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 (+) | 159 | 2 | 161 |
Negative (-) | 1 | 157 | 158 | |
Total number | 160 | 159 | 319 |
Sensitivity
(95%CI : 96.55%~99.89%)
- 99.38%
Specificity
(95%CI : 95.53%~99.65%)
- 98.74%
Total clinical coincidence rate
(95%CI : 97.27%~99.68%)
- 99.06%
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 (+) | 158 | 2 | 160 |
Negative (-) | 2 | 157 | 159 | |
Total number | 160 | 159 | 319 |
Positive coincidence rate
(95%CI : 95.56%~99.66%)
- 98.75%
Negative coincidence rate
(95%CI : 95.53%~99.65%)
- 98.74%
Total coincidence rate
(95%CI : 96.82%~99.51%)
- 98.75%
III Accuracy
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.