When you suspect the worst, you need rapid results.
Anti-SARS-CoV-2 Rapid Test is a rapid, one-step lateral flow assay intended for the presumptive qualitative detection of IgM and IgG antibodies to the SARS-CoV-2 virus in patients suspected of a COVID-19 infection.
IgM antibodies are generated initially by the body as a result of infection at about the time symptoms appear. They will dissipate within approximately one month. IgG antibodies are generated by the body about one week after symptoms appear and last for an extended amount of time.
By using a patient’s finger prick blood, serum, or plasma specimen, the Anti-SARS-CoV-2 Rapid Test offers a turnaround time of only 15 minutes.
The implications are that a person may be able to go back to work and resume their normal lives if they know their immune status. It is very likely that many people already have been infected with the coronavirus without knowing it, due to a lack of symptoms. Putting people back to work has profound economic implications.
People who have recovered would have a negative PCR test because they’ve already cleared the virus and would have a positive IgG antibody test showing that they have long-term immunity to the novel coronavirus.
This simple-to-use test requires no equipment or special expertise or training to implement.
• Rapid Results – 15 minutes for a readout
• No special equipment or facilities needed
• Clear, easy-to-interpret results
• Built-in controls
• Room temperature storage
• High sensitivity – 97.4%
• High specificity – 96.2%
This is not a point of care (POC) test.
For Use with Blood:
For Use with Serum:
Anti-SARS-CoV-2 Rapid Test is an immunoassay intended for the presumptive qualitative detection of IgM and IgG antibodies to the SARS-CoV-2 virus in plasma from anticoagulated human blood (Heparin / EDTA / sodium citrate), serum, or capillary finger prick blood (no anticoagulants or additives) from individuals with signs and symptoms of infection who are suspected of COVID-19 infection. Testing is limited to certified laboratories able to perform highly complex tests in the laboratory.
The Anti-SARS-CoV-2 Rapid Test is intended for use by clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.
This test should not be used as the sole basis for patient management decisions. Test results must be combined with clinical observations, patient history, and epidemiological information.
Follow-up testing with a molecular diagnostic test should be considered to confirm the infection status. This test is not intended for the screening of donated blood.
This test will be useful in identifying asymptomatic and mildly symptomatic carriers of the SARS-CoV-2 virus. It will also be helpful in identifying persons who were infected by the virus previously, but may not have been properly diagnosed.
Hardy Diagnostics has permission to sell this test under the FDA’s Emergency Use Authorization (EUA) program. Please note the following information:
This test has not been reviewed by FDA
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in recent contact with the virus, due to the lag time between exposure and the patient’s antibody response. Follow-up testing with a molecular diagnostic test should be considered in order to rule out infection in these individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform of infection status.
Positive results may be due to past or present infections with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43 or 229E.
This test is for use by licensed laboratories and does not apply to at-home testing.
Not to be used for blood donor screening