Rapid Test Streptococcus A Intermedical Qualitative Determination of Streptococcus A Antigen in Pharyngeal Swab by Immunochromatography 10 Pieces Intermedical

Description
Rapid immunochromatographic test for the qualitative determination of Streptococcus A antigen in throat swabs, intended as an aid in the diagnosis of Group A Streptococcus infection.
In this test, specific antibody to Streptococcus A carbohydrate antigen is coated on the test region.
During the test, the extracted throat swab reacts with the anti-Strep A antibody coated on the particles. This mixture migrates to the membrane where it reacts with the anti-Strep A antibody present, generating a red line in the test region. The presence of this red line in the test region indicates a positive result, while its absence indicates a negative result. As a procedural control, a red line will always appear in the control region if the test was performed correctly. If no red line appears, the test result is invalid.

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. Pass 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.
Swabs containing modified Stuart or Amies transport medium can also be used with this product.
If culture is desired, gently rotate the swab tip on a Group A selective blood agar (GAS) plate before using the swab with the Strep 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. 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 against the inside of the tube and squeeze the bottom of the tube while removing the swab. Discard the used swab.
Insert the dropper tip into the top of the test tube. Place the test 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 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.
The intensity of the red color in the test region (T) varies depending on the concentration of Streptococcus A present in the sample. Any shade of red in the test region (T) should therefore be considered a positive result.

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
For professional in vitro diagnostic use only.
Do not use after expiration date.
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 external control solution bottles.
The test should be used to determine Streptococcus A antigen only on throat swab. It is not able to determine either the quantitative value or the percentage increase in the concentration of Streptococcus A antigen.
This test only indicates the presence of Strep A antigen in the specimen due to either viable or non-viable Group A Streptococcus 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 should 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 open wounds in the mouth when collecting samples.
As with all diagnostic tests, results must be interpreted in light of the patient's overall clinical picture.

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

Format
10 test kit containing:
- Reagent 1 for Strepto A (2 M sodium nitrite);
- Reagent 2 for Strepto A (0.027 M citric acid);
- test cards;
- sterile swabs;
- package leaflet;
- dropper dispenser;
- test tubes for sample extraction;
- support for test tubes/reagent;
- 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, P. R., et al. Manual of Clinical Microbiology, 6th Edition, ASM Press, Washington DC p. 299-307.
2. Webb, K.H. 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