| Comparison of Test Results of Kit and Clinical Reference Standard Results | |||
|---|---|---|---|
| Test kit results (Covid 19 Antigen Test) | Clinical Reference Standard Results | Total | |
| Positive group | Negative group | ||
| Positive | 45 | 5 | 50 |
| Negative | 4 | 296 | 300 |
| Total | 9 | 301 | 350 |
Diagnostic Sensitivity: 45/(50)100%=90%
Diagnostic Specificity: 296/(300)100%=98.67%
The Total Coincidence Rate: (45+296)/(45+5+4+296)*100%=97.43%
| SARS-COV-2 | Dilution | Viral concentration in the Ag device | R1 | R2 | R3 |
|---|---|---|---|---|---|
| P0 | 1 | 1000pg | + | + | + |
| P1 | 50 | 200pg | + | + | + |
| P2 | 100 | 100pg | + | + | + |
| P3 | 200 | 50pg | + | + | + |
| P4 | 400 | 20pg | + | + | + |
| P5 | 800 | 10pg | + | + | + |
| P6 | 1600 | 5pg | + | - | - |
| SARS-COV-2 | Dilution | Viral concentration in the Ag device | Repetition | Results |
|---|---|---|---|---|
| P5 | 800 | 10pg | R1 | + |
| R2 | + | |||
| R3 | + | |||
| R4 | + | |||
| R5 | + | |||
| R6 | + | |||
| R7 | + | |||
| R8 | + | |||
| R9 | + | |||
| R10 | + | |||
| R11 | + | |||
| R12 | + | |||
| R13 | + | |||
| R14 | + | |||
| R15 | + | |||
| R16 | + | |||
| R17 | + | |||
| R18 | + | |||
| R19 | + | |||
| R20 | + |
| SARS-COV-2 | Dilution | Viral concentration in the Ag device | Repetition | Results |
|---|---|---|---|---|
| P3 | 200 | 50pg | R1 | + |
| R2 | + | |||
| R3 | + | |||
| R4 | + | |||
| R5 | + | |||
| R6 | + | |||
| R7 | + | |||
| R8 | + | |||
| R9 | + | |||
| R10 | + | |||
| P5 | 800 | 10pg | R1 | + |
| R2 | + | |||
| R3 | + | |||
| R4 | + | |||
| R5 | + | |||
| R6 | + | |||
| R7 | + | |||
| R8 | + | |||
| R9 | + | |||
| R10 | + |
| Microorganism | Quantity | Results |
|---|---|---|
| Influenza A | 8 | 0/8 |
| Influenza B | 5 | 0/5 |
| RSV | 5 | 0/5 |
| SARS | 3 | 1/3 |
| Adenovirus | 4 | 0/4 |
| ParaFlu | 3 | 0/3 |
| M.Pneumonia | 5 | 0/5 |
| Measles virus | 2 | 0/2 |
| Streptococcus pneumoniae | 1 | 0/1 |
| Staphylococcus aureus | 1 | 0/1 |
| EBV | 3 | 0/3 |
| Coxsachie virus CA16 | 2 | 0/2 |
| AIV H7N9 | 1 | 0/1 |
| AIV H5N1 | 1 | 0/1 |
| Saliwa | 3 | 0/3 |
| Negative serum/plasma | 20 | 0/20 |
| The cross-reactivity test results of InfluA positive samples by SARS-COV-2 antigen test kit | |||
|---|---|---|---|
| Test kit results (Covid 19 Antigen Test) | Clinical Reference Standard Results | Total | |
| Positive group | Negative group | ||
| Positive | 0 | 0 | 0 |
| Negative | 8 | 0 | 8 |
| Total | 8 | 0 | 8 |
| The cross-reactivity test results of InfluB positive samples by SARS-COV-2 antigen test kit | |||
|---|---|---|---|
| Test kit results (Covid 19 Antigen Test) | Clinical Reference Standard Results | Total | |
| Positive group | Negative group | ||
| Positive | 0 | 0 | 0 |
| Negative | 5 | 0 | 5 |
| Total | 5 | 0 | 5 |
| The cross-reactivity test results of ParaFlu positive samples by SARS-COV-2 antigen test kit | |||
|---|---|---|---|
| Test kit results (Covid 19 Antigen Test) | Clinical Reference Standard Results | Total | |
| Positive group | Negative group | ||
| Positive | 0 | 0 | 0 |
| Negative | 3 | 0 | 3 |
| Total | 3 | 0 | 3 |
| The cross-reactivity test results of RSV positive samples by SARS-COV-2 antigen test kit | |||
|---|---|---|---|
| Test kit results (Covid 19 Antigen Test) | Clinical Reference Standard Results | Total | |
| Positive group | Negative group | ||
| Positive | 0 | 0 | 0 |
| Negative | 5 | 0 | 5 |
| Total | 5 | 0 | 5 |
| The cross-reactivity test results of SARS positive samples by SARS-COV-2 antigen test kit | |||
|---|---|---|---|
| Test kit results (Covid 19 Antigen Test) | Clinical Reference Standard Results | Total | |
| Positive group | Negative group | ||
| Positive | 1 | 0 | 1 |
| Negative | 2 | 0 | 2 |
| Total | 3 | 0 | 3 |
| The cross-reactivity test results of Adenovirus positive samples by SARS-COV-2 antigen test kit | |||
|---|---|---|---|
| Test kit results (Covid 19 Antigen Test) | Clinical Reference Standard Results | Total | |
| Positive group | Negative group | ||
| Positive | 0 | 0 | 0 |
| Negative | 4 | 0 | 4 |
| Total | 4 | 0 | 4 |
| The cross-reactivity test results of Saliva positive samples by SARS-COV-2 antigen test kit | |||
|---|---|---|---|
| Test kit results (Covid 19 Antigen Test) | Clinical Reference Standard Results | Total | |
| Positive group | Negative group | ||
| Positive | 0 | 0 | 0 |
| Negative | 0 | 3 | 3 |
| Total | 0 | 3 | 3 |
| The cross-reactivity test results of Serum/Plasma positive samples by SARS-COV-2 antigen test kit | |||
|---|---|---|---|
| Test kit results (Covid 19 Antigen Test) | Clinical Reference Standard Results | Total | |
| Positive group | Negative group | ||
| Positive | 0 | 0 | 0 |
| Negative | 0 | 20 | 20 |
| Total | 0 | 20 | 20 |
Apply 2 full drops of the sample diluent solution(60-70ul) vertically into the sample well of the test cassette. The results are observed after 20minutes and sowed on clinical significance after 20 minutes.
Collection method of Nasopharyngeal swab specimen:
The operator holds the swab by the right hand and holds the head of the subject fixedly by the left hand. Putting the sab downing backwards the bottom of the nasal cavity and penetrate slowly and gently. Do not overexert to avoid traumatic hemorrhage. When the tip of the swab touching the posterior parries of the paranasal cavity, letting the swab
remain in the place for a few seconds (about 3seconds) and rotating the swab gently for one cycle and then remove the swab slowly.
The head of the person to be collected is slightly tilted and his mouth is wide open, exposing the pharyngeal tonsils on both sides. Wipe the swab across the root of the tongue. Wipe the pharyngeal tonsils n both sides of the person to be collected back and forth with a little force or at least 3 times, and then wipe up and down the posterior pharyngeal wall for the least 3 times.
Add 550ul sample diluent solution into the sampling tube, dip the swab after sample collection into the sample diluent solution, make the solution fully permeate the swab, rotate and squeeze the swab 10 times, then pull out the swab, and take the remained liquid as the sample to be tested.
