LIMITATIONS OF THE TEST
1. This reagent is a qualitative test and cannot be used for quantitative determination of antibody content.
2. This reagent is used for the detection of human whole blood, serum or plasma samples. It cannot be used for the detection of saliva, urine or other body fluids.
3. The test results of this product are for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms / signs, medical history, other laboratory tests, treatment response, and epidemiology.
4. In the early stage of infection, if the virus-specific IgM antibody is not produced or the titer is very low, it will lead to negative results. If a virus infection is suspected, the patient should be reminded to check again within 10-20 days and take a second sample, which should be the same as the first sample. Simultaneously test under conditions to determine if there is a seroconversion or a virus-specific IgG or IgM antibody titer that is significantly
higher in the first infection.
5. The interpretation of positive results should be further determined in conjunction with clinical symptoms and other etiological methods (nucleic acid and sequencing).
6. Negative results indicate that no new coronavirus IgM / IgG antibodies have been detected, but if the new coronavirus IgM / IgG antibody content in the sample is below the minimum detection limit of the kit, negative results may also be obtained.
PRODUCT PERFORMANCE
Appearance: The appearance of the reagent should be neat and tidy, and the text symbol should be clearly marked. There is no leakage. The test strip is intact.The positive rate, precision, and minimum detection limit of this product meet therequirements of quality standards, and the product quality is stable during the validity period. Hepatitis B virus surface antigen antibody, Hepatitis C virus antibody, Hepatitis E virus IgM antibody, Hepatitis A virus IgM antibody, Syphilis antibody, HIV antibody, Rheumatoid factor, Antinuclear antibody, Coxsackie virus A16 IgM antibodies, adenovirus IgM antibodies, respiratory syncytial virus IgM antibodies, influenza A virus antibodies, EV71 virus IgM antibodies, Mycoplasma pneumoniae IgM antibodies, anti-mitochondrial antibody (AMA) positive samples, and high-concentration
non-specific IgG (serum total IgG) will not cause interference with this product.
NOTES
This product is for in vitro diagnostic use only.
The operation steps cannot be omitted or simplified.
The positive samples detected by this kit need to be confirmed by other methods.
Disinfect or treat all samples and reagents as potential sources of contamination in accordance with local regulations.
INDEX OF SYMBOLS
