PRECAUTIONS

1) For in vitro diagnostic use and professional use only.

2) Read the package insert instruction before use the kit.

3) Do not use beyond the expiration date which appears on the package label.

4) Do not open the sealed pouch, unless ready to conduct the assay.

5) Bring all reagents to room temperature (15°C-30°C) before use.

6) Do not use the components in any other type of test kit as a substitute for the components in this kit.

7) Haemolized blood may be used for the testing, but do not take precipitants.

8) Wear protective clothing and disposable gloves while assaying samples. Wash hands thoroughly after performing the test.

9) Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving them for at least one hour. Alternatively, they can be treated with 0.5 to 1% solution of sodium hypochlorite for one hour before disposal.

10) Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.

11) Wear protective clothing and disposable gloves while assaying samples. Wash hands thoroughly after performing the test.

12) Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving them for at least one hour. Alternatively, they can be treated with 0.5 to 1% solution of sodium hypochlorite for one hour before disposal.

13) Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.

11) Read result after 30 minutes may give erroneous results.

12) Do not perform the test in a room with strong air flow, ie. an electric fan or strong air- conditioning.

13) As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

14) Excess sample volume (>5µL) can give false positives.