INDICAID Point of Care (POC) COVID-19 Rapid Antigen Test
INDICAID Point of Care (POC) COVID-19 Rapid Antigen Test
Description
INDICAID COVID-19 Rapid Antigen Test - The Most Economical And Effective Solution
The INDICAID COVID-19 Rapid Antigen Test (CE-IVD) is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigens in direct nasal swab samples. Antigens are present in the SARS-CoV-2 virus, and can be bound with specific antibodies.
When a virus enters a human body and begins to multiply, the body begins to react to the viral antigens, possibly resulting in symptoms.
The INDICAID COVID-19 Rapid Antigen Test Rapid detects antigens from the SARS-CoV-2 virus and can be used for COVID-19 screening during active infection.
A Rapid Point Of Care COVID-19 Test
- Sensitivity and Specificity
− COVID-19 – Sensitivity 100%, Specificity 98% - FDA Emergency Use Authorization (EUA)
- Visually read in 10 minutes
For use in CLIA waived Point of Care facilities operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
COVID-19 Test Validation
The clinical performance of the INDICAID COVID Test was evaluated by testing 50 positive and 50 negative SARS-CoV-2 retrospective clinical specimens from unique donors that were previously confirmed by a molecular test.
The 100 clinical specimens were nasopharyngeal swab samples diluted in saline. Testing was performed at one investigational site by two untrained operators who were blinded to the RT-PCR results of the samples.
The samples were first randomized, then each sample eluate was inoculated onto kit-provided swabs and processed as instructed in the test procedure.
The INDICAID COVID Test correctly detected 48/50 positive samples and demonstrated no false positives for the negative samples.
Materials Provided In Kit:
1. 25 individually wrapped Test Devices
2. 25 Buffer Solution Vials
3. 25 individually wrapped Swabs
4. 1 IFU and Quick Reference Guide
FAQs About The Rapid Antigen INDICAID COVID Test
How does the INDICAID Rapid Antigen COVID-19 Test work?
This test is designed to detect the presence of SARS-CoV-2 antigens from nasal swab samples. Antigens are present in the SARS-CoV-2 virus, and can be used as markers for disease exposure.
How far should I insert the testing swab into my nostrils?
Inserting the swab 1 inch into your nostril should be far enough to collect samples for the INDICAID COVID-19 test. You can stop pushing the swab when you feel a slight resistance and proceed to collect your sample. Samples should be collected gently.
Is it harmful if the testing solution has been spilled?
If the test solutions have been spilled, flush abundantly with water upon disposal. Avoid having the test solutions come into contact with your eyes, skin, and mouth. If contact occurs with the eyes, flush with water immediately and seek medical help. If contact occurs with your skin, wash the area with soap and rinse with water.
Do not ingest or inhale the test solutions. If accidental ingestion occurs, please seek medical help immediately.
What Should I do with my test unit after reading the results?
After recording your COVID-19 test results, carefully wrap and seal all of the product components and dispose of them by throwing them into the garbage just like any other household trash. Wash your hands thoroughly after handling and disposing of the components.
Is the INDICAID Covid test FDA approved?
Although the INDICAID COVID-19 Rapid Antigen Test is not FDA approved, it has been authorized by the FDA under an Emergency Use Authorization.
Specs:
| Quantity | 25/Box; 18 Boxes/Case |
| Specimen Type | Direct Anterior Nasal swab |
| Intended Use | Qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab samples from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset, or within 2 to 3 days of potential exposure to a person suspected of being infected with COVID-19. |
| Storage Condition | 36º-86ºF (2º-30ºC) Do not freeze. Avoid direct sunlight. |
| Shelf Life | Expiration is labeled during manufacturing, and it’s currently calculated 6 months from manufacturing date. However, the FDA has recently approved actual expiration to be extended 3 months beyond the date printed on the INDICAID® packaging (i.e. 9 months from date of manufacture). |
Shipping
bttn offers a variety of shipping options to best fit your orders. All orders over $199 include free shipping. For those under $199, a $10 fee will be added, while those under $99 will have a $20 fee added for shipping. Products weighing over 100lbs will be marked in our system as “freight collect” and someone from our team will reach out to you directly to confirm shipping costs. For more information on our shipping policy, please refer to our shipping policy page.
Return Policy
Cancellation Policy
Most of our products ship out within 24-48 business hours, depending on availability. If you wish to cancel your order, you must request a cancellation the same day your order is placed. Please contact support@bttnusa.com with your order number to request a cancellation. After your cancellation has been confirmed, you will be issued a refund to your original form of payment. If your order is shipped before cancellation is confirmed, you will not be able to cancel your order.
Damaged or Defective Products
Please inspect your order upon receipt and contact bttn immediately if your product is damaged, defective, or incorrect. If your product is damaged, you need to contact support@bttnusa.com within 72 hours of receiving your order. Please include your order number, a description of the issue, and a photo. If damage is reported after 72 hours, your product will no longer be eligible for return. Additionally, if a photo is not included in your correspondence, we will be unable to verify eligibility for a prepaid return label.
Return Policy
bttn will only accept returns up to 14 business days after your delivery date. Your product must be returned in the same packaging, condition and quantity it was delivered.
If your product is eligible for return contact support@bttnusa.com In the email, place the order number in the subject line, include a brief description of the reason for returning, and attach any applicable pictures.
bttn will not accept returns for the following products:
- Any item which has been used after opening, stickered, marked, defaced, or is without all original packaging, labeling, package inserts, or operating manuals
- Products that are regulated and/or require a medical license to purchase
- Products that are refrigerated
- Products labeled ‘hazardous’
- Products labeled ‘sterile’ or ‘sterilized’
- Products used to analyze human body tissue
- Products containing hazardous chemicals
- Products that are non-stock (product status is 14-21 Days) or have been drop-shipped (product status is 7-14 Days) directly from the manufacturer non-stocked
- All brands of COVID tests
- All discontinued products
- All narcotics and other controlled substances
- All syringes
- All short-dated (e.g. less than 90-day shelf life), outdated, or seasonal products
- N95 Masks - N95 masks are designed to fit securely on the face and may cause discomfort, bruising and or broken skin on the bridge of the nose. bttn will not accept returns on
- N95/KN95 masks due to the way the may fit or feel while wearing them
Upon receiving your return request, our supply team will determine if your product qualifies for a return based on the above guidelines. Customers are responsible for the shipping costs associated with returning the product, unless the product arrived damaged (please review damage products policy above) or you received the wrong product.
If your order qualifies for a return label (products that are damaged or defective within policy terms), our supply team will issue you a return label through email. You will have 14 business days to drop off your product at the designated courier location.
The product will be inspected for quality assurance upon delivery and a refund will be issued to the original form of payment. Once the refund has been issued it can take up to 7-10 business days to reflect on your original form of payment.
Any requests to return products after 14 days from receipt will be denied.