SARS-CoV-2 Antigen Swab Test Cassette
SARS-CoV-2 Antigen Swab Test Cassette (新冠病毒抗原拭子快速测试纸卡) is a one-step qualitative lateral flow rapid diagnostic test kit, based on the Colloidal Gold Chromatographic Immuno Double Antibody Sandwich principle, which is used to detect SARS-CoV-2 Antigen in human Anterior Nasal & Oropharyngeal Swab specimen.
IFU, CE and ISO
Please refer to the Instruction for Use (IFU), related CE and ISO13485 certificates for SARS-CoV-2 Antigen Swab Test Cassette as follow:
- IFU of SARS-CoV-2 Antigen Swab Test Cassette
- Notification Form
- CE Self-Declaration of Conformity (DOC)
- Clinical Report
- Materials Safety Data Sheet (MSDS)
- ISO13485:2006 Certificate
All the documents and certificates provided here on the website are subjected to changes without prewarning. Please check with your sales manager for the latest version for practical uses, such as product registration; before carrying out an assay, reading the Instruction for Use included in the test kit is always a good practice.
Detailed information of SARS-CoV-2 Antigen Swab Test Cassette
- General and Technical information of this SARS-COV-2 Swa test kit;
- Packing specification of this SARS-COV-2 Swa Card style test kit (gross weight in full kit package and in bulk packing);
- Specimen used to carry out the assay, and the requirements on specimen collection, storage and processing; and,
- Specific immuno assay principle used in this SARS-CoV-2 Antigen Swab Test Kit.
Main technical information of this Antigen test kit is listed in the following table:
|Catalog No.:||nCOV 500|
|Description:||SARS-CoV-2 Antigen Swab Test Cassette|
|Category:||Respiratory Tract Disease|
|Specimen:||Anterior Nasal & Oropharyngeal Swab|
|No. of Step:||One Step|
|Reading Time:||15 Minutes|
|Quan. or Qual.:||Qualitative|
|Assay Principle:||Colloidal Gold Chromatographic Immuno Double Antibody Sandwich|
The standard kit size of this SARS-CoV-2 Antigen Swab Card test kit is 20 tests per box; 32 boxes per carton.
To save freight cost, sometimes bulk packing is used, meaning test strip, cassette or multi-test panel is packed in single aluminum pouch; 50 or 100 pouches in one plastic bag; and then plastic bags are packed in cartons along with the unfolded boxes for the test kits. In this way, the customers can easily pack the tests into test kits after receiving the bulk packed goods.
|Tests per Kit:||20 Tests|
|Dimension of Kit Box:||21.0 * 12.3 * 8.1 CM|
|Boxes per Carton:||32 Kits|
|Tests per Carton (BULK):||800 Tests|
|G.W. per Carton (Boxed):||10.3 KG|
|G.W. per Carton (Bulk):||12.8 KG|
|Carton Dimension:||53 * 44 * 35 CM|
|Carton Volume:||0.082 CBM|
- 20 Test Cassettes in single pouch;
- 2X8mL Extraction Reagent (Singe reagent available upon requirement);
- 20 Specimen sampling swabs (Nasopharyngeal or Oropharyngeal);
- 20 extraction dropper;
- 1 workstation to stand the extraction tubes;
- Instruction for use
To carry out the assay with a SARS-CoV-2 Antigen Swab Test Cassette, Anterior Nasal & Oropharyngeal Swab should be collected according to the instructions given in the Instruction For Use included in the test kit. After collecting, it is preferable to perform the testing as early as possible; if not viable, the specimen should be stored properly. A general introduction about the collection, and storage of the specimens is given below.
1. Ask the individual to face upward and open the mouth until exposing the pharyngeal tonsils on both sides.
2. Wipe the base of the tongue with a cotton swab, gently wipe pharyngeal tonsils back and forth on both sides for at least 3 times, and then wipe the posterior pharyngeal wall up and down for at least 3 times.
Anterior Nasal Swab
1. To collect nasal swab specimen, inert the swab into one nostril until the soft tip of the swab is not visible.
2. Rotate it in a circle around the inside edge of the nostril for at least 3 times.
3. And then use the same tip to repeat the procedure in the other nostril 3 times.
Anterior Nasal & Oropharyngeal Swab Storage Condition
It is recommended that swab specimens be processed as soon as possible after collection.
If swabs are not processed immediately they should be placed into a dry, sterile, and tightly sealed plastic tube for storage. Swabs can be stored dry at room temperature for up to 24 hours.
Colloidal Gold Chromatographic Immuno Double Antibody Sandwich method is used in this SARS-CoV-2 Antigen Swab Test Cassette to detect the SARS-CoV-2 Antigen in human Anterior Nasal & Oropharyngeal Swab specifically. The introduction of this Colloidal Gold Chromatographic Immuno Double Antibody Sandwich testing principle is given blow.
In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.
In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.
During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.
This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.
When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.
If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.