SARS-CoV-2 Antigen IVD Kit Lollipop(Saliva)Whitelist CE
Certification
Product Performance Index
Clinical verification
In order to evaluate the diagnostic performance, this study used
COVID-19-positive specimens from 120 individuals and
COVID-19-negative specimens from 400 individuals. These specimens
were tested and confirmed by the RT-PCR method. The results are as
follows:
| Method | Clinically confirmed (RT-PCR) | Total results |
Antigen test card
| Results | Positive | Negative |
| Positive | 115 | 6 | 121 |
| Negative | 5 | 394 | 399 |
| Total | 120 | 400 | 520 |
Sensitivity:95.83%(115/120),95%CI(90.54%,98.63%)
Specificity:98.50%(394/400),95%CI(96.76%,99.45%)
Total coincidence rate: 97.88%(509/520),95%CI(96.25%,98.94%)
Limitations of Inspection Methods
1. This product is only suitable for the detection of human saliva
samples. It detects the virus content in the sample extract,
regardless of whether the virus is infectious. Therefore, the test
results of the same sample using this product may not be correlated
with the virus culture results.
2. The test card of this product need to be restored to room
temperature before use. Improper temperature may cause abnormal
test result.
3. During the testing process, the test results did not match the
clinical results due to insufficient saliva collection samples or
improper collection and specimen extraction operations.
4. During the use of this product, you need to strictly follow the
operating steps of the manual. Improper operating steps and
envi-ronmental conditions may cause abnormal test results.
5. The positive test result of this product cannot distinguish
between SARS-CoV and SARS-CoV-2.
6. A negative test result of this product cannot rule out the
possibility of other pathogens being positive.
7. Negative test results are recommended to be verified with
nucleic acid detection reagents to avoid the risk of missed test.
