Case of INDICAID COVID-19 Rapid Antigen Test (25 Tests per Box, 450 Tests per Case)

POINT OF CARE USE ONLY - CLIA # REQUIRED BEFORE SHIPPING OR ORDER CONFIRMATION (By laboratories certified under the CLIA that meet the requirements to perform high or moderate complexity, or waived tests)

PLEASE EMAIL YOUR CLIA ID TO ORDERDESK@SNTBIOTECH.COM BEFORE ORDER CAN BE FULFILLED.

The INDICAID™ COVID-19 Rapid Antigen Test is an immunochromatographic lateral flow assay that uses highly sensitive antibodies to detect antigen from SARS-CoV-2 in direct anterior nasal swab samples from patients who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset.

What is included with this kit?

This COVID-19 rapid antigen nasal test kit is sold in boxes of 25 individual testing cassettes and includes the following:

• (25) Rapid Testing Cassettes
  • Foil pouched test device containing one test strip which
    is encased in plastic device cassette.
• (25) Extraction Vials/Caps
  • The extraction vial contains 400 μl extraction buffer
    solution.
• (25) Anterior Nasal Swabs
  • Swabs for shallow nasal specimen collection
• (1) Instruction For Use Insert

Disclosure:

• This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;

* This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and,

• The emergency use of this product 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.

Below is the link to the FDA EUA for Indicaid.

https://www.fda.gov/media/151212/download

Below is the link to the FDA IFU for Indicaid.

https://www.fda.gov/media/151215/download

Below is a link to the Factsheet for Healthcare Providers

https://www.fda.gov/media/151213/download

Below is a link to the Factsheet for Patients

https://www.fda.gov/media/151214/download

What is included with this kit?

This COVID-19 rapid antigen nasal test kit is sold in boxes of 25 individual testing cassettes and includes the following:

• (25) Rapid Testing Cassettes
  • Foil pouched test device containing one test strip which
    is encased in plastic device cassette.
• (25) Extraction Vials/Caps
  • The extraction vial contains 400 μl extraction buffer
    solution.
• (25) Anterior Nasal Swabs
  • Swabs for shallow nasal specimen collection
• (1) Instruction For Use Insert

 Accuracy Summary:

Positive Percent Agreement: 93.1%

Negative Percent Agreement: 98.2%

CPT CODE: 87426

Intended Use of Rapid COVID-19 Antigen Nasal Test Kit

• This COVID-19 Antigen test is a lateral flow immunochromatographic assay
  intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in
  anterior swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom
  onset.
• 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
• Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen
  is generally detectable in anterior nasal swab specimens during the acute phase of infection.
• Positive results indicate the presence of viral antigens, but the clinical correlation with patient
  history and other diagnostic information is necessary to determine infection status. Positive
  results do not rule out a bacterial infection or co-infection with other viruses. 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 are presumptive and confirmation with a molecular assay, if necessary, for
  patient management may be performed. 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.
• The Indicaid COVID-19 Antigen is intended for use by medical professionals or trained
  operators who are proficient in performing tests and trained clinical laboratory personnel or
  individuals trained in point of care settings. The Indicaid COVID-19 Antigen is only for use
  under the Food and Drug Administration’s Emergency Use Authorization.