InBios COVID Test Instructions: An Overview
The InBios COVID-19 test is a diagnostic tool for detecting the SARS-CoV-2 virus. This overview will guide you through understanding the test’s instructions. The test detects viral proteins from nasal swab samples.
The InBios SCoV-2 Ag Detect Rapid Self-Test is a lateral flow immunoassay designed for the qualitative detection of the SARS-CoV-2 nucleoprotein antigen. This test utilizes anterior nasal swab samples collected directly from individuals, offering a convenient method for detecting COVID-19 at home. Requiring no specialized training, it delivers results within 20 minutes, making it a suitable diagnostic tool for self-testing. The test kit includes all necessary components, such as tests, dropper bottles, and swabs, ensuring a user-friendly experience. It’s important to carefully read the instructions before use.
Intended Use and Authorization
The InBios SCoV-2 Ag Detect Rapid Self-Test is designed for the qualitative detection of SARS-CoV-2 antigens. It’s authorized for home use, offering results to individuals suspected of COVID-19.
Emergency Use Authorization (EUA) Status
The InBios SCoV-2 Ag Detect Rapid Self-Test has received Emergency Use Authorization (EUA) from the FDA. This authorization allows for its use in diagnosing COVID-19 during the public health emergency. It’s important to note that because it has only been authorized for emergency use, it has not undergone the same rigorous approval process as tests with full FDA approval. The EUA is in effect for the duration of the COVID-19 emergency, as declared by the Department of Health and Human Services. Be sure to check for any updates to the authorization status.
Target Population: Adults and Children
The InBios SCoV-2 Ag Detect Rapid Self-Test is designed for use by a broad population, including both adults and children. Specifically, it is authorized for self-collection by individuals aged 14 years and older. For children between the ages of 2 and 13, samples must be collected by an adult. This ensures proper sample collection technique and accurate test results. The test is intended for individuals suspected of having COVID-19, particularly within the first seven days of symptom onset, as determined by their healthcare provider.
Materials Required for Testing
To perform the InBios SCoV-2 Ag Detect Rapid Self-Test, you’ll need the test device in the pouch, a single-use dropper bottle, a nasal swab, and a timing device.
Components Included in the Test Kit
The InBios SCoV-2 Ag Detect Rapid Self-Test kit contains all essential components for conducting the test at home. Each kit includes a sealed test device, designed for single use to ensure accurate results. A sterile nasal swab is provided for sample collection, designed for comfortable and effective use. The kit also contains a dropper bottle with the reagent solution necessary for developing the test. Detailed instructions for use are included.
Additional Items Needed (e.g., Timer)
While the InBios SCoV-2 Ag Detect Rapid Self-Test kit provides most necessary components, some additional items are required to perform the test effectively. A timer or stopwatch is crucial for accurately timing the test development, ensuring correct results. A clean, flat surface is needed to perform the test. It’s recommended to have a waste container readily available for disposal of used test components, maintaining hygiene and safety.
Step-by-Step Test Procedure
This section provides a detailed guide on performing the InBios COVID-19 test. It covers sample collection using a nasal swab and running the test to get accurate results.
Sample Collection: Nasal Swab Instructions
To collect a nasal swab sample, insert the swab tip into the nostril. Gently push the swab into the sample port while pressing the handle down. The swab should cover the sample turnover for instructions. This test can be performed using shallow nasal swab samples, and requires no mixing step. Directly test your nasal swab sample; no mixing is needed. The nasal swab collection process should be non-invasive and cause minimal discomfort.
Running the Test: Inserting Swab and Developing Results
After collecting the nasal sample, firmly hold the top of the test. Place the swab tip into the sample port. Gently push the swab tip into the sample port while pressing the swab handle down. The SCoV-2 Ag Detect Rapid Self-Test requires no mixing step. Fast results are obtained in 20 minutes. The test can be performed using anterior nasal swab samples and takes less than 25 minutes.
Interpreting Test Results
The test is positive if both the control line and test line are visible. A negative result shows only the control line. Review instructions for accurate interpretation of results.
Positive Result: Identifying the Control and Test Lines
A positive test result indicates the detection of COVID-19 antigen. Look for the presence of both the control line (C) and the test line (T) in the designated areas on the test device. Even a faint test line should be considered a positive result. It is crucial to consult with your healthcare provider if you receive a positive result. A positive result means that it is very likely you have COVID-19, and it is important to be under the care of your healthcare provider.
Negative Result: Absence of the Test Line
A negative test result is indicated by the presence of the control line (C) only. The test line (T) will be absent in this scenario. The absence of the test line suggests that the COVID-19 antigen was not detected in the sample. If you suspect you have COVID-19, you may need to purchase additional tests to perform serial (repeat) testing. See instructions for use for complete details. To increase the chance that the negative result for COVID-19 is accurate, you should test again in 48 hours if you have symptoms.
Invalid Result: What to Do
An invalid test result occurs when the control line (C) does not appear. If this happens, the test is considered invalid and you should repeat the test with a new test kit. Make sure to carefully follow all the instructions provided in the user manual to avoid an invalid result. Review the test procedure, ensuring all steps are correctly performed, and that the test device has not expired. It is essential to contact Technical Support before testing patient specimens if you have any questions.
Accuracy and Limitations
The InBios SCoV-2 Ag Detect Rapid Self-Test’s accuracy has been studied. Performance data regarding sensitivity and specificity is available. Note that performance may differ in asymptomatic individuals or with serial screening.
Sensitivity and Specificity of the Test
The InBios SCoV-2 Ag Detect Rapid Self-Test demonstrated a relative sensitivity of 85.71% and a relative specificity of 100% in initial evaluations. These values indicate the test’s ability to correctly identify positive and negative samples. Remember that the performance of the test is still being studied in patients without signs and symptoms of respiratory infection and for serial screening, so the performance may differ in these populations. Refer to the instructions for use for the most up-to-date information.
Potential for False Negatives and Positives
Like all diagnostic tests, the InBios SCoV-2 Ag Detect Rapid Self-Test has the potential for false negatives and false positives. A false negative result may occur if the viral load is low, especially early in the infection. Antigen tests, such as the SCoV-2 Ag Detect Rapid Self-Test, have a higher chance of giving you a false negative result. A false positive may occur due to cross-reactivity with other respiratory viruses or other factors.
Repeat Testing Recommendations
To increase accuracy, serial (repeat) testing is recommended. If you have symptoms, test again in 48 hours. If you don’t have symptoms, test two more times, 48 hours apart.
Serial Testing for Increased Accuracy
To enhance the reliability of your COVID-19 test results, especially when using antigen tests like the InBios SCoV-2 Ag Detect Rapid Self-Test, serial testing is highly recommended. Due to the potential for false negatives with antigen tests, repeat testing can help confirm your initial result, particularly if you suspect exposure or are experiencing symptoms. Following the recommended testing schedule improves the chances of accurately detecting the virus.
When to Repeat the Test
If you initially test negative but have symptoms, repeat the test within 48 hours to increase accuracy. For asymptomatic individuals, test two more times, at least 48 hours apart. Repeat testing is crucial due to the potential for false negatives, especially early in an infection when viral loads may be low. Adhering to this testing schedule helps ensure reliable results and reduces the risk of unknowingly spreading the virus.
Storage and Handling
Proper storage is crucial for test integrity. Maintain the test kit at room temperature as indicated in the instructions. Avoid exposure to extreme heat or freezing conditions to ensure accurate results.
Proper Storage Conditions
To maintain the integrity and effectiveness of the InBios SCoV-2 Ag Detect Rapid Self-Test, it is crucial to adhere to proper storage conditions. Always store the test kit in its original packaging at room temperature, typically between 2°C to 30°C (36°F to 86°F). Avoid exposing the test components to direct sunlight, excessive heat, or freezing temperatures, as these conditions can compromise the test’s accuracy and reliability. Ensure the test kit remains dry and is not stored in areas with high humidity. Proper storage guarantees consistent and dependable results.
Where to Find Instructions for Use
The complete instructions for use are included within the test kit packaging. You can also visit the InBios website for a digital copy and additional resources, ensuring proper test administration.
Locating the Instructions
The instructions for use are included in the test kit packaging. Look for a folded leaflet or booklet. The InBios website provides a digital version. Access the “Downloads” tab on the InBios website to locate the SCoV-2 Ag Detect Rapid Self-Test instructions. These instructions offer step-by-step guidance. Review these instructions carefully before performing the test. Understanding each step ensures accurate results. Follow all directions for proper sample collection and interpretation. Contact Technical Support at 1-866-INBIOS1 for assistance.
