Throat Swab Strep A Rapid Test Kit One Step Disposable Plastic Cassette

【INTENDED USE】

The Strep A Rapid Test (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Group A Streptococcus antigens in human throat swab specimens. This kit is intended for use as an aid in the diagnosis of Strep A infection.

【INTRODUCTION】

Beta-hemolytic Group A Streptococcus is a major cause of upper respiratory infections such as tonsillitis, pharyngitis, and scarlet fever. Early diagnosis and treatment of Group A Streptococcal pharyngitis has been shown to reduce the severity of symptoms and further complications, such as rheumatic fever and glomerulonephritis. Conventional methods for detecting Strep A infection are dependent on isolation and subsequent identification of the organism, and often require 24- 48 hours. Recent development of immunological techniques to detect Group A Streptococcal antigen directly from throat swabs allow physicians to diagnose and administer therapy immediately.

【PRINCIPLE】

The Strep A Rapid Test (Swab) detects Group A Streptococcus antigens through visual interpretation of color development on the internal strip. Anti-Strep A antibodies are immobilized on the test region of the membrane. During the test, the specimen reacts with polyclonal anti-Strep A antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient Strep A antigen in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that proper volume of specimen has been added and membrane wicking has occurred.

【MAIN CONTENTS】

• Rapid test cassette with desiccant.

• Sampling Swab

• Reagent 1

• Reagent 2

• Extraction Tube

• Package insert

【PRECAUTIONS】

• For professional in vitro diagnostic use only. 
• Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new extraction tube for each specimen obtained.
• Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in any area where specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Do not interchange or mix reagents from different lots. Do not mix solution bottle caps.
• Use only dacron or rayon tipped sterile swabs with plastic shafts such as those provided. Do not use calcium alginate, cotton tipped, or wooden shafted swabs.
• Reagents 1 & 2 are slightly caustic. Avoid contact with eyes or mucous membranes. In the event of accidental contact, wash thoroughly with water.
• The positive control contain sodium azide, which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of these solutions always flush with copious amounts of water to prevent azide buildup.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded according to local regulations.

【STORAGE AND STABILITY】

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.

• Keep away from direct sunlight, moisture and heat.

• DO NOT FREEZE.

【DIRECTION OF USE】

Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.

1. Prepare swab specimens:

1) Place a clean extraction tube in the designated area of the workstation. Add 5 drops of Reagent 1 to the extraction tube, then add 4 drops of Reagent 2. Mix the solution by gently swirling the extraction tube.

1) Immediately immerse the swab into the extraction tube. Use a circular motion to roll the swab against the side of the extraction tube so that the liquid is expressed from the swab and can reabsorb.

2) Let stand for 1-2 minutes at room temperature, then squeeze the swab firmly against the tube to expel as much liquid as possible from the swab. Cap the extraction tube with the attached dropper tip. Discard the swab following guidelines for handling infectious agents.

2. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the cassette with patient or control identification. For best results, the assay should be performed within one hour.

3. Add 3 drops (approximately 120 µL) of extracted solution from the extraction tube to the sample well on the test cassette. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the observation window. As the test begins to work, color will migrate across the membrane.

4. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 15 minutes.

【INTERPRETATION OF RESULTS】

POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.

INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.