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COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19.
Hawaii J Health Soc Welf. 2020 05 01; 79(5):136-142.HJ

Abstract

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.

Authors+Show Affiliations

Department of Tropical Medicine, Medical Microbiology, and Pharmacology, John A. Burns School of Medicine, University of Hawai'i at Manoa, Honolulu, HI (LLC, SPC, VRN). Pacific Center for Emerging Infectious Diseases Research, John A. Burns School of Medicine, University of Hawai'i at Manoa, Honolulu, HI (LLC, SPC, VRN).Department of Tropical Medicine, Medical Microbiology, and Pharmacology, John A. Burns School of Medicine, University of Hawai'i at Manoa, Honolulu, HI (LLC, SPC, VRN). Pacific Center for Emerging Infectious Diseases Research, John A. Burns School of Medicine, University of Hawai'i at Manoa, Honolulu, HI (LLC, SPC, VRN).Department of Tropical Medicine, Medical Microbiology, and Pharmacology, John A. Burns School of Medicine, University of Hawai'i at Manoa, Honolulu, HI (LLC, SPC, VRN). Pacific Center for Emerging Infectious Diseases Research, John A. Burns School of Medicine, University of Hawai'i at Manoa, Honolulu, HI (LLC, SPC, VRN).

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32432217

Citation

Ching, Lauren, et al. "COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19." Hawai'i Journal of Health & Social Welfare, vol. 79, no. 5, 2020, pp. 136-142.
Ching L, Chang SP, Nerurkar VR. COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19. Hawaii J Health Soc Welf. 2020;79(5):136-142.
Ching, L., Chang, S. P., & Nerurkar, V. R. (2020). COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19. Hawai'i Journal of Health & Social Welfare, 79(5), 136-142.
Ching L, Chang SP, Nerurkar VR. COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19. Hawaii J Health Soc Welf. 2020 05 1;79(5):136-142. PubMed PMID: 32432217.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19. AU - Ching,Lauren, AU - Chang,Sandra P, AU - Nerurkar,Vivek R, PY - 2020/5/21/entrez PY - 2020/5/21/pubmed PY - 2020/5/27/medline KW - COVID-19 KW - RT-PCR KW - SARS-CoV-2 KW - molecular diagnostic testing KW - serological diagnostic testing SP - 136 EP - 142 JF - Hawai'i journal of health & social welfare JO - Hawaii J Health Soc Welf VL - 79 IS - 5 N2 - 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. SN - 2641-5224 UR - https://www.unboundmedicine.com/medline/citation/32432217/COVID_19_Special_Column:_Principles_Behind_the_Technology_for_Detecting_SARS_CoV_2_the_Cause_of_COVID_19_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/32432217/ DB - PRIME DP - Unbound Medicine ER -