IgG / IgM Antibody Rapid Diagnostic COVID-19 Test
The novel coronaviruses belong to the B genus. COVID-19 is an acute repository infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, in the incubation period is 1-14 days, mostly 3 to 7 says. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny rose, sore throat, myalgia and diarrhea are found in a few cases.
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Intended use:
- The COVID-19 gig/IgM Rapid Test device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV IgG in human whole blood, serum or plasma. The test is for professional use only.
Warning:
- This test has been authorized by FDA under an EUA for use by authorized laboratories
- This test has not been FDA cleared or approved
- This test has been authorized for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
- This test 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 Act, 21 U.S.C § 360bbb-(b)(1), unless the authorization is terminated or revoked sooner
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronaviruses strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- This product is intended for professional use and not for home use
- Not for the screening of donated blood
Test procedure:
1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
For serum or plasma specimens:
Using the provided disposable pipette, draw the specimens up to the Fill Line, and transfer all the specimen (app. 5 μl) into the specified well of the test device, then add 2 drops of buffer and start the timer.
For venous whole blood specimens:
Using the provided disposable pipette, draw the specimens up to the Fill Line (avoid the specimens entering the bubble of the disposable pipette) and transfer one drop of the specimens into the specimens well of the test device, then add 2 drops of buffer and start the timer.
