COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19.
COVID-19
RT-PCR
SARS-CoV-2
molecular diagnostic testing
serological diagnostic testing
Journal
Hawai'i journal of health & social welfare
ISSN: 2641-5224
Titre abrégé: Hawaii J Health Soc Welf
Pays: United States
ID NLM: 101750601
Informations de publication
Date de publication:
01 05 2020
01 05 2020
Historique:
entrez:
21
5
2020
pubmed:
21
5
2020
medline:
27
5
2020
Statut:
ppublish
Résumé
Nationwide shortages of tests that detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and diagnose coronavirus disease 2019 (COVID-19) have led the US Food and Drug Administration (FDA) to significantly relax regulations regarding COVID-19 diagnostic testing. To date the FDA has given emergency use authorization (EUA) to 48 COVID-19 in vitro diagnostic tests and 21 high complexity molecular-based laboratory developed tests, as well as implemented policies that give broad authority to clinical laboratories and commercial manufacturers in the development, distribution, and use of COVID-19 diagnostic tests. Currently, there are 2 types of diagnostic tests available for the detection of SARS-CoV-2: (1) molecular and (2) serological tests. Molecular detection of nucleic acid (RNA or DNA) sequences relating to the suspected pathogen is indicative of an active infection with the suspected pathogen. Serological tests detect antibodies against the suspected pathogen, which are produced by an individual's immune system. A positive serological test result indicates recent exposure to the suspected pathogen but cannot be used to determine if the individual is actively infected with the pathogen or immune to reinfection. In this article, the SARS-CoV-2 diagnostic tests currently approved by the FDA under EUA are reviewed, and other diagnostic tests that researchers are developing to detect SARS-CoV-2 infection are discussed.
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
136-142Subventions
Organisme : NIGMS NIH HHS
ID : P30 GM114737
Pays : United States
Informations de copyright
©Copyright 2020 by University Health Partners of Hawai‘i (UHP Hawai‘i).
Déclaration de conflit d'intérêts
The authors report no conflicts of interest.
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