What is a covid-19 Rapid Antigen Test kit?

With the vast spread of Covid-19, doctors’ offices and health care facilities were helpless due to the massive shortage of test kits and testing supplies all over the world. In some cases, poor testing capabilities also resulted in the vast spread of the SARS-CoV-2 virus. Due to this nationwide problem, many pharmaceutical companies and healthcare professionals started researching to produce covid-19 rapid antigen testing kits to support the world. Covid-19 rapid antigen testing kit identifies the people who currently have a viral infection.

Originally, Rapid antigen tests were generally used in the diagnosis of respiratory illnesses. Due to this fast-spreading global threat, medical professionals started using rapid antigen detection tests to look for proteins produced by the SARS-CoV-2 virus, which is COVID-19. At Global Supply Exchange Orlando FL, we invented a 15 Minute SARs-CoV-2 Oral Rapid™ Covid-19 Rapid Antigen Testing kit. This Covid-19 Rapid Antigen Testing kit is legally approved to be sold and distributed in the USA, with its sibling approved in 31 countries worldwide with a CE Mark.

 

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Oral Rapid™ covid-19 rapid antigen testing from Global Supply Exchange Orlando FL

Did you know Oral Rapid™ is the world’s first laboratory-developed oral rapid covid-19 rapid antigen testing kit made to detect SARS-CoV-2 antigen? This Oral Rapid covid-19 rapid antigen testing kit is a Laboratory Developed Antigen Test (LDT) and is proudly made in the United States of America. Our 15 Minute SARs-CoV-2 Oral Rapid™ Covid-19 Rapid Antigen Testing kit is legally approved to be sold and distributed in the USA with its sibling approved in 31 countries worldwide with a CE Mark.

To maintain the high efficacy of this unique product, we made sure only high complexity laboratories can distribute this device in the USA. All laboratories must validate our 15 Minute SARs-CoV-2 Oral Rapid Antigen Test using the Laboratory Developed Test (LDT) pathway; the U.S. Dept controls of Health and Human Services (HHS). It permits the lawful sale of our SARs-CoV-2 Oral Rapid Antigen Testing kits in the USA. HHS approved this pathway in mid-August 2020, and then just on December 5th, 2020, it was adopted by the CDC when the FDA formerly “authorized laboratory-based antigen tests.” This detailed guidance is an essential requirement to help guide employer groups, healthcare institutions, and states to conduct front-line testing 100% via Rapid Antigen Tests.

The ORAL RAPID ™ test can only be offered for sale as a Laboratory Developed Test under the CLIA guidance for LDT performance. The test will need to be administered by a healthcare professional trained by the respective high complexity laboratory. Even though the test results can be read on-site, they are not official until uploaded to our test platform and validated by the Lab Director. 20 Flocked Oral Swabs are provided within this kit is (20) for the intended purpose of oral specimen collection.

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What makes our Oral Rapid™ covid-19 rapid antigen testing kit special?

The ORAL RAPID ™ covid-19 rapid antigen testing kit is an American Laboratory Developed Test kit. As a distributor, we have taken extensive measures to ensure that our 15 Minute SARs-CoV-2 Oral Rapid ™ Antigen Test Device is fully compliant with all applicable government regulatory authorities such as HIPAA, CDC, HHS, and CLIA. Our covid-19 rapid antigen testing kit can be legally sold in the USA.

• We possess software where every single test picture is uploaded, and our laboratory director (and his team) review every test result and formally provides a test result diagnosis. This enables each testing site to become an extension of our high complexity laboratory(s), including full LIS (Laboratory Information System) compatibility.

• As an add-on service, we also offer a physician of record service for test service centers or employer staffing agencies who require this national service for billing purposes.

• We have contracted with some of the largest and most reputable medical staffing agencies in the world. They are well-versed with our device and are available to provide licensed medical professionals for employer organizations or testing sites who require additional services at a nominal fee included in the device’s purchase.

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