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., rapid tests, PCR...

Apr 2, 2019 · Current 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 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 considerably amplified in the trying times of the COVID-19 pandemic.

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 analytes in a single sample, which facilitates the diagnosis of many complex diseases.

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 POCT based on scientific research and clinical evidence.

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 pathology and considers organisational governance and clinical safety responsibilities.

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 of the version first published in 2002 as DB 2002(03). • A clinical need must be identified before the implementation of a POCT service.

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 years and is estimated to reach USD 50.6 billion by 2025 from USD 29.5 billion in …

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 laboratory, to ensure reliable results comparable to those obtained within the clinical laboratory.