DiaPharma Group, Inc.

For in vitro use only -- For research use only

Lyophilized plasmas, at defined Annexin V, tPA: Ag and uPA: Ag concentrations, as measured with the DiaPharma Annexin V kit (DPGR004A), DiaPharma tPA: Ag kit (DPGRK011A), DiaPharma uPA: Ag kit (DPGR013A) for the quality control assays. This assay is standardised by reference to the NIBSC international standard. The target values and the acceptance ranges, indicated on the flyer, are valid for DiaPharma Annexin V, tPA: Ag ,uPA:Ag only. The results obtained can vary, when these controls are used with other kits according to the assay reactivity and its standardization. These controls can nevertheless be used with different kits for quality control and testing run to run variability, but the acceptable values must be determinated by each laboratory.

Kit contents and preparation:

• 3 vials of 1 ml of normal plasma, lyophilised, at a high Annexin V, tPA and uPA concentration (Control I). UTA Control I (high): restore the vial with 1 ml distilled water ; let for 15 min at room temperature; mix gently until complete dissolution of the content.
• 3 vials of 1 ml of normal plasma, lyophilised, at a low Annexin V, tPA and uPA concentration (Control II). UTA Control II (low): restore the vial with 1 ml distilled water ; let for 15 min at room temperature; mix gently until complete dissolution of the content.

The concentrations and the acceptance ranges for controls I and II, can present variations from lot to lot, but are indicated on the flyer provided with each set of controls.

These plasmas are stable for:

• In their original package, and before any use, when stored at 2-8°C, the reagents are stable until the expiration date printed on the kit.
• 24 hours at room temperature (18-25°C)
• 48 hours at 2-8°C
• 2 months, frozen in their original vial, or in a plastic tube (before use, thaw in a water bath at 37°C, for at least 15 min).

Excipients: Glycine, stabilizers.

Note: this product replaces DPGS010K (Annexin V Plasma Control), DPGS012K (tPA Plasma Control), DPGS016K (uPA Plasma Control).

Note: a minimum of 20 (20 sets of 2 x 3 x 1 ml) is required for this item.