Group A Streptococus Antigen Test
Group A Streptococus Antigen Test (链锁状球菌(A类)抗原快速拭子检测试纸卡) 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 Group-A Streptococcal antigen in human Throat & nasal swab specimen.
Detailed information for Group A Streptococus Antigen Test is provided below, including:
- General and Technical information of this STRP test kit;
- Packing specification of this STRP 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 Streptocoaus-A Test Kit.
Main technical information of this Strep-A test kit is listed in the following table:
| Former Cat. No.: | STRP 451 |
|---|---|
| Description: | Group A Streptococus Antigen Test |
| Category: | Respiratory Tract Disease |
| Style: | Card |
| Unit: | PCS |
| Specimen: | Throat & nasal swab |
| No. of Step: | One Step |
| Reading Time: | 5 Minutes |
| Cut Off: | 2.5*105 Organism/Test |
| Specification: | 5.0 mm |
| Quan. or Qual.: | Qualitative |
| Assay Principle: | Colloidal Gold Chromatographic Immuno Double Antibody Sandwich |
The standard kit size of this Streptocoaus-A Card test kit is 20 tests per box; 40 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 * 12.5 * 6.5 CM |
| Boxes per Carton: | 40 Kits |
| Tests per Carton (BULK): | 1200 Tests |
| G.W. per Carton (Boxed): | 14.0 KG |
| G.W. per Carton (Bulk): | 15.0 KG |
| Carton Dimension: | 53 * 45 * 36 CM |
| Carton Volume: | 0.085 CBM |
Materials Provided
- Strep-A Antigen Test Cassette in individual foil pouch (20×);
- Extraction Reagent A: NaOH (5ml);
- Extraction Reagent B: Acid (5ml);
- Extraction Reagent C: Oxidation Reagent (5ml);
- Sterile Throat Swabs (20×);
- Plastic Pipette for sample transfer (20×);
- Instruction For Use (IFU).
To carry out the assay with a Group A Streptococus Antigen Test, Throat & nasal 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.
Throat Swab
To collect a throat swab specimen, vigorously rub a rayon throat swab on both tonsillar surfaces and the posterior pharynx.
Remove swab from mouth and insert, tip down, into paper wrapper.
Nasal Swab Specimen
Use the sterile swab supplied in the kit. Insert this swab into the nostril that presents the most secretion under visual inspection.
With gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one inch in the nostril). Rotate the swab three times against the nasal wall.
Or, insert the swab into nostril parallel to the palate and leave in place for a few seconds to absorb specimens.
Throat & Nasal 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 Group A Streptococus Antigen Test to detect the Group-A Streptococcal antigen in human Throat & nasal 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.
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