CE Home Women Luteinizing Hormone Ovulation Pregnancy Rapid Test Kit
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Home Luteinizing Hormone Ovulation Test Cassette
For the qualitative detection of Human chronic gonadotropin in urine
INTENDED USE
PRINCIPLE
For a positive specimen, the conjugate binds to the LH forming an antibody-antigen complex. This complex binds to the LH antibody as a capture regent on the test region and produces a colored band when LH concentration is equal to or greater than 20mIU/ml. The Home Ovulation Test Midstream also provides a built-in process control.
This control band verifies that 1) sufficient urine volume was added 2) proper urine flow was obtained 3) the test is functioning correctly. The absence of a control band may indicate the test was not performed correctly or that the test did not function correctly.
ASSAY PROCEDURE
INTERPRETATION OF RESULT
Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).
Precision
Intra-assay
In the study, two replicate assays were performed with each of two specimens containing 0, 20mIU/ml LH. Correct negative and positive results were registered in 100% of the assays.
Inter-assay
The study involved the same two specimens containing 0, 20mIU/ml LH. The samples were analyzed in 12 independent assays with y.b.t. Home Ovulation cassette originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays.
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Product Tags: Home Luteinizing Hormone Ovulation Cassette CE Luteinizing Hormone Ovulation Test Cassette Women Luteinizing Hormone Ovulation Cassette |
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