcare settings to collect, transport, and store blood specimens for coagulation testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19, with testing performed by authorized laboratories, the agency further noted.
In a separate FAQ page on the FDA website, the agency noted that the shortage in sodium citrate tubes in the US is due to "an increase in demand and recent vendor supply challenges."
This type of blood collection tube, which is also referred to as a "light blue top" tube, was added to the FDA's device shortage list in June, and the agency has suggested conservation strategies for these tubes during the COVID-19 emergency.
"The FDA recommends healthcare and laboratory facilities develop and implement conservation strategies to minimize the use of these tubes and maintain the quality and safety of care for patients who need coagulation testing," FDA wrote.