COVID-19 TESTING AND INFORMATION

MAKO just released a targeted next generation sequencing research panel that covers more than 99% of the SARS-Cov-2 genome. With this new panel, MAKO is able to detect the new B117 variant of COVID-19 that was first reported in the United Kingdom. Additionally, this new NGS research panel gives MAKO the capabilities to detect new variants caused by COVID-19 mutations that may arise giving public health leaders access to the most recent data.

MAKO now offers clients and partners the entire end-to-end solution for COVID-19 response from antigen to antibody to PCR to sequencing. MAKO is the one-stop-shop for laboratory services.

MAKO recently added a new laboratory based antigen test to continue building out its COVID-19 diagnostic offering to aid in the fight against the pandemic. The test will help individuals determine if they have active COVID-19 virus in their system. MAKO partnered with Diasorin to bring this highly sensitive antigen test to the masses. With a sensitivity of 97.1% and a specificity of 100%, utilizing nasal and nasopharyngeal swabs, MAKO is able to turn results around in less than 24 hours with a capacity to run over 100,000 tests per day. The MAKO Antigen test looks for the identification of SARS-CoV-2 N protein antigen, which is generally detectable during the acute phase of infection. The MAKO Antigen test combines a highly accurate in-lab antigen test with a high-throughput platform to support large scale screening of the active virus of COVID-19. This cost effective test will help mass screening and determine whether a person diagnosed with the virus continues to have and carry the virus. MAKO continues to be the one-stop-shop for your laboratory needs.

MAKO leads the way with a COVID-19 Saliva PCR test enabling fast, low-cost results for high-frequency surveillance testing. MAKO, alongside ThermoFisher, validated the Applied BioSystems TaqCheck SARS-CoV-2 Fast PCR assay that uses raw saliva samples, simplifying lab workflows. These tests results are available within 24-48 hours of receipt in the laboratory. MAKO’s proactive measure comes at the right time when mass surveillance is at the forefront of discussion. MAKO’s Saliva COVID-19 PCR test combines the quality results you expect from gold-standard PCR technology with rapid answers to help you drive decisions to keep your community safe. Plus, the multi-target design compensates for emerging SARS-CoV-2 variants and mutations to provide confidence in results.

COVflu-19™ is MAKO Medical’s SARS-CoV-2 + Influenza A + Influenza B diagnostics test. COVflu-19 detects and differentiates RNA from multiple respiratory viruses simultaneously. Collected via nasopharyngeal and nasal swabs, COVflu-19 is run on the highly accurate, real time PCR instruments, specifically Life Technologies QuantStudio 12k Flex Systems and uses the Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit assay.

COVflu-19 gets a targeted specificity to 100% of currently available complete genomes for SARS-CoV-2 and robust performance for detecting Flu A and B strains, providing increased confidence in results.

Fact Sheet (PDF)

Press Release (PDF)

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.

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.

• Rapid Turnaround COVID-19 Testing
• ThermoFisher SCIENTIFIC – Preferred Service Provider
• 3-day turnaround time upon sample collection
• Real-Time-PCR utilizing Life Technologies 12K Flex Systems

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

• Statewide Coverage
• Around the Clock Positive Test Notifications
• On-Call Courier Support
• Domestic Collection Kit Manufacturing Pipeline
• Validated Collection Kits – Nasopharyngeal and Oropharyngeal Swabs in Saline and Universal Transport Media and Copan ESwab
• Cash pay price: $125

The COVID-19 pandemic brought many businesses to a standstill. Now it’s 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.

MAKO Medical Laboratories is a CLIA and CAP accredited laboratory. MAKO Medical Laboratories deploys the 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.

MAKO Medical Laboratories’ COVID-19 test was validated and independently tested in two separate laboratories. Our team 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.

MAKO Medical Laboratories’ validation and verification has been signed off by our Laboratory Director, Dr. Chad Rund.