Description

One-Step Pregnancy hCG Urine Test Cassette CLIA Waived 25/Box

The Pregnancy urine test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. hCG is a hormone produced by the placenta, which, in normal subjects, provides an early indication of pregnancy. The One-Step Pregnancy urine test provides a qualitative screening result and is for healthcare professionals' use only and not for self-testing. The test is available in cassette, strip, and mid-stream formats.

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced in pregnancy that is made by the developing embryo after conception and later by the syncytiotrophoblast. In a normal pregnancy, hCG can be detected in urine as early as 1-2 weeks after conception. hCG levels continue to rise very rapidly, usually exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. Early pregnancy testing, in general, is based on the detection or measurement of hCG. The Pregnancy One Step Rapid Test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. At the level of claimed sensitivity, the Pregnancy One Step Rapid Test shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH, and hTSH at high physiological levels.

hCG Urine Test Cassette
Method	Lateral flow test
Sensitivity / Detection Level	25 mIU/mL
Accuracy	> 99%
Sample	Urine
Read time	3-5 minutes
Storage	Room temperature
Shelf life	12-18 months from the manufacture date
CLIA Classification	Waived
FDA 510(k) No.	#103574

One-Step hCG Pregnancy Test Cassette

Features & Benefits

CLIA Waived & FDA Approved for Urine
Sensitivity: 25 mIU
Simple one-step procedure
Speedy results; minimizes user error
Built-in Control Indicates the test has been performed correctly
12-18-month shelf life at room temp. (from date of manufacture)
No special storage requirements to maintain stability
Consistent, on-time supply & superior customer service / technical support

Download & Print Reference Documents

One-Step hCG Pregnancy Cassette Package Insert

hCG Format Options
Format	Sensitivity	Catalog No.	Certifications
hCG Pregnancy Rapid Test Strip	25 mIU/ml	GAHCG-101a	CE Marked, FDA CLIA Waived
hCG Pregnancy Rapid Test Cassette	25 mIU/ml	GAHCG-102a	CE Marked, FDA CLIA Waived
hCG Pregnancy Rapid Test Midstream	25 mIU/ml	GAHCG-103a	CE Marked, FDA CLIA Waived