Testing for COVID-19
February 29, 2020: Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics – As part of the FDA’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for diagnostics testing in laboratories certified to perform high complexity testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the public health emergency.
Regulatory Clearance
In February 2020, the Logix Smart COVID-19 Test kit received CE marking approval, the principle regulatory clearance allowing the test to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of COVID-19 in European Union states and other markets that accept a CE-IVD mark as valid regulatory approval.
SARS-CoV-2 (COVID-19)
The disease was first reported in 31-Dec-2019 by the Chinese government to the World Health Organization (WHO) after a cluster of pneumonia of unknown cause was identified in the city of Wuhan, Hubei province, China. The virus was found genetically similar to SARS-CoV, responsible for the 2002-2003 outbreak of severe acute respiratory syndrome. Signs and symptoms include fever, fatigue, dry cough, and shortness of breath. Cases of severe infection can result in pneumonia, acute respiratory distress syndrome (ARDS), and kidney failure leading to death in some cases. Based on early evidence, many of those who died had other conditions such as hypertension, diabetes, or cardiovascular disease that impaired their immune system. Person-to person transmission, especially close contact, has been confirmed in asymptomatic and symptomatic phases of the disease. The degree of transmission on each phase has not been established yet. The incubation period has shown to be from 1 to 12.5 days, however, because SARS had a 14 days incubation period, the CDC and WHO recommends considering a 14 days incubation period where self-isolation and quarantine is recommended. There have been reported outliers of 24 days incubation period.
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