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Report of the 2019 NIST-FDA workshop on standards for next generation sequencing detection of viral adventitious agents in biologics and biomanufacturing.
Cleveland MH, Anekella B, Brewer M, Chin PJ, Couch H, Delwart E, Huggett J, Jackson S, Martin J, Monpoeho S, Morrison T, Ng SHS, Ussery D, Khan AS. Cleveland MH, et al. Biologicals. 2020 Mar;64:76-82. doi: 10.1016/j.biologicals.2020.02.003. Epub 2020 Feb 22. Biologicals. 2020. PMID: 32094072 Free PMC article.
Digital PCR for the characterization of reference materials.
Cleveland MH, He HJ, Milavec M, Bae YK, Vallone PM, Huggett JF. Cleveland MH, et al. Mol Aspects Med. 2024 Apr;96:101256. doi: 10.1016/j.mam.2024.101256. Epub 2024 Feb 14. Mol Aspects Med. 2024. PMID: 38359699 Free article. Review.
Development and interlaboratory evaluation of a NIST Reference Material RM 8366 for EGFR and MET gene copy number measurements.
He HJ, Das B, Cleveland MH, Chen L, Camalier CE, Liu LC, Norman KL, Fellowes AP, McEvoy CR, Lund SP, Almeida J, Steffen CR, Karlovich C, Williams PM, Cole KD. He HJ, et al. Among authors: cleveland mh. Clin Chem Lab Med. 2019 Jul 26;57(8):1142-1152. doi: 10.1515/cclm-2018-1306. Clin Chem Lab Med. 2019. PMID: 31112502 Free PMC article.
RNA reference materials with defined viral RNA loads of SARS-CoV-2-A useful tool towards a better PCR assay harmonization.
Vierbaum L, Wojtalewicz N, Grunert HP, Lindig V, Duehring U, Drosten C, Corman V, Niemeyer D, Ciesek S, Rabenau HF, Berger A, Obermeier M, Nitsche A, Michel J, Mielke M, Huggett J, O'Sullivan D, Busby E, Cowen S, Vallone PM, Cleveland MH, Falak S, Kummrow A, Keller T, Schellenberg I, Zeichhardt H, Kammel M. Vierbaum L, et al. Among authors: cleveland mh. PLoS One. 2022 Jan 20;17(1):e0262656. doi: 10.1371/journal.pone.0262656. eCollection 2022. PLoS One. 2022. PMID: 35051208 Free PMC article.
Results of German external quality assessment schemes for SARS-CoV-2 antigen detection.
Vierbaum L, Wojtalewicz N, Grunert HP, Zimmermann A, Scholz A, Goseberg S, Kaiser P, Duehring U, Drosten C, Corman V, Niemeyer D, Rabenau HF, Obermeier M, Nitsche A, Michel J, Puyskens A, Huggett JF, O'Sullivan DM, Busby E, Cowen S, Vallone PM, Cleveland MH, Falak S, Kummrow A, Schellenberg I, Zeichhardt H, Kammel M. Vierbaum L, et al. Among authors: cleveland mh. Sci Rep. 2023 Aug 14;13(1):13206. doi: 10.1038/s41598-023-40330-2. Sci Rep. 2023. PMID: 37580353 Free PMC article.
One in seven pathogenic variants can be challenging to detect by NGS: an analysis of 450,000 patients with implications for clinical sensitivity and genetic test implementation.
Lincoln SE, Hambuch T, Zook JM, Bristow SL, Hatchell K, Truty R, Kennemer M, Shirts BH, Fellowes A, Chowdhury S, Klee EW, Mahamdallie S, Cleveland MH, Vallone PM, Ding Y, Seal S, DeSilva W, Tomson FL, Huang C, Garlick RK, Rahman N, Salit M, Kingsmore SF, Ferber MJ, Aradhya S, Nussbaum RL. Lincoln SE, et al. Among authors: cleveland mh. Genet Med. 2021 Sep;23(9):1673-1680. doi: 10.1038/s41436-021-01187-w. Epub 2021 May 18. Genet Med. 2021. PMID: 34007000 Free PMC article.
Validation of ctDNA Quality Control Materials Through a Precompetitive Collaboration of the Foundation for the National Institutes of Health.
Williams PM, Forbes T, P Lund S, Cole KD, He HJ, Karlovich C, Paweletz CP, Stetson D, Yee LM, Connors DE, Keating SM, Destenaves B, Cleveland MH, Lau CJ, Barrett JC, Kelloff GJ, McCormack RT. Williams PM, et al. Among authors: cleveland mh. JCO Precis Oncol. 2021 Jun 1;5:PO.20.00528. doi: 10.1200/PO.20.00528. eCollection 2021. JCO Precis Oncol. 2021. PMID: 34250423 Free PMC article.
17 results