CE Home Women Luteinizing Hormone Ovulation Pregnancy Rapid Test Kit

Home Luteinizing Hormone Ovulation Test Cassette

For the qualitative detection of Human chronic gonadotropin in urine

INTENDED USE

Home Ovulation Test Midstream is an in vitro diagnostic (IVD) qualitative test for rapid detection of human luteinizing hormone (LH) in urine at a sensitivity of 20mIU/ml.

PRINCIPLE

Home Ovulation Test Midstream is a qualitative, two site sandwich immunoassay for the determination of human luteinizing hormone (LH) in urine specimens. The membrane was precoated with LH specific antibodies on the test region. During the test, the specimen is allowed to react with the LH monoclonal antibody-colloid gold conjugate, which was pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by the capillary action.

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

1. Remove the midstream test device from pouch by tearing.

2. Take off the clear cap from sample end of device and put it to other end of device to cover window area.

3. Hold the end of cap and put the urine holes in urinating stream for 3-5 seconds.

4. Re-cap the device and lay it on flat surface.

5. Wait for 10-15 minutes to read result. Do not try to interpret results after 15 minutes.

INTERPRETATION OF RESULT

Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).

Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).

Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test Midstream.

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.