Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like
| Autor: | Adam Z. Bard, Mark M. Mizrachi, Hetal D. Marble, Jochen K. Lennerz |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Oncology
2019-20 coronavirus outbreak medicine.medical_specialty Emergency Use Authorization Time Factors Coronavirus disease 2019 (COVID-19) business.industry Extramural United States Food and Drug Administration Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Pcr assay Polymerase Chain Reaction United States Pathology and Forensic Medicine Food and drug administration Limit of Detection Internal medicine COVID-19 Nucleic Acid Testing Molecular Medicine Medicine Humans business Laboratories Perspectives |
| Zdroj: | The Journal of Molecular Diagnostics : JMD |
| ISSN: | 1943-7811 |
| Popis: | The coronavirus disease 2019 (COVID-19) response necessitated innovations and a series of regulatory deviations that also affected laboratory-developed tests (LDTs). To examine real-world consequences and specify regulatory paradigm shifts, legislative proposals were aligned on a common timeline with Emergency Use Authorization (EUA) of LDTs and the US Food and Drug Administration (FDA)-orchestrated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) labeling update study. The initial EUA adoption by LDT developers shows that the FDA can have oversight over LDTs. We used efficiency-corrected microcosting of our EUA PCR assay to estimate the national cost of the labeling update study to $0.3 to $1.4 million US dollars. Labeling update study performance data showed lower average detection limits in commercial in vitro diagnostic (IVD) assays versus LDTs (32,000 ± 75,000 versus 71,000 ± 147,000 nucleic acid amplification tests/mL; P = 0.04); however, comparison also shows that FDA review of IVD assays and LDTs did not prevent differences between initial and labeling update performance (IVD assay, P |
| Databáze: | OpenAIRE |
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