ADEXUSDx® COVID-19 Antibody Test Convenience Pack (Box of 50)

Lateral-flow Immunoassays

United States

Specimens may be infectious. Use universal precautions when performing this assay. Use routine laboratory precautions. Avoid any contact between hands, eyes, or mouth during sample collection and testing. Use appropriate personal protective equipment (laboratory coat, gloves, and eye protection) during patient sample handling. Wash hands thoroughly after handling specimens. All samples and materials used in this test procedure must be disposed in a biohazard waste container. Proper handling and disposal methods should be established according to local regulations. DO NOT USE the test if desiccant packet is missing. Discard test and use a new test. DO NOT USE the test if the pouch was not sealed. DO NOT USE the test beyond the expiration date stated on the pouch. Always check expiration date prior to performing test. DO NOT REUSE the test. Each test device is for single use only. Ensure finger is completely dry before performing fingerstick.

The ADEXUSDx® COVID-19 Test is an in vitro lateral-flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human venous whole blood (dipotassium EDTA), plasma (dipotassium EDTA), serum, and fingerstick whole blood. The ADEXUSDx® COVID-19 Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARSCoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The ADEXUSDx® COVID-19 Test should not be used to diagnose or exclude acute SARS-CoV-2 infection.

For Emergency Use Authorization only. For prescription use only. For in vitro diagnostic use only. This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.  This product has been authorized only for detecting the presence of total antibodies to 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.

Convenience Pack

This product was manufactured in NOWDiagnostics, Inc. facilities based on a quality system compliant with GMP for Medical Devices and ISO 13485.

15 Minutes

15-30 Minutes

Human venous whole blood (dipotassium EDTA), plasma (dipotassium EDTA), serum, and fingerstick whole blood