Description: INTENDED USE
This product is intended for the detection of 2019-Novel Coronavirus(2019-nCoV). It is suitable for qualitative detection of IgG/IgM antibodies in human serum, plasma, and whole blood. 2019-Novel Coronavirus belongs to the new coronavirus of the genus β, which has an envelope, the particles are round or oval, often polymorphic, and the diameter is 60-140nm. Its genetic characteristics are significantly different from SARSr-CoV and MERSr-CoV. Current research shows that it has more than 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45). After infection with 2019-nCoV, the common symptoms are fever, fatigue, dry cough, dyspneaetc. Some severe patients appear the symptoms including acute respiratory distress syndrome, septic shock, metabolic acidosis that is difficult to correct, and coagulation disorders. Some patients have mild symptoms and no fever. Most of patients have a good prognosis, while a few are in critical condition or even die. Both IgM and IgG are immunoglobulin which are produced by
the immune system to provide protection against the 2019-nCoV.The level of IgM antibody begins to rise within 1 week and achieves the peak at 2-3 weeks after the initial infection. While the IgG appears later than IgM (usually in 14 days after infection) and achieves the peak at 5 weeks,lasting for 6 months or even several years. When the antibody titer of patients in the convalescence period is 4 times (or more than 4 times) higher or lower than that in the acute period, which has clinical diagnostic significance for virus infection.
PRINCIPLE OF DETECTION
This product is based on capture and solid-phase immunochromatography methods for determination. The specimen (whole blood/serum/plasma) flows from the blood separator through to the conjugate release pad (which occurs the conjugation reaction between IgM/IgG antibody in the specimen and the anti gencolloidal gold of 2019-nCoV to form an immunecomplex of IgM /IgG antibody and colloidal gold-labeled antigen) due to capillary action. Then migrate to a capture zone of nitrocellulose membrane-immobilized antibody (mouse-anti-human IgM antibody, T1 line) to form an immunecomplex of colloidal gold-labeled antigen,IgM antibody and mouse-anti-human IgM antibody, thereby generating a T1 red line. The unreacted immunecomplex continues to flow upward, will be captured by the mouse-anti-human IgG antibodies (T2 line) to form an immunecomplex of colloidal gold-labeled antigen, IgG antibody and mouse-anti-human IgG antibody, thereby generating a T2 red line. The remaining uncaptured immunecomplex moves upward, combining
with C line (quality control line) to indicate the completion of this reaction.
LIMITATIONS OF TEST METHODS
1. The test results of this product are only for clinical reference and should not be used as the only basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms/signs, medical history, treatment reactions and epidemiology and other laboratory tests. It is recommended to repeat the test for suspicious samples at intervals.
2. The accuracy of detection is affected by the sample collection process. Improper sample collection and storage process will affect the test results and should avoid high temperature and direct sunlight.
3. This production provides a qualitative test for the novel coronavirus IgM antibody and IgG antibody in the sample, but not quantified detection.
4. Due to the limitation of the testing methodologies, it cannot ruled out the possibility of the novel coronavirus infection based on negative results. It is recommended to combine other test results and clinical symptom to make an accurate diagnosis.
PRODUCT PERFORMANCE INDICATOR
1. Sensitivity: Test with the enterprise’s sensitivity reference product.
2. Conformity rate of Negative Control: Test with the enterprise’s negative reference product and the test results are all negative for the 2019-nCoVIgG/IgM antibody, with a conformity rate of 100%.
3. Conformity rate of Positive Control: Test with the enterprise’s positive reference product and the test results show that the PC01-PC05 and PC11-PC15 of 2019-nCoVIgG antibodies are positive, with a conformity rate of 100%; the PC06-PC15 of 2019-nCoV IgM antibody are positive, with a conformity rate of 100%.