DiaPharma Group, Inc.

For In Vitro Diagnostic Use

Intended use

For control of accuracy when using the Coatest APC Resistance cat # K823120 (823120), Coatest APC Resistance V cat # K823120 (823120) and Coatest APC Resistance VS cat # K823138 (823138) kits.

Reagent -- Composition, Packaging, Storage and Stability

Chromogenix Control Plasma Level 2 is a lyophilized preparation of citrated human plasma. Stability: hours at 20-25°C, 6 hours at 2-8°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.

Procedure

Reconstitute each vial with 1.0 mL deionized water, filtered through 0.22 µm or NCCLS type II water¹. Allow to stand at room temperature for 30 minutes. Swirl gently before use.

Expected Values

Different clotting times will be obtained with different types of instruments depending on the clot detection principle. The following ranges cover the expected clotting times when performing analysis of Control Plasma Level 2 with the above batch number using the Coatest APC Resistance and Coatest APC Resistance V / VS kits.

COATEST® APC RESISTANCE

Turbidimetric/photometric (e.g. ACL, MLA)

Electro-mechanical (e.g. ST 4, KC, Fibrintimer)

COATEST® APC RESISTANCE V / VS

All instruments

Reference

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