For professional and in vitro diagnostic use only.

[INTENDED USE]
The COVID-19 IgG/IgM Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with Novel coronavirus.

[SUMMARY]
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory 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, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

[PRINCIPLE]
The COVID-19 IgG/IgM Rapid Test device is a qualitative membrane strip based immunoassay for the detection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing Novel coronavirus recombinant envelope antigens conjugated with Colloid gold (Novel coronavirus conjugates), 2) a nitrocellulose membrane strip containing two test lines (IgG and IgM lines) and a control line (C line). The IgM line is pre-coated with the Mouse anti- Human IgM antibody, IgG line is coated with Mouse anti-Human IgG antibody. When an adequate volume of test specimen is dispensed into the sample well of the test device, the specimen migrates by capillary action across the device. IgM anti-Novel coronavirus, if present in the specimen, will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent pre-coated on the IgM band, forming a burgundy colored IgM line, indicating a Novel coronavirus IgM positive test result. IgG anti-Novel coronavirus if present in the specimen will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent coated on the IgG line, forming a burgundy colored IgG line, indicating a Novel coronavirus IgG positive test result. Absence of any T lines (IgG and IgM) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has
occurred.

[WARNINGS AND PRECAUTIONS]
• For in vitro diagnostic use only.
• For healthcare professionals and professionals at point of care sites.
• Do not use after the expiration date.
• Please read all the information in this leaflet before performing the test.
• The test device should remain in the sealed pouch until use.
• All specimens should be considered potentially hazardous and handled in the same
manner as an infectious agent.
• Because there is a window period for the time when the body produces antibodies
after infection and the types and amounts of antibodies produced by different human
bodies at different time periods are various, it will cause individual differences in
actual test results.
• The used test device should be discarded according to federal, state and local
regulations.