INTENDED USE
Rapid 2019-nCoV IgG/IgM Combo Test Card is an immunochromatography based one step in vitro test. It
is designed for the rapid qualitative determination of IgG and IgM antibodies to 2019 novel coronavirus
(2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. Rapid 2019-nCoV IgG/IgM Combo
Test Card is a supplement detection for COVID-19 suspected infected patients besides nucleic acid test,
which could greatly raise the accuracy of the detection for COVID-19.
SUMMARY
Corona Virus Disease 2019 (COVID-19) is an acute infectious disease caused by 2019 novel coronavirus
(SARS-CoV-2). 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.
PRINCIPLE
Rapid 2019-nCoV IgG/IgM Combo Test Card utilizes the principle of immuno-chromatography. Mouse antihuman 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.
MATERIALS PROVIDED
1. Rapid 2019-nCoV IgG/IgM Combo Test Card
2. Sample buffer
3. 2 μL capillary pipet
4. Instructions for Use
The one- step Troponin I test is a fast in vitro immunochrographic test. It is designed for qualitative determination of cardiac trophonin I (cTnI) in human serum or plasma specimens as an aid in the diagnosis of myocardial infarction.
Principle: sample mobilizes gold anti-cTnI conjugate that is coated on the conjated pad. The mixture moves along the membrane by capillary action and reacts with anti-cTnI antibody that is coated on the test region.
Packing is 1 test/pouch. 25 pouches/box
Sensitivity: 1.0ng/ml
Innovation Biotech (Beijing) Co., Ltd.
Add: Room 818 block AS, No.165 Fushi road, shijingshan Dist, BeiJing, China
Tel: 0086-010-68867437
Website: www.invbio.com
Whatsapp/skype:8619150944219
