Clinical laboratories are on the diagnostic front lines of the efforts in the United States to prevent the spread of the severe acute respiratory syndrome (SARS-CoV-2), the virus which is responsible for the COVID-19 outbreak. SARS-CoV-2 is different from severe acute respiratory syndrome coronavirus (SARS-CoV) that caused the SARS outbreak in 2003.
Currently, all testing for novel coronavirus in the United States is performed by the Centers for Disease Control and Prevention, using a CDC-developed test known as the 2019-nCoV Real-Time RT- PCR Diagnostic Panel. But soon, coronavirus testing will also be performed by state public health medical laboratories.
At present, clinical labs are collecting blood samples for testing by authorized public health laboratories. However, clinical labs should prepare for the likelihood that they will be asked to perform coronavirus testing using CDC tests or some other tests which are currently under development.
The manager of Chemistry and Referral Testing, Bodhraj Acharya at the Laboratory Alliance of Central New York said that we need to be more vigilant and understand every detail related to the virus and the testing. He said if the situation comes that you have to perform testing, you should be ready for it.
The CDC has setup up a website with all the information about novel coronavirus including a section, especially for the lab professionals. The section ‘Information for Health Departments on Reporting a Person Under Investigation (PUI) or Laboratory-Confirmed Case for COVID-19’ includes the guidelines for sample collection, handling and shipping samples. It also has lab biosafety guidelines.
The current criteria for determining PUIs include the clinical features like fever or lower respiratory illness, which are combined with the epidemiological risk factors such as the recent visit to China or any close contact with lab-confirmed coronavirus patient.
The CDC notes that recent criteria are subject to change as any additional information related to the virus becomes available. The CDC also advises the health workers to consult with local or state health departments if they think that the patient meets the criteria.
The CDC has developed a rapid test kit, but distribution to public health labs has been delayed due to manufacturing defect.
Each kit can test 700 to 800 patients and provide results in four hours by using respiratory specimens. The FDA also issued a Novel Coronavirus Emergency Use Authorization (EUA) allowing state and local public health labs to perform testing using the CDC-developed Real-Tie RT-PCR diagnostic Panel.
However, the agency revealed that manufacturing defect with one of the used reagents had caused state labs to get ‘inconclusive lab results’
The director of CDC National Center for Immunization and Respiratory Diseases (NCIRD), Nancy Messonnier said that the CDC is reformulating the reagents and moving quickly to get those back out to the labs at the state and local public health laboratories.
She added that the agency is planning to develop a serologic test; identifying people exposed to the virus and developed immunity without getting sick. She said this will help in determining if people are seroconverting and how widespread the virus is. This will help in controlling COVID-19 outbreak.
The medical laboratory professionals are advised to monitor the website of CDC regularly for continuing updates, as well as website set up the WHO to provide updated technical guidance for laboratories.