Strep A Rapid Test

INTENDED USE

Strep A Rapid Test Strip is a rapid immunoassay for the qualitative detection of Group A Streptococcal (Group A Strep)antigen from throat swab specimens as an aid to the diagnosis of Group A Strep pharyngitis or for culture confirmation.

KIT COMPONENTS

20 Individually packed test Strips	Each Strip contains a strip with colored conjugates and reactive reagents pre-coated at the corresponding regions.
1 bottle of Extraction Buffer A - 5ml	Buffer solution containing 1.0 M Sodium Nitrite with yellow cap.
1 bottle of Extraction Buffer B - 5ml	Buffer solution containing 0.4 M Acetic Acid with white cap.
20 Extraction tubes	For specimens preparation use.
1 Workstation	Place for holding buffer vials and tubes.
1 Package insert	For operation instruction.
1 Positive control swab (on request only)	Contain inactived Group A Streptococcal and sodium azide. For External control.
1 Negative control swab (on request only)	Not contain Group A Streptococcal. For external control.

MATERIALS REQUIRED BUT NOT PROVIDED

Timer

For timing use.

STORAGE AND STABILITY

· The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

· The test must remain in the sealed pouch until use.

· Do not freeze.

· Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence ofmicrobial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagentscan lead to false results.

PROCEDURE

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

Extraction Procedure:

1. Provide 4 drops of Extraction Buffer A to the extraction tubes.

2. Add 4 drops of Extraction Buffer B to the tube and mix the liquids thoroughly.

3. Immediately place the swab specimen in the tube. Use a circular motion to roll the swab against the side of theExtraction Tube so that the liquid is squeezed out from the swab and reabsorb again for 2 minutes.

4. At the end of the extraction the swab should be squeezed totally to remain as much liquid as possible in theextraction tube. The swab must be disposed according the local guidelines for handling infectious agents and chemical reagents.

Test Procedure:

5. Remove the test from its sealed pouch and use it as soon as possible. To obtaine a best result, the assy shouldbe performed within one hour.

6. Hold the strip at the handle with the product name imprints. Do not touch the membrane part of the strip to avoidcontamination.

7. Dip the test strip vertically in the extraction buffer for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing the strip.

8. As the test begins to work, you will see color move across the membrane.

Take the strip out of the specimen afterwards and place it on a non-absorbant flat surface. Start the timer and wait for the colored line(s) to appear. The result should be read at 5 minutes.Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS

POSITIVE :	Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE:	Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID:	Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. But the substances level can not be determined by this qualitative test.

2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.