A new coronavirus test template developed by the US Centers for Disease Control and Prevention is being refined by the agency so it can be shared with domestic and international partners to help identify more cases of the virus. In the meantime, state labs can use the posted assay for coronavirus on the CDC’s website for testing of residents within their jurisdiction and send results to the CDC.
The US Centers for Disease Control and Prevention (CDC) has posted instructions for how to run a real-time reverse transcription polymerase chain reaction (RT-PCR) assay to detect coronavirus and is sharing it with state labs to help detect more cases of the virus.
“In addition, we are refining use of this test so we can provide it as a test kit to state health departments and laboratories,” Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Disease, told reporters at a 27 January news briefing on the spread of the virus in the US. (Also see "Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive" - Medtech Insight, 24 Jan, 2020.)
Messonnier added that as of Monday, the CDC had identified 110 “persons under investigation” who are suspected of having the virus in 26 states, and five people had tested positive for the disease.
But she downplayed the risk of the virus spreading in the US, noting that each infected person is likely to infect only between one to three other individuals, and that to date, many people who have traveled to the Wuhan region and believe they had contracted it, have already reported in to health-care providers and state health departments, and now have limited contacted with others.
Nevertheless, the number of people who will be sickened by the virus is “likely to increase,” Messonnier said. She expects that more people will need an accurate diagnostic for coronavirus.
“Our longer-term plan is to share these tests with domestic and international partners to serve as part of agencies’ international resources,” Messonnier added.
The CDC has also uploaded the entire genome sequence of the virus, and the sequence is similar to one that Chinese authorities have posted, she said.
Test Details Specimen Types, Reagents And Limitations
The real-time RT-PCR panel for coronavirus and instructions for use that the CDC posted online provides information on the types of specimens that are to be collected, reagents to be used, test platforms, and limitations of the assay.
It also spells out supplies and equipment needed, how to extract nucleic acid, quality controls and how to interpret test results. The CDC also emphasized that when conducting the test, laboratorians should wear personal protective equipment, such as gowns, gloves, and eye protection.
Messonnier noted that the CDC is growing the virus in cell culture, which is necessary for further studies, including for additional genetic characterization.