Features / Benefits:

• Rapid Results in 10 mins
• CLIA Waived
  
• Sensitivity: 95.8%
• Specificity: 99.2%
• Individual buffer vials

Packaging:

1 box : 25kits

1 case: 25 boxes

1 case : 625 kits

Please click the link below to view the intended use and instructions for use.

https://www.fda.gov/media/149056/download

Please click the below link to view the IFU and Spec Sheet.

https://www.fda.gov/media/149055/download

Please click the link below to view the Factsheet for Healthcare Providers

https://www.fda.gov/media/149054/download

Below is a link to Sienna-Clarity COVID-19 Antigen Rapid Test Cassette - Patient Fact Sheet

https://www.fda.gov/media/149057/download

Disclosure:

In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories; use by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests.

This product 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.

This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and in the USA, 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 the virus that causes COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless declaration is terminated or the authorization is revoked sooner.

Accuracy Summary:

Positive Percent Agreement: 87.5%

Negative Percent Agreement: 98.90%

CPT CODE: 87426

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
• (25) Nasopharyngeal Swabs
  • Swabs for nasopharyngeal specimen collection
  • Can be used for shallow nasal collection as well
• (1) Instruction For Use Insert
• (1) Positive Control Swab
• (1) Negative Control Swab

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
  nasopharyngeal swab specimens directly collected, or collected in BD universal transport media,
  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 nasopharyngeal 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 Sienna 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 Sienna COVID-19 Antigen is only for use
  under the Food and Drug Administration’s Emergency Use Authorization.

Instructions for Collection and Use

Nasopharyngeal Swab Sample Collection Procedure

Procedural Notes
• Process the test sample immediately after collection.
• Use only provided or recommended nasopharyngeal swab for specimen collection.
• Collect the specimen wearing safety gloves to avoid contamination.
• Do not touch the tip (specimen collection area) of the swab.
• Collect samples as soon as possible after the onset of symptoms.

 Additional Notes

• Allow test devices, reagents, specimens, and/or controls to equilibrate to room
  temperature (15~30°C) prior to testing.
•  Remove the Sienna™ COVID-19 Antigen test device and extraction vial from its foil
  pouch immediately before testing.
•  The Sienna™ COVID-19 Antigen kit IS INTENDED to be used only with a direct
  nasopharyngeal swab specimen or a swab in BD universal transport media.
•  The Sienna™ COVID-19 Antigen kit IS NOT INTENDED for testing other liquid
  samples such as nasal wash or aspirate samples as results can be compromised by over
  dilution.