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Change in Actin FS Sensitivity

Here is a new message from frequent contributor Joyce Low at St. Vincent’s in Sydney.

“Our lab has been using Actin® FS since 2007. For us, different lot numbers have been reasonably similar in terms of the reference interval 25–35 s on Stago instruments and heparin therapeutic interval of 50–75 or 80s determined by anti-Xa assay. In part, this was due to pretesting of each new lot before accepting it. Very recently, Siemens has modified (tightened quality control in their terminology) the reagent so that the heparin therapeutic range of the reagent in at least 3 different lot numbers I have tried is something like 60–90 or 100s or even higher. This is causing our laboratory huge problems with modifications in lab procedures and IT, changes in all sorts of protocols where heparin is used in the hospital, informing all the clinicians, etc. We are seeking an explanation from the manufacturer and confirmation of future stability of the reagent. There must be hundreds of labs using this reagent around the world so I would like to know how they are reacting to the change.”

Thank you Joyce, let’s see if others have experience the same shift in Actin FS results.

Comments (2)
Anticoagulant Therapy
Gmcdowell
Sep 5, 2013 11:23am

We are seeing a similar pattern with ACTIN FSL this year. W
We are seeing a similar pattern with ACTIN FSL this year. We have pre-tested several lots, all with reduced heparin sensitivity. Due to this and a general decline in customer support, we are hoping to implement a new platform in coagulation at our hospital.

Alan Neal
Aug 24, 2013 9:55pm

We had a simular (But in reverse) problem with FSL. Approx
We had a simular (But in reverse) problem with FSL. Approx 2 years ago a reformulation resulted in a significant reduction in heparin sensitivity, with significant increased clinical risk. We had to rapidly amend protocols across 4 hospitals. Despite request for ‘please explain,’ no information about this change was received (or why wasn’t detected by manufacturer)- We no longer use this product.

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