First Home Test Kit (PIXEL) for the new Coronavirus Authorized by Food and Drug Administration (FDA)

The US Food and Drug Administration (FDA) said on April 22 that it has issued an emergency authorization for the first in-home test kit for the new coronavirus . This test kit is called "Pixel" and is a nasal swab kit that will be American independent laboratory giant LabCorp sells it with testing fee US $ 119. The FDA specifically noted that no other home testing or sample collection kits have been authorized yet, and many similar products from startups have not been authorized. "With this action, there is now a convenient and reliable option that allows patients to collect samples in a comfortable and safe home." FDA Commissioner Dr. Stephen Hahn said in a statement. The test is a door-to-door collection kit. The user can use a nasal swab to collect the sample, and then use the included shipping package to send the sample back to the laboratory for testing. The FDA stated that the data submitted by LabCorp indicates that this home test kit is as safe and accurate as the sample collection at the doctor's office, hospital, or other test site.

LabCorp said that the company will first provide testing to medical staff and first-aid personnel who may have been exposed to the new coronavirus and will also provide to consumers with a test kit "in the coming weeks". The company also pointed out that since the testing is carried out in the consumer's home, this will reduce the need for masks and other protective equipment that are usually required to collect test samples. At present, the detection of new coronavirus mainly relies on in-car detection as well as outpatient and hospital testing. These tests have a high barrier to entry in terms of risk status, symptoms and performance. Home testing can improve the overall detection rate, while reducing the risk of frontline medical staff, helping scientists better understand the true scope and depth of the new coronary pneumonia pandemic. Family collection and testing procedures will support telemedicine and help patients with transportation difficulties and remote areas to be tested. When governors of various states in the United States complained about the "test shortage", companies such as Wal-Mart, Target, CVS Health, and Walgreens all set up direct inspection sites in the parking lot.

"We currently have three inspection points in operation, and we plan to expand the new crown inspection to multiple inspection points next week. We have accumulated a lot of experience, and we can build the correct model to expand the inspection points in the required areas as soon as possible." A spokesperson said earlier. But Wal-Mart and CVS executives acknowledged the challenges of providing this service, including the difficulty of providing employees with protective equipment. The advent of kits that allow people to collect their own nasal specimens at home may open up testing for a wider population. Medical experts say that home swab testing may increase consumer convenience and reduce the need for people to go to the clinic, because they may inadvertently expose health care providers and other patients to infections.

However, some experts have warned that the accuracy of nasal swab testing may not be as good as the gold standard for health workers collecting coronavirus samples, which requires a long nose swab to be inserted into the back of the throat through the nasal cavity. For example, a small peer-reviewed study from France reported last week that using a nasal swab to detect coronavirus has a higher false negative rate than a longer swab. In addition, home sampling may also increase the time it takes people to obtain test results. Previously, startups including Everlywell, Carbon Health and Nurx have also developed home test kits, but have not been authorized by the FDA. In early March, the FDA announced that it would allow laboratories or companies to sell new coronavirus home test kits and apply for emergency approval 15 days later. After receiving this news, several companies, including Everlywell, Carbon Health and Nurx, offered to produce home test kits, and some companies have even begun to sell them.

But on March 21, the FDA updated the guidelines, saying that their regulatory exemptions "do not apply to home testing, including collecting samples and sending them to clinical laboratories." Subsequently, these companies had to immediately stop selling their testing kits. The FDA explained that this was done to ensure the accuracy of the test. "It is important to ensure that the specimens collected by the family are still able to provide accurate test results after they are transported to the laboratory," an FDA spokesperson said, they were worried that the transportation process after the user took the sample himself would reduce the accuracy of the test. "Sample collection at home or by a medical service provider outside of the designated collection point will increase concerns about sample stability, transportation, and proper collection materials."

Many experts disagree with this approach of FDA, and think that FDA is too cautious. Alex Tabarrok, a professor of economics at George Mason University, said, "Now, we need as many tests as possible to make nurses, hospitals, and clinics bear the burden of potential patients. The FDA has repeatedly delayed approval of new China ’s detection methods have left the United States a few weeks behind, paying the price of life. "Although the FDA has not yet approved the home test kits of companies such as Everlywell, Carbon Health and Nurx, FDA is actively maintaining communication with the developers of the test reagents. Christina Song, director of communications strategy at Everlywell, said that since the FDA issued a statement last Friday, the company has regularly met with the FDA to discuss how to conduct home sample collection testing. "In order to facilitate sample collection, the test may use a short nasal swab and will include a free remote health consultation to provide an independent doctor for those patients who receive a positive diagnosis at home. We hope to be open to the public as soon as possible. "The independent laboratory giant LabCorp is an American medical diagnostic company, founded in 1971, with more than 40 years of experience, its products include through the on-site testing of its Pixel series of colorectal cancer, diabetes and heart lipids.

In addition to routine clinical testing, the company also provides high-precision testing services including cancer, diabetes, heart lipids, HIV genotype and phenotype, and genetic diagnosis. Major clients include doctors, hospitals, managed health organizations, government agencies, employers, pharmaceutical companies, and other independent clinical laboratories.

https://www.pixel.labcorp.com/at-home-test-kits/covid-19-test