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2020 ; 79
(5
): 136-142
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
COVID-19 Special Column: Principles Behind the Technology for Detecting
SARS-CoV-2, the Cause of COVID-19
#MMPMID32432217
Ching L
; Chang SP
; Nerurkar VR
Hawaii J Health Soc Welf
2020[May]; 79
(5
): 136-142
PMID32432217
show ga
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.