CoaguSense Assure PT Care Prothrombin Time User Manual page 8

Control Strips and Control Activation Solution
Quality control is an important part of PT testing to verify the integrity of the
®
performance characteristics of the testing system. The Assure PT Care Meter has
been designed with multiple internal systems to ensure proper system function.
When powered ON, the meter runs an extensive self-check protocol to ensure, for
example, that operating temperature, timing functions, battery level and optical and
mechanical functions are within specification. There are 2 Low and High Control
Strips, and a Control Activation Solution shipped with each test strip kit. Each
control strip contains plasma which is generated from a pool of normal donors
where the Vitamin K dependent proteins are removed and added back at different
levels to represent the 'Low' and 'High' level ranges. Real plasma allows for a
fully functional liquid quality control test of both the a) reagent's ability to generate
a clot and b) the analyzer's ability to detect a clot. Control testing confirms the
performance of the system and should be completed immediately for each new lot
of test strips received.
NFC Tag:
Near Field Communication (NFC) Tag is a micro data tag with antenna that
contains the lot specific test strip kit information. Transfer of the lot specific data
to the meter can be accomplished through surface contact of the matching NFC
symbols. The NFC Tag communicates the unique data for each lot of strips to the
meter. The meter reads the data stored in the NFC Tag and auto populates the
relevant test strip information on the screen.
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