SARS-CoV-2 IgM/IgG Test Kit
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 kit 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 M line and indicating an IgM positive result. Similarly as the IgM antibody, If the specimen contains IgG antibody, G line will appear red color and indicate an IgG positive result. If neither antibody is present, a negative result is displayed.
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
20 test cards
40 test cards
Note: ：The components in different batches cannot be used interchangeably.
1. The kit should be stored at 2℃~30℃,sealed,avoid direct sunlight and the validity period is 18
2. The test card should be used within 1 hour after taking out from the foil pouch.
3. Specimen diluent should be used within 14 days after opened and stored at 2℃~30℃.
【Requirements of Specimen】
1. It is suit to test the type of specimen human serum, plasma, and whole blood.
2. The specimen of whole blood can be prepared by anticoagulants as follow: EDTA, heparin, sodium citrate.
3. The serum and plasma can be stored at 2℃~8℃for 7 days, -20℃±5℃ for 1 year, and Freeze-thaw less than 3 times if store in -20℃±5℃。
4. The anticoagulated whole blood should be store it in 2℃~8℃ for less than 2 days.
5. The specimen should be slowly returned to room temperature and mixed before testing if it store in low temperature.
Please read the protocols carefully before testing.Do not open sealed foil pouch before using.
1.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.
2. 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
3.Take10μL 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.
4.Wait for 10 minutes, and read the results by viewing the detection window. Please read results in 15min.
5. All wastes should be treated as potential infectious materials.
1. Negative Result
If only the quality control line (C) is red, but the detection lines of G and M are not visible, then no SARS-CoV-2 antibody has been detected and the result is negative.
2. Positive Result, M only
If both the quality control line (C) and the detection line of M are red, then SARS-CoV-2 IgM antibody has been detected and the result is positive for the IgM antibody.
3. Positive Result, G only
If both the quality control line (C) and the detection line of G are red, then SARS-CoV-2 IgG antibody has been detected and the result is positive for the IgG antibody.
4. Positive Result, G and M
If the quality control line (C) and the two detection lines of G and M are red, then SARS-CoV-2 IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.
5. Invalid results:
If the control line is not red, the test is invalid. The operation may not have been followed correctly or the kit may have deteriorated. It is recommended that the specimen be re-tested.
【Quality Control and Validity of Results】
The whole workflow and the quality of kit is control by quality control line (C).
1. If the quality control line (C) is red in test, it illustrate that the whole workflow and the quality of kit are qualified.
2. If the quality control line (C) is not red in test, no matter what the detection line display, it illustrate that the operation may not have been followed correctly or the kit may has deteriorated. It is recommended that the specimen be re-tested.
1. The kit is designed to test the specimens of whole blood, plasma, serum, not suit for other type of specimens.
2. The kit is a qualitative assay. It is not designed to determine the quantitative concentration of SARS-CoV-2 antibody.
3. The test result is only for clinical reference, a confirmed diagnosis should only be made after all clinical and laboratory findings have been evaluated.
4. Negative results may be caused by low concentrations of SARS-CoV-2 IgG/IgM antibody in the specimen, and should not be the sole basis of a patient management decision.
【Warnings and Precautions】
1. The kit should only be used by qualified and trained staff.
2. Improper collection, transport, storage or freeze-thaw repeatedly of specimen may lead to wrong result.
3. Operation condition, such as temperature and humidity, or incorrect storage of kits may lead to a
wrong result. Do not immerse test card in water.
4. Do not use test card, specimen diluent beyond the indicated expiration date.
5. Specimens should always be treated as if infectious and/or biohazards in accordance with safe laboratory procedures, and appropriate protection should be taken for tester during operation. Dispose of all used or damaged test cards, residual specimens, or other kit component as biohazards materials.
6. The kit is only used for in vitro diagnosis.
1. 59 confirmed case specimens were tested by SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold),55 were positive and the sensitivity was 93.22%(95% CI:82.73%~97.81% ). 147 negative specimens were detected by SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold), 145 were negative and the specificity was 98.64%(95% CI: 94.67%~99.76%).
2. Specimens which tested positive with parainfluenza virus antibody,influenza A antibody,influenza B antibody,hepatitis B surface antigen,hepatitis C virus antibody,treponema pallidum antibody,HIV antibody,EB virus antibody from patients were investigated with by SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold), the results showed no cross reactivity.
3. The specimens with hemoglobin, triglyceride and bilirubin will interfere the test results, and the maximum allowable concentrations are 5mg/ml, 10mg/ml and 0.2mg/ml respectively.
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