SARS-CoV-2 Ag Saliva Test Stick
SARS-CoV-2 Ag Saliva Test Stick (新冠病毒唾液抗原检测试纸笔型) 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 Saliva specimen.
IFU, CE and ISO
Please refer to the Instruction for Use (IFU), related CE and ISO13485 certificates for SARS-CoV-2 Ag Saliva Test Stick as follow:
- EC Design Examination Certificate for SARS-COV-2 Antigen Test of Home Use
- IFU of SARS-CoV-2 Ag Saliva Test Stick
- 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 Ag Saliva Test Stick
- General and Technical information of this SARS-COV-2 test kit;
- Packing specification of this SARS-COV-2 Stick 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 Saliva Test Kit.
Main technical information of this Antigen test kit is listed in the following table:
|Description:||SARS-CoV-2 Ag Saliva Test Stick|
|Category:||Respiratory Tract Disease|
|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 Saliva Stick test kit is 1 tests per box; 260 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:||1 Tests|
|Dimension of Kit Box:||18.5 * 6.0 * 2.0 CM|
|Boxes per Carton:||260 Kits|
|Tests per Carton (BULK):||800 Tests|
|G.W. per Carton (Boxed):||10.5 KG|
|G.W. per Carton (Bulk):||22.5 KG|
|Carton Dimension:||54 * 45 * 41 CM|
|Carton Volume:||0.100 CBM|
- 1 Test Stick in single pouch;
- Instruction For Use (IFU).
To carry out the assay with a SARS-CoV-2 Ag Saliva Test Stick, Saliva 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. Rinse individual’s mouth with clear water and discard before test is recommended.
2. Wait for 5 mins before saliva collection.
3. Instruct individual to place their lips over the collecting funnel and collect saliva until the saliva reaches the indicator line (about 1ml).
(Attention: Do not eat, drink, smoke or use oral hygiene products for at least 10 minutes before the collection process)
Saliva Storage Condition
The saliva specimens should be tested as soon as possible after collection.
Colloidal Gold Chromatographic Immuno Double Antibody Sandwich method is used in this SARS-CoV-2 Ag Saliva Test Stick to detect the SARS-CoV-2 Antigen in human Saliva 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.