Quantitative determination of coagulation factors
IVD
Store at 2 - 8ºC.
PRODUCT CHARACTERISTICS
The calibrator is lyophilised human plasma, containing
PT, APTT and Fibrinogen that allows expressing the
analytical results in different units as concentration
(mg/dL), percentage (%) or activity rate, by manual
method.
REAGENTS
Calibrator. Human plasma. Sodium azide 0.95 g/L.
Coagulation factors concentration is indicated below.
PRECAUTIONS
Components from human origin have been tested and
found negative for the presence of HBsAg, HCV and
antibody to HIV (1/2). However handle cautiously as
potentially infectious.
CALIBRATION
Reference values have been calculated from a pool of
normal plasma.
PREPARATION
Reconstitute () with 1.0 mL of distilled water. Mix
thoroughly, avoiding foam forming. Bring to room
temperature for about 30 minutes before use.
STORAGE AND STABILITY
The calibrator 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, stable for 4 hours at room
temperature (15-25ºC) or 24 hours at –20ºC, if frozen
immediately.
PROCEDURE
To be used in manual assays.
