Calibrator AdviseDx SARS-CoV-2 IgM 1 X 2.0 mL For the Calibration of the Alinity i Systems when used for the Qualitative Detection of IgM Antibodies to SARS-CoV-2

Features

• The AdviseDx SARS-CoV-2 IgM Assay is for use under an FDA EUA only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
• The AdviseDx SARS-CoV-2 IgM Calibrator Kit is for the calibration of the Alinity i system when used for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tube, and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium heparin)
• At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity; AdviseDx SARSCoV-2 IgM assay should not be used to diagnose acute SARS-CoV-2 infection
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
• Negative results do not preclude acute SARSCoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
• False positive results for the AdviseDx SARS-CoV-2 IgM assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
• Due to the risk of false positive results, confirmation of positive results should be considered using a second, different IgM assay
• Contains inactivated, cell-free, human blood-derived material, reactive for anti-SARS-CoV-2 IgM
• This product has been authorized only for the presence of IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens
• This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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 authorization is terminated or revoked sooner

More Information

• AdviseDx SARS-CoV-2 IgM FDA EUA Letter
• AdviseDx SARS-CoV-2 IgM Calibrator for use with Alinity i System
• AdviseDx SARS-CoV-2 IgM Healthcare Providers Fact Sheet
• AdviseDx SARS-CoV-2 IgM Recipients Fact Sheet