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Better tests, better care: improved diagnostics for infectious diseases.
Caliendo AM, Gilbert DN, Ginocchio CC, Hanson KE, May L, Quinn TC, Tenover FC, Alland D, Blaschke AJ, Bonomo RA, Carroll KC, Ferraro MJ, Hirschhorn LR, Joseph WP, Karchmer T, MacIntyre AT, Reller LB, Jackson AF; Infectious Diseases Society of America (IDSA). Caliendo AM, et al. Clin Infect Dis. 2013 Dec;57 Suppl 3(Suppl 3):S139-70. doi: 10.1093/cid/cit578. Clin Infect Dis. 2013. PMID: 24200831 Free PMC article. Review.
Unmet diagnostic needs in infectious disease.
Blaschke AJ, Hersh AL, Beekmann SE, Ince D, Polgreen PM, Hanson KE. Blaschke AJ, et al. Diagn Microbiol Infect Dis. 2015 Jan;81(1):57-9. doi: 10.1016/j.diagmicrobio.2014.10.005. Epub 2014 Oct 25. Diagn Microbiol Infect Dis. 2015. PMID: 25456043 Free PMC article.
Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.
Caliendo AM, Hanson KE. Caliendo AM, et al. J Clin Microbiol. 2016 Apr;54(4):829-33. doi: 10.1128/JCM.00063-16. Epub 2016 Jan 20. J Clin Microbiol. 2016. PMID: 26791369 Free PMC article.
Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. ...In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson …
Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be reg …
Maintaining Life-saving Testing for Patients With Infectious Diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests.
Caliendo AM, Couturier MR, Ginocchio CC, Hanson KE, Miller MB, Walker KE, Frank GM; Infectious Diseases Society of America; the American Society for Microbiology; and the Pan-American Society for Clinical Virology. Caliendo AM, et al. Clin Infect Dis. 2016 Jul 15;63(2):151-4. doi: 10.1093/cid/ciw260. Epub 2016 Apr 26. Clin Infect Dis. 2016. PMID: 27118790
Advancing Diagnostics to Address Antibacterial Resistance: The Diagnostics and Devices Committee of the Antibacterial Resistance Leadership Group.
Tsalik EL, Petzold E, Kreiswirth BN, Bonomo RA, Banerjee R, Lautenbach E, Evans SR, Hanson KE, Klausner JD, Patel R; and the Diagnostics and Devices Committee; of the Antibacterial Resistance Leadership Group. Tsalik EL, et al. Clin Infect Dis. 2017 Mar 15;64(suppl_1):S41-S47. doi: 10.1093/cid/ciw831. Clin Infect Dis. 2017. PMID: 28350903 Free PMC article. Review.
Influence of Molecular Testing on Influenza Diagnosis.
Yarbrough ML, Burnham CD, Anderson NW, Banerjee R, Ginocchio CC, Hanson KE, Uyeki TM. Yarbrough ML, et al. Clin Chem. 2018 Nov;64(11):1560-1566. doi: 10.1373/clinchem.2018.289363. Epub 2018 Sep 12. Clin Chem. 2018. PMID: 30209032 Free PMC article. No abstract available.
1,356 results