COVID-19 Antigen Pen Home Test
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Rapid Covid Antigen Test Card
Introducing the Fastep COVID-19 Antigen Pen Home Test – Are you concerned about your health in these challenging times? The Fastep COVID-19 Antigen Pen Home Test is here to provide you with a convenient and reliable solution for at-home COVID-19 testing. With easy-to-follow instructions and quick results, you can take control of your health and help protect yourself and your loved ones.
Kit Contents Inside the Fastep COVID-19 Antigen Pen Home Test kit, you will find everything you need to perform the test with confidence:
- Test Pen
- Base
- Swab
- Timer (not included)
Quick Reference Instructions
Prepare for the Test
- Wash your hands with soap and water for 20 seconds or use hand sanitizer.
- Remove the Swab Cap from the Test Pen and discard it.
- Gently insert the Swab end of the Pen into one nostril about 1/2 – 3/4 of an inch.
- Firmly rub the swab at least 5 times against the inside walls of the nostril in a circular motion. Do not just spin the swab.
- Repeat the process with the same swab in the other nostril.
Test Procedure
- Place the Base on a flat surface.
- Insert the Test Pen into the Base, ensuring the orange band is completely covered by the base.
- Leave the test upright and set a timer for 15 minutes.
Read and Interpret Your Results After the 15 minutes have passed, carefully interpret your results:
- A pink line should always appear at the control (CC) region, confirming that the test is working properly.
- Locate the letters CC and TT at the top and bottom of the results window.
Results Interpretation
COVID-19 Positive (+) If both the Control (CC) line and the Test (TT) line are visible, the test is positive. A positive result means that the virus that causes COVID-19 was detected in your sample. Please contact your healthcare provider or local health authority immediately and follow isolation guidelines.
COVID-19 Negative (-) If the Control (CC) line is visible, but the Test (TT) line is not, the test is negative. However, a negative result does not rule out COVID-19 entirely. If you have symptoms, consider retesting in 48 hours. If symptoms persist, seek medical advice.
Invalid Result If the Control (CC) line is not visible, the test is invalid. In this case, retest with a new swab and a new test device.
Storage and Stability Store the kit at temperatures between 2‑30°C / 36‑86°F and protect it from direct sunlight. Make sure not to freeze the kit, and use it within 1 hour of opening the foil package.
Important Notes
- This test is authorized for non‑prescription home use with self‑collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two (2) years or older.
- Do not use this test on children under 2 years of age. Children between 2 and 14 years of age must be aided or supervised by an adult when carrying out the test.
- If you have symptoms of COVID-19, consider serial testing (testing multiple times over several days) for more accurate results.
- Always consult your healthcare provider for further guidance and medical care.
The Fastep COVID-19 Antigen Pen Home Test is a vital tool to help you stay informed and make informed decisions about your health. Get yours today and take charge of your well-being.
Introducing the Fastep COVID-19 Antigen Pen Home Test by Drug Bulk Test Company
Meet the Fastep COVID-19 Antigen Pen Home Test, your dependable and effective solution for the detection of SARS-CoV-2 antigens. This cutting-edge testing kit has been designed to deliver swift and precise results, establishing itself as an indispensable tool in the ongoing fight against COVID-19.
Emergency Use Authorization (EUA) Compliance
Rest assured, our Fastep COVID-19 Antigen Pen Home Test is fully compliant with Emergency Use Authorization (EUA) guidelines, certifying its appropriateness for diagnostic testing in emergency scenarios. It stands as a valuable addition to your pandemic response toolkit.
In Vitro Diagnostic Utility
The Fastep COVID-19 Antigen Pen Home Test is exclusively intended for in vitro diagnostic purposes, ensuring accurate outcomes when used in accordance with the provided instructions. Whether you’re a healthcare professional or an individual concerned about safeguarding your health, this test is a dependable choice.
Stay Well-Informed with Official Resources
To stay up-to-date and access the latest COVID-19 information, we encourage you to visit the Centers for Disease Control and Prevention (CDC) website at www.cdc.gov/COVID19. For comprehensive insights into Emergency Use Authorizations (EUAs), please consult the official FDA website at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
Prioritize Community Well-Being
Make community well-being your top priority by integrating the Fastep COVID-19 Antigen Pen Home Test into your testing protocols. Place your trust in its precision and effectiveness as we join forces to combat the ongoing pandemic. With this test, you can seize control of your health and contribute to the collective endeavor to overcome COVID-19.
How to use Rapid Covid Antigen Test Card
Guidelines for Test Usage
• Serial testing is recommended for individuals who initially receive negative results. For symptomatic individuals, repeat testing should occur at least twice over three days, with a 48-hour gap between tests. Asymptomatic individuals should undergo testing three times over five days, again with at least 48 hours between each test. Please be aware that additional test kits may be required for this serial (repeat) testing protocol.
• In the event of a negative test result, if you continue to experience symptoms associated with COVID-19 and both your initial and subsequent tests are negative, it is possible that you do not have a COVID-19 infection. Nevertheless, it is advisable to seek follow-up consultation with your healthcare provider for further evaluation.
• A positive test result indicates the presence of proteins from the virus responsible for COVID-19 in the sample. This strongly suggests that you may have a COVID-19 infection. In such cases, it is essential to consult with your healthcare provider for appropriate guidance and potential treatment.
Test Procedure for a Swab Test Kit
This procedure outlines the steps for using a typical swab test kit, which can be used for various testing purposes, such as for viral infections. Always follow the specific instructions provided with your test kit, as procedures may vary slightly.
- Preparation:
- Remove the Test Pen and the Base from the packaging.
- Note: Use the test within one hour of opening the packaging.
- Swab Cap Removal:
- Carefully remove the swab cap from the Test Pen. Discard the swab cap immediately.
- Sample Collection:
- Gently insert the swab end of the Pen into one nostril, approximately half to three-quarters of an inch.
- Firmly rub the swab against the inside walls of the nostril in a circular motion at least five times.
- Avoid spinning the swab.
- Repeat the same process in the other nostril.
- Important: Ensure both nostrils have been swabbed to avoid inaccurate results.
- Instructions for Swabbing Children:
- For children, it might not be necessary to insert the swab as far into the nostril.
- If required, another person may assist by holding the child’s head during the swabbing process.
- Activation and Testing:
- Place the Base on a flat surface.
- Insert the swab end of the Pen into the Base.
- Locate the orange band on the pen.
- Press firmly to insert the swab all the way into the base until the orange band is fully covered by the base.
- Warning: Incorrect insertion of the test pen can lead to inaccurate results.
- Reading the Results:
- Leave the assembled test upright and set a timer for 15 minutes.
- After 15 minutes, read the results in the results window.
- Note:
- Do not read the results before 15 minutes as it may lead to an inaccurate reading.
- Do not interpret the results after 30 minutes.
- Post-Test Disposal:
- After completing the test, dispose of the used materials in the trash responsibly.
How to read the Results - Rapid Covid Antigen Test Card
Product Results Interpretation Guide
Important Notice: To ensure the accuracy of the test, initiate result interpretation only after a 15-minute wait. Avoid evaluating the outcome if more than 30 minutes have passed since conducting the test, as this may lead to errors in interpretation.
Understanding the Results Window:
- Identify the ‘Control’ (CC) and ‘Test’ (TT) labels positioned at the top and bottom within the results display area.
- After allowing 15 minutes to pass, you should observe the emergence of a rose-tinted stripe next to the ‘Control’ (CC) marker. This line serves as an indicator that the test is functioning as intended.
Always adhere to the instructions to confirm the test has been performed correctly and to ensure the reliability of the results.
COVID-19 Positive (+): A visible Control (C) line and Test (T) line or a faint Test (TT) line alongside a Control (CC) line indicate a positive COVID-19 test result, requiring immediate contact with healthcare professionals and adherence to isolation guidelines due to a high likelihood of COVID-19 infection, although there’s a very slight possibility of a false positive.
COVID-19 Negative (-): If the Control (C) line is visible but the Test (T) line is not, the test is negative. To ensure accuracy, retest after 48 hours if symptoms are present on the first day, or test two more times with at least 48 hours between each if no symptoms are present initially. A negative result means COVID-19 was not detected, but false negatives are more common in antigen tests. If symptoms persist, consider follow-up testing or seek care from a healthcare provider.
COVID-19 Invalid (x): If the control (C) line is not visible, the test is invalid; retest using a new swab and test device, and note that the control line might appear within a few minutes, while the test line may take up to 15 minutes to show up.
Common Inquiries
What are the possible disadvantages and advantages of using the test?
Potential disadvantages may consist of:
- Discomfort that might occur while obtaining the sample.
- The chance of receiving an inaccurate test result (refer to the Warnings and Understanding Your Results sections for additional details).
Potential advantages involve:
- Utilizing the test outcomes, along with supplementary data, can aid you and your healthcare professional in making well-informed decisions regarding your healthcare management.
- By identifying a COVID-19 infection, the test could play a role in preventing the transmission of the virus to your loved ones and the wider community.
For further details on Emergency Use Authorizations, please visit: FDA Emergency Use Authorization.
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