ROCKVILLE, Md., Oct. 22, 2020 /PRNewswire/ -- Spartan Medical Inc. announced the launch of a Comprehensive COVID-19 Testing Solution to assist the Department of Veterans Affairs with their protocolized clearance and improved workflow for patient procedures. Since the start of the novel Coronavirus pandemic, Spartan Medical, a CVE certified Service-Disabled Veteran-Owned Small Business (SDVOSB), has been sourcing best-in-class products and services to address the growing need of the Federal Government to effectively test patients for SARS-CoV-2. "Our company takes pride in understanding the market needs of the VA and DoD Healthcare Systems by identifying the highest quality products from verified manufactures to address this critical requirement," said Vince Proffitt, President, and Founder of Spartan Medical. "By understanding the big picture, we have assembled premium products and services to offer a comprehensive solution for our fellow veterans, service-members, their family members, and those who care for them."
Spartan identified the GeneFinder™ COVID-19 Plus RealAmp Kit as one of the top Qualitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) Testing Kits on the market. Negotiations with US-supplier ELITechGroup MDx, based in Bothell WA, have resulted in an agreement to supply large quantities of the test kit to Veteran's hospitals and healthcare centers across the country. The GeneFinder is a 100% qualitative gene-based test that has received Emergency Use Authorization (EUA) from the FDA. A one-step, three-gene system, it targets the N gene, E gene and RdRp gene for high sensitivity and reproducibility. Three-gene systems provide much greater adaptability over one or two gene systems in the likely event the SARS-CoV-2 virus mutates. Further, GeneFinder runs on open-source lab analyzers commonly found throughout any healthcare system.
A recent article from the Journal of Bone and Joint Surgery (JBJS) titled, "Orthopaedic Guidelines for the COVID-19 Post-Outbreak Period" published the first orthopedic guidelines, to our knowledge, for testing patients prior to receiving orthopedic surgery. In addition to routine blood testing, pulmonary computed tomography (CT), and taking a patient's temperature, the article identifies qRT-PCR and Antibody testing as the suggested protocol for all orthopaedic surgical procedures.
To provide a complete solution for testing prior to orthopaedic procedures, in compliance with the published guidelines, Spartan identified the Cellex qSARS-CoV-2 IgG/IgM Rapid Antibody Testing Kit This test was developed and is manufactured by Cellex Incorporated, a US biotechnology company, and distributed by HealthDatix. The Cellex Testing Kit is a lateral-flow, whole blood system that has demonstrated high sensitivity and specificity in detecting both IgM & IgG antibodies; and, a 99.7% negative predictive value without additional instruments or lab equipment. The Cellex Rapid Antibody Test Kit received EUA from the FDA and consists of a portable cassette (like an at-home pregnancy test), that can be used anywhere, and produces results within fifteen (15) minutes. "Most of the Antibody test kits that have received EUA capture either the IgG antibody OR the IgM antibody for SARS-CoV-2. Only a few systems capture BOTH IgG/IgM, and those systems typically require a reader or lab equipment," Eric Jania, Director of COVID-19 Testing Solutions for Spartan Medical, said in a statement. "We like the Cellex Rapid Antibody Test for its high sensitivity, specificity, and ease-of-use to allow Providers at any medical center the ability to determine results at point-of-care (POC), without the need for machines. It's also a significant cost savings given the Federal Government does not need to purchase capital equipment to run a rapid COVID test."
In a recent editorial last week from the Journal of American Medical Association (JAMA), titled, "Combining Rapid PCR and Antibody Tests Improved COVID-19 Diagnosis," the authors reference a paper from Cell Reports Medicine that identifies some key benefits of using PCR and Antibody test specifically to identify a now dormant SARS-CoV-2 variant. When the researchers combined results from the PCR test, with results from rapid lateral-flow IgG/IgM Antibody tests, the positive predictive value increased to 100%. Consistent with the suggested COVID-19 testing guidelines from JBJS, the JAMA editorial and Cell Reports Medicine paper identifies potential benefits of using both PCR and Antibody tests.
Eric Jania, Director of COVID-19 Testing Solutions
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SOURCE Spartan Medical Inc.