CLIA Guidance for one and all

The COVID-19 pandemic is largely responsible for the changes that have occurred in the healthcare industry over the last year and half. Those changes include the growth of remote patient healthcare and at-home testing.

At-home COVID testing, for example, allows those who may be concerned about exposure to test from the safety of their own home. At-home testing helps to minimize unnecessary exposure and / or transmission, while also helping to reduce the strain on an already struggling healthcare system. However, there is more to at-home testing than meets the eye.

It is imperative to understand that not all tests are sourced equally. This is where understanding CLIA, and the relation with at-home testing, comes in.

What is CLIA?

CLIA stands for The Clinical Laboratory Improvement Amendments of 1988. According to the CDC, these amendments are regulations which “include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent or treat disease.” It is important to note there are exceptions to the CLIA if used for surveillance purposes. However, for our purposes, these exceptions are not relevant.

CLIA is extremely important to give correct diagnosis and treatments for patients. In most severe cases if there is a failure in providing the correct treatment or diagnostics it can result in an unnecessary patient death.

What is the connection between at home testing and CLIA?

The connection comes in terms of scoring by the FDA. CLIA provides seven unique testing criterias in order to assign a complexity category rating for clinical laboratory test systems. If commercially available, the FDA will provide approval or clearance during pre market testing.

With this, Medek Health can further investigate and see the approval process for test kits that will soon be available to the commercial market. Medek Health has been able to narrow the field and choose top performing manufacturers from the United States. We can provide the best of the best for at-home testing, Antigen testing, Antibody testing and RT-PCR testing.

What is a CLIA waiver?

The certificate of waiver is a special certificate that allows medical facilities to legally examine a patient with a waived test in order to make a diagnostic or determine treatment. Timeliness, accuracy, and reliability must still be met. Additionally, manufacturing instructions must be followed to achieve all of these standards. 

The FDA approves waived tests that have a low risk of incorrect results due to user error. Waived tests also have low risk of hurting the patient. Examples of these are pregnancy tests, urine tests etc. Patients are able to purchase these tests and get accurate results quicker than going to a doctor. However, this is not an alternative when facing severe symptoms and an illness that does require clinical grade testing. 

Medek Health has been able to partner up with aiDX Laboratories in order to offer a Covid-19 rapid testing solution that allows anyone to test from anywhere in order to survey their current condition on infection.

What does it mean for me- the patient?

As a patient, truthfully, most of this may be irrelevant when it comes to testing. After all, the most important thing patients should be focusing on is their health- and the results these tests are able to provide. 

With CLIA & the FDA, you feel confident that, wherever you choose to get tested (at home or at the lab), you have options. Medek Health is able to bring these options closer to your home by getting Covid-19 test kits to your doorstep. With at home testing, you eliminate any worry about infection, availability / in-stock issues, or concerns about accuracy. Just get the result and act accordingly. 

What does it mean for my practice?

CLIA takes your practice to the next level. In some instances, you could be a step away from getting a CLIA number that allows you to do COVID-19 clinical testing. With Medek Health as a partner, we can address all your COVID-19 related needs as an all-in-one solution. Regardless of what testing solution you choose, we can always tailor it based on your growing or shrinking needs. 

Testing with confidence 

Whether you are self-testing at home, or administering tests as part of your practice’s patient care, with Medek Health as your partner, you can test with confidence. You can have the assurance that your testing is safe and your results are accurate.