IMMUNOBIO COVID 19 test kit

Test Procedure

Nasopharyngeal or oropharynx swab
Method Gold standard reagent(PCR) Total Results
SARS-CoV-2Antigen Rapid Test (COVID-19 Ag) Results Positive Negative
Positive 105 0 105
Negative 2 200 202
Total Result 107 200 307

Relative Sensitivity: 98.13% (95%CI: 93.02%~99.90% Relative Specificity: 100% (95%CI:97.73%~100.00% Accuracy: 99.35% (95%CI:97.50%~99.98%)

Nasal Swab

Method Gold standard reagent(PCR) Total Results
SARS-CoV-2Antigen Rapid Test (COVID-19 Ag) Results Positive Negative
Positive 103 0 103
Negative 7 100 107
Total Result 110 100 210

Relative Sensitivity: 93.64% (95%CI: 87.23%~97.10% Relative Specificity: 100% (95%CI:95.56%~100.00%) Accuracy: 96.67% (95%CI:93.15%~98.51%)

Saliva
Method Gold standard reagent(PCR) Total Results
SARS-CoV-2Antigen Rapid Test (COVID-19 Ag) Results Positive Negative
Positive 112 1 113
Negative 11 99 110
Total Result 123 100 223
Relative Sensitivity: 91.06% (95%CI: 84.55%~95.08% Relative Specificity: 99.00% (95%CI:94.01%~99.99% Accuracy: 94.62% (95%CI:90.74%~96.99%)

 
Test Procedure   Quality control Internal program control is included in the test. The colored lines appearing in the control area (C) are internal program control. It confirms sufficient specimen volume and correct procedure technique. This kit does not provide control standards; however, it is recommended that positive and negative controls be tested as a good laboratory procedure to confirm the test procedure and verify proper test performance. Performance characteristics Relative Sensitivity, Specificity and Accuracy The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) has been evaluated with specimens obtained from a population of positive and negative specimen. Results were confirmed by a commercial SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA kit, cutoff 30% signal inhibition).
Method A commercial SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA kit) Total Results
SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) Results Positive Negative
Positive 32 0 32
Negative 1 167 168
Total Result 33 167 200
Relative Sensitivity: 96.97%95%CI83.35%99.99%)   Relative Specificity: 100.00%95%CI97.29%100.00% Accuracy: 99.50%95%CI96.94%99.99%

Test Procedure