The State of the Blood Collection Tube Industry

Please make sure to check out Medriva's Blood Collection Tube Series.



Why are Sodium Citrate tubes in Short Supply?

The US FDA, Health Canada, NHS, and many other regulatory agencies have determined there is an inevitable supply shortage of sodium citrate (light blue top) tubes at that time due to a rapid increase in demand and relatively recent vendor-supply challenges, and added the devices, i.e., product codes including GIM as well as JKA for sodium-citrate tubes just) to the section 506J device shortage list.

In response to an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges, the U.S. Food Drug Administration (FDA) is aware that the United States of America is experiencing abundant interruptions in blood specimen collection tubes' supply. 

All specimen collection tube(s) were added to the list of devices in shortage by the FDA on January 19, 2022. In June 2021, the FDA listed sodium citrate tubes (light-blue tops) on device shortage lists for the first time. 

To minimize blood collection tubes' use and maintain quality and safe patient care, the FDA recommends healthcare providers, laboratory admins, and phlebotomists consider blood-specimen collection tube conservation strategies.

The tubes used to collect blood specimens are in short supply. Right?

Yes, sodium citrate tubes and other tubes for blood specimen collection are in short supply. 

Due to increased demand and recent vendor supply challenges, the FDA determined several types of blood specimens collection tube products are in short supply. They were included on the section 506J device's shortage list under product codes, i.e., GIM and JKA. 

The list of device shortages shows the types of devices that were deemed in short supply by the FDA. This list will be updated as needed.

To help ensure patient access to blood collection whenever medically necessary, the FDA continues to monitor the situation.

Is it possible to collect and test blood samples from the same color tubes from different manufacturers?

No, you don't have to. Blood collection tubes from different manufacturers may differ in their draw and test specifications, possibly affecting the results of certain tests.

Training personnel must perform validation testing using established reagents and instruments before transferring between tubes from different manufacturers. Your current collection system may not work with certain tube collection systems manufactured by other manufacturers. Using other tube collection systems may require additional staff training.

What does the FDA do to address the challenges of blood specimen collection tubes?

The FDA recommends phlebotomists, laboratory directors, and other personnel take measures to prevent the use of blood specimen collection tubes and maintain quality and a safe patient experience when medically necessary. 

The FDA has granted Becton Dickinson an Emergency-Use-Authorization (EUA) for sodium citrate's blood specimen collection tubes (light-blue tops) to collect, transport, and store blood samples for coagulation tests in patients along with COVID-19. Only authorized laboratories are authorized to use these tubes for blood collection.

How does EDTA differ from sodium citrate?

Similarly to EDTA, citrate works in the following manner;

• Calcium is removed from the blood by this treatment. It has the advantage that, unlike EDTA, it is reversible so that the mineral calcium can be re-added back to study the coagulation process under fully controlled conditions. The coagulation-related factors are measured in citrated plasma.
• It acts as an anticoagulant and can treat blood clots.
• Citrate, which can sequester Ca++ ions in vitro, has been used for nearly 100 years. It is possible to coagulate blood with no chelation by inhibiting the contact pathway with corn-trypsin-inhibitor (CTI).
• An EDTA tube is exactly what it sounds like.
• This acid is EDTA or ethylenediaminetetraacetic acid. Calcium is bound to EDTA in blood, preventing blood from immediately clotting. K2EDTA is sprayed to the tube walls of MEDEVAC Tube Series by Medriva.

How CBC is mainly administered?

A lavender top or micro collection tube(s) containing EDTA is required. Draw an additional blue top (sodium citrate) tube to clump EDTA platelets.

The sodium heparin tubes are used for what?

The green color indicates that the main anticoagulant is sodium heparin or lithium heparin. It is most commonly used to prepare heparinized plasma and whole blood and bone marrow specimens. The tube should be inverted several minutes later after collection to prevent clotting. 

Sodium citrate is an anticoagulant. How is it used?

Anticoagulant solutions USP 4% SODIUM CITRATE are applied to tubing between Apheresis procedures. In Apheresis collection tubing, the solution is mainly connected. Apheresis devices determine the dosage and meter it well into the tubing set by the device.

What is the purpose of sodium citrate in blood tubes?

It is used to study citrate utilization test(s) on the Koser Citrate Medium. Citric acid acts as a buffer to resist changes in pH. It is used in blood collection tubes and interferes with clotting by chelating calcium ions.

Due to the COVID-19 public health emergency and recent vendor supply challenges, the U.S. Food Drug Administration, i.e., the FDA is currently experiencing significant complications in blood specimen collection tubes. 

Please make sure to check out Medriva's Blood Collection Tube Series.