An international public health response is currently underway to monitor and contain an outbreak of the Corona Virus Disease (COVID-19). COVID-19 was first identified in Wuhan City, Hubei Province, China in late 2019. While this coronavirus is novel, the coronavirus family is large. Found in many species of animals including camels, cat, cattle and bats, coronaviruses can cause illness in humans ranging from the common cold to severe infections.
Chinese authorities have reported thousands of confirmed cases of COVID-19 in China, including cases outside Wuhan City, and there are a growing number of confirmed cases outside of China including in the US. Early in this outbreak, many of the patients were reportedly linked to a large seafood and animal market suggesting animal-to-person spread. However, a growing number of patients report no exposure to animal markets, suggesting limited person-to-person spread is occurring. It remains unclear how easily or sustainably this virus is spreading between people.
Chinese health authorities posted the full genome of the 2019-nCoV virus in GenBank on January 11, 2020, which has enabled CDC to establish a CLIA-compliant RT-PCR assay to detect the novel virus. On February 4, 2020, FDA approved an emergency use authorization (EUA) for this new assay which allows CDC to begin distributing test kits to public health laboratories through the International Reagent Resource (IRR).
Below is a summary of the current state of the laboratory response to COVID-19, and resources for public health laboratories actively conducting or preparing to conduct testing for the virus.
On January 30, 2020, WHO declared COVID-19 a Public Health Emergency of International Concern (PHEIC) under the 2005 International Health Regulations. On January 31, 2020, the HHS Secretary declared a public health emergency for the entire US which paved the way for EUA assays and the mobilization of resources to support the response. On February 4, 2020, FDA issued an EUA for the CDC 2019-Novel Coronavirus (2019 n-CoV) Real-Time RT-PCR Diagnostic Panel. On February 11,2020, WHO announced a new name for the disease responsible for the novel outbreak to the Corona Virus Disease (COVID-19), caused by the Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) virus.
On January 22, 2020, APHL established its Incident Command System (ICS) and activated its Emergency Operations Center (EOC). The ICS approach enables APHL to effectively coordinate with CDC and other partners to respond to COVID-19. APHL's priorities are:
Ensure public health laboratories have timely diagnostics to perform quality laboratory testing in their jurisdictions
Support public health laboratories with reporting test results to sample submitters and CDC
Provide technical assistance and credible communications to public health laboratories, partners and the public.
APHL continues to monitor the response, providing assistance to member public health laboratories as they bring on the CDC EUA test.
Laboratory Testing Resources
APHL has developed eight test message scenarios to support data exchange work, 4 for HL7 2.5.1 and 4 for HL7 2.3.1. Sample messages include:
CDC has published the following interim guidelines, but this is a very dynamic response so please check CDC's website for the most up to date information: