Please refer to "Patient Fact Sheet" Below:
Below is a link to Instruction for Use "IFU" and Quick Reference Guide.
Please refer to "FDA Emergency Use Authorization(EUA)" Below:
Please refer to FDA Shelf Life Extension Below:
Warnings and Precautions:
- For in vitro diagnostic use only.
- For prescription use only.
- This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, 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.
- Federal Law restricts this device to sale by or on the order of a licensed practitioner (US only).
- This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens.
- 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.
- Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories.
- Do not use kit past its expiration date.
- Do not store or test specimens in viral transport media, as it may result in false positive or false negative results.
- It is recommended that personal protection equipment and gloves (not provided) be worn when running each test and handling patient specimens.
- The Extraction Solution in this kit contains a detergent and a preservative that will inactivate cells and virus particles. Samples eluted in this solution are not suitable for culture.
- Test Devices are single use only and should be discarded after use. Do not re-use the Test Device.
- Proper sample collection, storage and transport are essential for correct results. Specimens should be prepared in accordance with the instructions provided in the "Specimen Collection and Storage" section.
- Excess blood or mucus on the swab specimen may interfere with test performance, potentially yielding an inaccurate result. Avoid touching any bleeding areas of the nasopharynx when collecting specimens.
- Users should test specimens as quickly as possible after specimen collection.
- Specimens may be infectious. Use Universal Precautions when performing this assay.
- Use routine laboratory precautions. Do not eat, drink, or smoke in the area where samples are being handled and testing is being conducted. Avoid any contact between hands, eyes or mouth during sample collection and testing.
- Wear personal protective equipment (PPE) in accordance with laboratory and institutional policies, such as laboratory coats, disposable gloves, and eye protection when handling patient samples.
- Wash hands thoroughly after handling specimens and used cartridge.
- Dispose of used test device in a biohazard waste container. Proper handling and disposal methods should be established according to local regulations.
- Avoid splashing or aerosolization of samples or reagents as droplets are a means of transmission of SARS-CoV-2 virus. All drops and spills must be wiped up with an appropriate disinfectant such as a sodium hypochlorite solution with 0.5% active chlorine, and all soiled materials must be disposed of as infectious waste.
- ※ This test has not been FDA cleared or approved. This webpage is intended for U.S. audiences only. This webpage may contain information on products that are targeted to U.S. audiences, and could contain product details or information not approved in countries or regions outside U.S