HCG Test Kit

Human Chorionic Gonadotropin (HCG) Test Kit

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:

Urine	Content
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	(Repeatability and Reproducibility) 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

WARNINGS AND PRECAUTIONS

For in vitro diagnostic use only.

Do not use after the expiration date shown on the pouch. Do not reuse.
Do not use if the pouch seal or its packaging is compromised.
Do not mix and interchange different specimens.
Wear protective clothing such as laboratory coats, disposable gloves and eye protection while handling potentially infectious materials or performing the assay.
Wash hands thoroughly after finishing the tests.
Do not eat, drink or smoke in the area where the specimens or kits are being handled.
Clean up spills thoroughly with appropriate disinfectants.
Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing procedures.
Dispose of all specimens and used kits in a proper biohazard container. The handling and disposal of the hazardous materials should follow local, national or regional regulations.
Keep out of children’s reach.