One Step Strep A Swab Test Self-Diagnostic Streptococcus 1 Test

One Step Strep A Swab Test Self-Diagnostic Streptococcus 1 Test

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Code Minsan

987242219

Brand: LEADING MED SRL

Sponsorizzato
Code
987242219

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Description One Step Strep A Swab Test Self-Diagnostic Streptococcus 1 Test

Test for the qualitative detection of group A streptococcal antigen from throat swab specimens.

Sample Collection and Preparation
1. Collect the specimen 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 sample collection.

How to use

How to use

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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 into the respective extraction tube and mix thoroughly.
2. Place the sample extraction swab 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 as possible from the swab. Discard the swab.
3. Cap the test tube and mix the contents by shaking gently.
The sample must be tested immediately.
4. Remove the test from the sealed foil pouch by tearing where it is the mark and place the test on a clean, dry, flat surface. Add 3 drops of mixed liquid sample from the tube to the sample well (depicting an arrow) of the test cassette by inverting and squeezing the tube.
5. Wait 10 minutes and read the results. Do not read the results after 15 minutes.

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

Warnings
1 This kit is for in vitro self-test use only.
Do not ingest.
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 punctured or not well sealed.
6. Discard after use. The test is disposable.
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 located 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 device used, the swab and the extraction tube should be treated as contagious waste and therefore thrown into biohazard containers.

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 Streptococcus. This test does not provide any information on pharyngitis other than those caused by type A streptococcal infection. 2. A negative result may occur due to insufficient specimen collection, or the addition of insufficient reagents A and B. If symptoms persist or intensify, always consult your doctor.
3. Excess blood or mucus in the sample collected could interfere with the performance of the test and could induce a false positive result. Do not touch your tongue, cheeks, teeth or any bleeding areas of your mouth with the swab during the sample collection phase.
4. As with any diagnostic procedure, a diagnosis should only be confirmed by a doctor after having evaluated all clinical and laboratory findings.
5. Since a toxic composition is present in the test kit and the highest rate of morbidity from upper respiratory tract infections has been found in children, the test should be carried out by parents or another adult member of the family on all minors under 16 years of age.

Storage
Store at 4 °C- 30°C in the sealed package until the expiry date.
Keep away from sunlight, moisture and heat. Do not freeze.
Preferably open the sachet just before carrying out the test.

Format
Contents:
- 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 extraction tubes.
- 2 sterile throat swabs. The swab is used to collect the sample.
- Extraction reagents A and B (warning: reagent B is toxic if ingested).
- Information leaflet with instructions for use.
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