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 resultsTotal
Confirmed diagnosisNegative
Test reagent
results
Positive (+)1592161
Negative (-)1157158
Total number160159319

Sensitivity

(95%CI : 96.55%~99.89%)

  • 99.38% 99.38%

Specificity

(95%CI : 95.53%~99.65%)

  • 98.74% 98.74%

Total clinical coincidence rate

(95%CI : 97.27%~99.68%)

  • 99.06% 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 resultsTotal
Positive (+)Negative (-)
Test reagent
results
Positive (+)1582160
Negative (-)2157159
Total number160159319

Positive coincidence rate

(95%CI : 95.56%~99.66%)

  • 98.75% 98.75%

Negative coincidence rate

(95%CI : 95.53%~99.65%)

  • 98.74% 98.74%

Total coincidence rate

(95%CI : 96.82%~99.51%)

  • 98.75% 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% 100%
  • Negative sample rate 98.7% (159 of 160 samples) 98.07% 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 resultsNumber of casesPercentage
Earlier than the nucleic acid test results315%
Same as the nucleic acid test results1470%
Later than the nucleic acid test results315%

The comparisons above show that there were no statistical significantly differences between the test-kit and the clinical diagnostic results.