Product Detail
- Getting a quick result within 15-30 minutes – no need for a follow-up appointment to discuss the result
- Easy handling which does not require specific training
- No instrument required
- Allowing decentralized testing or access to testing in areas where laboratory testing is not available
The benefit of having a SARS-CoV-2 Antigen test available
The SARS-CoV-2 virus causes respiratory tract infection. It is transmitted mainly via respiratory droplets after close contact, and primary viral replication is presumed to occur in mucosal epithelium of the upper respiratory tract (nasal cavity and pharynx)1 . At these locations viral load peaks within the first week after symptom onset, and then declines2 .
A SARS-CoV-2 antigen test detects the presence of the SARS-CoV-2 virus from part of the upper respiratory tract swab specimens by identifying a nucleoprotein that is carried by the virus. The test identifies current infection during the acute phase of COVID-19, while the virus is still present in large quantities in the respiratory tract.
Features and benefits of the SARS-CoV-2 Rapid Antigen Test
Besides laboratory PCR testing, antigen assays can also be offered as rapid testing in near-patient settings. The SARS-CoV-2 Rapid Antigen Test is a rapid chromatographic immunoassay intended for the qualitative detection of specific antigens of SARS‑CoV‑2 present in the human nasopharynx. This test is intended to detect antigen from the SARS‑CoV‑2 virus in individuals suspected of COVID‑19. This product is strictly intended for professional use in laboratory and Point of Care environments. Similar to laboratory instruments, it detects a SARS-CoV-2 antigen, the nucleoprotein. It can therefore be used to assess whether a person is infected with SARS-CoV-2 by providing a qualitative result showing coloured bands indicating the presence of SARS-CoV-2 antigens.
The SARS-CoV-2 Rapid Antigen Test enables fast decision making e.g. whether patients need to be put in quarantine, reducing the risk of further spreading. In addition to that it allows for screening of individuals after confirmed exposure to a SARS-CoV-2 infected person or individuals at risk of exposure such as healthcare workers.
The SARS-CoV-2 Rapid Antigen Test allows for decentralized testing at the point of care and helps to expand the range and quantity of direct virus testing into otherwise inaccessible locations. Rapid point of care testing can sometimes be the only viable option if lab testing is not sufficiently available. In addition to that, the SARS-CoV-2 Rapid Antigen Test is an instrument free test, allowing testing in rural/ low-infrastructure areas.
The benefits of the SARS-CoV-2 Rapid Antigen Test in short:
INTENDED USE
COVID-19 Antigen Rapid lest Cassette is for in vitro qualitative detection of specific antigens to SARS-CoV-2 present in human throat or nasal cavity. It cannot be used as the basis for the diagnosis and exclusion of COVID-19.
This reagent is used to detect cases with suspected symptoms of COVID-19 within 7 days. If suspected symptoms are more than 7 days, it is recommended to test with COVID-19 antibodies or nucleic acid reagents.
The main clinical symptoms of COVID-19 are: Fever, dry cough, fatigue, a few patients will have stuffy nose, runny nose and diarrhea.
PRINCIPLE
This kit uses double antibody sandwich immunoassay to detect specific antigens to SARS-CoV-2 in human throat or nasal cavity. The membrane was precoated with SARS-CoV-2 specific antibody on the test zone and goat anti mouse IgG antibody on the control zone. During the test, the specimen is allowed to react with SARS-CoV-2 specific antibody-colloidal gold particles conjugate, which was predried on the test. The conjugate binds to the SARS-CoV-2 forming an antibody~antigen complex. The complex moves forward on the membrane by the capillary action, then the complex is captured by specific antibody to SARS-CoV-2 on the test zone to produce a visual red color line. The color line is positive correlated with the amount of SARS-CoV-2 in specimen.
Regardless of the presence of SARS-CoV-2, as the mixture continues to move across the membrane to the control zone, the complex is captured by immobilized goat anti mouse IgG antibody to form a distinct red line.
REAGENTS AND MATERIALS PROVIDED
1. Test cassette (individually pouched)
2. Each pouch contains one cassette with one desiccant bag
3. Sample preservation solution
4. Disposable sampling swab
5. Instruction for use
STORAGE
COVID-19 Antigen Rapid Test Cassette should be stored in dark place at 2~30°C for 24 months from the date of manufacture. Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, use it immediately. Do not use the test beyond the indicated expiration date.
