Covid-19 Rapid Testing Terms and Conditions
About this Test
This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certiﬁed under the CLIA that meet the requirements to perform moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certiﬁcate of Waiver, Certiﬁcate of Compliance, or Certiﬁcate of Accreditation.
This is not a medical health examination or test. It is Covid-19 screening to help mitigate the spread of Covid-19 at the workplace. If the result is negative it does not necessarily mean that you are not infected
The test performance has been validated by Drug Test Compliance according to waived testing under Clinical Laboratory Improvement Amendments (CLIA). The sensitivity of the assay is dependent on the quality of the specimen collected for testing.
What Your Results Mean
Results are for the identiﬁcation of the SARS-CoV-2 nucleocapsid protein antigen. The antigen is generally detectable in nasopharyngeal or anterior nasal swab specimens during the acute phase of infection.
Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the deﬁnite cause of disease. . If it is positive it is highly recommended that you get tested at NY Department of Health or CDC recommended testing facility
Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection, and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and conﬁrmed with a molecular assay, if necessary, for patient management.
For more COVID-19 Resources, please visit http://cdc.gov/coronavirus/2019-ncov/.