test product
Catalog Number: A01-01-113 (strip)/ A01-01-122 (cassette)/ A01-01-130 (Midstream)
INTENDED USE:
Artron one-step Human Chorionic Gonadotropin (HCG) Test Kit is a rapid and convenient immunochromatographic in vitro assay for the detection of HCG hormone in urine to help in early diagnosis of pregnancy. The device is designed for professional and self-testing use. The test provides a visual, qualitative result. Clinical expertise and professional judgment should be sought to further evaluate the result of the test.
DESCRIPTION:
HCG is a hormone produced by trophoblastic tissue and it appears around the 8-9th day after ovulation, or around the 4th day after conception. In a 28-day cycle with ovulation occurring at day 14, HCG can be detected in urine or serum in minute quantities around day 23, or 5 days before the expected menstruation. The hormone concentration doubles approximately every 2 days and peaks between 7-12 weeks after the first day of the last menstrual period. In normal females, HCG in urine provides an early indication of pregnancy. The elevated HCG levels are also associated with trophoblastic diseases and certain nontrophoblastic neoplasms. Thus, the possibility of other diseases must be eliminated before the diagnosis of pregnancy can be made.
SAMPLE TYPE:
Time to Results:
10 min (Strong positive specimens may produce positive results in as little time as 1 minute. Confirm negatives in 10-20 minutes.)
Analytical Sensitivity:
20mIU/mL
Analytical Specificity:
No cross-reactions were observed from all tested analytes at different concentrations
Interference:
No interference from common biological and chemical analytes
Diagnostic Sensitivity:
100%
Diagnostic Specificity:
98.1%
Accuracy:
99%
Precision
The precision was determined by replicate assays of both positive and negative samples with devices from three different production lots. The resultant data indicated no appreciable variation between tests and lots when testing both positive and negative samples.
Storage condition:
Store at 2-30°C, avoid direct sunlight and freezing.
Shelf life:
36 months
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WARNINGS AND PRECAUTIONS
- Product manufactured by leading Canadian IVD company
- Read test results in as fast as 5 minutes
- Over 99% accurate of the test to ensure a worry-free experience
- Easy to use with a user-friendly design and clear instruction