For In Vitro Diagnostic Use

As a prediluent of plasma samples in connection with the use of Coatest APC Resistance V, cat # K823120 (823120) and Coatest APC Resistance VS, cat # K823138 (823138). Predilution allows for determination of resistance to activated protein C, caused by the factor V:Q506 (factor V Leiden) mutation, in plasma from untreated individuals and from patients on oral anti-coagulant (OAC) or heparin therapy.

Stabilized, lyophilized human plasma, with a low level of FV activity, containing the heparin antagonist Polybrene®. Reconstitute with 4.0 mL of deionized water, filtered through 0.22 μm or NCCLS type II water.(1) Allow to stand for 30 minutes at 20-25°C. Swirl gently before use.

CAUTION: Each donor unit used in the preparation of human source reagent has been tested by FDA approved methods for the presence of Hepatitis B surface antigen and antibodies to HIV 1 and 2 and Hepatitis C and found to be negative. However, since no test can completely rule out the presence of these blood borne diseases, the handling and disposal of human source reagents from this product should be made with care.

Avoid contact with skin and eyes (S24/25).
Do not empty into drains (S29).
Wear suitable protective clothing (S36).

Storage conditions and stability

The sealed, lyophilized reagent is stable at 2-8°C until the expiry date printed on the label. Avoid contamination of the reconstituted reagent by microorganisms.

The reconstituted reagent is stable for 8 hours at 15-25°C, 24 hours at 2-8°C and for 3 months at -20°C or below.

The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.

1. National Committee for Clinical Laboratory Standards. Specifications for reagent water used in the clinical laboratory, NCCLS Approved Standard: ASC-3 EP 0 690 991.