Product details
Intended Use
This product is a rapid, one step test for the qualitative detection of Group A Streptococcus (GAS) from throat swab. This is a simple, rapid and non instrumental diagnostic method. For professional in vitro diagnostic use only.
Test Principle
This product is a lateral flow chromatographic immunoassay for the detection of Group A Streptococcus antigen in human throat swab samples. The membrane is pre-coated with monoclonal antibodies against Group A Streptococcus antigens on the test line region.
Main Contents
Components provided are listed in the table.
| Materials / provided |
Quantity (1 Test/Kit) |
Quantity(5Tests/Kit) |
Quantity(25Tests/Kit) |
| Test Kit |
1 test |
5 tests |
25 tests |
| Swabs |
1 pieces |
5 bottles |
15/2 bottles |
| Sample Lysis Solution |
1 bottle |
5 pcs |
25 pcs |
| Instructions For Use |
1 piece |
1 piece |
1 piece |
| Certificate of Conformity |
1 piece |
1 piece |
1 piece |
Operation Flow
1.Remove an extraction tube from the kit and a test box from the film bag by tearing the notch. Put them on the horizontal plane.
2.Soak the smear below the liquid level of the sample extraction buffer, rotate and press 5 times. Immerse time of smear at least 15 s.
3.Remove the swab and press the edge of the tube to squeeze out the liquid in the swab. Throw the swab into the biological hazardous waste.
Fix the pipette cover firmly on the top of the suction tube. Then gently turn the extraction tube 5 times.Transfer 2 to 3 drops (about 100 ul) of the sample to the sample surface of the test band and start the timer.
4.Read the results in 15-20 minutes. The result explanation time is not more than 20 minutes.
For more information, please refer to the IFU or watch the product operation video:
Result Interpretation
Negative result
Both the quality control C line and the detection T line appear, and the result is positive for Group A Streptococcus antigen.
Positive Result
Only the quality control C line appears and the detection T line does not show color, it indicates that there is no Group A Streptococcus antigen in the specimen.
Invalid Result
No visible colored band appears at control line after performing the test. Review the test procedure and repeat the test using a new test device.
Order Information
| Product Name |
Cat. No |
Size |
Specimen |
Shelf Life |
Trans. & Sto. Temp. |
|
Group A Streptococcus Antigen Test Kit (Immunochromatographic Assay)
|
B019C-01 |
1test/kit |
Throat swab sample |
18 Months |
2-30℃ / 36-86℉ |
| B019C-05 |
5 tests/kit |
| B019C-025 |
25 tests/kit |