Digital Diagnostics: Over-the-Counter (OTC) and Point-of-Care (POC)
Develop a technical infrastructure for handling RWD/RWE to support the conversion from emergency use authorizations (EUAs) to 510(k) clearances for COVID-related IVDs (e.g., …
Special Topic: Point-of-Care Testing (POCT) and In Vitro Diagnostics (IVDs)
Apr 2, 2019 · Current POCT is available for pregnancy testing, blood glucose testing, HIV testing, hemoglobin concentrations, complete blood count, cardiac biomarkers and numerous …
Microfluidic Point-of-Care Testing: Commercial Landscape and …
Point-of-care testing (POCT) allows physicians to detect and diagnose diseases at or near the patient site, faster than conventional lab-based testing. The importance of POCT is …
Trends in Multiplex Immunoassays for In Vitro Diagnostics and …
The tremendous advances in multiplex immunoassays (MIAs) are leading to novel in vitro diagnostics (IVD) and point-of-care testing (POCT). MIAs can simultaneously detect numerous …
Point-of-Care Testing - StatPearls - NCBI Bookshelf
May 29, 2023 · The National Academy of Clinical Biochemistry (NACB) has developed evidence-based guidelines for POCT, providing grading and recommendations to optimize the use of …
Integrating in vitro point of care diagnostics: guidance for urgent ...
Aug 29, 2023 · This guidance provides information on the key requirements to support integration of in vitro diagnostic (IVD) PoCT devices into these services. It also outlines the role of …
Dec 14, 2020 · The aim of this document is to provide advice and guidance on the management and use of point of care testing (POCT) in vitro diagnostic (IVD) devices. It is a revised edition …
POCT systems make up an important segment of the in-vitro diagnostic (IVD) market, nearly the 30%. The global POC diagnostic market is anticipated to show rapid growth over the next …
Cur-rent POCT is available for pregnancy testing, blood glucose testing, HIV testing, hemoglobin concentrations, complete blood count, cardiac biomarkers and numerous additional applications.
Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition This document provides guidance to users of in vitro diagnostic (IVD) devices outside the clinical …