Description
The PharmaCare SARS-CoV-2 IgM/IgG Test Kit is intended for the qualitative detection of SARS-CoV-2 IgM and IgG antibodies in human serum, plasma and whole blood specimens, as an auxiliary diagnosis of COVID-19.
The outbreak of the novel corona virus disease (COVID-19) has created an urgent need for an accurate and rapid test method to quickly identify large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. PharmaCare provides rapid and simple point-of-careand at-home lateral flow immunoassays which can detect IgM and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes and can detect patients at different infection stages.
Based on the principle of colloidal gold immunochromatography to detect the SARS-CoV-2 IgM/IgG antibodies in human serum, plasma and whole blood specimens. When the specimen is added to the specimen well, the specimen is absorbed into the device by capillary action, if the specimen contains SARS-CoV-2 IgM antibody, the antibody will bind to the colloidal gold-labeled SARS-CoV-2 antigen. The antibody/antigen complex will be captured by the anti-human IgM antibody immobilized on the nitrocellulose membrane, forming a red IgM line and indicating an IgM positive result. Similarly as the IgM antibody, if the specimen contains IgG antibody, the IgG line will show a red color and indicate an IgG positive result. If neither antibody is present, a negative result is displayed.
Directions
Components
Test Card :
- Mouse anti-human IgM antibody, mouse anti-human IgG antibody and rabbit IgG antibody fixed on the nitrocellulose membrane
- Colloidal gold-labeled SARS-COV-2 recombinant antigen and goat anti-rabbit IgG antibody fixed on glass fiber conjugate pad
- Absorbent paper
- PVC board
- Plastic clip
- Desiccant
Specimen Diluent (0.9%NaCl solution)
Note: The components in different batches cannot be used interchangeably.
Storage Conditions
- The kit should be stored at 2ºC-30ºC, sealed. Avoid direct sunlight and the validity period is 18 months.
- The test card should be used within 1 hour after taking out from the foil pouch.
- Specimen diluent should be used within 14 days after opened and stored at 2ºC-30ºC.
Requirements of Specimen
- It is best to test the type of specimen human serum, plasma, and whole blood.
- The specimen of whole blood can be prepared by anticoagulants as follow: EDTA, heparin, sodium citrate.
- The serum and plasma can be stored at 2ºC~8ºCfor 7 days, -20ºC±5ºC for 1 year, and Freeze-thaw less than 3 times if store in -20ºC±5ºC.
- The anticoagulated whole blood should be store it in 2ºC~8ºC for less than 2 days.
- The specimen should be slowly returned to room temperature and mixed before testing if it store in low temperature.
Test Procedure
Please read the protocols carefully before testing. Do not open sealed foil pouch before using.
- The kit does not need to be installed. Before use, check the Test Card to insure the foil pouch is undamaged and the Specimen Diluent is no leakage.
- Bring the Test Card and the Specimen Diluent to room temperature before testing,The Test Card should be used in 1 hour after remove from foil pouch
- Take 10μL of serum or plasma or whole blood specimen to the specimen well of Test Card and then add 2 drops (80 μL) of Specimen Diluent to the specimen well, avoid air bubbles.
- Wait for 10 minutes, and read the results by viewing the detection window. Please read results in 15min.
- All wastes should be treated as potential infectious materials.
