NIDS COVID-19 Antigen Rapid Test Kit (POC)

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Covid Tests

PN-0002

Learn About 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)?

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Shipping, Payment, & Returns

Shipping

Bttn provides free shipping on all of our products. Due to high demand, orders for covid tests will not ship until the first week of January

Payment Options

Payments are accepted via card, check, or PO.

If you are paying by check, please promptly send all checks to 146 N Canal St Suite 300, Seattle, WA 98103.

If paying by PO follow the steps below:
1) Ensure that your Purchase Order correctly reflects the order placed on bttnusa.com
2) Download your organization's PO to your computer
3) Open your email application
4) Create a new email with the subject line "Bttn (Order #)" PO
5) Add accounting@bttnusa.com as the recipient
6) Attach your organization's PO
7) Press Send

Return Policy

30-day return policy.

You can request a return up to 30 days after receiving your item. To be eligible for a return, your item must be in the same condition that you received it, unworn or unused, with tags, and in its original packaging. You’ll also need the receipt or proof of purchase.

To start a return, you can contact us. If your return is accepted, we’ll send you a return shipping label, as well as instructions on how and where to send your package. Items sent back to us without first requesting a return will not be accepted.

Contact us for any return questions at support@bttnusa.com