CLINICAL STUDY
Comparative analyses of clinical diagnostic
I Clinical diagnostic study
The comparison of the detection by the test-kit of IgG and/or IgM antibodies against SARS-CoV-2 compared with the clinical diagnostic results is shown in the following table:
| clinical diagnosis results | Total | |||
|---|---|---|---|---|
| confirmed diagnosis | Negative | |||
| Test reagent results | Positive (+) | 186 | 8 | 194 |
| Negative (-) | 16 | 372 | 388 | |
| Total number | 202 | 380 | 582 | |
Sensitivity
(95%CI : 87.52%~95.07%)
- 92.08%
Specificity
(95%CI : 95.90%~98.93%)
- 97.89%
Total clinical coincidence rate
(95%CI : 93.94%~97.21%)
- 95.88%
II Nucleic acid tests
The comparison of the detection by the test-kit of IgG and/or IgM antibodies against SARS-CoV-2 compared with the nucleic acid test results is shown in the following table:
| Nucleic acid test results | Total | |||
|---|---|---|---|---|
| Positive (+) | Negative (-) | |||
| Test reagent results | Positive (+) | 116 | 78 | 194 |
| Negative (-) | 10 | 378 | 388 | |
| Total number | 126 | 456 | 582 | |
Positive coincidence rate
(95%CI : 86.01%~95.63%)
- 92.06%
Negative coincidence rate
(95%CI : 79.17%~86.07%)
- 82.89%
Total coincidence rate
(95%CI : 81.74%~87.56%)
- 84.88%
III Accuracy
The word “exclusion” is normally used for a patient who cannot participate in the analyses (too old, wrong sex; complications with other diseases, taking medicine etc.). What we mean in our text is that the patient is negative for SARS-CoC-2 and therefore we should use the word “negative”. The “test reagent” is the liquid in the second bottle in the test. It is correct that this reagent is important for the test; but it is the result of the analysis with the entire test kit (bound antibodies to the device etc.) that is responsible for the detection. Therefore, a much better phrase is “Test kit results”
Positive sample rate: 100% (160 of 160 samples)
Negative sample rate 98.07% (159 of 160 samples)
- Positive sample rate: 100% (160 of 160 samples) 100%
- Negative sample rate 98.7% (159 of 160 samples) 98.07%
IV Detection time
Comparison of the first positive detection point detected by the test-kit of IgG and/or IgM antibodies against SARS-CoV-2 compared with the nucleic acid test. The comparison is based on continuous sample collection from the same patients at different time points. The comparison is shown in the following table:
| Test reagent results | Number of cases | Percentage |
|---|---|---|
| Earlier than the nucleic acid test results | 3 | 15% |
| Same as the nucleic acid test results | 14 | 70% |
| Later than the nucleic acid test results | 3 | 15% |
The comparisons above show that there were no statistical significantly differences between the test-kit and the clinical diagnostic results.
Downloads
For more information please select a download
Test Kit -IgG IgM Antibody to SARS-CoV-2
April 28, 2020 | Download 
Clinical study-Antibodies against Corona Virus
April 28, 2020 | Download