Our comprehensive COVID-19 monitoring strategy was designed with the assistance of medical experts and includes ongoing, data-driven COVID-19 testing of workers without symptoms, as well as those who exhibit certain symptoms or have been in close contact with someone who has the virus.
United Medical Equipment BSNI is ready to meet your specific testing needs and goals by building flexible programs that work for you and your budget. By creating a custom employee testing solution, you decide what is most important for you and your employees.
As a part of our commitment to team member safety and continually evolving efforts to protect workers from COVID-19, we offer these solutions to you.
What is the COVID-19 Antigen Test?
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reason to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more then 48 hours between tests.
The CareStart™ COVID-19 Antigen test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories and at the Point of Care by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only to detect the presence of the SARS-CoV-2 nucleocapsid protein antigen, not for any other viruses or pathogens; this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.
- EUA letter (FDA): https://www.fda.gov/media/142916/download
- IFU (Instructions for Use): CareStart COVID-19 Antigen test – Instructions for Use (fda.gov)
- Fact Sheet for Healthcare Providers: https://www.fda.gov/media/142917/download
- Fact Sheet for Patients: https://www.fda.gov/media/142918/download
What is the COVID-19 IgG/IgM Rapid Antibody Test?
The COVID-19 IgG/IgM Rapid Test Cassette is an Antibody test. It detects coronavirus antibodies that appear in the bloodstream after people have been infected. It also helps determine whether a patient has protection against COVID-19.
When a person is infected with a virus for the first time, the immune system triggers the production of antibodies that are specific to that virus. These antibodies have the power to attach to the virus so that the immune system can destroy it. If antibodies are present, they will be found inside plasma or blood samples.
Our easy-to-use COVID-19 test kit provides results in 10 minutes!
Emergency Use Authorization (EUA) Letter (FDA)
- Emergency Use Authorization (EUA) Letter: https://www.confirmbiosciences.com/wp-content/uploads/2021/01/EUA200056-Healgen-LOA-05-29-2020-FINAL.pdf
- FACT SHEET FOR HEALTHCARE PROVIDERS: https://www.confirmbiosciences.com/wp-content/uploads/2020/06/Health-Care-Fact-Sheet.pdf
- FACT SHEET FOR RECIPIENTS: https://www.confirmbiosciences.com/wp-content/uploads/2020/06/Recipient-Fact-Sheet.pdf
- FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): https://www.fda.gov/media/135659/download
- FDA FACT SHEET: ANTIBODY TEST OVERSIGHT AND USE FOR COVID-19: https://www.confirmbiosciences.com/wp-content/uploads/2020/05/FDA-Fact-Sheet-Antibody-Test-Oversight-and-Use.pdf
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has not been FDA cleared or approved.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This product is intended for professional use and not for home use.
Not for the screening of donated blood.
UMEBSNI Mobile Solution
Our mobile testing specialists are committed to addressing you and your company’s needs.
UMEBSNI has experienced medical staff that provides onsite COVID-19 Rapid Testing and mobile solutions to implement employee safety. Mobile units and medical staff are on call and are capable of deployment for extended periods of time.
Mobile teams are available Nationwide.
Let us work together to assess your needs so that we can provide a free comprehensive proposal.
- Assess your current operation.
- How many employees will you need to test?
- What hurdles are you facing to reopen?
- What is your desired date to open?
- What is the frequency of tests needed?
- What are your budget constraints?
- Will you need a mobile unit deployment or medical staff?
- For how many days would a mobile unit be needed?
- Let us cover your PPE needs at the same time – masks, gloves, sanitizer, etc.