Description
Rapid immunochromatographic test for the determination quality of the Streptococcus A antigen on a throat swab, intended as an aid for the diagnosis of Group A Streptococcus infection.
In this test, the specific antibody against Streptococcus A carbohydrate antigen is adhered to the reactive area of the test.
During the test, the extracted throat swab reacts with the anti-Streptococcus A antibody attached to the particles. This mixture migrates to the membrane where it reacts with the anti-Streptococcus A antibody present, generating a red band in the test area. The presence of this red band in the test reactive area is indicative of a positive result, while its absence is indicative of a positive result. indicative of a negative result. As a procedural control, the following will appear: always a red band in the control area, if the test is was carried out correctly. If no red band appears, the test result is not correct. valid.

Mode instructions for use
Sample collection
Use only the reagents and sterile 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 collection of samples.

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.
With this product you can You can also use swabs containing modified Stuart or Amies transport medium. If you wish to culture, rotate the swab tip slightly on a Group A selective (GAS) blood agar plate before using the swab with the card for the Strepto A rapid test (Throat Swab).

Test procedure
Bring the card, reagents, throat swab and/or controls to room temperature (15 -30 °C) before the analysis.
Remove the card from the sealed bag and use it immediately.
Holding the Reagent 1 bottle in a vertical position, pour 4 drops (approximately 240 mcL) into a test tube sample extraction. Reagent 1 is Red. Holding the Reagent 2 bottle upright, add 4 drops (approximately 160 mcL) to the tube. Reagent 2 is colorless. Mix the solution by gently rotating the tube. The addition of Reagent 2 to Reagent 1 changes the color of the solution from red to yellow.
Immediately add the throat swab to the yellow solution contained in the tube. Shake 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. Then dispose of the used swab.
Insert the tip of the dropper into the upper part of the test tube. Place the card on a clean, flat surface. Add 3 drops of solution (approximately 100 mcL) to the sample well (S) on the test card 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 area (C), the other in the test area (T). A positive result indicates that there is Streptococcus A was detected.
The intensity of the red color in the test zone (T) varies depending on the concentration of Streptococcus A present in the sample. Any shade of red in the test area (T) must therefore be considered an indication of a positive result.

NEGATIVE: a red band appears in the control area (C). No red or pink band is seen in the test zone (T). A negative result indicates that the Streptococcus A antigen is not present in the blood. present in the sample or is present below the detectable threshold of the test. The patient sample should be cultured to confirm the absence of Streptococcus A infection. If clinical symptoms are not compatible with the results, take another sample for culture.

INVALID: not no band appears. The most important reasons probable causes of the failure of the control band to appear are an insufficient sample volume or incorrect execution of the procedure. Review the procedure and repeat the test with a new card. If the problem persists, do not use any more. the kit and contact your local distributor.

Warnings
For professional in vitro diagnostic use only.
Do not use after the expiry date.
Do not eat, drink or smoke in the area where specimens and kits are handled.
Handle all specimens as potentially infectious. Observe adequate precautions against microbiological risks in all phases of analysis and follow standard procedures for the correct disposal of samples.
During the analysis of samples wear protective clothing: laboratory coat, disposable gloves and hand protection eyes.
Humidity and temperature can negatively affect the results.
Do not use the test if the bag is damaged.
Reagent 2 contains an acidic solution. If solution contacts 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 reagent bottle caps. caps of the bottles of external control solutions.
The test must be used for the determination of Streptococcus A antigen only on a throat swab. Is not serious; capable of determining né the quantitative value né the percentage increase in the concentration of Streptococcus A antigen.
This test indicates only the presence of Streptococcus A antigen in the specimen due to Group A Streptococcus bacteria, both viable and non-viable.
A negative result must be confirmed by culture. A negative result can be due to a concentration of Streptococcus A antigen present in the throat swab that is inadequate or lower than the detectable level of the test.
The sterile swabs provided with this test must be used for specimen collection. No other swabs have been validated for this test.
A quantity of Excessive blood or mucus on the swab may cause interfere with test results and result in a false positive result. Avoid contact of the swab with the tongue, cheeks and teeth and any oral areas in which there are open wounds at the time of sampling.
As with all diagnostic tests, the results must be interpreted in light of the clinical picture patient overall.

Storage
Store in the sealed bag at room temperature or in the refrigerator (2-30 °C). Do not freeze.
The card is stable until the expiry date indicated on the sealed pouch. Keep the card in the sealed bag until needed. Do not use after the expiry date.

Format
10 test kit containing:
- Reagent 1 for Strepto A (2 M sodium nitrite);
- Reagent 2 for Strepto A (citric acid 0.027 M);
- test card;
- sterile swabs;
- information leaflet;
- dropper dispenser;
- extraction tubes sample;
- support for tubes/reagents;
- 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%).

Bibliography
1. Murray, PR, et al. Manual of Clinical Microbiology, 6th Edition, ASM Press, Washington DC p. 299-307.
2. Webb, KH. Does Culture Confirmation of High-sensitivity Rapid Streptococcal Tests Make Sense? A Medical Decision Analysis. Pediatrics (Feb 1998), 101:2, 2.
3. Bisno AL, Gerber MA, Gwaltney JM, Kaplan EL, Schwartz RH. Diagnosis and Management of Group A Streptococcal Pharyngitis. Clinical Infectious Diseases (1997), 25: 574-83.
4. Needham CA, McPherson KA, Webb KH. Streptococcal Pharyngitis: Impact of a High-sensitivity Antigen Test on Physician Outcome. Journal of Clinical Microbiology (Dec 1998), 36: 3468-3473.
5. Shea, YR, Specimen Collection and Transport, Clinical Microbiology Procedures Handbook, Isenberg, HD, American Society of Microbiology, Washington DC, 1.1.1- 1.1.30, 1992.
6. Nussinovitch, M, Finkelstein Y, Amir J, Varsano, I. Group A beta-hemolytic streptococcal pharyngitis in preschool children aged 3 months to 5 years. Clinical Pediatrics (June 1999), 38: 357-360.
7. Woods WA, Carter CT, Stack M, Connors Jr AF, Schlager TA. Group A Streptococcal Pharyngitis in Adults 30 to 65 years of age. Southern Medical Journal (May 1999), 491-492.

Cod. C-37/10