Descrizione Clinica
TEST
STREPTOCOC
Description
Quick test for group A streptococcus detection in throat infections.
Mode of use
Sample collection
Use only sterile reagents and buffers provided in the kit.
Take the sample with the sterile pharyngeal pad provided in the kit. Pass the swab on the rear pharynx, tonsils and other inflamed areas.
Avoid contact of the tampon with the tongue, cheeks and teeth.
The test should be performed preferably immediately after sampling. Samples can be stored in a clean, dry plastic tube at an ambitious temperature of up to 8 hours or at 2-8°C up to 72 hours. With this product you can also use pads containing modified Stuart or Amies transport.
If you want to make a crop, turn the swab tip slightly on a selective blood plate for the A (GAS) group before using the pad with the card for the Strepto A quick test (pharyngeal stud).
Test procedure
Bring the card, reagents, the pharyngeal pad and/or ambient temperature controls (15-30°C) before the analis.
Remove the card from the sealed bag and use it immediately.
Keeping the Reagent 1 bottle vertically, pour 4 drops (about 240 mcl) into a sample extraction tube. Reagent 1 is red. Keeping the Reagent 2 bottle vertically, add 4 drops (about 160 mcl) to the tube. Reagent 2 is colorless. Mix the solution by gently turning the tube. The addition of Reagent 2 to Reagent 1 changes the color of the solution from red to yellow.
Add the pharyngeal pad immediately to the yellow solution contained in the tube. Shake the swab in the tube 15 times. Leave the pad in the tube for 1 minutes. Then press the swab inside the tube and squeeze the bottom of the tube while removing the swab. Remove the buffer.
Insert the tip of the dropper at the top of the tube. place the card on a clean flat surface. Add 3 drops of solution (100 mcl) to the well for samples (S) and start the timer.
Wait for the appearance of the band/e red/e.
Read the result after 5 minutes. do not interpret the result after 10 minutes.
Interpretation of results
Positive: two distinct red bands appear, one in the control area (C), the other in the reactive zone (T). A positive result indicates that the Streptococco A was detected in the sample.
Negative: a red band appears in the control area (C). There is no red or pink band in the reactive area (T). a negative result indicates that the antigen of Streptococco A is not present in the sample or is present below the detectable threshold of the test. The patient's sample must be subjected to cultivation to confirm the absence of Streptococco A infection. If clinical symptoms are not compatible with the results, take another sample for cultivation.
Not valid: no band appears. The most probable reasons for the failure of the control band are an insufficient volume of sample or incorrect execution of the procedure. Review the procedure and repeat the test with a new card. If the problem persists, do not use the kit anymore and contact the local distributor.
Warnings
In case of ingestion: in case of malaise, call an anti-veleni or medical center.
In case of contact with the eyes: rinse carefully with water for a few minutes. Remove contact lenses if present and easy to do. Keep rinseing. If irritation persists, consult a doctor.
Don't freeze. Do not use after the expiry date.
Exclusively for professional in vitro diagnostic use.
Do not eat, drink or smoke in the area where samples and kits are manipulated.
Manipulate all samples as potentially infectious. Observe the appropriate precautions against microbiological risks in all phases of analysis and follow standard procedures for correct disposal of samples.
During sample analysis wear protective clothing: lab coats, disposable gloves and eye protection.
Humidity and temperature can adversely affect results.
Do not use the test if the bag is damaged.
Reagent 2 contains an acid solution. If the solution comes in contact with the skin or eyes, rinse with plenty of water.
The positive and negative controls contain Proclin300 as a preservative.
Don't trade reagent bottle caps.
Do not exchange the cappucci of the bottles of external control solutions.
The Strpto A Rapid Test Card (Florence) is exclusively for in vitro diagnostic use. The test must be used for determining the antigen of Streptococcus A only on pharyngeal pads. It is not able to determine neither the quantitative value nor the percentage of increase of the antigen condition of Streptococcus A.
This test only indicates the presence of antigen of Streptococcus A in the sample due to Streptococcus bacteria of group A, both vital and non-viable.
A negative result must be confirmed by cultivation. A negative result can be due to an antigen concentration of Streptococcus present in the inadequate or lower pharyngeal buffer at the detectable level of the test.
The sterile buffers provided on this test must be used for sample picking. Other buffers have not been validated for this test.
An excessive amount of blood or mucus on the swab can interfere with the test results and determine a false positive result. Avoid contact of the swab with the tongue, cheeks and teeth and any oral zones in which there are open wounds at the momeno of the sampling.
As with all diagnostic tests, the results must be interpreted in the light of the overall clinical picture of the patient.
Conservation
Store at room temperature or refrigerator (2-30°C).
Validity of whole packaging: 16 months.
Format
Kit content:
- reagent 1 for Strepto A (sodium nitrite 2 M)*;
- reagent 2 for Strepto A (citric acid 0.027 M);
- card;
- sterile tampons;
- methodical;
- dropper dispenser;
- test pieces for sample extraction;
- test/reagent support;
- positive control for Strepto A (Proclin Non-vitational A Straep 300 0.01%);
- negative control for Strepto A (Strepto C non vital Proclin 300 0.01%).
*Keep away from the reach of children. Wear gloves and protective clothing for eyes and face.
Cod. 70773
Quick test for group A streptococcus detection in throat infections.
Mode of use
Sample collection
Use only sterile reagents and buffers provided in the kit.
Take the sample with the sterile pharyngeal pad provided in the kit. Pass the swab on the rear pharynx, tonsils and other inflamed areas.
Avoid contact of the tampon with the tongue, cheeks and teeth.
The test should be performed preferably immediately after sampling. Samples can be stored in a clean, dry plastic tube at an ambitious temperature of up to 8 hours or at 2-8°C up to 72 hours. With this product you can also use pads containing modified Stuart or Amies transport.
If you want to make a crop, turn the swab tip slightly on a selective blood plate for the A (GAS) group before using the pad with the card for the Strepto A quick test (pharyngeal stud).
Test procedure
Bring the card, reagents, the pharyngeal pad and/or ambient temperature controls (15-30°C) before the analis.
Remove the card from the sealed bag and use it immediately.
Keeping the Reagent 1 bottle vertically, pour 4 drops (about 240 mcl) into a sample extraction tube. Reagent 1 is red. Keeping the Reagent 2 bottle vertically, add 4 drops (about 160 mcl) to the tube. Reagent 2 is colorless. Mix the solution by gently turning the tube. The addition of Reagent 2 to Reagent 1 changes the color of the solution from red to yellow.
Add the pharyngeal pad immediately to the yellow solution contained in the tube. Shake the swab in the tube 15 times. Leave the pad in the tube for 1 minutes. Then press the swab inside the tube and squeeze the bottom of the tube while removing the swab. Remove the buffer.
Insert the tip of the dropper at the top of the tube. place the card on a clean flat surface. Add 3 drops of solution (100 mcl) to the well for samples (S) and start the timer.
Wait for the appearance of the band/e red/e.
Read the result after 5 minutes. do not interpret the result after 10 minutes.
Interpretation of results
Positive: two distinct red bands appear, one in the control area (C), the other in the reactive zone (T). A positive result indicates that the Streptococco A was detected in the sample.
Negative: a red band appears in the control area (C). There is no red or pink band in the reactive area (T). a negative result indicates that the antigen of Streptococco A is not present in the sample or is present below the detectable threshold of the test. The patient's sample must be subjected to cultivation to confirm the absence of Streptococco A infection. If clinical symptoms are not compatible with the results, take another sample for cultivation.
Not valid: no band appears. The most probable reasons for the failure of the control band are an insufficient volume of sample or incorrect execution of the procedure. Review the procedure and repeat the test with a new card. If the problem persists, do not use the kit anymore and contact the local distributor.
Warnings
In case of ingestion: in case of malaise, call an anti-veleni or medical center.
In case of contact with the eyes: rinse carefully with water for a few minutes. Remove contact lenses if present and easy to do. Keep rinseing. If irritation persists, consult a doctor.
Don't freeze. Do not use after the expiry date.
Exclusively for professional in vitro diagnostic use.
Do not eat, drink or smoke in the area where samples and kits are manipulated.
Manipulate all samples as potentially infectious. Observe the appropriate precautions against microbiological risks in all phases of analysis and follow standard procedures for correct disposal of samples.
During sample analysis wear protective clothing: lab coats, disposable gloves and eye protection.
Humidity and temperature can adversely affect results.
Do not use the test if the bag is damaged.
Reagent 2 contains an acid solution. If the solution comes in contact with the skin or eyes, rinse with plenty of water.
The positive and negative controls contain Proclin300 as a preservative.
Don't trade reagent bottle caps.
Do not exchange the cappucci of the bottles of external control solutions.
The Strpto A Rapid Test Card (Florence) is exclusively for in vitro diagnostic use. The test must be used for determining the antigen of Streptococcus A only on pharyngeal pads. It is not able to determine neither the quantitative value nor the percentage of increase of the antigen condition of Streptococcus A.
This test only indicates the presence of antigen of Streptococcus A in the sample due to Streptococcus bacteria of group A, both vital and non-viable.
A negative result must be confirmed by cultivation. A negative result can be due to an antigen concentration of Streptococcus present in the inadequate or lower pharyngeal buffer at the detectable level of the test.
The sterile buffers provided on this test must be used for sample picking. Other buffers have not been validated for this test.
An excessive amount of blood or mucus on the swab can interfere with the test results and determine a false positive result. Avoid contact of the swab with the tongue, cheeks and teeth and any oral zones in which there are open wounds at the momeno of the sampling.
As with all diagnostic tests, the results must be interpreted in the light of the overall clinical picture of the patient.
Conservation
Store at room temperature or refrigerator (2-30°C).
Validity of whole packaging: 16 months.
Format
Kit content:
- reagent 1 for Strepto A (sodium nitrite 2 M)*;
- reagent 2 for Strepto A (citric acid 0.027 M);
- card;
- sterile tampons;
- methodical;
- dropper dispenser;
- test pieces for sample extraction;
- test/reagent support;
- positive control for Strepto A (Proclin Non-vitational A Straep 300 0.01%);
- negative control for Strepto A (Strepto C non vital Proclin 300 0.01%).
*Keep away from the reach of children. Wear gloves and protective clothing for eyes and face.
Cod. 70773
