Oral Fluid Rapid Antigen Saliva Test Kit Completed Via Nasopharyngeal Swab

【Note】

• For in vitro diagnostic use.
• This test has been authorized only for the detection of SARS-CoV-2 IgM and IgG antibodies, not for any other viruses or pathogens.
• Treat all specimens as potentially infectious. Follow universal precautions when handling samples, this kit and its contents.
• Proper sample collection, storage and transport are essential for correct results.
• Leave test card sealed in its foil pouch until just before use. Do not use if pouch is damaged or open.
• Do not use kit past its expiration date.
• Do not mix components from different kit lots.
• Do not reuse the used test card.
• Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
• Do not store specimens in viral transport media for specimen storage.
• All components of this kit should be discarded as Biohazard waste according to Federal, State and local regulatory requirements.
• Solutions used to make the positive control swab are non-infectious. However, patient samples, controls, and test cards should be handled as though they could transmit disease. Observe established precautions against microbial hazards during use and disposal.
• Wear appropriate personal protection equipment and gloves when running each test and handling patient specimens. Change gloves between handling of specimens suspected of SARS-COV-2.

Something you need to learn about:
1) What is the difference between an antigen test and a molecular test?
An antigen test detects specific proteins on the surface of the virus. These tests are quicker and less expensive, but have a higher chance of missing an active infection, according to the FDA.
A molecular (PCR or polymerase chain reaction) test detects the virus’s genetic material. These tests require a more complex technology to get results, and it usually takes a day or two to get those results (depending on lab capacity, results may take up to a week).
If an antigen test shows a negative result and you have reason to believe you may have the virus (because of symptoms or exposure), your doctor may order a molecular test to confirm the results.

2) Which tests are more accurate?
No test is 100% accurate, but the molecular tests are considered to be more accurate than the antigen tests, according to available research.
According to the FDA, an antigen test cannot “definitively rule out active coronavirus infection,” but positive results are “highly accurate” (negative results may require a confirmation test).
Harvard Medical School wrote in August that the reported rate of false negatives with molecular testing is as low as 2% and as high as 37%. A molecular test using a deep nasal swab will have fewer false negative results than samples from throat swabs or saliva, they say.
For antigen testing, Harvard noted that the reported rate of false negative results can be as high as 50%, but that the FDA has granted emergency use authorization for a more accurate antigen test.
In general, some of the issues that may affect the accuracy of a test include ineffective swabbing, contamination or mishandling of the sample, or problems with the testing chemicals, according to the FDA.

3) If antigen tests are less accurate, why would we use them?
Experts say the value in the rapid antigen tests is in the frequency of the testing rather than the accuracy, with repeated testing recommended. According to Science, getting a false negative in an antigen test two or three times in a row is rare. This strategy lines up with the NPR report mentioned above, which would employ daily testing of those in high-risk areas.

4) Who must be tested for COVID-19?
As per the Minister’s Directive: COVID-19: Long-Term Care Home Surveillance Testing and Access to Homes (Minister’s Directive) effective January 8, 2021, all staff, student placement and volunteers working in long-term care homes must be tested regularly in accordance with the Minister’s Directive, unless the exception for individuals who have previously had laboratory confirmed COVID-19 applies. The testing requirements in the Minister’s Directive include all individuals working in long-term care homes who are: • Staff as defined in the Long-Term Care Homes Act, 2007 • Volunteers as defined in the Long-Term Care Homes Act, 2007 • Student placement, meaning any person working in the long-term care home as part of a clinical placement requirement of an educational program of a college or university, and who does not meet the definition of “staff” or “volunteer” under the Long-Term Care Homes Act, 2007. The Minister’s Directive also includes additional testing and documentation requirements for general visitors, caregivers and support workers.