待议
COVID-19 IgM Antibody Test Kit
Colloidal gold method

Overview
ü COVID-19 IgM Antibody Rapid Test Kit is an immunochromatographic assay for rapid, qualitative detection of COVID-19 IgM Antibody in human serum and plasma samples. The test is to be used as an aid in the diagnosis of COVID-19, which is caused by 2019-nCoV.
ü IgM antibodies are produced by the human body early in a viral infection. IgM antibody levels in COVID-19 patients usually become detectable 3-5 days after the onset of symptoms and resolve within 1 to 2 weeks after recovery. Therefore, IgM antibody elevation can be used as a diagnostic reference in the early stage of 2019-nCoV infection.
Advantages
ü Research and development under the guidance of academician Zhong Nanshan
ü The result can be read by eyes in 15 minutes
ü Various specifications with 1 test, 20 tests and 50 tests
ü High sensitivity and specificity
Sensitivity | Specificity | Total consistent |
91.29%(283/310) (95%CI: 87.58%~94.18%) | 98.34% (237/241) (95%CI: 95.81%-99.55%) | 94.37% (520/551) 92.11%-96.15% |
Storage condition
Stored at 2℃~30℃ for 6 months
Detection process


Interpretation of 2019-nCoV nucleic acid and antibody test results
No | Nucleic Acid | IgM | IgG | Clinical significance |
1 | + | + | + | The patients have been shown to have a certain immune function for the 2019-nCoV (persistent antibody IgG has been produced). |
2 |
+ |
+ |
- | Patients may be infected in early period, the immune response first produced antibody IgM, and the IgG or IgG did not reach to the lower limit of diagnostic reagent. |
3 | + | - | + | Patients may be infected in the middle or late stage or recurrent infection. |
4 | + | - | - | 2019-nCoV infection may be at the window stage. |
5 |
- |
+ |
+ | The 2019-nCoV was recently infected and recovered. The virus was cleared in vivo. IgM has not been reduced to the lower limit of detection. |
6 |
- |
+ |
- | IgM positive result indicates that 2019-nCoVinfection is most likely to be infected at acute stage. It is necessary to consider the result of nucleic acid detection. It needs repeated sampling and reexamination. IgM false positive caused by positive rheumatoid factor and other factors needs to be rechecked and observed after 1 weeks. |
7 |
- |
+/- |
- | It suggested that the 2019-nCoV with very low viral load was initially infected in the initial infection period. The viral load was lower than the detection limit of nucleic acid. The body produced a small amount of IgM, and had not yet produced IgG. Or the IgM false-positive caused by the positive rheumatoid factor of patients, etc., which need to be rechecked and observed after 1 weeks. The diagnosis was based on the changes of IgM and IgG. |
8 |
- |
- |
+ | It suggested that the 2019-nCoV could be infected previously, but the virus was recovered or the body was cleared. The IgG produced by the immune response remained long and was detected in the blood. |
9 | - | - | - | Healthy people or infection incubation period. |

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