As of this moment on 25-Apr-2020 at 7:15AM, there have been 2, 828, 772 confirmed cases of COVID-19 and 197, 924 deaths worldwide (Source, Please note that due to the novelty of SARS-CoV-2, virus that causes COVID-19, the data we currently have available on confirmed cases/death rate is limited). One of the many limitations in the COVID-19 situation, particularly in the United States, has been testing availability. Making tests more readily available can aid in the process of evolving our “new normal” for daily living.
To confirm whether someone is positive for carrying the SARS-CoV-2 virus, a lab test is typically conducted. A standard lab test takes time to process and return with a result. In addition to receiving a positive result from a lab test, healthcare providers use a series of other assessments (ie. chest x-rays) when confirming a diagnosis. While test processed by a lab are very reliable, they are often limiting in the context of infectious diseases that may require quick intervention due to the lengthy processing time. As a result, there’s a part of the medical device marketplace dedicated to producing tests that yield rapid results (ie. in minutes/hours rather than days). Now, these test have limitations when compared to those performed by a lab. That’s why when the FDA receives a submission for one of these devices, some of the data that is reviewed looks at sensitivity (proportion of patients with a disease who test positive) and specificity (proportion of patients with a disease who test negative) of the product in comparison to a standard lab test being used. This sensitivity and specificity data is used to evaluate the accuracy of the product. For example, when evaluating this data, it’s important to look at how many potential false negatives (or false positives) a particular device may yield. I’ve worked on studies for this type of medical device for detecting (seasonal) influenza (type A & B) before.
LabCorp recently announced the availability of a self-collection kit for COVID-19 that was approved by the FDA via Emergency Use Authorization for the testing of COVID-19. The functional purpose of this kit is so that people can test themselves for the virus above. While I myself haven’t reviewed the sensitivity and specificity of this device, I trust that the FDA has done a thorough job of review prior to emergency use authorization.
Here’s the device (click on red front link): COVID-19 Test (At-Home Kit)
Here are press releases from LabCorp and Pixel in regards to the device (click on red front links): (1) LabCorp COVID-19 Self-collection Test Kit Receives FDA Emergency Use Authorization, (2) Introducing Self-Collection Kits for COVID-19 Testing
Here’s the press release from the FDA as well as the letter of authorization (click on red front links): (1) Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection, (2) LabCorp COVID-19 RT-PCT Letter of Authorization
The cost of this at-home testing device is $119 and there’s a process to get the kit detailed in the first link shared. As of 24-Apr-2020, “We will work with you to get your purchase reimbursed by your health plan. We are actively working on a more streamlined solution so you don’t have to pay up front.” Per LabCorp/Pixel’s press release, it is their intent to: “Initially, the COVID-19 self-collection kits will be made available to healthcare workers and first responders who may have been exposed to the virus or may have coronavirus symptoms, which is consistent with prioritization guidance issued by the Centers for Disease Control (CDC).”
While this isn’t the “one solution that solves it all” (there’s never just one solution that solves it all), it’s a step in the right direction.