Quantitative determination of coagulation factors
IVD
Store at 2 - 8ºC.
PRODUCT CHARACTERISTICS
The Control is a lyophilised human plasma, used to evaluate the
precision and accuracy of PT, APTT and Fibrinogen
determinations in human plasma.
REAGENTS
Human plasma collected with 0.4% sodium citrate
anticoagulant, with a NORMAL concentration of coagulation
factors.
Coagulation factors concentration is indicated below.
PRECAUTIONS
Each unit of source material used in the preparation of this
product has been tested by an FDA licensed method and found
non-reactive for HBsAg and negative for antibodies to HIV and
HCV. However, as no known test method can offer complete
assurance that products derived from human blood will not
transmit infectious diseases, this product must be handled as
potencially infectious biological material.
STORAGE AND STABILITY
The control is stable until the expiration date on the label when
stored tightly closed at 2-8ºC and contaminations are prevented
during their use. Do not use reagents over the expiration date.
After reconstitution, it’s stable for 8 hours tightly closed at 2-8ºC.
Gently mix contents prior to each use.
Erratic values, product color variations, or lack of vacuum in the
vials could indicate product deterioration. However, poor control
performance could also be due to other factors within the test.
PROCEDURE
The Control should be run as a sample, at the initiation of
testing each day and at least once each shift, or with each
group of assays. Controls should also be tested with each
reagent change or major instrument adjustment. Compare test
results obtained to the expected results for the test method
and control plasma.
