SARS-CoV-2 IgM/IgG Antibody Assay Kit Rapid Test Kit CE

Intended use
For in vitro diagnostic use in the qualitative determination of IgM and IgG antibodies to SARS-CoV-2 virus in human serum and plasma specimens. It is intended for use only in individuals with clinical signs and symptoms consistent with SARS-CoV-2 infection as a supplementary detection indicator in conjunction with nucleic acid detection. It cannot be used as the sole basis for the confirmation or exclusion of novel coronavirus-infected pneumonia. And it is for medical institutions use only.

Assay procedure
Please read this manual carefully before use. Please follow the procedures below.
- Tear off the seal of aluminum foil bag and carefully take out the test card.
- Take 10μL of sample into the diluent-containing test tube and blend well for 5s~10s.
- Add 2~3 drops of blended sample vertically and slowly to the sample well of the test card, and leave it at ambient temperature.

- Observe the result within 10~15 minutes, and the interpretive result is invalid after 15 minutes


Result Interpretation
- Positive (+):
Both the quality control line (line C) and the detection line (line G) developed color, indicating that a novel coronavirus IgG antibody was detected in the sample.
Both the quality control line (line C) and the detection line (line M) developed color, indicating that a novel coronavirus IgM antibody was detected in the sample.
The quality control line (line C), detection lines (line G) and (line M) all developed color, indicating that both the novel coronavirus IgG antibody and the novel coronavirus IgM antibody were detected in the sample.
- Negative (-): Only the quality control line (line C) developed color.
- Invalid: The quality control line (line C) did not develop color, indicating that the test strip has failed due to deterioration or incorrect operation. Retest is recommended.

Performancecharacteristics

1. Limit of detection (LOD)
Detection of 3 SARS-CoV-2-IgG enterprise LOD reference products, L1 is positive, L2 can be positive or negative, and L3 is negative.
Detection of 3 SARS-CoV-2-IgM enterprise LOD reference products, L1 is positive, L2 can be positive or negative, and L3 is negative.

2. Positive coincidence rate
Detection of 5 SARS-CoV-2-IgM/IgG enterprise positive reference products, IgG antibodies in P1, P2, and P3 are positive, IgM antibodies in P4 and P5 are positive, and the positive coincidence rate≥5/5.

3. Negative coincidence rate
Detection of 20 SARS-CoV-2-IgM/IgG enterprise negative reference products, the coincidence rate of IgG antibody≥20/20, and the coincidence rate of IgM antibody negative reference products≥18/20.

4. Repeatability
Detection of 1 SARS-CoV-2-IgM/IgG enterprise repeatability reference product in parallel for 10 times. The IgM antibody/IgG antibody is positive and consistent in color development.

5. Cross-reactivity
This product has no cross-reaction with endemic human coronavirus (HKU1, 0C43, NL63 and 229E), H1N1, H3N2, H5N1, H7N9, influenza B, respiratory syncytial virus, rhinovirus, adenovirus, enterovirus, EB virus, measles virus, Anti-human cytomegalovirus, rotavirus, norovirus, mumps virus, and varicella-zoster virus antibodies.

Sensitivity: 89.4%
Specificity: 98.5%
Sample Source:
Chengdu Public Health Clinical Medical Center (52 samples)
Sichuan Provincial People’s Hospital (787 samples)