Lumit™ Dx SARS-CoV-2 Immunoassay

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The Lumit™ Dx SARS-CoV-2 Immunoassay is a qualitative in vitro diagnostic test intended for the detection of antibodies to SARS-CoV-2 in serum or plasma, utilizing a novel, proprietary detection system.

The Lumit™ Dx SARS-CoV-2 Immunoassay is indicated in conjunction with clinical presentation and the results of other laboratory tests as an aid in identification of patients with recent or prior SARS-CoV-2 infection. Results from the test should not be used as the sole basis for diagnosis or to exclude SARS-CoV-2 infection. See clinical sensitivity data for days post symptom onset of positive results observed. Positive results will occur only after infection and are indicative of recent or prior infection. False positive results can occur due to cross-reactivity from pre-existing antibodies or other possible causes.

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests.

For prescription use only. For in vitro diagnostic use only.

Reports to healthcare providers should include the following information: Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. This test should not be used for screening of donated blood.

This test has not been reviewed by the FDA.