Specificity : 99.8%(95%CI:94.4%-99.9%)
Brand:
DEEPBLUE
Intended use
This product is used for in vitro qualitative detection of the SARS-CoV-2 antigen in human nasal swab specimen. It is intended for personal use by untrained layman as a rapid test method for novel coronavirus infection.
Test principle
This kit uses the double antibody-sandwich method to detect SARS-CoV-2 N protein. When the suction end of the test device absorbs a certain amount of specimen, the specimen will move forward along the test device. If the specimen contains an antigen, the antigen binds to mouse anti- SARS-CoV-2 N protein monoclonal antibody labeled with colloidal gold on the binding pad, and the immune complex forms a sandwich complex with another coated mouse anti- SARS-CoV-2 N protein monoclonal antibody which was coated on the test line, a visible colored line will show up, which indicates that the SARS-CoV-2 antigen is positive. The test device also contains a quality control line, regardless of whether there is a test line, the red quality control line should appear. If the quality control line does not appear, it indicates that the test result is invalid and need to do the test again.
Product advances
1.Room temperature storage.
2.No need instrument, get results within 15 minutes.
3.Identify acute or early infection.
4.No reduction in sensitivity test against the Alpha, Beta, Delta, Gamma, Lambda, Omicron variant and so on.
Materials and Components
1.Test Device
2.Instruction
3.Collection Bag
Product Information
| Specification | 1pcs/box,5pcs/box,20pcs/box |
| Specimen | Saliva |
| Storage | 4-30℃ |
Test Procedure
Allow test device extraction reagent and specimens to equilibrate to room temperature(15 ~ 30 ℃） prior to testing.Please keep the temperature at 15 ~ 30 ℃ and the humidity at 20%-80% during the whole test.
1.Specimen Collection
（1）Open the package and take out the test device.
（2）Remove the cap of the test device, place the suction end under the tongue for about 90 seconds, to ensure the suction end is filled with saliva and purple-red substance is moving in the observation window, take out the test device, cover the cap and then place the test device flat on the desktop.
2.Test Results
Read result at 15 minutes.Do not read results after 30 minutes.
Clinical Performance
The overall study scale was 336 cases, 122 positive samples and 214 negative samples.Statistics of test results of saliva samples:
|
Reference RT-PCR Assay |
95% Wilson Score CI |
|||||||
|
LCI |
UCI |
|||||||
|
DEEP BLUE SARS- CoV-2 Ag Test Midstream-Saliva
|
|
POS |
NEG |
Total |
PPA |
97.5% |
90.9% |
99.2% |
|
POS |
119 |
1 |
120 |
NPA |
>99.5% |
94.9% |
99.9% |
|
|
NEG |
3 |
213 |
216 |
PPV |
>99.2% |
94.1% |
99.9% |
|
|
TOTAL |
122 |
214 |
336 |
NPV |
98.6% |
93.3% |
99.6% |
|
Address
No. 777 Jimingshan Road, High-Tech Development Zone, 230088 Hefei, Anhui, PEOPLE'S REPUBLIC OF CHINA
