Home and Clinical Laboratory Improvement Amendments-Waived Testing for Infectious Diseases-How Do These Fit in the Testing Landscape?

Copyright © 2023 Elsevier Inc. All rights reserved..

Though testing for infectious diseases has long been performed in traditional clincial laboratory settings, more widespread availability of waived testing is expanding accessibility of patients to rapid test results. This is being further expanded to home testing. Nevertheless, with this greater democratization and availability of clinical testing there are important limitations that need to be balanced. In this article, we review the current test landscape for infectious diseases waived testing and opportunities for assuring optimal quality testing.

Medienart:

E-Artikel

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

Zur Gesamtaufnahme - volume:44

Enthalten in:

Clinics in laboratory medicine - 44(2024), 1 vom: 29. März, Seite 13-21

Sprache:

Englisch

Beteiligte Personen:

Lu, Jacky [VerfasserIn]
Butler-Wu, Susan M [VerfasserIn]

Links:

Volltext

Themen:

Antigen-based CLIA-waived testing
Clinical Laboratory Improvement Amendments
Emergency use authorization
Home or over-the-counter testing
Journal Article
Review

Anmerkungen:

Date Completed 29.01.2024

Date Revised 10.04.2024

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1016/j.cll.2023.10.005

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM367712083