Delivery 2-6 working days.
- Relative Sensitivity: 86.67%
- Relative Specificity: 100%
Overall Agreement: 95.09%
The COVID-19 antigen Rapid Test Device detects COVID-19 antigens through visual interpretation of color development on the strip. COVID-19 antibodies are immobilized on the test region of the membrane respectively. During testing, the extracted specimen reacts with anti- COVID-19 antibodies conjugated to colored particles and pre coated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient COVID-19 antigens in the specimen, colored band will form at the according test region of the membrane. The presence of a colored band in the test region indicates a positive result for the particular viral antigens, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with COVID-19 viruses. Any reactive specimen with the COVID-19 antigen Rapid Test must be confirmed with alternative testing method(s).
The COVID-19 antigen Rapid Test is suitable for use in hospitals, clinics, testing laboratories, and other medical facilities.
The COVID-19 antigen Rapid Test is a one-time use test. If a positive result is obtained, it is necessary to confirm this with another test method. If the test is negative, it does not mean that the subject is not a carrier of the virus.
The COVID-19 antigen Rapid Test Device was evaluated with a total of 44 bacterial and viral isolates. Bacterial isolates were evaluated at a concentration between 107 and 109 org/mL. Viral isolates were evaluated at a concentration of at least 104–108 TCID50/mL. Adenovirus 18 and Parainfluenza virus 3 were tested at 102 TCID50/mL and 14 influenza virus.
This product can be used for diagnostic in laboratories or for healthcare institutions. Please note that these tests are for PROFESSIONAL USE and must be used by PERSONAL HEALTHCARE PROFESSIONALS only.
Advantages of the test
The COVID-19 antigen Rapid Test Device is a rapid visual immunoassay for the qualitative, presumptive detection of COVID-19 antigens from throat swabs and nasopharyngeal swab specimens.
1.Acts using throat swabs and nasopharyngeal swab specimens;
2.Detects COVID-19 antigens through visual interpretation of color development on the strip;
3.Confirmed using PCR (Polymerase Chain Reaction).
Fast and easy:
- Results can be read in 10 minutes;
- Visual explanation of test results;
- No additional tools or instruments are needed.
The kit consists of:
- 1 COVID-19 Antigen Rapid Test;
- 1 Extraction solution;
- 1 Extraction tube;
- 1 Sterile nasal swab;
- 1 Leaflet.