Mira’s COVID-19 testing has been developed in line with the FDA’s Emergency Use Authorization requirements. As a high complexity CLIA-certified laboratory, we have permission from the FDA and CDC to validate a protocol for COVID-19 testing, which we have completed.
Clinical Laboratory Improvement Amendments (CLIA) are standards set out by the United States government to regulate clinical laboratories conducting testing on human beings. CLIA certification requires a rigorous process to ensure a laboratory meets the government’s quality standards to accept human samples for reliable, accurate, and timely testing and reporting.
Coronavirus Disease 19, or COVID-19, is a virus that causes severe acute respiratory syndrome called coronavirus 2 (SARS-CoV-2). COVID-19 is an RNA virus, which means it has RNA, versus DNA, as its genetic material. (Please read here to learn more about genetics and the relationship between DNA and RNA.). To determine whether an individual is infected with the COVID-19 virus, we collect a small sample of an individual’s DNA and RNA via a throat swab. After isolating the RNA from the sample, we use a technique called reverse transcriptase-polymerase chain reaction (RT-PCR), which turns the RNA into DNA, and then amplifies the DNA into multiple copies for detection. If a person has the COVID-19 virus in their sample, their test will be “positive;” if they are not “shedding” the virus (i.e. they were never infected or are no longer contagious), their result will be “negative.” This test is very sensitive and can detect as little as 1 copy of coronavirus RNA in a patient’s sample.
MiraDx’s cancer research has largely focused on DNA biomarkers that disrupt the non-coding sections and binding of RNAs, which are strongly implicated in cancer biology. Since COVID-19 is actually an RNA virus, we have been able to repurpose much of our existing equipment and protocols for our cancer-related research to test for the virus.
Mira’s test uses PCR technology to measure the virus itself, which means it is both much more sensitive in its ability to pick up early infections, as well as informative in indicating when an individual who may have been infected is no longer contagious. Another technology current available for testing detects a person’s immune reaction to the infection, by identifying immunoglobulins (also called antibodies) in a person’s blood. Antibody testing can tell you if you have been infected, but the first antibody which appears (called IgM) is not measurable until 7-10 days after infection. Thus, this approach does not detect early infections. In addition, this approach does not tell you if you are still shedding virus, which would indicate that you are still contagious.
Test results can be delivered to the patient within 24-48 hours from receipt of the sample at our Los Angeles-based laboratory.
Mira has an initial testing capacity to process 3,000 tests per day, with plans to scale up over the next month. We are increasing our testing inventory to offer hundreds of thousands of tests.
The test kit includes an air-tight vial, collection swab, and a biohazard bag, with simple instructions for collecting the sample needed for testing. The sample is collected under the supervision of a healthcare professional. Once the sample has been collected, you simply place the swab back in the vial, tighten the lid, tip the contents back and forth several times, and seal the vial in the biohazard bag.
Before a sample is collected, a patient’s basic demographic and health information must be uploaded into MiraDx’s secure web site, and we match their test sample with their patient information via barcode scanning. This way, when the sample is received by the MiraDx laboratory, it can easily pull up the patient’s information associated with the testing kit. After testing, MiraDx reports results directly to the patient, and a physician of their choice. All positive results will be reported directly to the public health authority for the state in which the patient resides.
Yes. For individuals who test positive, we recommend follow-up testing to confirm when they are no longer shedding the virus, and thus no longer at risk of exposing others to infection.
If an individual tests positive, we are required to share the information with your state’s public health agency, and we also share the information with a physician of your choice for further follow-up and treatment advice. There are many resources out there for patients who test positive for COVID-19, but it is imperative that you seek immediate and reliable healthcare if you have tested positive, and that you self-isolate to avoid exposing others to the risk of infection. MiraDx may be able to offer follow-up testing to determine when you are no longer contagious.
Yes. Although the testing is very accurate, it is possible that a negative test may result if testing takes place too early in the infection. If symptoms persist, a follow-up test may be considered.
Per the CDC and FDA guidelines, we are required to report positive cases to the State Health Board, and will also notify a physician of your choice if your results are positive.
We will work directly with reporting physicians on the best way to report results to them. You will also receive your reports directly via an email address that you provide.
MiraKind is happy to accept donations which are directed to help support testing for essential workforce. You can learn more and donate at www.mirakind.org.
We are prioritizing testing for essential workers at this time. If you are inquiring on behalf of an entity in need of testing, please contact us at firstname.lastname@example.org.
At this time, we are not able to provide at-home testing. If you are an individual looking to get tested and believe you may have been exposed to someone with COVID-19 and/or are currently experiencing symptoms, please contact your health care provider immediately. You can also find more information about the testing resources offered by your state here.
As well, MiraDx is unable to provide test kits or test kit components independently of its full testing process.