Offering expanded capacity and increased diagnostic capabilities during this time of crisis
In response to the novel coronavirus (SARS-CoV-2), Mako Medical Laboratories has worked rapidly to develop a new multiplex real-time RT-PCR diagnostic test to enable clinical and government providers to quickly diagnose COVID-19 caused by SARS-CoV-2 infection.
Mako Medical Laboratories is a CLIA and CAP accredited laboratory that has an FDA approved COVID-19 test utilizing Applied Biosystems TaqPath COVID-19 Combo Assay and emergency use authorization. Mako Medical Laboratories’ Mako’s COVID-19 test was validated and independently tested in two separate laboratories with seven times as many samples as required.
The EUA process only requires one bridging study and 10 samples, five positive and five negative. Mako Medical Laboratories performed two bridging studies with 70 samples, 35 positive and 35 negative. There was 100% reconfirmation and no discordance with both studies.
Additionally, Mako Medical Laboratories performed a Limit of Detection study according to FDA guidelines. Mako Medical Laboratories demonstrated comparable Limits of Detection to the Applied Biosystems TaqPath COVID-19 Combo Assay emergency use authorization.
The FDA stated that an EUA is not required for Mako Medical Laboratories’ test at this time and the test modifications are covered under the laboratories’ CLIA certification. The FDA stated to Mako Medical Laboratories that laboratories using the ThermoFisher assay as authorized in their EUA, such as Mako Medical Laboratories, do not need to conduct additional validation. Furthermore, the FDA stated that Mako Medical Laboratories should proceed with verification as would be done with any test kit purchased to run in a lab.
For laboratories, such as Mako Medical Laboratories, that are running EUA-authorized test kit or have modified an EUA-authorized test per FDA policies, the FDA does not provide documentation. Validation and/or verification should be signed off by the laboratory director per the lab’s normal procedures. Mako Medical Laboratories’ validation and verification has been signed off by our Laboratory Director, Dr. Chad Rund.
Mako Medical Laboratories is utilizing Applied Biosystems TaqPath COVID-19 Combo Assay. This is a fast, highly sensitive multiplex diagnostic solution that is needed for the real-time PCR detection of RNA from the SARS-CoV-2 virus.
Watch how MAKO is working around the clock in the battle against coronavirus:
We are honored to serve our country and citizens through this pandemic and will continue to actively invest in infrastructure and expanded capacity to meet the local, state, and federal needs.
What NC Providers are saying:
“MAKO’s partnership during this pandemic and commitment to accurate resulting and efficient turn times has had a tremendously positive impact on our response and allocation of resources. As important, it’s relieved staff and patient anxieties – a critical factor to manage in any health crisis.”
Bert Beard, CEO of Maria Parham, a Duke Life Point Hospital
“MAKO Medical has proven to be a true laboratory partner for FirstHealth of the Carolinas. During this COVID-19 crisis, when every hospital bed is needed and every illness could be an emergency, MAKO has not only met our needs, but has gone above and beyond to exceed our expectations.
Their willingness to pick up and transport potential COVID-19 test samples has allowed for the rapid turnaround of test results – many in the same day. This testing capability ensures we have the capacity to care for our patients and helps us preserve valuable hospital resources.”
Brian Canfield, Chief Operating Officer at FirstHealth Moore Regional Hospital
The COVID-19 pandemic brought many business to a standstill. Now its time to get our country moving again.
MAKO Medical is currently offering businesses across the country a major competitive advantage coming out of the COVID-19 crisis: SARS-CoV-2 IgG testing, the complete back-to-work solution. As a full service CAP-accredited lab, we do the screenings, we run the tests, we provide the results. And most importantly, we can get your business moving again – quickly.
Call MAKO Medical at 844-625-6522 to learn more and to set up an employee screening today!
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