Assay Time: 5-10 minutes

² REAGENTS AND MATERIALS

- 20*Test devices, with disposable droppers

- 20*Assay buffer

- 20*Cotton swabs

- Products Manual

² TEST PROCEDURE

Allow the test, specimen, extraction buffer to room temperature prior to testing

-Take out the test device from the foil pouch and place it horizontally.

-Place the Extraction Tube in the workstation.Place the swab specimen in the Extraction Tube. Rotate the swab for approximately 10seconds while pressing the head against the inside of the tube

-Suck the treated sample extraction from the assay buffer tube and place 3 drops into the sample hole “S” of the test device.

-Interpret the result in 5-10 minutes. Result after 20 minutes is considered as invalid.

² INTERPRETATION OF RESULTS

- Positive: The presence of both “C” line and zone “T” line, no matter T line is clear or vague.

- Negative: Only clear C line appear. No T line.

- Invalid: No colored line appears in C zone. No matter if T line appears.

² STORAGE AND STABILITY

The kit can be stored at room temperature (4-30°C). The test kit is stable through the expiration date (24 months) marked on the package label. DO NOT FREEZE. Do not store the test kit in direct sunlight.

² PRECAUTIONS

- All reagents must be at room temperature before running the assay.

- Do not remove test cassette from its pouch until immediately before use.

- Do not use the test beyond its expiration date.

- The components in this kit have been quality control tested as standard batch unit. Do not mix components from different lot numbers.

- All specimens are of potential infection. It must be strictly treated according to the rules and regulations by local states.