Introducing the Boson Antigen Covid Test: Rapid Covid Antigen Test Card
Welcome to the forefront of rapid and reliable COVID-19 detection with the Boson Rapid Home Antigen Covid Test Card. This user-friendly kit is designed for the swift identification of SARS-CoV-2 antigens in anterior nasal specimens, providing a valuable tool for emergency use authorization (EUA) purposes.
Key Features:
- Rapid Results: Experience quick and efficient results for on-the-spot insights.
- In vitro Diagnostic Use: Ensuring accuracy in diagnostic applications.
Important Information:
- Emergency Use Authorization (EUA) Only: Specifically authorized for emergency use to address critical situations.
- For More Information on EUAs: Visit the FDA’s Emergency Use Authorization information page here.
- COVID-19 Updates: Stay informed with the latest information on COVID-19 by visiting CDC`s Covid information.
Harness the power of the Rapid Covid Antigen Test Card from Boson for accurate and timely results in the detection of SARS-CoV-2 antigens. For emergency use authorization purposes and in vitro diagnostic use only.
Documentation:
Included in the Kit:
- Sealed pouch containing the Test Cassette
- Buffer tube
- Sealed pouch containing the Swab
Not Provided but Required:
- Clock or timer and Tube holder
Storage and Stability:
- Ensure the kit is stored at temperatures between 2-30°C / 36-86°F, shielded from direct sunlight.
- The expiration date is visible on the external packaging; refrain from freezing the kit.
Covid rapid antigen – Test Procedure
Preparation Steps:
- Cleanse your hands with soap and water or use hand sanitizer before initiating the test.
- Examine the test expiration date on the pouch containing the Test Cassette.
- Prior to commencing the test, allow the kit to reach room temperature.
Important Note:
- Individuals aged 14 years and older can self-collect a nasal swab sample.
- For children aged 2 to 13 years, testing should be administered by an adult.
Reading the Covid rapid antigen test
Positive - A line appears in regions (C) and (T)
If a Control (C) line and the Test (T) line are visible, the test is positive. Any faint visible pink/purple test (T) line with the control line (C) should be read as positive.
Negative - A line appears in region (C)
If the Control (C) line is visible, but the Test(T) line is not visible, the test is negative.
Invalid - No line appears in region (C)
If a control line (C) is not visible, even if the test line is visible, the result must be considered invalid.
Accuracy of the Rapid Covid Antigen Test
Performance Evaluation: The accuracy of the Rapid Covid Antigen Test Card has undergone meticulous assessment through a prospective clinical study involving symptomatic individuals. This evaluation utilized an Emergency Use Authorization (EUA) molecular test as the comparator method, ensuring a robust benchmark for analysis.
Study Insights: Data from this comprehensive study, meticulously analyzed with the minimum recommended number of low positives, revealed noteworthy performance metrics. Specifically, the test demonstrated an 82.7% correct identification rate for positive samples and an impressive 99.1% correct identification rate for negative samples.
This analytical summary aims to provide a clear and concise perspective on the accuracy of the Rapid Covid Antigen Test Card, offering a reliable snapshot of its performance characteristics.
Analytical Overview: Rapid Covid Antigen Test Card
Intended Use: The Rapid Covid Antigen Test Card is designed as a lateral flow immunoassay to qualitatively detect the nucleocapsid protein antigen from SARS-CoV-2. This test holds authorization for non-prescription home use with self-collected anterior nasal swabs from individuals aged 14 and older, and adult-collected swabs from individuals aged 2 and older. The testing regimen involves two tests over three days with a minimum 24-hour gap between tests.
Scope of Authorization: This test is authorized for individuals with COVID-19 symptoms within the first 6 days of onset or those without symptoms but with epidemiological reasons to suspect COVID-19.
Limitations and Considerations:
- The test does not differentiate between SARS-CoV and SARS-CoV-2.
- Positive results indicate the presence of viral antigens but require clinical correlation for infection status determination.
- Positive results do not rule out bacterial infection or co-infection with other viruses.
- Individuals testing positive should self-isolate and seek follow-up care, considering additional confirmatory molecular testing.
Negative Result Considerations:
- Negative results are presumptive and may require confirmation with a molecular assay in high likelihood scenarios.
- Negative results do not exclude SARS-CoV-2 infection and should not solely guide treatment or management decisions.
- Clinical context, recent exposures, and symptoms should be considered in interpreting negative results.
Post-Testing Actions:
- Individuals with negative results experiencing persistent COVID-like symptoms should seek follow-up care.
- All results should be shared with healthcare providers for public health reporting.
- Healthcare providers will report results to relevant authorities as per regulatory requirements.
Testing Setting and Authorization:
- The test is authorized for non-prescription self-use or by an adult lay user testing individuals 2 years or older in a non-laboratory setting.
- Strict adherence to the FDA’s Emergency Use Authorization is mandated.
This analytical breakdown aims to enhance user understanding and adherence to guidelines for the Rapid Covid Antigen Test Card. Always consider the context and consult healthcare professionals for comprehensive interpretation and guidance.
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