August 10, 2020
MAKO Medical, a health care diagnostic laboratory that specializes in helping you take control of your healthcare by offering accurate testing and quick results, announced exciting results from the national organization accrediting laboratories.
As a College of American Pathologists (CAP) accredited laboratory, MAKO Medical Laboratories enrolls in continuous proficiency testing of all current and new laboratory tests. CAP’s proficiency testing program adds a level of quality assurance to testing ensuring MAKO delivers accurate, reliable test results to properly diagnose. Most recently, MAKO enrolled in CAP’s COV2 molecular proficiency testing program.
“Enrolling in the CAP COV2 program, enables MAKO to assess the entire workflow from nucleic acid extraction through detection. We are able to test the quality of our assay.” says Steve Hoover, Vice President of Laboratory Operations.
MAKO Medical Laboratories deploys an EUA- FDA approved COVID-19 RT-PCR assay utilizing the Applied Biosystems TaqPath Combo Kit assay. MAKO completed two separate bridging studies to validate the assay. Each study came back with 100% reconfirmation and no discordance for all results.
But that was not the only 100% MAKO would receive. All of MAKO’s work and focus on quality paid off once again as the company submitted its CAP proficiency testing samples. CAP compared the MAKO COVID test results with over 1,500 other CAP laboratories. The first week of August, MAKO Medical Laboratories learned the company scored 100% on its CAP COV2 molecular proficiency testing. MAKO’s scores were spot on the average of CAP’s values.
“MAKO’s success and CAP proficiency test results demonstrate that MAKO’s assay is trusted, reliable, and ‘cream of the crop,’” Josh Arant, Chief Operating Officer. “We rigorously and continually test the validity of our assay. I am so proud of our scientific and clinical teams. Their hard work and dedication to quality continues to help citizens and organizations needing reliable testing services.”
MAKO Medical Laboratories will continue to assess the quality of its COV2 assay by performing at least two proficiency tests each year.
The COVID-19 pandemic has presented both a challenge and an opportunity for MAKO Medical. At first, the pandemic reduced the core lines of business close to 40%. Then, in two short weeks, the MAKO team rose to the challenge and began providing COVID-19 testing.
Since April MAKO has:
- Processed more than 650,000 COVID-19 tests in 22 states in the U.S.
- MAKO reported results for over 95% of tests within 48 hours upon receipt.
- In addition to the COVID-19 nasal swabs that people have become accustomed to seeing, MAKO Medical is now processing the Diasorin Liaison SARS-CoV-2 S1/S2 IgG antibody tests which are EUA FDA approved and validated.
- MAKO Medical is currently processing more than 30,000 tests per day.
- The company recently renovated 7,000 square feet to its Henderson, NC facility expanding its accessioning space.
- MAKO went from one PCR instrument for research and development to ten dedicated to COVID-19 PCR instruments.
- In addition, MAKO added eight antibody instruments that help read tests and may indicate previous COVID-19 infection.
- MAKO has also added people, expanding its operations from 50 employees working on one shift, to 400 people working around the clock.
- MAKO is partnering with Luminate Health to provide a new patient portal offering real-time COVID-19 test results.
- Faster turnaround times set MAKO Medical apart from its competitors. MAKO Medical returns COVID-19 test results in three days from collection.
- Forbes Magazine included MAKO Medical in the publications inaugural list of America’s Best Startup Employers for 2020. Out of the thousands of qualified organizations in the United States, only 500 companies earned this distinction.