Rapid Test Kit RightSign™ Antibody Test COVID-19 IgG / IgM Whole Blood / Serum / Plasma Sample 20 Tests CLIA Waived for Fingerstick Whole Blood

Features

• Testing of serum
• plasma and venous whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
• 42 U.S.C. 263a
• that meet requirements to perform moderate or high complexity tests Testing of fingerstick whole blood specimens 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 high
• moderate or waived complexity tests Product ships from McKesson with minimum 30 days dating Testing of fingerstick whole blood specimens 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 RightSign™ COVID-19 IgG/IgM Rapid Test Cassette should not be used to diagnose acute SARS-CoV-2 infection Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities False positive results 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 second
• different IgG or IgM assay RightSign™ COVID-19 IgG/IgM Rapid Test Cassette is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in in human venous whole blood (sodium heparin
• EDTA
• and sodium citrate)
• serum or plasma (sodium heparin
• potassium EDTA and sodium citrate) This test uses anti-human IgM antibody (test line IgM)
• anti-human IgG (test line IgG) and goat anti-mouse IgG (control line C) immobilized on a nitrocellulose strip This test 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 Act
• 21 U.S.C. § 360bbb3(b)(1)
• unless the authorization is terminated or revoked sooner RightSign™ COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2
• indicating recent or prior infection