CLINICAL STUDY
Comparative analysis of clinical diagnosis results with Test-kit results:
Sensitivity: 92.08%; (95%CI : 87.52%~95.07%)
Specificity: 97.89%; (95%CI : 95.90%~98.93%)
Total clinical coincidence rate: 95.88%. (95%CI : 93.94%~97.21%)
- Sensitivity 92.08%
- Specificity 97.89%
- Total clinical coincidence rate 95.88%
Comparative analysis of Test-kit results:
Positive coincidence rate: 92.06%; (95%CI : 86.01%~95.63%)
Negative coincidence rate: 82.89%; (95%CI : 79.17%~86.07%)
Total coincidence rate: 84.88%. (95%CI : 81.74%~87.56%)
- Positive coincidence rate 92.06%
- Negative coincidence rate 82.89%
- Total coincidence rate 84.88%
Accuracy rate (test performed on patients at Jinyintan Hospital, China)
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%
Comparative analysis of clinical diagnostic results with results from the test-kit
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:
Sensitivity: 92.08%; (95%CI : 87.52%~95.07%)
Specificity: 97.89%; (95%CI : 95.90%~98.93%)
Total clinical coincidence rate: 95.88%. (95%CI : 93.94%~97.21%)
| clinical diagnosis results | Total | |||
|---|---|---|---|---|
| confirmed diagnosis | exclusion | |||
| Test reagent results | Positive (+) | 186 | 8 | 194 |
| Negative (-) | 16 | 372 | 388 | |
| Total number | 202 | 380 | 582 | |
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: 92.06%; (95%CI : 86.01%~95.63%)
Negative coincidence rate: 82.89%; (95%CI : 79.17%~86.07%)
Total coincidence rate: 84.88%. (95%CI : 81.74%~87.56%)
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:
The results showed that there was no statistically significant difference between the detaction reagent and the clinical diagnosis results.
| 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.