Component:
| Component |
Main component |
| Test Device (20) |
Each foil pouch contains one single-use test device with one strip. Each strip contains a test line (T1) of monoclonal antibody specific to influenza type A antigen, a test line (T2) of monoclonal antibody specific to influenza type B antigen, a test line (T3) of monoclonal antibody specific to SARS-CoV-2 antigen and a control line (C) of anti-mouse antibody. |
| Extraction Solution (0.5mL×20) |
The main ingredient is Phosphate Buffered Saline (PBS), and the loading capacity is 500ul/tube. |
Storage and Stability:
This kit is kept at 2~30℃, under sealed state of aluminum foil bag. Its shelf life is 18 months. After the unsealing of aluminum foil bag, this kit should be used within one hour. Production date and expiry date are shown in the package or label.).
Specimen collection and requirements
1. Specimen collection
A) Nasal Swabbing
Completely insert the sterilized swab, which is supplied in this kit into the nasal basin, and swab several times to collect the epidermal cells of mucus.
B) Throat Swabbing
Insert the sterilized swab deep into the throat and swab several times to collect the epidermal cells of the mucus. Contamination of the swab with saliva should be avoided.
2. Specimen extraction
Take a sample extract, remove the aluminum foil from the tube mouth, and place it on a paper tube rack.
Place the swab from which the sample was collected into the extraction tube and submerge the swab by squeezing the tube a few times. Remove the swab and then cover the drip tip, mix well and set aside.
Samples can be stored at room temperature for 3 hours. If they cannot be used within 3 hours, specimens should be kept at and as soon as possible placed in -70℃. If there is no -70℃ refrigerator, specimens should be kept at 2-8℃, but it should not exceed 4 days.
Test Procedure:
1 .Bring the test to room temperature (15-30℃) before use.
2. Open the foil pouch, take out the test and lay it on an even surface.
3. Add 3 drops (about 100 µL) of extraction mixture into the sample well (S).
4. Read and record the results at 15 minutes after addition of samples.
NOTE: Result will be invalid after 20 minutes. The experiment should be completed at a temperature of 15 to 30°C and a humidity of 35% to 85%. After observing and recording the result, dispose of bio-hazardous materials by following the practices of your institution. Discard all the materials in a safe and acceptable manner in compliance with all the federal, state, and local requirements.
Performance Characteristics:
For Flu A
1.Negative reference coincidence rate
Use 10 samples of Flu A Ag negative reference to test, the test results should not be positive, the negative coincidence rate should be 10/10；
2.Positive reference coincidence rate
Use 10 samples of Flu A Ag positive reference to test, the test result should all be positive, the positive coincidence rate should be 8/10;
3.Sensitivity
Use 3 samples of Flu A Ag sensitivity reference to test, L1 should be detected, L2 should be detected or not, L3 should not be detected.
4.Repeatability
Use 1 sample of internal control repeatability reference（J1）to complete the parallel test for 10 tests, the results should be coincident.
5.Cross-reaction and interference reaction
Use positive samples of Rhinovirus, RS virus, Influenza B virus strain, Chlamydia, Mycoplasma and Bacterial Infection to do the tests, the test results should be negative.
6.The Clinical study
The Flu A Rapid Test has been evaluated with 160 clinical samples. Both 73 negatives and 87 positives were confirmed by Viral culture results.
The Flu A Test v.s. Viral culture results
| Test Method |
Clinica results |
Total |
| Positive |
Negative |
| The Flu A Test |
Positive |
82 |
11 |
93 |
| Negative |
9 |
174 |
183 |
| Total |
91 |
185 |
276 |
[1] Sensitivity = A/（A＋C）×100 ％＝90.1%
[2]Specificity = D/（B＋D）×100 ％＝94.05%
[3]Crude coincidence rate = (A+D)/(A+B+C+D)×100% ＝92.75%
[4]Consistency factor kappa = 0.837
For Flu B
1.Negative reference coincidence rate
Use 10 samples of Flu B Ag negative reference to test, the test results should not be positive, the negative coincidence rate should be 10/10；
2.Positive reference coincidence rate
Use 10 samples of Flu B Ag positive reference to test, the test result should all be positive, the positive coincidence rate should be 8/10;
3.Sensitivity
Use 3 samples of Flu B Ag sensitivity reference to test, L1 should be detected, L2 should be detected or not, L3 should not be detected.
4.Repeatability
Use 1 sample of internal control repeatability reference（J1）to complete the parallel test for 10 tests, the results should be coincident.
5.Cross-reaction and interference reaction
Use positive samples of Rhinovirus, RS virus, Influenza A virus strain, Chlamydia, Mycoplasma and Bacterial Infection to do the tests, the test results should be negative.
6.The Clinical study
The Flu B Rapid Test has been evaluated with 130 clinical samples. Both 80 negatives and 50 positives were confirmed by Viral culture results.
The Flu B Test v.s. Viral culture results
| Test Method |
Viral culture results |
Total |
| Positive |
Negative |
| The Flu B Test |
Positive |
75 |
15 |
90 |
| Negative |
6 |
162 |
168 |
| Total |
81 |
177 |
258 |
[1] Sensitivity = A/（A＋C）×100 ％＝92.6%
[2] Specificity = D/（B＋D）×100 ％＝91.5%
[3] Crude coincidence rate= (A+D)/(A+B+C+D)×100% ＝91.86%
[4] Consistency factor kappa = 0.816
For COVID-19 Ag
1.Negative reference coincidence rate
Use 10 samples of COVID-19 Ag negative reference to test, the test results should not be positive, the negative coincidence rate should be 10/10；
2.Positive reference coincidence rate
Use 10 samples of COVID-19 Ag positive reference to test, the test result should all be positive, the positive coincidence rate should be 8/10;
3.Sensitivity
Use 3 samples of COVID-19 Ag sensitivity reference to test, L1 should be detected, L2 should be detected or not, L3 should not be detected.
4.Repeatability
Use 1 sample of internal control repeatability reference（J1）to complete the parallel test for 10 tests, the results should be coincident.
5.Cross-reaction and interference reaction
Use positive samples of Rhinovirus, RS virus, Influenza A virus, Influenza B virus, Chlamydia, Mycoplasma and Bacterial Infection to do the tests, the test results should be negative.
6.The Clinical study
The COVID-19 Ag Rapid Test has been evaluated with 300 clinical samples. Both 200 negatives and 100 positives were confirmed by PCR.
The COVID-19 Ag Test vs. PCR
| Test Method |
PCR |
Total |
| Positive |
Negative |
| The COVID-19 Ag Test |
Positive |
99 |
0 |
99 |
| Negative |
1 |
200 |
201 |
| Total |
100 |
200 |
300 |
[1]Sensitivity = A/（A＋C）×100 ％＝99%
[2]Specificity = D/（B＋D）×100 ％＝100%
[3]Crude coincidence rate= (A+D)/(A+B+C+D)×100% ＝99.7%
[4]Consistency factor kappa = 0.992
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