Intended Use

The Strep A Antigen Test Kit allows for the rapid detection of Group A Streptococcal antigen directly from patient throat swab specimens. The test is intended for use as an aid in the diagnosis of Group A Streptococcal infection. For use by healthcare professionals.

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MATERIALS

Materials Provided

·Test strips

·Disposable specimen droppers

·Buffer (for whole blood only)

·Test cards

·Package insert

Materials Required But Not Provided

·Specimen collection containers

·Lancets (for fingerstick whole blood only)

·Disposable heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)

·Centrifuge (for plasma only)

·Timer

Positive Result:

Two lines appear. One coloured line should be in the control line region(C) and another apparent coloured line should be in the test line region(T).

NOTE: The color intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.

Negative:

One coloured line appears in the control line region(C). No line appears in the test line region (T)

Invalid:

Control line fails to appear.

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

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