NIDS COVID-19 Antigen Rapid Test Kit (POC)
$416.00
NIDS COVID-19 Antigen Rapid Test Kit (POC)
$416.00
Mfr item code
N/A
Description
NIDS COVID-19 Antigen Rapid Test Kit (POC)
The NIDS COVID-19 Antigen Rapid Test Kit is a lateral flow immunoassay (LFI) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct mid-turbinate (MT) nasal swabs from individuals who are suspected of having COVID-19 by their healthcare provider within the first seven (7) days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
The NIDS COVID-19 Antigen Rapid Test Kit does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein. Antigen is generally detectable in MT nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigen, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Additional confirmatory testing with a molecular test for positive results may be necessary for results with and without serial testing, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection.
This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
Need more information about the NIDS COVID-19 Antigen Rapid Test Kit (POC)?
Download more information here:
- FDA Emergency Use Authorization (EUA) Letter
- Instructions For Use
- Quick Reference Guide
- Fact Sheet For Healthcare Providers
- Fact Sheet For Patients
Additional Information:
The NIDS COVID-19 Antigen Rapid Test Kit (POC) is a quick and easy way to test for the presence of the COVID-19 virus. Simply collect a sample from the patient and run the test to get results in as little as 15 minutes. This POC test is perfect for use in high-risk areas or for patients who may have been exposed to the virus.
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.
Specifications
Manufacturer Item Code
N/A
