Coronavirus Diagnostic Tests

Coronavirus Diagnostic Tests

The Centers for Disease Control and Prevention (CDC) continues to closely monitor an outbreak of respiratory illness caused by a novel coronavirus SARS-CoV-2 and the related disease known as COVID-19, which was initially detected in China during December 2019.

On February 4, 2020, the US FDA issued an emergency use authorization enabling the emergency use of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This FDA authorization allows the use of the test at any CDC-qualified lab across the country. 

On February 5, 2020, the U.S. HHS announced the opening of an Easy Broad Agency Announcement for the development of 2019-nCoV diagnostics and is now accepting abstract submissions for potential funding. The diagnostics must utilize platforms already cleared by the U.S. FDA, with a viable plan to meet requirements for the FDA to consider Emergency Use Authorization within 12 weeks of an award.

On February 18, 2020, the WHO Situation Report #29 announced the WHO Operations Support and Logistics (OSL) continues to gather and assess the needs of Member States for critical items. On 14 February, OSL started the dispatch of laboratory COVID-19 testing kits for 56 countries. As of 17 February, 37 shipments have been dispatched to 34 countries and 3 regional offices. Currently, the WHO says there are 15 laboratories identified to provide reference testing support for 2019-nCoV. The 2019-nCoV Realtime RTPCR test is reported to produce results in just 4 hours.

On February 21, 2020, a practical “how-to” protocol for healthcare and public health professionals” was published by the WHO. This protocol was designed to determine viable virus presence and persistence on fomites in various locations where a COVID-19 patient is receiving care or isolated, and to understand how fomites may play a role in the transmission of the virus.

CDC Interim Testing Guidance

This CDC page includes interim guidance for laboratory professionals working with specimens from PUI for human infections with the 2019-nCoV:

  • The diagnostic is a reverse transcriptase-polymerase chain reaction (PCR) test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test result indicates likely infection with 2019-nCoV and infected patients should work with their health care provider to manage their symptoms and determine how to best protect the people around them. Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
  • Under this EUA, the use of the 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for patients who meet the CDC criteria for 2019-nCoV testing.
  • Testing is limited to qualified laboratories designated by the CDC and, in the U.S., those certified to perform high complexity tests. 

Qualifying Potential Patients

Healthcare providers should contact their local/state health department immediately to notify them of patients with fever and lower respiratory illness who traveled to China within 14 days of symptom onset.

The CDC recommends collecting and testing upper respiratory (nasopharyngeal AND oropharyngeal swabs), and lower respiratory (sputum, if possible)) for those patients with productive coughs. The induction of sputum is not indicated. Specimens should be collected as soon as possible once a PUI is identified, regardless of the time of symptom onset.

State and local health departments who have identified a PUI should immediately notify the CDC’s Emergency Operations Center (EOC) at 770-488-7100 to report the PUI and determine whether testing for 2019-NCoV at CDC is indicated. The EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.

Updated CDC Guidance 

February 3, 2020: Infection Prevention and Control Recommendations for Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) or Patients Under Investigation for 2019-nCoV in Healthcare Settings.

Infection control procedures including administrative rules and engineering controls, environmental hygiene, correct work practices, and appropriate use of personal protective equipment (PPE) are all necessary to prevent infections from spreading during healthcare delivery. Prompt detection and effective triage and isolation of potentially infectious patients are essential to prevent unnecessary exposures among patients, healthcare personnel, and visitors at the facility. All healthcare facilities must ensure that their personnel is correctly trained and capable of implementing infection control procedures; individual healthcare personnel should ensure they understand and can adhere to infection control requirements.

This guidance is based on the currently limited information available about 2019-nCoV related to disease severity, transmission efficiency, and shedding duration.

Guidelines for Collecting, Handling, and Testing Clinical Specimens from PUIs for the 2019-nCoV

Store specimens at 2-8°C and ship overnight to CDC on an ice pack. Label each specimen container with the patient’s ID number (e.g., medical record number), unique specimen ID (e.g., laboratory requisition number), specimen type (e.g., serum) and the date the sample was collected. Complete a CDC Form 50.34 for each specimen submitted. In the upper left box of the form, 1) for test requested select “Respiratory virus molecular detection (non-influenza) CDC-10401” and 2) for At CDC, bring to the attention of entering “Stephen Lindstrom: 2019-nCoV PUI”.

NOTE:  The information is sourced from the US CDC on February 5, 2020, and has been reviewed by Dr. Robert Carlson on February 22, 2020.