Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

For all donor specimens with investigational Alinity s HBsAg and Alinity s HBsAg Confirmatory results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.

For all donor specimens with investigational Alinity s HTLV I/II results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.

For all donor specimens with investigational Alinity s Anti-HCV results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.

For all donor specimens with investigational Alinity s HIV Ag/Ab Combo results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.

For all donor specimens with investigational Alinity s Anti-HBc results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.

For all donor specimens with investigational Alinity s Chagas results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.