One test included. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical. Particularly, the identification of subclinical or asymptomatic cases is important to reduce or stop the infection because these individuals may transmit the virus. As an intended point-of-care (POC) designated test with a 10 min processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.
- Detect SARS-CoV-2 nucleocapsid protein antigen with ultra high performance
- Identify acute infection with 88.4% sensitivity and 100% specificity
- EUA granted by FDA
- No equipment required
- Rapid results within 10 minutes
- Minimally invasive specimen collection (nasopharyngeal swabs) Intended at POC setting (i.e., in patient care settings) by medical professionals
Note for Healthcare Providers: the CARES Act reimburses each test (CARES Act Category 1 CPT codes 86328 and 86769). If providers are out of network, private insurers are required to reimburse.
Center for Disease Control & Prevention Testing Recommendations
Who should get tested
- People who have symptoms of COVID-19.
- People who have had close contact (within 6 feet for a total of 15 minutes or more) with someone with confirmed COVID-19.
- People who have taken part in activities that put them at higher risk for COVID-19 because they cannot socially distance as needed, such as travel, attending large social or mass gatherings, or being in crowded indoor settings.
- People who have been asked or referred to get testing by their healthcare provider, or state health department.
Not everyone needs to be tested. If you do get tested, you should self-quarantine/isolate at home pending test results and follow the advice of your health care provider or a public health professional.
How to get tested for current COVID-19 infection
- You can visit your state or local health department’s website to look for the latest local information on testing.
- If you have symptoms of COVID-19 and want to get tested, call your healthcare provider first.
- If you test positive, know what protective steps to take to prevent others from getting sick.
- If you test negative, you probably were not infected at the time your sample was collected. The test result only means that you did not have COVID-19 at the time of testing. Continue to take steps to protect yourself.
Considerations for use of a strategy to test for SARS-CoV-2 infection
SARS-CoV-2 testing may be incorporated as part of a comprehensive approach to reducing transmission in non-healthcare workplaces. Symptom screening, testing, and contact tracing pdf icon[58 pages] are strategies to identify workers infected with SARS-CoV-2, the virus that causes COVID-19, so that actions can be taken to slow and stop the spread of the virus.
Employees undergoing testing should receive clear information on:
- the manufacturer and name of the test, the type of test, the purpose of the test, the reliability of the test, any limitations associated with the test, who will pay for the test, and how the test will be performed, and
- how to understand what the results mean, actions associated with negative or positive results, who will receive the results, how the results may be used, and any consequences for declining to be tested.
Individuals tested are required to receive patient fact sheets as part of the test’s emergency use authorization.
The Occupational Safety and Health Administration has issued interim guidance for enforcing the requirements of 29 CFR Part 1904 with respect to the recording of occupational illnesses, specifically cases of COVID-19. Under OSHA’s recordkeeping requirements, COVID-19 is a recordable illness, and thus employers are responsible for recording cases of COVID-19, if the case meets certain requirements. Employers are encouraged to frequently check OSHA’s webpage at www.osha.gov/coronavirus for updates.