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Compliance In Focus
Posted by Sara Kalas on Mon, Jun 1, 2020

First At-Home COVID-19 Diagnostic Test

The first diagnostic test for at-home patient collection to detect COVID-19 was provided

First At-Homne COVID-19 Diagnostic Test approval to be added to the Emergency Use Authorization (EUA) list by the U.S. Food and Drug Administration (FDA). The Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test was originally authorized on March 16th, 2020; however, its approval was limited to only be used at specific testing centers designated by LabCorp. On April 5th, 2020, the FDA approved an amendment to include a home specimen collection method. This would allow healthcare providers to determine if a patient could benefit from the Pixel by LabCorp COVID-19 Test Home Collection Kit. Although this sounds like an ideal way for patients to be tested for the virus without leaving the comforts of their own home and possibly infecting others, the test is not being offered to everyone. Just like personal protective equipment (PPE) like facemasks and respirators intended for medical use, the FDA has had to regulate supply during this pandemic.

In order for you to be approved for the kit to be sent to you, you must take a survey and meet all of the following criteria:
  1. Be a healthcare worker or first responder.
  2. You cannot live in New York, New Jersey, Maryland, or Rhode Island. (The test is not available in these states due to restrictions on how laboratory tests may be ordered.)
  3. Have severe or mild symptoms of COVID-19.
  4. Be exposed to (within 6 feet for prolonged period of time or coughed on by) someone diagnosed with COVID-19, been in contact with (within 6 feet for prolonged period of time or coughed on by) someone who is sick, or live, work, or have visited a place where COVID-19 is widespread.
  5. Lastly, you must be considered high-risk.
 
If you are determined to be eligible, a kit is sent to your home.

Once you receive the kit and complete the nasal swab collection by following the provided instructions, you must ship the specimen back to LabCorp for the testing. The results take about 2-4 days from the date of specimen pick up. This assessment does not test for antibodies or immunity.

Even though this test was authorized for emergency use, it is important to keep in mind that this test is not FDA-approved or cleared for diagnostic testing to detect SARS-COV-2. The FDA has had to regulate diagnostic testing during this pandemic to ensure patient access to accurate diagnostics. There are some uncontrollable factors that may create false negatives when allowing these types of diagnostic tests to be collected at home and not in a testing center. Patients do not have formal training to collect a proper sample, shipping may be delayed or have unfavorable conditions back to the lab, or sample could be rejected due to an unacceptable reason. These factors could create a high false negative rate and lead people who are actually infected to believe they are not. The FDA commissioner states that they have worked with LabCorp to ensure the at-home tests demonstrates safe and accurate sample collection as those conducted at an approved testing site.

Many tests, medical devices, and drugs have been deemed reliable and given EUA by the FDA during the COVID-19 pandemic but have not been FDA approved or cleared. This means they have not successfully advanced through clinical trials for the use of SARS-COV2. Do you still trust them? Do you think they should still have to go through clinical trials before being deemed reliable? Tell us your thoughts.

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photo credit: liverpoolhls testTubes4 via photopin (license)

Topics: COVID-19, Diagnostic Testing

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