Self Test One Step Covid-19 POCT 2019-NCoV Antigen Rapid Test Kit Nasal Swab Home Use
| Name | Covid-19 (2019-nCoV) Antigen Rapid Test Cassette |
| Type | Qualitative Test without Analyzer |
| Place of Orgin | Foshan, China |
| Detection Principle | immune colloidal gold |
| Method | lateral flow test |
| Sensitivity | 97.06% |
| Specificity | 97.41% |
| Specimen | Nasal or Oral Swab |
| Format | Cassette |
| Reading Time | 15mins |
| Sample | AVAILABLE |
| Shelf Life | Room temperature for 18 months |
| Brand | dewei |
| Certificates | White List, CE, EU FSC |
Applicable Department of Rapid Test
Emergency Department
ICU
Pneumology Department
Cardio-Pulmonary Function Department
Intended use of Nasal Swab Antigen Test
The rapid test kit is used for qualitative determination of novel coronavirus (SARS-CcV-2) antigen in human nasal swab samples in vitro.. This kit is offered to clinical laboratories and healthcare workers for point-of-care testing, and not for at home testing, in compliance with Section IV.D. of the FDA’s Policy for COVID-19 Diagnostic Test.
Principle of Nasal Swab Antigen Test
After an appropriate amount of sample is added to the detection well, the sample moves under the action of the capillary. The new coronavirus antigen in the sample will combine with colloidal gold-labeled new coronavirus N protein antibody to form a colloidal gold-antigen-antibody complex. The immune complex product is then chromatographed along the nitrocellulose membrane to the detection area (T), binds to the pre-coated N protein monoclonal antibody, and forms a purple line, indicating that the new coronavirus antigen is positive.
The quality control antibody-labeled colloidal gold particles are chromatographed to the quality control area (C) and combined with the pre-coated anti-quality control antibody to form a purple C line, indicating that the test is effective. If the QC line does not appear, the test result is invalid.
Storage & Shelf Life of Rapid Test
• Store at 36 ~ 86 º F (4 ~ 30 º C) in the sealed pouch up to the expiration date.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
Manufacturer Dewei R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.
Manufacturer Dewei Production management
Automated production line.
No defective is allowed.
Stock alarm every month.
Sufficient capacity to support customer inquiry.
Quality is primary concern, Dewei is strict on production and inspection from raw material to finsihed products. DEWEI has passed ISO13485, CE and CFDA certification, you would trust DEWEI products when you start to have the excellent service.
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