| Message: | 1. Purpose The purpose of this proposal is to provide an validation of the analytical sensitivity. The production of at least three consecutive 2019-nCOV IgG/IgM Rapid Test Device products shall be controlled.
3. Material Positive Control:2019-nCOV-IgM; Positive Control:2019-nCOV-IgG; Validation lot 1:NO1G01T; Validation lot 2:NO1G02T; Validation lot 3:NO1G03T.
4. Method Tests the low positive control of 2019-nCOV-IgM,2019-nCOV-IgG and negative sample.Each specimen tests in 11 tests.Read the positive result at 10 min.Do not interpret the result after 15 minutes.
5. Interpretation of results Positive result:≥G3 Negative result:<G3
6. QC Acceptance Criteria Serum/Plasma specimens:C-line≤3min. Whole blood specimens:C-line≤5min. C-line≥G8 in 10min.
The 2019-nCOV IgG/IgM Rapid Test Device can show good performance using the positive and negative samples. url:http://www.codewel.com |
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