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LH Test
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LH Urine Midstream

Catalog NO.            PROUCT NAME

ABT-FT-C3              LH Urine Midstream


Accu-Tell® One Step LH Ovulation Test is a self-testing immunoassay for the qualitative detection of human Luteinizing hormone (LH) to predict the time of ovulation.

SENSITIVITY AND SPECIFICITY
The Accu-Tell® One Step LH Ovulation Test at a concentration of 35mIU/mL or greater. 300 know negative urine samples were
equally divided into 6 groups.Each group of samples(50) were spiked with LH to the concentration of 0mlU/ml, 10 mlU/ml, 20 mlU/ml, 35 mlU/ml, 50 mlU/ml and 5 IU/ml separately, calibration against WHO 3rd international standard. Each group of sample of samples were tested with Accu-Tell® One Step LH Ovulation Test. The results from this study gave 100% agreement with the expected results.
Result 0mlU/ml 10mlU/ml 20mlU/ml 35mlU/ml 50mlU/ml 5lU/ml Total
Positive        0                0                 0              50             50        50       150
Negative     50               50                50             0               0          0        150
Total          50               50                 50            50             50        50       300

Diagnostic sensitivity=100%(150/150)
Diagnostic specificy=100%( 150/150)
INTERFERENCE TESTING
Accu-Tell® One Step LH Ovulation Test has been tested with commonly known drugs and hormones including FSH(200mlU/ml),and TSH (200µIU/ML),At the levels tested,none of these substances interfered with the expected test results
For example:
Acetaminophen 20mg/dl
Acetylsalicylic Acid 20mg/dl
Ascorbic Acid 20mg/dl
Atropine 20mg/dl
Caffeine 20mg/dl
Gentesic Acid 20mg/dl
Glucose 2g/dl
Hemoglobin 1mg/dl

LIMITATIONS


1. Reagents used in the test kit are cross-reactive with HCG. The kit is intended only for the analysis of LH in HCG-free samples. Page 2 of 2 Version: 0901-sr One Step LH Ovulation Test Midstream for Urine Samples Effective Date: 2009-03
2. Women suffering form polycystic ovary syndrome may have elevated LH concentration.
3. The test kit will not work properly if you are pregnant, menopausal, or taking birth control pills.
4. The test kit results should not be affected by pain relievers. Antibiotics containing HCG or LH may affect the test and should not be taken while using the Accu-Tell® One Step LH Ovulation Test.

5.The test provides a presumptive diagnosis for the time of ovulation. The user should not take any decision of medical relevance without first consulting his or her medical practitioner