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

How to use
Sample collection
Use only the sterile reagents and swabs provided in the kit.
Collect the sample with the sterile throat swab provided in the kit. Swab 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 specimen collection. Specimens may 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. Swabs containing modified Stuart or Amies transport medium may also be used with this product.
If culture is desired, gently rotate the swab tip on a group A selective blood plate (GAS) before using the swab with the Strepto A Rapid Test Device (Throat Swab).
Test procedure
Bring the test card, reagents, throat swab and/or controls to room temperature (15-30°C) before testing.
Remove the card from the sealed pouch and use it immediately.
Holding the Reagent 1 bottle upright, add 4 drops (approximately 240 mcl) to a sample extraction tube. Reagent 1 is red in color. Holding the Reagent 2 bottle upright, add 4 drops (approximately 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 color of the solution from red to yellow.
Immediately add the throat swab to the yellow solution in the tube. Shake the swab in the tube 15 times. Leave the swab in the tube for 1 minute. Then press the swab into the tube and squeeze the bottom of the tube while removing 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 lines appear, one in the control region (C), the other in the test region (T). A positive result indicates that Streptococcus A has been detected in the sample.
Negative: A red line appears in the control region (C). No red or pink line appears in the test region (T). A negative result indicates that Strep A antigen is not present in the specimen or is present below the detectable threshold of the test. The patient specimen should be cultured to confirm the absence of Strep A infection. If clinical symptoms are inconsistent with the results, another specimen should be collected 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, discontinue use of the kit and contact your local distributor.

Warnings
If swallowed: Call a poison control center or doctor if you feel unwell.
In case of eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If irritation persists, seek medical advice.
Do not freeze. Do not use after expiration date.
For professional in vitro diagnostic use only.
Do not eat, drink or smoke in the area where specimens and kits are handled.
Handle all specimens as if potentially infectious. Observe appropriate precautions against microbiological hazards at all stages of the analysis and follow standard procedures for proper disposal of specimens.
Wear protective clothing when analyzing samples: lab coat, disposable gloves, and eye protection.
Humidity and temperature can negatively 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 reagent bottle caps.
Do not interchange the caps of the external control solution bottles.
The Rapid Test Card Strpto A (Throat Swab) is for in vitro diagnostic use only. The test must be used to determine the antigen of Streptococcus A on throat swab only. It is not able to determine the quantitative value or the percentage of increase in the antigen status of Streptococcus A.
This test only indicates the presence of Strep A antigen in the specimen due to either viable or non-viable Group A Strep bacteria.
A negative result should be confirmed by culture. A negative result may be due to inadequate or less than detectable levels of Strep A antigen in the throat swab.
The sterile swabs provided with this test are to be used for specimen collection. No other swabs have been validated for this test.
Excessive blood or mucus on the swab may interfere with the test results and cause a false positive. Avoid contact of the swab with the tongue, cheeks, teeth, and any oral areas where there are open wounds when the samples are collected.
As with all diagnostic tests, results must be interpreted in light of the patient's overall clinical picture.

Conservation
Store at room temperature or in the refrigerator (2-30°C).
Validity with intact packaging: 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;
- methodical;
- dropper dispenser;
- test tubes for sample extraction;
- test tube/reagent support;
- 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 and face protection.

Code 70773