Rapid Strep A Pharyngeal Test Strep A Antigen Detection on Pharyngeal Swab by Professional Immunochromatography 10 Pieces Sofarmapiu' Sofarmapiu'

Description
Rapid test for the detection of group A streptococcus in throat infections.

Instructions for use
Sample collection
Use only the reagents and sterile swabs provided in the kit.
Collect the sample with the sterile pharyngeal swab provided in the kit. Swipe the swab over the posterior pharynx, tonsils, and other inflamed areas.
Avoid contact of the swab with the tongue, cheeks, and teeth.
The test should preferably be performed immediately after sample collection. Samples can be stored in a clean, dry plastic tube at room temperature for up to 8 hours or at 2-8°C for up to 72 hours. This product can also be used with swabs containing modified Stuart or Amies transport medium.
If a culture is desired, lightly rotate the tip of the swab on a selective blood agar plate for group A (GAS) before using the swab with the Strepto A rapid test card (pharyngeal swab).
Test procedure
Bring the card, reagents, pharyngeal swab, and/or controls to room temperature (15-30°C) before analysis.
Remove the card from the sealed pouch and use it immediately.
Holding Reagent 1 bottle upright, dispense 4 drops (approx. 240 mcl) into a sample extraction tube. Reagent 1 is red. Holding Reagent 2 bottle upright, add 4 drops (approx. 160 mcl) to the tube. Reagent 2 is colorless. Mix the solution by gently swirling the tube. Adding Reagent 2 to Reagent 1 changes the solution color from red to yellow.
Immediately add the pharyngeal swab to the yellow solution in the tube. Swirl the swab in the tube 15 times. Leave the swab in the tube for 1 minute. Then press the swab against the inside of the tube and squeeze the bottom of the tube as you remove the swab. Discard the swab.
Insert the dropper tip into the top of the tube. Place the card on a clean, flat surface. Add 3 drops of solution (100 mcl) to the sample well (S) and start the timer.
Wait for the red band(s) to appear.
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 zone (C), the other in the reaction zone (T). A positive result indicates that Streptococcus A has been detected in the sample.
Negative: A red band appears in the control zone (C). No red or pink band is noted in the reaction zone (T). A negative result indicates that Streptococcus A antigen is not present in the sample or is present below the detectable threshold of the test. The patient's sample should be cultured to confirm the absence of Streptococcus A infection. If clinical symptoms are not compatible with the results, collect another sample for culture.
Invalid: No band appears. The most likely reasons for the control band not appearing are insufficient sample volume or incorrect procedure. Review the procedure and repeat the test with a new card. If the problem persists, stop using the kit and contact your local distributor.

Warnings
If swallowed: if feeling unwell, call a poison control center or doctor.
If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If irritation persists, consult a doctor.
Do not freeze. Do not use after the expiry date.
For professional in vitro diagnostic use only.
Do not eat, drink, or smoke in the area where samples and kits are handled.
Handle all samples as potentially infectious. Observe appropriate precautions against microbiological hazards at all stages of analysis and follow standard procedures for proper disposal of samples.
Wear protective clothing during sample analysis: laboratory coat, disposable gloves, and eye protection.
Humidity and temperature can adversely affect results.
Do not use the test if the pouch is damaged.
Reagent 2 contains an acidic solution. If the solution comes into contact with skin or eyes, rinse with plenty of water.
Positive and negative controls contain Proclin300 as a preservative.
Do not interchange the caps of the reagent bottles.
Do not interchange the caps of the external control solution bottles.
The Strepto A rapid test card (pharyngeal swab) is for in vitro diagnostic use only. The test should be used for the determination of Streptococcus A antigen only on a pharyngeal swab. It cannot determine either the quantitative value or the percentage increase of the Streptococcus A antigen condition.
This test only indicates the presence of Streptococcus A antigen in the sample due to group A Streptococcus bacteria, both viable and non-viable.
A negative result must be confirmed by culture. A negative result may be due to an inadequate concentration of Streptococcus A antigen present in the pharyngeal swab or below the detectable level of the test.
The sterile swabs provided with this test must be used for sample collection. No other swabs have been validated for this test.
Excessive blood or mucus on the swab can interfere with test results and lead to a false positive result. Avoid contact of the swab with the tongue, cheeks, and teeth and any oral areas where open wounds are present at the time of sample collection.
As with all diagnostic tests, results should be interpreted in light of the patient's overall clinical picture.

Storage
Store at room temperature or in a refrigerator (2-30°C).
Shelf life unopened: 16 months.

Format
Kit contents:
- Reagent 1 for Strepto A (2 M sodium nitrite)*;
- Reagent 2 for Strepto A (0.027 M citric acid);
- Card;
- Sterile swabs;
- Method;
- Dropper dispenser;
- Sample extraction tubes;
- Tube/reagent rack;
- Positive control for Strepto A (non-viable Strepto A Proclin 300 0.01%);
- Negative control for Strepto A (non-viable Strepto C Proclin 300 0.01%).
*Keep out of reach of children. Wear gloves and eye/face protection.

Code. 70773