Wuxi Owgels Medical Instruments Co., Ltd
Wuxi Owgels Medical Instruments Co., Ltd
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Nasal/Throast SwabTest Kits Antigen Test for fresh swabs COVID-19 Antigen Rapid Diagnostic
Interference
Potential Endogenous Interference of the COVID-19 Antigen Rapid Test was evaluated using natural clinical samples. No Antigen false negative or false positive results were observed with the following potential interference substances at the stated concentrations:
| Human Blood | 1% V/V |
| Mucosal protein | 1mg/ml |
| Phenylephrine | 1% V/V |
| Oxymetazoline | 1% V/V |
| Triamcinolone | 50mg/L |
| Ribavirin | 50mg/L |
Overall Clinical Performance of Antigen Test Kit
A total of above 157 positive samples and 260 negative samples were detected to evaluate the clinical performance of the COVID-19 Antigen Rapid Test Kit. The Result is below:
| Sansure Covid-19 RT-PCR Assay | ||||
| Positive | Negative | Total | ||
| Kewei COVID-19 Antigen Rapid Assay | Positive | 143 | 0 | 143 |
| Negative | 14 | 260 | 274 | |
| Total | 157 | 260 | 417 | |
INTERPRETATION OF RESULTS
NEGATIVE:
If only the C band is present, the absence of any burgundy color in the T band indicates that no COVID-19 antigens are detected in the specimen. The result is negative.
POSITIVE:
In addition to the presence of C band, if T band also emerged, then the test indicates the presence of COVID-19 antigens in the specimen. The result is positive.
INVALID:
Control line fails to appear. Incorrect procedural techniques and invalid test kit are the most likely reasons for control line failure. Read the instructions carefully again and repeat the test with a new test kit. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
