One Step Strep A Test Wondfo 1 Piece

One Step Strep A Test Wondfo - Streptococcus A

Immunoassay side-scroll test for the qualitative detection of Group A Streptococcus antigen from throat swab specimens to aid in the early diagnosis of Group A Streptococcus infection.
For in vitro self-testing use.
When the sample is added to the sample well, capillary action causes the sample to migrate across the membrane. When the Estreptococcal Group A antigen levels in the specimens are at or above the cut-off, a visible colored line appears in the Test Region indicating a positive result. The absence of such a colored line in the Test Region (T) suggests a negative result . If the test has been performed correctly, a colored line will appear over the control region (C) as a procedural control.

Sample collection and preparation

1. Collect the sample with the sterile throat swab provided in the kit.
2. Hold the tongue down with a tongue depressor. Swab the back of the pharynx, tonsils and other inflamed areas. Avoid touching the tongue, cheeks and teeth with the swab.
3. The test should ideally be performed immediately after specimen collection.

How to use

Bring the device and extraction reagents to room temperature (10°C-30°C) before performing the test.
1. Add 4 drops of Extraction Reagent A and 4 drops of Reagent B to the respective extraction tube and mix thoroughly.
2. Place the sample extraction buffer into the tube.
Shake the swab ten times. Leave the swab in the tube for one minute. Then remove the swab while squeezing the swab head against the inside of the tube as you remove it to remove as much liquid from the swab as possible. Discard the swab.
3. Cap the tube and mix the contents by gentle swirling.
The sample must be tested immediately.
4. Remove the test from the sealed foil pouch by tearing at the notch and place the test on a clean, dry, flat surface. Add 3 drops of mixed liquid sample from the tube to the sample well (showing an arrow) of the Test Cassette by inverting and squeezing the tube.
5. Wait 10 minutes and read the results. Do not read results after 15 minutes.

Reading the results

Positive
If two color lines are visible in both the test region (T) and the control region (C), the result is positive. Indicates that you may be in the stage of Streptococcus A infection and should consult your doctor.
Negative
If only one colored line appears in the control region (C) and no colored line appears in the test region (T), the result is negative.
Indicates that the concentration of group A streptococcal antigen is at or below the limit of detection of the assay.
Invalid
No line visible or only one line visible in the test region but not in the control region. This is an indication of procedural error and/or that assay reagent deterioration has occurred.
Repeat the test with a new kit. If the test is still invalid, please contact the distributor or shop where you purchased the product, providing the lot number.

Precautions

1. This kit is for in vitro self-testing use only.
Do not swallow.
2. Do not interchange caps between reagents.
3. Do not use the test beyond the expiration date.
4. Keep out of reach of children.
5. Do not use the test if the pouch is perforated or not tightly sealed.
6. Throw away after use. The test is for single use.
7. Avoid contact of reagents A and B with eyes, sensitive mucous membranes, membranes, cuts, abrasions, etc. If these reagents come into contact with skin or eyes, rinse thoroughly with water.
8. Do not eat, drink or smoke in the area where the samples are and where the test will take place.
9. Protective gloves should be worn when handling the sample. Wash your hands thoroughly after the procedure.
10. The used device, the swab and the extraction tube must be treated as infectious waste and therefore thrown into the containers for biohazardous objects

Limitations

1. The results of this test should not be used to determine pharyngitis infections, as pharyngitis can be caused by organisms other than group A strep. This test does not provide any information about pharyngitis other than those caused by type A strep infection. TO.
2. A negative result may occur due to insufficient specimen collected, or insufficient addition of reagent A and B. If symptoms persist or worsen, always consult your physician.
3. Excess blood or mucus in the collected sample could interfere with test performance and could lead to a false positive result. Do not touch the tongue, cheeks, teeth, or any bleeding areas of the mouth with the swab during the specimen collection step.
4. As with any diagnostic procedure, a diagnosis should only be confirmed by a physician after evaluating all clinical and laboratory findings.
5. Since there is a toxic composition in the test kit and the highest morbidity rate from upper respiratory tract infections has been found in children, the test should be performed by parents or another adult family member on all minors under the age of 16.

storage

Store at 4°C-30°C in the sealed pouch until the expiry date.
Keep away from sunlight, moisture and heat. Do not freeze.
Preferably open the pouch just before testing.

Format

Content
1. 2 individually sealed sachets, each containing:
- test device;
- desiccant sachet.
The desiccant is for storage purposes only, it is not used during the testing procedure.
2. 2 extraction tubes.
3. 2 sterile throat swabs. The swab is used to collect the sample.
4. Extraction Reagents A and B (Caution: Reagent B is toxic if swallowed).
5. Package leaflet with instructions for use.

Code W39-CH