Rapid diagnostic Covid-19 Antigen Rapid Test Kit disposable Oral Saliva
COVID-19 Antigen Rapid Test Kit is a solid phase immunochromatographic assay for the in vitro qualitative detection of nuleocapsid protein antigen from 2019 Novel Coronavirus in human oral saliva specimen.
This kit is a solid phase immunochromatographic sandwich assay that is intended for the rapid, qualitative and differential detection nucleocapsid protein antigen from SARS-CoV-2 in human oral saliva specimens.Testing is only limited to professional laboratories.
| SPECIMEN COLLECTION AND HANDLING |
| 1. | Gargle with clean water before sampling |
| 2. | Unscrew the lid of the Extraction Tube, insert the saliva specimen collection funnel and screw it tightly. |
| 3. | Cough up secretions deep in the throat, accumulated in the oral cavity. |
| 4. | Use a saliva specimen collection funnel to collect fresh secretions in the oral cavity, reach the oral secretion scale mark. |
| 5. | Unscrew the funnel to allow the secretions to slip into the extraction buffer, tighten the funnel immediately and shake the collection tube. |
| 6. | Rotate to remove the funnel, place the white tip into the collection tube. |
QUILITY CONTROL
1. Internal Control
The test contains a built-in control feature, the C Line which is immobilized with goat anti- mouse IgG. The C line develops to be visible after addition of samples. If the C line does not develop, the test is invalid. Review the procedure and repeat the test with a new cassette.
2. External Control:
Good laboratory practice suggests the use of positive and negative controls to ensure the test reagents are working and the test is correctly performed. The test kit doesn’t include positive control and negative control, which can be got from Kewei. The positive control from kewei is a sample including non-infectious recombinant COVID-19 nucleocapsid antigen; its concentration is about twice of LoD. It’s recommended to test the control particularly under the following circumstances: A new operator uses the kit; A new lot of test kits are used; A new shipment of kits is received; A new test environment is used (new place, new temperature etc.); Other conditions in order to conform with local or national regulations.
Note: When performed properly, C line should be visible for the negative control and T line should be visible for the positive control. If the correct control result is not obtained, do not perform patient tests or report patient result. Contact technical support or your local distributor.
FAQ
Q1. Are you a factory or trading company?
A: We are factory, professional in vitro diagnostic (IVD) clinical testing products for many years.
Q2. Do you offer customer brand ?
A: We have been doing OEM and ODM service for more than 16 years. Protection of your sales area, ideas of design and all your private information.
Q3. What certificate do you have ?
A: CE, ISO 9001, ISO13485 certificates
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