Client: Thromboplastin Manufacturer / ISI Assignments
The International Normalised Ratio (INR) in conjunction with the Prothrombin Time (PT) test allows healthcare providers to monitor how well a patient is managing their dose of Warfarin or Coumadin. The World Health Organization (WHO) has established a range that all people taking these drugs should fall within in comparison to the general population. The WHO has created a procedure to develop an International Sensitivity Index which allows an appropriate INR value to be determined for these patients. The purpose is to ensure that the same patient anywhere in the world will receive the same result no matter what instrument, laboratory or reagent is used to monitor their therapy.
In order to comply with WHO ISI parameters, our client required us to provide them with a primary ISI value. Our lab is the only commercial laboratory in North America that is able to acquire the appropriate therapeutic donors and then perform the testing required to produce an ISI value.
• Working with our local specimen collection centers, we recruited the number of appropriate donors both normal and warfarin patients
• We assayed the thromboplastin (reagent supplied by the company) on a designated instrument (of which we have a wide variety to select from)
• We used the “Gold Standard” international reference plasma (RTF/16 or RBT/16) to perform the manual method as dictated by the WHO
• We then regress the data and provide the result to the manufacturer so that they can provide that information to healthcare providers using their product
As the only commercial laboratory in North America providing this service, our clients rely on us for timely and accurate results. We take these activities very seriously as our work provides our clients with the basic information required to maintain the health of millions of people.