Description
COVID-19 IgM/IgG
GenBody COVID-19 IgM/IgG device is a chromatographic immunoassay kit for the rapid and differential detection of immunoglobulin M (IgM) and immunoglobulin G (IgG) against COVID-19 using serum, plasma and whole blood.

- Assay procedure
Capillary blood is used to do the test, prick the finger and collect the blood by a capillary tube. And then, load the blood onto the sample well (S) of the test device.
- Reading and interpretation of results
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- Negative: ONLY one band in the control line (C). No COVID-19-specific IgM and IgG were detected. Re-test in 3-5 days if COVID-19 is suspected.
- IgM Positive: two bands appear in the test line (T) and control line (C) in the left side of device.
- IgG Positive: two bands appear in the test line (T) and control line (C) in the right side of device.
- IgG and IgM Positive: each two bands appear in the test line (T) and control line (C) in both side of device.
- Invalid result: If at 15 minutes, the red band does not appear in the control line (C), the result is considered invalid. If the test is invalid, a new test should be performed with a new patient specimen and a new test device.
- Limitations of the test
GenBody COVID-19 IgM/IgG is designed for the detection of IgM and IgG antibodies against novel coronavirus (2019-nCoV). This kit can provide a fast and simple results but, do not completely exclude the possibilities of false positive or false negative results caused by various factors. For confirmation, please make a final decision with clinical symptoms, other testing results, and doctor’s assessment, collectively.
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- GenBody COVID-19 IgM/IgG is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.
- Instructions for use will contain the following information
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- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- Not intended for the screening of donated blood.
- Cross-reactivity/analytical specificity
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- Materials
- Substance to be tested in this experiment: listed in the Table 1.
- Testing device: GenBody COVID-19 IgM/IgG (Lot No.:FJ001).
- Methods
- The listed substances or anti-sera/plasma were used as the specimens of the testings. 10 ul of each material was loaded into the kit.
- Test procedure was fully followed by the manual of GenBody COVID-19 IgM/IgG.
- Results (table 1): As shown in table 1, all of the listed substances did not affect the proper reaction of the kit (not cross-reactive).
- Materials
Table 1. Cross-reactivity of GenBody COVID-19 IgM/IgG
No. | Substance or anti-sera/plasma | Conc. or titer | Results of 3 replicates |
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1 | HCV Seroconversion panel (ZeptoMetrix Corp., USA) |
7.037 s/CO | All negatives |
2 | HIV Seroconversion panel (ZeptoMetrix Corp., USA) |
5.42 s/CO | All negatives |
3 | Dengue performance panel (Seracare Inc., USA) |
10.9 s/CO | All negatives |
4 | Zika IgG (AbBaltis Inc., UK) | Not declared | All negatives |
5 | Chikungunya IgG (AbBaltis Inc., UK) | Not declared | All negatives |
6 | Yellow fever IgG (AbBaltis Inc., UK) | Not declared | All negatives |
7 | Adenovirus IgM (AbBaltis Inc., UK) | Not declared | All negatives |
8 | Leptospira IgG (AbBaltis Inc., UK) | Not declared | All negatives |
9 | Respiratory syncytial virus IgG (AbBaltis Inc., UK) |
Not declared | All negatives |
10 | Mycoplasma pneumoniae IgGM (AbBaltis Inc., UK) |
Not declared | All negatives |
11 | Mycoplasma pneumoniae IgM (AbBaltis Inc., UK) |
Not declared | All negatives |