Professional Manufacturer of Rapid Test Devices
Place of Origin: | China |
Brand Name: | Newscen |
Certification: | ISO9001, CE, TUV, FDA |
Model Number: | COVID-19 Antigen |
Minimum Order Quantity: | 10 Boxes or 400 Kits (40 Kits/Box) |
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Price: | USD0.37/Cassette |
Packaging Details: | 40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm |
Delivery Time: | 8 days |
Payment Terms: | T/T, Western Union, MoneyGram |
Supply Ability: | 50,000 Kits Per Day |
Formatthroat Or Nasal Swab: | Cassette | OEM/ODM: | Available |
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Result Time: | 3-20 Minutes | Usage: | For In Vitro Diagnostic Use Only |
Certificate: | CE, TUV | Manufacturer/Trader: | Manufacturer |
High Light: | Coronavirus Antigen Rapid Test Cassette,In Vitro Diagnostic Rapid Test Cassette,ISO9001 Home Coronavirus Test Kit |
Hot Sale In Vitro Diagnostic Coronavirus Antigen Rapid Test Cassette (Swab) Used At Home
COVID-19 Antigen Rapid Test Cassette
For the qualitative detection of SARS-CoV-2 antigen in human throat swab or nasal swab
Main Features
☀ High Sensitivity, Some Products can reach 100%
☀ High Specificity, Some Products can reach 100%
☀ Reliable: High Accurate, Early Detection of The Presence Of Virus
☀ Simple: No complicated Instrument Required
☀ Convenient: Room Temperature Storage, patented Built-In Control line for easy operation with high accuracy
☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes
☀ Certified by Authoritative Certification System and Standards
☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"
Intended Use
COVID-19 Antigen Rapid Test 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.
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.
Assay Procedure
1. All clinical samples must be at room temperature before beginning the assay.
2. Open the package, the pouch should be sealed well. If the test reagent store in the refrigerator, it should be restored to room temperature. Then open the pouch and take out the test cassette, place it on the platform.
3. Add 2 drops of patient sample extraction solution which from the tube into S Well, Observe the result in 15~20 minutes, interpret the test result after 20 minutes may cause false result.
Interpretation of Results
☀ Positive: One color line in the control zone (C) and one color line in the test zone (T). This indicates that the sample contains SARS-CoV-2 antigen.
☀ Negative: Only one color line in the control zone (C). This indicates that no SARS-CoV-2 antigen has been detected.
☀ Invalid: If no color line appears in the control zone (C), the test is invalid. Discard the test cassette and perform with new cassette.
Built-In Control
COVID-19 Antigen Rapid Test Cassette has a built-in procedural control that demonstrates assay validity. A color line appeared on the control zone (C) indicates that the test runs correctly.
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.
Contact Person: Mr. Randy.Zhang
Tel: 008618611273771