Description
For in vitro diagnostic use.
WARNINGS AND PRECAUTIONS
- Do not use the test kit beyond the expiration date printed on the pouch.
- Do not use the test kit if the pouch is punctured or not well sealed.
- Do not interchange reagent bottle caps.
- Do not interchange external control solution bottle caps.
- Discard after use. The test strip cannot be used more than once.
- The extraction tube and swab are single use items – do not use with multiple specimens.
- Do not eat, drink or smoke in the area where the specimens and kits are handled.
- Test strips must remain sealed in the pouch until just prior to use.
- Reagent A and B are caustic. Avoid contact with eyes, sensitive mucous membranes, cuts, abrasions, etc.If these reagents contact the skin or eyes, flush with a large volume of water.
SPECIMEN COLLECTION AND PREPARATION
- Only use the reagents and sterile swabs provided in the kit.
- Collect the throat swab specimen with the sterile swab that is provided in the kit. Swab the posterior pharynx, tonsils and other inflamed areas. Avoid touching the tongue, cheeks and teeth with the swab.
- Testing should ideally be performed immediately after the specimens have been collected. Swab specimens may be stored in a clean, dry plastic tube for up to 48 hours at room temperature (15-30C (59°F-86°F)] or 72 hours at 2-8°C (36-46°F).
- If a culture is desired, lightly roll the swab tip onto a Group A selective (GAS) blood agar plate before using the swab in the Rapid Strep A Antigen Test.
Positive Result：Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
Negative Result：One colored line appears in the control line region (C). No line appears in the test line region (T).
Invalid Result：Control line fails to appear.
NOTE: Insufficient specimen volume, incorrect operation procedure, or the use of expired tests are the most likely reasons for control band failure.
LIMITATIONS
- The Rapid Strep A Antigen Test is for in vitro diagnostic use only. The test should be used for the detection of Group A Streptococcal antigen in throat swab specimens only. Neither the quantitative value nor the rate of increase in Group A Streptococcal antigen concentration can be determined by this qualitative test.
- This test will only indicate the presence of Group A Streptococcal antigen in the specimen from both viable and non-viable Group A Streptococcus bacterium.
- A negative result must be confirmed by culture. A negative result may be obtained if the concentration of the Group A Streptococcal antigen present in the throat swab is not adequate or is below the detectable level of the test.
- The sterile swabs provided with this test must be used for specimen collection. Other swabs have not been validated with this test.
