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Detection Kit for COVID-19 IgM/IgG antibody (Lateral Flow Method)

An instruction manual

Product introduction
【Product Name】Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method)

【Packing】 25 tests / box

【Storage And Stability】It will keep for 18 months if stored in a cool and dry place at 2~30℃, away from sunlight, moisture, heat and frozen condition. Kit contents are stable until the expiration date printed on the outer box. After opening the package, the kit is effective to be used in 1 hour under room temperature (25℃) and humidity (<60%); Buffer solution should be re-capped in time after use.
Expected use
Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM/IgG antibodies in human whole blood, serum and plasma samples; This test is to be used as an aid in the clinical diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.

2019 Novel Coronavirus, now known as SARS-CoV-2 (previously known as 2019-nCoV), is a new β-type coronavirus, which is a single-stranded RNA virus that can cause human respiratory infections. Its genetic characteristics are significantly different from severe acute respiratory syndrome (SARS)-associated coronavirus and Middle East respiratory syndrome (MERS)-associated coronavirus. The main infection site of the SARS-CoV-2 is the lower respiratory tract, which has a higher incidence in the elderly. The incubation period of infection is variable. Common symptoms after infection with SARS-CoV-2 include respiratory symptoms, fever, cough, shortness of breath, and difficult breathing. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. The WHO has named the disease caused by SARS-CoV-2 as coronavirus disease 2019 (abbreviated “COVID-19”). SARS-CoV-2 is highly contagious and mainly transmitted through contact, droplet or airborne routes.
Detection principle
Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) is based on the principle of immunochromatography to determine the SARS-CoV-2 IgM/IgG antibodies in human whole blood, serum and plasma samples.

Detection of SARS-CoV-2 IgG antibodies: When a positive sample is detected, the SARS-CoV-2 IgG antibodies in the sample bound with colloidal gold-labeled SARS-CoV-2 antigens to form an immune complex. When the complex passes the Test Line (T), it binds to the anti-human IgG monoclonal antibody immobilized in the Test Line (T) of the device to form a new complex. This generates a colored test band that indicates a positive result. When the SARS-CoV-2 antibody level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Line (T) of the device. This indicates a negative result. To serve as a procedure control, a colored line will appear at the Control Line (C), if the test has been performed properly.

Detection of SARS-CoV-2 IgM antibodies: When a positive sample is detected, the SARS-CoV-2 IgM antibodies in the sample bound with colloidal gold-labeled anti-human IgM (μ chain) monoclonal antibody to form an immune complex. When the complex passes the Test Line (T), it binds to the SARS-CoV-2 antigen immobilized in the Test Line (T) of the device to form a new complex. This generates a colored test band that indicates a positive result. When the SARS-CoV-2 antibody level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Line (T) of the device. This indicates a negative result. To serve as a procedure control, a colored line will appear at the Control Line (C), if the test has been performed properly.
Product advantage
1. Fast, read the result in 15 minutes.

2. Convenient, flexible, no instrument needed.

3. IgM and IgG joined detection gives high sensitivity.

4. Highly specific without cross-reaction with common viruses.
Clinical symptoms
The main infection site of the SARS-CoV-2 is the lower respiratory tract. The incubation period of infection is variable. Common symptoms after infection with SARS-CoV-2 include respiratory symptoms, fever, cough, shortness of breath, and difficult breathing. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death.
Clinical symptoms
1. Early supplementary screening of 2019-nCoV infection for clinics, hospitals and CDC.

2. Screening for resumption of work in public institution and companies.

3. Screening for suspected population.

4. Screening for students back to school.