Quality Control Methods / Results

Analyses:

• PURITY: > 95% by SDS PAGE. Three bands corresponding to troponins I, T, and C.
• Immuno-reactivity of Tn-I and Tn-C confirmed by Western Blot analysis.
• Total Protein: Determined by Bradford Assay using BSA as reference standard.
• Troponin Complex concentration has been calculated from Tn-I content (Opus analyzer).

Optimum Storage Conditions: -25° C or below (Avoid repeated freeze thawing).

HAZARD TESTING & WARNINGS:

Blood samples from tissue donors used in the manufacture of this product have been tested at the donor level for HBsAg, Anti-HIV-1/HIV-2, & HCV by FDA approved methods and all results were non-reactive.

CAUTION: NO TEST CAN GUARANTEE A PRODUCT TO BE NON-INFECTIOUS. THEREFORE, ALL MATERIAL DERIVED FROM HUMAN FLUIDS OR TISSUES SHOULD BE CONSIDERED AS POTENTIALLY INFECTIOUS.

Use Statement: For use in Research or Remanufacture of non-injectable products not subject to license under PHS Act Section 351 only.