By Saumya Joseph
(Reuters) – The U.S. Food and Drug Administration authorized at-home sample collection for LabCorp’s COVID-19 diagnostic kit, the agency said on Tuesday, allowing patients to send in their nasal swab samples to the company’s labs for diagnosis.
The company said it had 60,000 at-home kits available and would prioritize initial delivery to healthcare workers, expecting to expand availability to U.S. customers in the coming weeks.
The kit, which has a list price of $119, would be shipped to patients only if they are found to be eligible and requires filling in a survey on the company’s website, LabCorp said.
The United States has been working to increase its testing capacity as it contends with an onslaught of infections, with over 746,000 cases and more than 39,000 deaths.
However, testing in the country has been held back in part by the lack of trained professionals to run the tests and a shortage of personal protective gear to ensure the safety of the employees collecting samples.
At-home sample collection would reduce the risk of transmitting the virus to medical staff but could come with shortcomings including whether a patient can collect the sample properly and ship it safely to the lab.
The FDA said it had worked with LabCorp to ensure that data from its sample collection kit, the first at-home test to be authorized by the agency, is as safe and accurate as it is at a doctor’s office, hospital or other testing sites.
“With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” the FDA said in a statement.
As long as instructions to use the kit are followed, there would be no difference in quality or results from patient-collected samples and those collected by professionals, the company said.
The at-home kit comes with cotton swabs to collect nasal specimens, a biohazard specimen bag and a FedEx overnight shipping envelope to mail the samples to labs. Results can be expected within a day or two of receipt of the sample by the lab.
LabCorp had launched its lab test for COVID-19 early in March and currently conducts nearly 55,000-65,000 tests a day. (https://reut.rs/2RUKeIp)
Shares of the company were up 2% at $148.55 in morning trading.
(Reporting by Saumya Sibi Joseph and Vishwadha Chander in Bengaluru; Editing by Anil D’Silva and Shinjini Ganguli)
