ASSAY PROCEDURE
Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed. Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface. Step 3: Be sure to label the device with specimen’s ID number. Step 4: For whole blood sample: Fill the dropper with the specimen then add 2 drops（App.50µL）of specimen into the sample well. Making sure that there are no air bubbles. Then add 2 drops of Sample Diluent immediately into the sample well. For Plasma/ Serum sample: Fill the dropper with the specimen then add 1 drop（App.25µL） of specimen into the sample well. Making sure that there are no air bubbles. Then add 2 drops of Sample Diluent immediately into the sample well. Step 5: Set up a timer. Step 6: Read the result at 10 minutes. Don’t read results after 30 minutes. To avoid confusion, discard the test device after interpreting the result.INTERPRETATION OF ASSAY RESULT
| POSITIVE RESULT: | 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 RESULT: | Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T). |
| INVALID RESULT:
| 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. |
