Overview of the InteliSwab Rapid Test
The InteliSwab Rapid Test is a lateral flow immunoassay device for detecting SARS-CoV-2 nucleocapsid protein antigen. It is authorized for home use under Emergency Use Authorization (EUA).
1.1. What the InteliSwab Rapid Test Is
The InteliSwab Rapid Test is a lateral flow immunoassay device designed for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen. It uses an integrated swab for anterior nasal sample collection and a test strip for visual results. The device is user-friendly‚ intended for non-prescription home use‚ and operates under Emergency Use Authorization (EUA) for COVID-19 detection.
Its innovative design combines swabbing and testing in one step‚ making it convenient for self-testing. The test provides results within minutes‚ offering a rapid and reliable solution for detecting active infections.
1.2. Purpose and Authorization
The InteliSwab Rapid Test is authorized under Emergency Use Authorization (EUA) for detecting SARS-CoV-2 nucleocapsid protein antigen. Its primary purpose is to provide quick‚ accurate COVID-19 detection for self-testing at home. The test is cleared for use by individuals aged 14 and older‚ with adult assistance recommended for younger users. It is designed to aid in identifying active infections and supporting public health efforts during the pandemic.
Principles of the Test
The InteliSwab Rapid Test uses a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid protein antigen; It employs an integrated swab for nasal sample collection and is visually interpreted.
2.1. How the Test Works
The InteliSwab Rapid Test operates as a lateral flow immunoassay‚ detecting SARS-CoV-2 nucleocapsid protein antigen. A nasal swab collects the sample‚ which is applied to the test strip. The antigen binds to antibodies on the strip‚ producing a visible line for positive results. The test provides results within 15-30 minutes‚ offering a quick and straightforward method for COVID-19 detection at home or in clinical settings.
2.2. Key Components of the Test
The InteliSwab Rapid Test includes a test strip coated with SARS-CoV-2 antibodies‚ an integrated swab for nasal sample collection‚ and a dropper to apply the sample; The test is compact‚ portable‚ and designed for simple‚ quick results‚ making it ideal for home or clinical settings. Its components ensure accurate detection of the virus‚ providing reliable results within 15-30 minutes.
Step-by-Step Instructions for Use
Wash hands‚ swab both nostrils gently‚ insert swab into the test strip‚ and wait for results. Follow all provided instructions carefully for accurate testing under EUA guidelines.
3.1. Preparing for the Test
Wash your hands thoroughly with soap and water for 20 seconds. Avoid eating‚ drinking‚ or smoking for 20 minutes before testing. Gather all materials‚ including the test device‚ swab‚ and instructions. Ensure the test kit is at room temperature and carefully read the package insert or visit www.inteliswab.com for detailed guidance.
3.2. Collecting the Nasal Swab Sample
Gently insert the integrated swab into one nostril‚ rotating it while advancing until resistance is met. Hold in place for 10-15 seconds‚ then slowly withdraw. Avoid touching the swab tip to any surfaces. The swab is pre-coated with a solution to stabilize the sample. Follow the instructions carefully to ensure an accurate test result. Visit www.inteliswab.com for additional guidance.
3.3. Performing the Test
After collecting the nasal swab‚ insert the swab into the provided test tube‚ breaking the swab at the designated breakpoint. Shake the tube gently for 5 seconds and pour 2-3 drops onto the test strip. Wait 10 minutes for the results. Do not interpret results after 15 minutes. For detailed instructions‚ visit www.inteliswab.com or call 1-833-601-0127.
Reading and Interpreting Results
Read results at 10 minutes. A positive result shows two lines; a negative shows one line. No lines indicate an invalid test; repeat if necessary.
4.1. Understanding Positive and Negative Results
A positive result shows two distinct lines‚ indicating the presence of SARS-CoV-2 antigen. A negative result displays one line‚ meaning no antigen was detected. If no lines appear‚ the test is invalid. Ensure results are read within the recommended 10-minute window for accuracy. Always follow the test instructions carefully to interpret results correctly and understand their implications for further action.
4.2. What to Do After Receiving Results
If the result is positive‚ immediately contact a healthcare provider for further guidance. A negative result means no antigen was detected‚ but follow public health guidelines. If the test is invalid‚ repeat the process with a new kit. Regardless of the outcome‚ always report results to your healthcare provider for appropriate next steps and ensure accurate interpretation of the test outcome.
Important Safety and Precautions
Handle the test kit carefully to avoid contamination. Avoid touching the swab tip or test strip. Store in a cool‚ dry place away from sunlight.
5.1. Handling the Test Kit Safely
Always wear gloves when handling the test kit to prevent contamination. Ensure the swab tip does not touch any surfaces. Store the kit in a cool‚ dry place‚ away from direct sunlight. Keep out of reach of children and pets to avoid accidental exposure or tampering with the components.
5.2. Disposal of Test Materials
Dispose of all test materials‚ including swabs and test cassettes‚ in a sealed plastic bag. Do not crush or bend the test kit components. After performing the test‚ discard materials according to local biohazard waste guidelines. If unsure‚ treat as medical waste. Ensure proper disposal to prevent environmental contamination and potential exposure. Recycle outer packaging if permitted by local regulations.
Troubleshooting Common Issues
If issues arise‚ check for expired tests‚ ensure proper swab technique‚ and verify all steps were followed. Contact support at 1-833-601-0127 for assistance.
6.1. Resolving Inaccurate Results
In case of inaccurate results‚ ensure proper swab technique‚ verify expiry dates‚ and check if the test was performed within the recommended temperature range. Avoid touching the test strip‚ and ensure the swab is inserted correctly into the extraction buffer. If issues persist‚ consult the user guide or contact OraSure Technologies at 1-833-601-0127 for further assistance.
6.2. Addressing Test Kit Errors
If the test kit exhibits errors‚ such as damaged components or faulty test strips‚ immediately replace it. Ensure the test kit is within its expiry date and stored correctly. Consult the user guide for troubleshooting or contact OraSure Technologies at 1-833-601-0127 for assistance. Visit www.InteliSwab.com for additional support and guidance on resolving test kit-related issues.
Additional Resources
For further assistance‚ visit www.InteliSwab.com or contact OraSure Technologies at 1-833-601-0127. Additional guidance and support resources are available on the official website and through customer service.
7.1. Contact Information for Support
For assistance with the InteliSwab Rapid Test‚ contact OraSure Technologies at 1-833-601-0127. Visit their official website at www.InteliSwab.com for detailed instructions‚ troubleshooting guides‚ and additional resources. Customer support is available to address any questions or concerns regarding test usage‚ interpretation‚ or technical issues. Ensure accurate results by following the provided guidelines and reaching out for help when needed.
7.2. Where to Find More Information
Visit the official InteliSwab website at www.InteliSwab.com for comprehensive instructions‚ troubleshooting guides‚ and FAQs. Additional resources‚ including user manuals and video tutorials‚ are available on the site. For detailed product information‚ refer to the package insert or contact customer support at 1-833-601-0127. Ensure you consult only authorized sources for accurate and up-to-date guidance on using the InteliSwab Rapid Test effectively.
Storage and Shelf Life
Store the InteliSwab Rapid Test in its original packaging at 59°F–86°F (15°C–30°C)‚ avoiding humidity and light. Shelf life is up to 24 months; check expiration date on packaging and avoid freezing.
8.1. Proper Storage Conditions
Store the InteliSwab Rapid Test in its original packaging at 59°F–86°F (15°C–30°C). Protect from humidity‚ direct sunlight‚ and freezing temperatures. Ensure the kit remains sealed and unopened until use. Avoid exposing the test to extreme conditions to maintain accuracy. Always check the expiration date on the packaging before use and follow the manufacturer’s guidelines for storage to ensure reliability and performance.
8.2. Expiry and Shelf Life Details
The InteliSwab Rapid Test has a shelf life of 12 months from the manufacturing date‚ as indicated on the packaging. Ensure not to use the test beyond its expiration date. Proper storage conditions‚ such as maintaining temperatures between 59°F–86°F (15°C–30°C)‚ are crucial for preserving the test’s effectiveness. Always verify the expiry date before conducting the test to ensure accurate results and compliance with safety standards.
Special Considerations
The InteliSwab Rapid Test is intended for self-collected anterior nasal samples and is authorized for use under Emergency Use Authorization (EUA). It is designed for detecting SARS-CoV-2 antigens and should not be used for diagnosing other conditions. Proper handling and storage are essential to maintain accuracy and safety.
9.1. Testing in Different Populations
The InteliSwab Rapid Test is designed for use in individuals aged 14 and older or children as young as 2 years old with adult assistance. It is intended for self-collection of anterior nasal swab samples from individuals suspected of COVID-19‚ including asymptomatic individuals. The test is suitable for use in various populations‚ including those who are vaccinated or unvaccinated‚ but is not intended for individuals with severe nasal congestion or other conditions that may limit sample collection.
9.2. Use Under Emergency Authorization
The InteliSwab Rapid Test is authorized for emergency use only under the FDA’s Emergency Use Authorization (EUA). It is intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in individuals suspected of COVID-19. The test is for non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 and older or children as young as 2 years old with adult assistance.
Always follow the instructions carefully for accurate results. The InteliSwab Rapid Test is a vital tool for early detection and prevention of COVID-19 spread. Use it responsibly.
10.1. Final Tips for Accurate Testing
For reliable results‚ always follow the instructions precisely. Handle the test kit safely to avoid contamination. Ensure proper swabbing technique and timing. Consult healthcare professionals if unsure. Store tests correctly to maintain integrity. Accurate testing helps prevent COVID-19 spread and ensures timely medical responses. Adhere to all guidelines for the best outcomes.
10.2. Importance of Following Instructions
Adhering to the InteliSwab Rapid Test instructions ensures accurate results and safety. Misuse can lead to incorrect outcomes or potential harm. Always follow the step-by-step guide‚ timing‚ and safety precautions. Proper handling and storage are crucial for test reliability. Compliance with Emergency Use Authorization (EUA) guidelines ensures the test performs as intended. Accurate testing protects health and prevents misinformation.