COVID-19 Test Registration

A viral test tells you if you have a current infection. There are different types of viral tests, including:

Antigen Detection Test

Viral antigens develop on the surface of cells infected with a specific virus. A viral antigen detection test is done on a sample of tissue that might be infected. Specially tagged (with dye or a tracer) antibodies that attach to those viral antigens are mixed with the sample. The tagged antibodies can be seen by using a special light (or other method). If the tagged antibodies are attached to the cells, the cells are infected with the virus.

Viral Molecular Detection Test

Using a sample of tissue or blood or other fluid, the test looks for the genetic material (DNA or RNA) of a specific virus. This test can show the exact virus causing an infection.

An Antibody tests tells you if you had a previous infection. An antibody test may not be able to show if you have a current infection, because it can take 1-3 weeks after infection to make antibodies. We do not know yet if having antibodies to the virus can protect someone from getting infected with the virus again, or how long that protection might last.

Guidance for Routine and Repeat COVID-19 Testing?

As an Emergency Medical Facility, we are unable to see non-sick patients for routine COVID-19 testing.  We DO test and treat patients who have emergency exposures to COVID-19 or emergency symptoms of COVID-19.  Patients should contact their primary physician or seek other community resources for routine or repeat testing. Following is additional information about repeat testing:

If you have previously tested negative, you may consider retesting at Elitecare 24 Hour Emergency Center in the following situations:

1. You develop additional or worsening symptoms since the time of initial testing
2. You have persistent symptoms related to COVID-19
3. You experience another emergency exposure to COVID-19 that might lead to an emergency medical condition

If you have previously tested positive and wish to discontinue home isolation, we are not recommending retesting. Rather, that you follow the CDC guidelines for ending home isolation. These can be found here: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/end-home-isolation.html . Retesting for work-return should be arranged through your primary physician and not through an emergency room. You may also seek community resources for work-return testing.

If you have previously tested positive and you have symptoms of a new infection, you should be evaluated by a physician.  The physician will determine if you need to be tested for a particular virus or bacterial infection.  In very rare cases, a person may become sick again with COVID-19 even after recovering from a previous illness.

According to the Centers for Disease Control and Prevention (CDC), there are two types of tests are available for COVID-19: viral tests and antibody tests.

If you are a close contact of someone with COVID-19 or you are a resident in a community where there is ongoing spread of COVID-19 and develop symptoms of COVID-19, call your healthcare provider and tell them about your symptoms and your exposure. They will decide whether you need to be tested, but keep in mind that there is no treatment for COVID-19 and people who are mildly ill may be able to isolate and care for themselves at home.

If your doctor sees that you meet the requirements for testing be sure to wear a mask, cover your coughs and sneezes, and frequently clean your hands on your way to be tested. If you experience severe pain, shortness of breath, or chest pain, you need to seek emergency care. See more symptoms here. For more information visit: CDC COVID-19 TESTING ADVICE. 

How Coronavirus Tests May Be Authorized

Americans rely on the FDA to provide an independent review of medical products, such as drugs, diagnostic tests, and other medical devices. During a public health emergency like the COVID-19 pandemic, there is an urgent need for products to diagnose, treat, or prevent a medical threat. There are three ways a coronavirus test might be used for this emergency:

1. Emergency Use Authorization (EUA) 
   In certain types of emergencies, the FDA can issue an Emergency Use Authorization, or EUA, to provide more timely access to critical medical products that may help during the emergency when there are no adequate, approved, and available options. The EUA process is different than full approval or clearance because in some emergency situations we cannot wait for all of the evidence needed for full FDA approval or clearance.  Instead, the FDA evaluates the options very quickly using the evidence that is available, carefully balancing the risks and benefits of the product as we know them, in addition to evaluating other criteria.
2. Lab Developed Test (LDT)
   A laboratory-developed test (LDT) is an in vitro (or laboratory) diagnostic test that is manufactured by and used within a single laboratory. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The FDA is providing flexibility to certain labs certified under CLIA to run high-complexity tests during the COVID-19 emergency. The FDA is providing flexibility for labs that develop and perform their own coronavirus testing where the lab validates the test, notifies FDA, and submits the validation data to the FDA within a certain timeframe as part of a EUA request. While many labs purchased commercial tests under an existing EUA, other labs developed and validated their own tests under this temporary policy.
3. State Authorization
   The FDA is providing flexibility to states who want to authorize labs certified to conduct high-complexity tests in that state to develop and perform coronavirus testing. Under this policy, the state or territory takes responsibility for the safety and accuracy of COVID-19 testing by laboratories in its state/territory and the lab does not submit a EUA request to the FDA.

This information has been provided by the FDA