Information

The Assure COVID-19 IgG/IgM Rapid Test Device, a test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 (often referred to as COVID-19 or the novel coronavirus) in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood.

The Assure COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. This is Some of the info for first page. Should be an overview of the company.

What We Know about Omicron

CDC has been collaborating with global public health and industry partners to learn about Omicron, as we continue to monitor its course. We don’t yet know how easily it spreads, the severity of illness it causes, or how well available vaccines and medications work against it.

Spread

The Omicron variant likely will spread more easily than the original SARS-CoV-2 virus and how easily Omicron spreads compared to Delta remains unknown. CDC expects that anyone with Omicron infection can spread the virus to others, even if they are vaccinated or don’t have symptoms.

Severe Illness

More data are needed to know if Omicron infections, and especially reinfections and breakthrough infections in people who are fully vaccinated, cause more severe illness or death than infection with other variants.

Vaccines

Current vaccines are expected to protect against severe illness, hospitalizations, and deaths due to infection with the Omicron variant. However, breakthrough infections in people who are fully vaccinated are likely to occur. With other variants, like Delta, vaccines have remained effective at preventing severe illness, hospitalizations, and death. The recent emergence of Omicron further emphasizes the importance of vaccination and boosters.

Vaccines

Vaccines remain the best public health measure to protect people from COVID-19, slow transmission, and reduce the likelihood of new variants emerging.

  • COVID-19 vaccines are highly effective at preventing severe illness, hospitalizations, and death.
  • Scientists are currently investigating Omicron, including how protected fully vaccinated people will be against infection, hospitalization, and death.
  • CDC recommends that everyone 5 years and older protect themselves from COVID-19 by getting fully vaccinated.
  • CDC recommends that everyone ages 16 years and older get a booster shot after completing their primary COVID-19 vaccination series. You are eligible for a booster at 5 months after completing Pfizer-BioNTech primary series, 6 months after completing Moderna primary series, and 2 months after the initial J&J/Janssen vaccine. Individuals ages 16-17 are only eligible for the Pfizer-BioNTech COVID-19 vaccine.

Masks

Masks offer protection against all variants.

  • CDC continues to recommend wearing a mask in public indoor settings in areas of substantial or high community transmission, regardless of vaccination status.
  • CDC provides advice about masks for people who want to learn more about what type of mask is right for them depending on their circumstances.

Testing

Tests can tell you if you are currently infected with COVID-19.

  • Two types of tests are used to test for current infection: nucleic acid amplification tests (NAATs) and antigen tests. NAAT and antigen tests can only tell you if you have a current infection.
  • Individuals can use the COVID-19 Viral Testing Tool to help determine what kind of test to seek.
    • Additional tests would be needed to determine if your infection was caused by Omicron.
    • Visit your state, tribal, local, or territorial health department’s website to look for the latest local information on testing.
  • Self-tests can be used at home or anywhere, are easy to use, and produce rapid results.
    • If your self-test has a positive result, stay home or isolate for 10 days, wear a mask if you have contact with others, and call your healthcare provider.
    • If you have any questions about your self-test result, call your healthcare provider or public health department.

Until we know more about the risk of Omicron, it is important to use all tools available to protect yourself and others.

What to do if you come into close contact with someone with COVID-19

  • A public health worker, other professional, or the person you came into close contact with may tell you that you are a close contact and have been exposed to COVID-19.
  • Follow recommendations for quarantine, testing, and wearing a well-fitting mask. Quarantine recommendations vary based on up-to-date COVID-19 vaccination status or history of prior COVID-19 infection in the past 90 days.
  • Monitor your symptoms. If you have an emergency warning sign (including trouble breathing), seek emergency medical care immediately.
  • If you develop symptoms, get tested immediately and isolate yourself from others. If your test result is positive, follow recommendations to isolate.
  • If you need help, health department staff can provide information about the best time to get a vaccine and resources for COVID-19 testing in your area.

If you are diagnosed with COVID-19 or have symptoms of COVID-19

Isolate

Stay at home away from others (isolate), except to get medical care.

  • Monitor your symptoms. If you have an emergency warning sign (including trouble breathing), seek emergency medical care immediately.
  • Stay in a separate room, away from other household members, if possible.
  • Use a separate bathroom, if possible.
  • Avoid contact with other household members and pets.
  • Don’t share personal household items, like cups, towels, and utensils.
  • Wear a well-fitting mask if you must be around other people.
  • Follow recommendations for isolation.
  • Tell your close contacts that you have COVID-19 right away so that they can follow recommendations to quarantine, get tested, and wear a well-fitting mask, depending on their vaccination and booster status or history of prior infection.
    • An infected person can spread COVID-19 starting 2 days before the person has any symptoms or tests positive. People who have COVID-19 don’t always have obvious symptoms.
    • A person is still considered a close contact even if they were wearing a mask while they were less than six feet from someone with COVID-19 for a cumulative total of 15 minutes or more over a 24-hour period.
      • You can call, text, or email your contacts. By letting your close contacts know they may have been exposed to COVID-19, you are helping to protect everyone.
      • If you would like to stay anonymous, there is also an online tool that allows you to tell your contacts by sending out emails or text notifications anonymously (tellyourcontacts.org).
      • There are exceptions to the close contact definition in K-12 indoor classroom settings
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