1. The One Step RV IgG/IgM Test can be performed used on Whole Blood /Serum / Plasma. 2. To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures. 3. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. For long term storage, specimens should be kept below -20â??. Whole blood should be stored at 2-8â?? if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. 4. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. Test Procedure Allow the test, specimen, buffer and/or controls to reach room temperature 15-30â?? (59-86â??) prior to testing. 1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible. 2. Place the test device on a clean and level surface. 3. Hold the dropper vertically and transfer 1 drop of specimen (approximately 10μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 80μl) and start the timer. See illustration below. 4. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes. Interpretation of Results Positive: Control line and at least one test line appear on the membrane. The appearance of T2 test line indicates the presence of RV specific IgG antibodies. The appearance of T1 test line indicates the presence of RV specific IgM antibodies. And if both T1 and T2 line appear, it indicates that the presence of both RV specific IgG and IgM antibodies. The lower the antibody concentration is, the weaker the result line is. Negative: One colored line appears in the control region(C). No apparent colored line appear in the test line region. Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.