To further curb off the Coronavirus pandemic, there is need for an enhanced testing nationwide testing but the US is already running short of testing kits and supplies needed to perform the testings meanwhile all hopes isn’t lost yet as there is possible at-home testings which can be done to further detect those with the illness.
The newest home test kit for the Coronavirus was authroized by the FDA in May and only required saliva samples which is more easy unlike the swab test and thus also eliminates the need for those feeling sick to go to a testing site which in turn means fewer people gets to be exposed to the virus itself.
With tests being carried out, those who have the coronavirus but do not know will now know as well those who are ill but aren’t exhibiting any symptoms of the disease. So once people know that they have the virus, they can then take proper measure to avoid spreading it to others.
And with that medical testing companies then started developing coronavirus home test kits although this development has started way back since March but the approval by the FDA was slow whereby as of May 2020, there were just few test kits approved by the FDA for home-testing and would require doctor’s order to get one. But in case you don’t know, we have some information about the FDA’s stance on how to get tested from home if you have symptoms of the COVID-19 illness or if you assume that you might have been exposed somehow.
AT-HOME TESTING OF COVID-19
There are currently two types of tests available for home use: swab tests and saliva tests. So let’s examine each of this testing styles one after the other shall we.
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Back in April 21st, the Food and Drug Association (FDA) did approved the first at-home test kit called Pixel by LabCorp. The development of the test kit was done based on collaboration between the two bodies and said it’s accurate as a sample taken by a doctor. The test is done by taking special swab enclosed in the Kit that the patient uses to take a sample from the nasal passage and then mailed out back to LabCorp. The test does require a doctor’s order first and you can’t buy it without one.
“Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Dr. Stephen Hahn said in a statement.
Since April 13th, the FDA has granted the Rutgers University’s RUCDR Infinite Biologics Biorepository emergency the authorization for a new method it developed which allowed it to make use of saliva as test samples to detect the presence of Coronavirus. And according to Rutgers, the saliva testing allows paitnets to self-collect samples at home and can be sent over to health care professionals which in turn prevent the latter from being exposed to the coronavirus at testing sites and reduce the demand for personal protective equipment which is running out faster.
Following that authorization from the FDA, two companies, Vault Health and 1Health.io, announced plans to sell the saliva tests for at-home use under supervision from a doctor through telemedicine. But it wasn’t until this past week, May 8th that the FDA then authorized Rutgers Clinical Genomics Laboratory to start testing samples of saliva collected at home for the Coronavirus using collection kits from Spectrum Solutions.
This is the first at-home diagnostic test using saliva samples, and it can only be obtained with a prescription from a doctor. The test must also be returned to the Rutgers Clinical Genomics Lab for processing.
Saliva tests are much less invasive, less uncomfortable and pose less risk for healthcare providers — so why did it take so long to approve them? The FDA needed to make sure the samples could provide the same level of accuracy as nasal swabs. When it comes to concerns over how the saliva tests perform compared to nasal swabs, the research is promising.
And then a Yale Public Health researcher found out that the saliva tests were much more dependable and sometimes more accurate than nasal swab tests. It’s also important to know that this study is only preliminary and not peer-reviewed because of this findings are not considered formal until a formal peer review can be completed.
WHERE DOES THE FDA STAND ABOUT AT-HOME TEST
As coronavirus began to spread rapidly in the US in early March, companies began developing at-home testing kits to screen for it. EverlyWell, Scanwell and Nurx all announced that they would make and distribute at-home tests directly to consumers. The companies, at the time each announced its testing kits, believed they were operating within the FDA’s Emergency Use Operation guidelines.
But then the body issued a public warning back in March 20th that companies trying to get the tests directly into the hands of consumers could be “fraudulent” since they are “unauthorized.” The FDA is said to be working with companies and laboratories in order to develop a test that can be done at home but as at that time, there were no home tests authorized by the body.
With that, many companies had to pause their orders for the testing due to the FDA’s warning but then EverlyWell still makes its test kits available to medical professionals alone.
HOW TO GET TESTED IN PERSON
In the most case, a doctor’s permit is needed to get tested and that includes people who think they’ve been exposed but have shown no symptoms of the disease. Getting tested is based on eligibility and criteria as well as where you live. But the best thing to do if you or someone around you fall sick is to first contact your doctor as to determine if the symptoms are those of COVID-19 and if the Doctor decides there is need for test, then they will order a test which will give you easy access to go for a drive-through at a testing center.
A doctor can also order an at-home test for you, which will be shipped to you. In that case, you will collect the sample and be responsible for sending it back to the lab.
But one important note is to avoid as much as possible to going to a doctor’s office or an Urgent care or ER if you have symptoms which matches those of the Coronavirus as that could expose unsuspecting healthcare workers as well as those who could be fatally ill at the risk.
The exception to this is if you have any emergency warning signs for COVID-19, which do require immediate medical attention. These can include difficulty breathing or shortness of breath, persistent pain or pressure in the chest, new confusion or inability to arouse and bluish lips or face. If you are able to call the hospital to tell them you are coming, try to do that so they can prepare appropriately.
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