ISO Certificated Antibody Self Test Kit SARS-COV-2 Test Kit

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.

[SPECIMEN]

• The test can be used to test Whole Blood/Serum/Plasma specimens.

• To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures.

• Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.

• Store specimens at 2-8℃ (36-46℉) if not tested immediately. Store specimens at 2-8℃ (36-46℉) up to 7 days. The specimens should be frozen at- 20℃ (-4℉) for longer storage. Do not freeze whole blood specimens.

• Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.

• Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.