Rapid Covid Antigen Test Card

Rapid Covid Antigen Test Card The Covid Instant Boson Test, also known as the Rapid Covid Antigen Test Card, is designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. It is authorized for non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 years or older, who should perform the test twice over three days with at least 24 hours (but no more than 48 hours) between tests. This authorization applies to individuals with symptoms of COVID-19 within the first 6 days of symptom onset or those without symptoms or specific epidemiological reasons to suspect COVID-19. Additionally, the Rapid Covid Antigen Test Card is intended for non-prescription home use with adult-collected anterior nasal swab samples from individuals aged 2 years or older, following the same testing frequency and criteria as mentioned earlier. It’s important to note that this test does not differentiate between SARS-CoV and SARS-CoV-2. Positive results indicate the presence of viral antigens, but further clinical assessment and additional confirmatory testing with a molecular test may be necessary. Negative results should be considered presumptive and should not be used as the sole basis for treatment or management decisions. Users are encouraged to share their test results with healthcare providers, and healthcare providers are required to report these results to relevant public health authorities. The test is authorized for non-prescription self-use and can be administered by an adult to another person aged 2 years or older in a non-laboratory setting. This test is authorized for emergency use by the Food and Drug Administration (FDA). Kit Contents Inside Rapid Covid Antigen Test Card kit, you’ll find everything you need for accurate testing: A buffer tube A test cassette in a sealed pouch A swab in a sealed pouch Additional Items (Not Provided) While we’ve included the essentials, please have these items on hand: A clock or timer A tube holder Storage and Stability To ensure reliable results, it’s crucial to store the kit properly: Keep it in a controlled environment between 2-30°C (36-86°F). Shield it from direct sunlight. The external packaging displays the expiration date; do not use the kit if expired. Avoid freezing the kit. Introducing the Rapid Covid Antigen Test Card Discover a reliable and rapid solution for detecting SARS-CoV-2 antigens with our Rapid Covid Antigen Test Card. This innovative testing card is designed for the qualitative detection of SARS-CoV-2 antigens in anterior nasal specimens, making it a crucial tool in the fight against COVID-19. Emergency Use Authorization (EUA) Compliant Our Rapid Covid Antigen Test Card is authorized for Emergency Use Authorization (EUA) purposes, ensuring its suitability for diagnostic testing under emergency conditions. It’s a valuable addition to your toolkit for pandemic response. In Vitro Diagnostic Use This Rapid Covid Antigen Test Card is intended for in vitro diagnostic use only, providing accurate results when used according to the instructions provided. It’s a reliable choice for healthcare professionals and individuals alike. Stay Informed with Official Resources To stay informed and access the most up-to-date information on COVID-19, we encourage you to visit the Centers for Disease Control and Prevention (CDC) website at www.cdc.gov/COVID19. Additionally, for more details on Emergency Use Authorizations (EUAs), please visit the FDA’s official website at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. Ensure the safety of your community and loved ones by utilizing the Rapid Covid Antigen Test Card in your testing protocols. Trust in its accuracy and effectiveness as we collectively combat the ongoing pandemic. How to use Rapid Covid Antigen Test Card Using the Product – Step by Step When you’re prepared to conduct the test, follow these straightforward instructions: After completing the test, dispose of the used materials in the trash. Proper adherence to these instructions ensures the accuracy of the test and reliable results. Preparation Before you begin the test, follow these simple steps: Step 1: Wash your hands thoroughly with soap and water, or use hand sanitizer. Step 2: Verify the test expiration date on the test cassette pouch. Step 3: When you’re ready to start the test, allow the kit to reach room temperature. Note For self-collection of a nasal swab sample: Individuals aged 14 years and older can collect their samples. Children between the ages of 2 to 13 years should have an adult perform the test. How to read the Results - Rapid Covid Antigen Test Card How To Read and interpret the test results effectively, follow these guidelines: 1. Timing is Crucial: Ensure that you do not read the result before 15 minutes or after 30 minutes from the time of testing. Reading the result outside this timeframe may lead to inaccurate interpretations. 2. Control Line (C): Examine the result window for the letters “C” and “T.” The letter “C” represents the control line. A pink or purple line should always appear at the “C” position. This line serves as a control and indicates that the test is functioning correctly. Negative Result: If the Control (C) line is visible, but the Test (T) line is not, the test is negative. A negative test result means that antigens from the virus causing COVID-19 were not detected in the specimen. However, it does not rule out the possibility of having COVID-19. Antigen tests may have a higher chance of false negative results compared to laboratory-based molecular tests. This means that there is an elevated likelihood of receiving a negative result when you actually have COVID-19. If you test negative but continue to experience COVID-19-like symptoms, such as fever, cough, and/or shortness of breath, you should seek follow-up care with your healthcare provider. Additionally, you should consider retesting in 24 hours (but no more than 48 hours) regardless of whether you have symptoms. Positive Result: If both the Control (C) line and the Test (T) line are visible, the test is positive. Even a faint, visible pink/purple Test (T) line alongside the Control (C) line should be interpreted as positive. A positive test result indicates that the virus causing COVID-19 was detected in your sample. In such a case, it is highly likely that you have COVID-19 and are contagious. Immediate action is necessary upon receiving a positive result. Contact your doctor, primary care physician, or your local health authority promptly. Follow local guidelines regarding self-isolation. Although very rare, there is a small chance that this test can provide a positive result that is incorrect (a false positive). Your healthcare provider will work with you to determine the best course of care based on your test results, medical history, and symptoms. Invalid Result: If the control line (C) is not visible, even if the test line is visible, the result should be considered invalid. An invalid result means that the test could not determine whether you have COVID-19 or not. In case of an invalid result, it is recommended to use a new swab to collect a fresh nasal specimen, and the test should be conducted again using a new test and tube. Frequently Asked Questions Q: What is COVID-19? A: COVID-19 is an acute respiratory infectious disease caused by the novel Betacoronavirus known as SARS-CoV-2. The virus primarily spreads from person to person, both by those with visible symptoms of COVID-19 and by asymptomatic individuals. The incubation period generally ranges from 1 to 14 days, with the average being 4-5 days. Common symptoms include fever, fatigue, and cough. For a comprehensive list of symptoms, please refer to: CDC Symptoms List. Q: What does an invalid test result mean? A: An invalid test result occurs when no control line appears on the test, regardless of whether any test line is visible. In such cases, the test was unable to determine your COVID-19 status. To resolve this, you should use a new swab to collect another nasal specimen and repeat the test with entirely new test components. Q: Will this test hurt? A: No, the nasal swab used in this test is not sharp and should not cause pain. While it might feel slightly uncomfortable, any significant pain should prompt you to stop the test and consult your healthcare provider. Q: What are the known potential risks and benefits of this test? A: Potential risks may include mild discomfort during the sample collection process and the possibility of incorrect test results (refer to the Result Interpretation section). Potential benefits encompass the use of test results, along with other relevant information, to make informed decisions about your healthcare. Additionally, these results can help limit the spread of COVID-19 within your family and community. Q: What is the difference between an antigen test and a molecular test? A: Various types of COVID-19 tests are available. Molecular tests, also known as PCR tests, identify genetic material from the virus. In contrast, antigen tests, such as the Rapid SARS-CoV-2 Antigen Test, detect proteins from the virus. Antigen tests are highly specific for the COVID-19 virus but may not be as sensitive as molecular tests. This means that a positive result from an antigen test is highly accurate, while a negative result does not definitively rule out infection. If your test result is negative, you should consult your healthcare provider to determine if additional molecular testing is necessary and whether you should continue self-isolation. Q: How accurate is this test? A: The performance of the Rapid SARS-CoV-2 Antigen Test Card was assessed through a prospective clinical study involving symptomatic individuals, with an EUA molecular test serving as the comparator method. The study data, which included a minimum number of low positive cases, revealed that the test correctly identified 82.7% of positive samples and accurately identified 99.1% of negative samples. For comprehensive details on test performance, please refer to Section 2.6 of the Health Care Provider Instructions for Use.