Two US-based companies, Perfumarie and BioLab Sciences, are partnering to do their part in accelerating the distribution of Assure EcoTest, a new FDA EUA-authorized point of care (PoC) rapid antibody test to help fight the coronavirus.

Based in Scottsdale, Arizona, BioLab Sciences is the home of Assure EcoTest, the rapid COVID-19 Result Tests to detect antibodies for the virus in just 10 minutes with 98% accuracy. With the help of private and official PPE supplier partners like Perfumarie, a sensory incubator and innovation lab in SoHo, New York City, test devices are now more accessible to healthcare agencies, hospitals, and outpatient facilities throughout the USA so we can stop the spread and reboot the Nation’s economy faster and more efficiently.

“Our goal is to help healthcare providers obtain the resources they need to detect COVID-19,” said Bob Maguire, President and CEO of BioLab Sciences. “These tests are helping equip physicians and healthcare leaders with the data they need to make informed public health decisions and help guide our nation as we navigate the future of the virus.”

Called the Assure EcoTest, this antibody detector is quick, efficient, and user-friendly. “The process is similar to a glucose test. For reliability and per FDA’s requirement, however, this test must be administered by and results reported by a licensed provider,” shared Perfumarie’s Founder & CEO Mindy Yang.

“The rapid antibody test detects the presence of IgG and IgM antibodies from COVID-19 generally available in whole blood, serum or plasma after an infection,” said Carlos Encinas, PhD, Chief Science Officer of BioLab Sciences. “With healthcare agencies and providers experiencing shortages and testing delays for molecular tests, these rapid antibody tests are a mission-critical need for the community to determine who has been infected by the novel coronavirus.”

As of June 1st, there were 12 Antibody (Serology) tests that have been authorized under the FDA’s new Emergency Use Authorization (EUA) including the test by BioLab Sciences. Of all the Antibody (Serology) tests, none are self-contained, like the BioLab Science Rapid 2019-nCov IgG/IgM Rapid Res Cassette Single Use Kit. There are 3 other tests are similar (from China and Malaysia), but the test by BioLab Sciences is the only one of its kind manufactured wholly in the US and authorized for Point of Care facilities.

BioLab Sciences also has one of the highest manufacturing rates of production in the United States with the capacity to produce more than 9 million tests per week to meet the pressing demand for quality testing. Biolab Sciences has partnered with Med Labs Supply as its authorized distributor of this product in the United States.

Serology testing for SARS-CoV-2 is at increased demand to better quantify the number of cases of COVID-19, including those that may be asymptomatic or have recovered. Serology tests are blood-based tests that can be used to identify whether people have been exposed to a particular pathogen by looking at their immune response.

In contrast, the RT-PCR tests currently being used globally to diagnose active cases of COVID-19 can only indicate the presence of viral material during infection and will not indicate if a person was infected and subsequently recovered.

The rapid tests are our first line of defense since they can give greater detail into the prevalence of a disease in a population by identifying individuals who have developed antibodies to the virus. A high-quality rapid antibody test can detect COVID-19 antibodies for a prolonged period, even after disease resolution, which enables identification of prior infection.

Knowledge of prior infection is epidemiologically important and represents a significant unmet need in the management of the COVID-19 pandemic. The Antibody (serology) test is a quick screening tool that yields results in just 10 minutes.

As a “Surveillance/Screening” Rapid Antibody Test, the Assure EcoTest Kit quickly allows us to sift through the populous of who is healthy and who has been exposed or infected by COVID-19. When a potentially infected citizen is rapidly identified, the next phase is a hand-off to the PCR molecular test to ensure a thorough evaluation is completed.

The PCR (molecular) test that is completed with a nasal swab or blood vial, as a “Diagnostic Tool” takes 2 -7 days for results. Although the PCR (molecular) test is the ultimate diagnostic tool, it has limitations in detecting someone who may have been infected but is asymptomatic.

In general, because each person’s immune system responds on its timeline, the results for Biolab Sciences’ aRTK are as follows:

  • Positive for IgM only = exposed within days and approximately up to 4 weeks ago
  • Testing positive for IgM is valuable information since numerous reports from the CDC and other sources indicate that a significant number of individuals (25% or more) that are infected remain asymptomatic which further contributes to an increase in the transmission of the virus.
  • Positive for IgM & IgG = exposed approximately 4–8 weeks ago
  • Positive for IgG only = exposed more than 8 weeks ago

For more information or order inquiries, please contact Perfumarie at InnovationLab@Perfumarie.com or visit PointOfCareTests.info for an application form.

 

About BioLab Sciences:

Headquartered in Scottsdale, Arizona, BioLab Sciences is focused on finding new ways for the body to heal itself. The company prides itself on developing better ways to address respiratory ailments, cardiovascular indications, pain management, ophthalmic issues, orthopedic injuries, wound care, aesthetic medicine, and more. BioLab provides reliable, safe products with the highest quality to help optimize body performance through continuous innovation, education, superior customer service and teamwork. For more information visit www.biolabsciences.net.

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