DiaPharma Group, Inc.

For in vitro use only -- For research use only

Lyophilized plasmas, at defined tPA: Ag concentrations, as measured with the DiaPharma tPA (Liquid Reagent) Ag kit (DPGC101A), for the quality control of tPA antigenic assays. This assay is standardized by reference to the NIBSC international standard. The target values and the acceptance ranges, indicated on the flyer, are valid for DiaPharma tPA: Ag (Liquid Reagent) only. The results obtained can vary, when these controls 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.

Reagents and preparation:

• 3 vials of 1 ml of normal plasma, lyophilized, at a high tPA concentration (Control I). 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, lyophilized, at a low tPA concentration (Control II). Restore the vial with 1 ml distilled water; let for 15 min at room temperature; mix gently until complete dissolution of the content.

The tPA: Ag 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.

Excipients: Glycine, stabilizers.

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).

Note: this product replaces DPGS012K/E (Plasma tPA Control)

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