The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV The test provides preliminary test results. Negative results don’t preclude 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision. Negative results don’t preclude COVID-19 infection. Positive results may arise due to past or present infection with non-SARS-CoV-2 coronavirus strains (such as coronavirus HKU1, NL63, OC43, or 229E.). For in vitro diagnostic use only. This item should be administered by a healthcare professional.
Corona Virus Disease 2019 (2019-nCoV) is an acute infectious disease caused by 2019 novel coronavirus (2019-nCoV). The incubation period of the disease is infectious and ranges from 1-14 days (mostly 3-7 days). Asymptomatic infections may also be the source of infection. Respiratory droplets and contact are the main routes of transmission. The initial symptoms of the patients include fever, fatigue and coughing, which gradually develops into dyspnea and other serious manifestations. Most of the patients have a good prognosis. Some of the severe cases may have acute respiratory distress syndrome or septic shock, or even death. At present, there is no specific treatment for the disease. There are several days of incubation period after infection with 2019-nCoV. IgM antibodies can be detected soon after the incubation period and remain for a short time. IgM positive in blood samples can be an indicator of acute infection. IgG antibodies appear after a few days of incubation period and remain for a long time. IgG positive in blood samples can be an indicator of present or previous infection.
This Test Card utilizes the principle of immuno-chromatography. Mouse anti- human IgM and human IgG antibodies are immobilized on the nitrocellulose membrane respectively, as two individual test lines (IgM line and IgG line) in the test window of the test device. The IgM line in the test window is closer to the sample well followed by IgG line. As the test sample flows through the membrane within the test device, the colored 2019-nCoV recombinant antigen-colloidal gold conjugate forms complexes with specific antibodies (IgM and/or IgG) to 2019 novel coronavirus, if present in the sample. This complex moves further on the membrane to the test region where it is captured by the anti-human IgM and/or human IgG antibodies coated on the membrane leading to formation of a colored band, which indicates positive test results. Absence of this colored band in the test window indicates a negative test result. A built-in control line will always appear in the test window when the test is performed properly, regardless of the presence or absence of anti-2019 novel coronavirus antibodies in the specimen.