COVID-19 Antigen test kit Uncut Sheet
The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human throat and nasal secretions.
The SARS-CoV-2 Antigen Rapid Test is for detection of SARS-CoV-2 antigens. Anti-SARS-CoV-2 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-SARS-CoV-2 antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another Anti-SARS-CoV-2 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region. The SARS-CoV-2 Antigen Rapid Test contains anti-SARS-CoV-2 monoclonal antibodies conjugated particles and another anti-SARS-CoV-2 monoclonal antibodies are coated in the test line regions.
A. 10-15 minutes get the test Result
B.With over 95% sensitivity and specificity
C. Easy operation, no need equipment
D. Require less Nasal and Saliva Specimen
E.Both nasal swab and Saliva swab test with high accuarcy
Storage and stability
The kit can be stored at room temperature or refrigerated (2-30°C). The Test Strip is stable through the expiration date printed on the sealed pouch. The Test Strip must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date. The stability of the kit under these storage conditions is 18 months
Specimen collection and Preparation
The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) can be performed using throat secretions and nasal secretions.
● Throat Secretions: Insert the sterile swab into the throat. Gently scrape the secretions around the wall of pharynx.
● Nasal Secretions: Insert the sterile swab into the deep nasal cavity. Gently rotate swab against wall of turbinate for several times. Make the swab wet as much as possible.
● Collect 0.5ml of assay buffer and place into a specimen collection tube. Insert the swab into the tube and squeeze the flexible tube to extrude the specimen from the head of the swab. Make the specimen resolved in the assay buffer sufficiently. Add the crystal tip onto the specimen collection tube.
The assay should be performed immediately in 2 hours after the specimen preparation. If the assay could not be carried immediately, the prepared specimen should be kept no more than 24 hours at 2-8°C or 7 days at -20°C.
Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly for more than two times. If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.
- Positive (+): Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the T line region.
NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV-2 present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such.
- Negative (-): One colored line appears in the control line region (C). No line appears in the T line region.
- Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
1. The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is for in vitro diagnostic use only. This test should be used for the detection of SARS-CoV-2 antigens in human throat and nasal secretions
2. The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) will only indicate the presence to SARS-CoV-2 in the specimen and should not be used as the sole criteria for the diagnosis of SARS-CoV-2 infections.
3. Results from immunosuppressed patients should be interpreted with caution.
4. If the symptom persists, while the result from COVID-19 Rapid Test is negative or non-reactive result, it is recommended to re-sample the patient few days late or test with an alternative test device such as PCR.
5. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
6. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of COVID-19 infection.
7. The potential impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated in the test.
8. Due to inherent differences between methodologies, it is highly recommended that, prior to switching from one technology to the next, method correlation studies are undertaken to qualify technology differences. One hundred percent agreement between the results should not be expected due to differences between technologies.
9. Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay.
1. Factory price, reasonable and competitive
2. OEM/ODM service, Not only packaging and brand customization, we have our own laboratory and R&D team, which can develop and customize proprietary products for customers
3. Timly and quickly feedback, anytime and anywhere for customer service.
4. Provide professional training and quality samples to help customers develop the market
5. Flexible trading methods to meet customer and business needs