REAGEN LLC
REAGEN INC, focusing on ELISA, PCR, and Lateral Flow testing kits including clinical disease detecting kits, food & feed safety test kits, and animal epidemic virus detecting kits in the US for 12
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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%)
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.
