Descrizione Clinica
SCREEN STEP-A
Description
Strep A is a quick immunochromatograph test for the qualitative detection of Strep A antigens in pharyngeal swab samples to assist the diagnosis of Group A Streptococcus infections.
Early diagnosis and treatment of group A streptococcus pharyngitis infections will reduce the severity of symptoms and further complications such as rheumatic fever and glomerulonephritis, so it would be useful to have at home a handy test to be able to make a diagnosis at the appearance of the first symptoms.
When the sample is added to the specific cockpit, the capillary action induces the sample to migrate through the membrane. When group A streptococcic antigen levels in samples are equal to or greater than the cut-off, a colored line visible in the test area indicates a positive result. The absence of this coloured line in the Test area (T) suggests a negative result.
If the test is performed correctly a colored line will appear on the control area (C) as a procedural control.
Mode of use
Collection and preparation of samples
1. Collect the sample with the sterile pharyngeal pad provided in the kit.
2. Keep your tongue down with a lower tongue. Tampon the back of the pharynx, tonsils and other inflamed areas. Avoid touching the tongue, cheeks and teeth with the tampon.
3. The test should be performed ideally immediately after the sample collection.
Procedure
Bring the device and extraction reagents to ambient temperature (10 °C-30 °C) before running the test.
1. Add 4 drops of the extraction agent A and 4 drops of reagent B in the respective extraction test and mix completely.
2. Place the sample extraction pad in the test tube.
Shake the tampon ten times. Leave the swab in the tube for a minute. Then remove the pad while crushing the swab head against the inside of the tube while removing it to eliminate as much liquid as possible from the pad. Drop the tampon.
3. Tap the tube and stir the content gently stirring.
the sample must be tested immediately.
4. Remove the test from the sealed aluminum sachet tearing where the notch is and place the test on a clean, dry and flat surface. Add 3 drops of liquid sample mixed by the test tube to the sample cockpit (reflecting an arrow) of the test box inverting and crushing the test tube.
5. Wait 10 minutes and read the results. Do not read the results after 15 minutes.
Reading results
Positive
If two color lines are visible both in the test zone (T) and in the control area (C), the result is positive. Indicates that you may be in a Streptococco A Infection phase and should be consulted with your doctor.
Negative
If a single coloured line appears in the control area (C) and no coloured line appears in the test range (T), the result is negative. Indicates that the concentration of the streptococcic antigen of group A is equal to or below the test detection limit.
Invalid
No visible line or one visible line in the test area but not in the control area. This is an indication of procedure error and/or a deterioration of the test reagent 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 batch number.
Precautions
1. This kit is exclusively for self-diagnostic use in vitro. Don't swallow.
2. Don't trade the plugs between the reagents.
3. Do not use the test beyond the expiry date.
4. Keep out of reach of children.
5. Do not use the test if the envelope is perforated or not well sealed.
6. Throw after use. The test is disposable.
7. Avoid contact of A and B reagents with eyes, sensitive mucosa, membranes, cuts, abrasions, etc. If these reagents come into contact with the 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 during sample manipulation. Wash your hands thoroughly after the procedure.
10. The device used, the buffer and the extraction test must be treated as contagious waste and therefore thrown into the containers for objects at biological risk.
Limitation
1. The results of this test should not be used to determine pharyngitis infections, since pharyngitis may be caused by organisms other than group A streptococcus. This test provides no information on pharyngitis other than those caused by type A streptococcus infection.
2. A negative result may occur due to an insufficient amount of sample collected, or to addition an insufficient reagent A and B. If the symptoms persist or intensify, always consult your physician.
3. The excess of blood or mucus in the sample taken, could interfere with the performance of the test and could induce a false positive result. Do not touch the tongue, cheeks, teeth or any bleeding areas of the mouth with the swab during the sample collection phase.
4. As with any diagnostic procedure, a diagnosis should be confirmed exclusively by a doctor after evaluating all clinical and laboratory results.
5. Since in the test kit there is a toxic composition and that the highest rate of disease from upper respiratory infections has been found in children, the test should be carried out by parents or another adult family member on all children under 16 years of age.
Conservation
Store between 4 °C and 30 °C in the sealed package until the expiry date. Keep away from sunlight, moisture and heat. Don't freeze. Preferably open the envelope just before testing.
Format
Packaging:
2 individually sealed envelopes, each containing:
- test device;
- drying bag.
The dryer is only for conservation purposes, it is not used during the test procedure.
2 extraction tests.
2 sterile pharyngeal pads. The swab is used to collect the sample.
Extraction agents A and B (attention: reagent B is toxic if it is ingested).
Illustrative sheet with instructions for use.
Cod. 971664533
Strep A is a quick immunochromatograph test for the qualitative detection of Strep A antigens in pharyngeal swab samples to assist the diagnosis of Group A Streptococcus infections.
Early diagnosis and treatment of group A streptococcus pharyngitis infections will reduce the severity of symptoms and further complications such as rheumatic fever and glomerulonephritis, so it would be useful to have at home a handy test to be able to make a diagnosis at the appearance of the first symptoms.
When the sample is added to the specific cockpit, the capillary action induces the sample to migrate through the membrane. When group A streptococcic antigen levels in samples are equal to or greater than the cut-off, a colored line visible in the test area indicates a positive result. The absence of this coloured line in the Test area (T) suggests a negative result.
If the test is performed correctly a colored line will appear on the control area (C) as a procedural control.
Mode of use
Collection and preparation of samples
1. Collect the sample with the sterile pharyngeal pad provided in the kit.
2. Keep your tongue down with a lower tongue. Tampon the back of the pharynx, tonsils and other inflamed areas. Avoid touching the tongue, cheeks and teeth with the tampon.
3. The test should be performed ideally immediately after the sample collection.
Procedure
Bring the device and extraction reagents to ambient temperature (10 °C-30 °C) before running the test.
1. Add 4 drops of the extraction agent A and 4 drops of reagent B in the respective extraction test and mix completely.
2. Place the sample extraction pad in the test tube.
Shake the tampon ten times. Leave the swab in the tube for a minute. Then remove the pad while crushing the swab head against the inside of the tube while removing it to eliminate as much liquid as possible from the pad. Drop the tampon.
3. Tap the tube and stir the content gently stirring.
the sample must be tested immediately.
4. Remove the test from the sealed aluminum sachet tearing where the notch is and place the test on a clean, dry and flat surface. Add 3 drops of liquid sample mixed by the test tube to the sample cockpit (reflecting an arrow) of the test box inverting and crushing the test tube.
5. Wait 10 minutes and read the results. Do not read the results after 15 minutes.
Reading results
Positive
If two color lines are visible both in the test zone (T) and in the control area (C), the result is positive. Indicates that you may be in a Streptococco A Infection phase and should be consulted with your doctor.
Negative
If a single coloured line appears in the control area (C) and no coloured line appears in the test range (T), the result is negative. Indicates that the concentration of the streptococcic antigen of group A is equal to or below the test detection limit.
Invalid
No visible line or one visible line in the test area but not in the control area. This is an indication of procedure error and/or a deterioration of the test reagent 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 batch number.
Precautions
1. This kit is exclusively for self-diagnostic use in vitro. Don't swallow.
2. Don't trade the plugs between the reagents.
3. Do not use the test beyond the expiry date.
4. Keep out of reach of children.
5. Do not use the test if the envelope is perforated or not well sealed.
6. Throw after use. The test is disposable.
7. Avoid contact of A and B reagents with eyes, sensitive mucosa, membranes, cuts, abrasions, etc. If these reagents come into contact with the 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 during sample manipulation. Wash your hands thoroughly after the procedure.
10. The device used, the buffer and the extraction test must be treated as contagious waste and therefore thrown into the containers for objects at biological risk.
Limitation
1. The results of this test should not be used to determine pharyngitis infections, since pharyngitis may be caused by organisms other than group A streptococcus. This test provides no information on pharyngitis other than those caused by type A streptococcus infection.
2. A negative result may occur due to an insufficient amount of sample collected, or to addition an insufficient reagent A and B. If the symptoms persist or intensify, always consult your physician.
3. The excess of blood or mucus in the sample taken, could interfere with the performance of the test and could induce a false positive result. Do not touch the tongue, cheeks, teeth or any bleeding areas of the mouth with the swab during the sample collection phase.
4. As with any diagnostic procedure, a diagnosis should be confirmed exclusively by a doctor after evaluating all clinical and laboratory results.
5. Since in the test kit there is a toxic composition and that the highest rate of disease from upper respiratory infections has been found in children, the test should be carried out by parents or another adult family member on all children under 16 years of age.
Conservation
Store between 4 °C and 30 °C in the sealed package until the expiry date. Keep away from sunlight, moisture and heat. Don't freeze. Preferably open the envelope just before testing.
Format
Packaging:
2 individually sealed envelopes, each containing:
- test device;
- drying bag.
The dryer is only for conservation purposes, it is not used during the test procedure.
2 extraction tests.
2 sterile pharyngeal pads. The swab is used to collect the sample.
Extraction agents A and B (attention: reagent B is toxic if it is ingested).
Illustrative sheet with instructions for use.
Cod. 971664533
