[HTML][HTML] Anti-SARS-CoV-2 antibodies in healthy donor plasma pools and IVIG products

C Romero, JM Díez, R Gajardo - The Lancet Infectious Diseases, 2021 - thelancet.com
C Romero, JM Díez, R Gajardo
The Lancet Infectious Diseases, 2021thelancet.com
Correspondence 766 www. thelancet. com/infection Vol 21 June 2021 for non-
bronchoalveolar lavage biomarkers, which have not been cleared or validated. Although this
proposal is reasonable to generate data in early research settings, one can hardly say that
we have enough evidence to derive consensus. Multiple issues arise with using definitions
in different clinical and research contexts. For instance, conservative definitions are not
actionable for clinical care or prevention studies—settings where the earliest therapy is …
Correspondence
766 www. thelancet. com/infection Vol 21 June 2021 for non-bronchoalveolar lavage biomarkers, which have not been cleared or validated. Although this proposal is reasonable to generate data in early research settings, one can hardly say that we have enough evidence to derive consensus. Multiple issues arise with using definitions in different clinical and research contexts. For instance, conservative definitions are not actionable for clinical care or prevention studies—settings where the earliest therapy is essential to improve clinical outcomes. We thank our colleagues for early efforts to understand and define this new entity, but fear that more caution is needed to acknowledge critical gaps in data. We believe that establishing consensus definitions for CAPA requires more efforts, especially those directed towards deriving biomarker performance characteristics.
NP reports grants from Health System Research Institute and Cystic Fibrosis Foundation, and personal fees from Shionogi, outside the submitted work. JM reports personal fees and non-financial support from MSD, Pfizer, Gilead, Cidara, F2G, Scynexis, and Bio-Rad, and grants from Pfizer and Gilead, outside the submitted work. KAM reports personal fees from Cidara, Sfunga, and MSD, outside the submitted work, and patents on fungal diagnostics with royalties paid by MycoMed Technologies.
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