| Autor: |
Sippert, Emilia, Volkova, Evgeniya, Rippee-Brooks, Meagan, Denomme, Gregory A., Flegel, Willy A., Lee, Christine, Araojo, Richardae, Illoh, Orieji, Liu, Zhugong, Rios, Maria, Arnoni, Carine Prisco, Latini, Flavia, da Silva, Flavia Sant’Anna, Vendrame, Tatiane Aparecida, Hyland, Catherine, Millard, Glenda, Liew, Yew-Wah, Teramura, Gayle, Harris, Samantha, Nakaya Fletcher, Shelley, Peyrard, Thierry, Poyot, Thomas, Martin-Blanc, Stephanie, Ochoa, Gorka, Westhoff, Connie, Vege, Sunitha, Denomme, Gregory A., Stef, Marianne A., Castilho, Lilian, dos Santos, Tamires Delfino, Piefer, Cindy, Bensing, Kathleen, Schanen, Michael, Scholz, Sabine, König, Sabrina, Bein, Gregor, Roeder, Lida, Sachs, Ulrich J., Wittig, Michael, Steiert, Tim A., Franke, Andre, Henny, Christine, Tani, Yoshihiko, Tanaka, Mitsunobu, Flegel, Willy A., Srivastava, Kshitij, Conceicao, Michelle, Resto, Claribel, Gannett, Michael Sel, Doescher, Andrea, Bonet Bub, Carolina, Aravechia, Maria Giselda, Costa, Thiago Henrique, Sirianni, Marilia Fernandes Mascarenhas, Santos, Leandro Dinalli |
| Zdroj: |
The Journal of Molecular Diagnostics; 20240101, Issue: Preprints |
| Abstrakt: |
Patients who carry RH blood group variants may develop Rh alloantibodies requiring matched red blood cell transfusions. Serologic reagents for Rh variants often fail to specifically identify variant Rh antigens and are in limited supply. Therefore, red blood cell genotyping assays are essential for managing transfusions in patients with clinically relevant Rh variants. Well-characterized DNA reference reagents are needed to ensure quality and accuracy of the molecular tests. Eight lyophilized DNA reference reagents, representing 21 polymorphisms in RHDand RHCE,were produced from an existing repository of immortalized B-lymphoblastoid cell lines at the Center for Biologics Evaluation and Research/US Food and Drug Administration. The material was validated through an international collaborative study involving 17 laboratories that evaluated each DNA candidate using molecular assays to characterize RHDand RHCEalleles, including commercial platforms and laboratory-developed testing, such as Sanger sequencing, next-generation sequencing, and third-generation sequencing. The genotyping results showed 99.4% agreement with the expected results for the target RHpolymorphisms and 87.9% for RHallele agreement. Most of the discordant RHalleles results were explained by a limited polymorphism coverage in some genotyping methods. Results of stability and accelerated degradation studies support the suitability of these reagents for use as reference standards. The collaborative study results demonstrate the qualification of these eight DNA reagents for use as reference standards for RHblood group genotyping assay development and analytical validation. |
| Databáze: |
Supplemental Index |
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