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 confirmed using a second, different IgG/IgM detection method. Laboratories are required to report all results to the appropriate public health authorities. The test is for use by trained laboratory or healthcare professionals. This assay is not intended for home testing (or self-testing). The Rapid Response™ COVID-19 IgG/IgM Rapid Test Device may detect a response to vaccination.