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RAPID ANTIGEN, RAPID ANTIBODY & PCR TESTS
What does it mean if the specimen tests positive for the virus that causes COVID-19?
A positive test result for COVID-19 indicates that antigens from SARS-CoV-2 were detected, and the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Patient management should follow current CDC guidelines.
The CareStart® System for Rapid Detection of SARS- CoV-2 has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.
All laboratories using this test must follow the standard testing and reporting guidelines according to their appropriate public health authorities.
What do I need to know about COVID-19 testing?
Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information” section).
• The CareStart® System for Rapid Detection of SARS-CoV-2 can be used to test nasal swab samples directly using a dual nares collection (swab inserted in both nares, 5 rotations per nare).
• The CareStart® System for Rapid Detection of SARS-CoV-2 should be ordered for the detection of COVID-19 in individuals who are suspected of COVID-19 by their healthcare provider and who are within the first five days of onset of symptoms.
The CareStart® System for Rapid Detection of SARS-CoV-2 is only authorized for use in laboratories in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate, high and waived complexity tests. This test is authorized for use at the point of care (POC), i.e., in patient care settings operating under a CLIA certificate of Waiver, certificate of compliance, or certificate of accreditation.
Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available at the CDC’s website (see links provided in “Where can I go for updates and more information” section).
Use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of having COVID-19 as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information” section).
What does it mean if the specimen tests negative for the virus that causes COVID-19?
A negative test result for this test means that antigens from SARS-CoV-2 were not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 7 of illness may be more likely to be negative compared to a RT- PCR assay. Therefore, negative results should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management.
When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19.
The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID- 19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing or testing with molecular methods should be considered by healthcare providers in consultation with public health authorities.
Risks from a false negative result include: delay or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.
A negative antigen test should not be the sole basis used to determine if a patient can end isolation precautions. For additional recommendations regarding infection control, refer to CDC’s Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (Interim Guidance) (see links provided in “Where can I go for updates and more information” section).
What are the symptoms of COVID-19?
Many patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea). The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat or new loss of taste or smell. Based on what is known about the virus that causes COVID-19, signs and symptoms may appear any time from 2 to 14 days after exposure to the virus.
Based on preliminary data, the median incubation period is approximately 5 days, but may range 2-14 days. Public health officials have identified cases of COVID-19 infection throughout the world, including the United States, which may pose risks for public health. Please check the CDC webpage for the most up to date information.
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ACCESSBIO's CARESTART™ COVID-19 Antigen
Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical.
As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.
OUR COVID-19 ANTIGEN TEST KIT IS FDA Emergency Use Authorized.
Should I get an ANTIBODY test?
If you feel you previously had COVID-19, but did not get tested at that time, an antibody test can confirm a COVID-19 diagnosis. Antibody tests may also be used to determine if a positive test result was false in cases where a patient never had symptoms of the virus. Lastly, the antibody test can confirm vaccine antibodies. The risk of getting COVID-19 once you have developed antibodies is low. Knowing if antibodies are present in your blood will help you make informed decisions about how much socialization is safe to resume. The COVID-19 antibody test will also provide important data on the scale of coronavirus infections in our community.