Thursday, October 31, 2019

October 31, 2019 at 05:11PM Procleix Zika Virus Assay

The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid test for the detection of Zika virus (ZIKV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, for transfusion. It is also intended for use in testing plasma or serum specimens to screen other living (heart-beating) donors of organs and Human Cells, Tissues, and Cellular and Tissue-Based Procucts (HCT/Ps), and in testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens. The assay is intended for use in testing individual donor samples. It is also intended for use in testing pools of human plasma composed of equal aliquots of not more than 16 individual specimens from volunteer donors of whole blood components. This assay is not intended for use as an aid in diagnosis of Zika virus infection.

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