Lifesign 35135 - Status hCG urine only (CLIA waived), 35/BX

• CLIA WAIVED for urine
• Clear and definitive result lines
• Serum & Urine 25 mIU/mL sensitivity
• Simple one-step procedure
• Results in 3-5 minutes

Status hCG urine summary and Explanation

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the placental trophoblastic cells shortly after the fertilized ovum is implanted in the uterine wall.1-4 The primary function of hCG is to maintain the corpus luteum during early pregnancy. The appearance of hCG in both urine and serum soon after conception, and its rapid rise in concentration make it an excellent marker for pregnancy. The hormone level may become detectable in both urine and serum as early as 7 to 10 days after conception.1- 4 The concentration of hCG continues to rise rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period and peaking in the 30,000- 100,000 mIU/mL range by 10 to 12 weeks into pregnancy. The hormone is comprised of two non-covalently bound dissimilar subunits containing approximately 30% carbohydrate by weight.5 The alpha subunit is structurally similar to other human pituitary glycoprotein hormones, whereas the beta subunit confers unique biological and immunological specificity to the molecule.

The Status hCG One-Step Pregnancy Test is a rapid test for detecting pregnancy. The test is a solid-phase, two-site immunometric assay in which a combination of monoclonal and polyclonal antibodies is used to selectively detect hCG in urine with a high degree of sensitivity. In the test procedure, sample is added to the sample well using a dropper and sample is allowed to soak in. If hCG is present in the specimen, it will react with the conjugate dye, which binds to the antibody on the membrane to generate a colored line. Presence of two colored lines, one at the Test Position and the other at the Control Position, indicates a positive result, while the absence of the line at the Test position indicates a negative result.

Status hCG urine only (CLIA waived) Test Kit Components

Test strip/device, disposable droppers.

This product does not contain any hazardous substances above 1% or above 0.1% levels required, depending on the hazard.

Status hCG urine only (CLIA waived) Physical and Chemical Properties

Reagents and Materials Provided

Status hCG One-Step Pregnancy Test kit contains enough reagents and materials to perform all the tests.

• Status device. (Test device containing the polyclonal anti-hCG coated membrane and a pad with the mouse monoclonal IgG (anti-hCG)-dye conjugate in a protein matrix containing 0.1% sodium azide)
• Disposable dropper
• Package insert

Materials Maybe Required but Not Provided

• Timer
• Specimen cup
• Latex gloves

Test Procedure

STEP 1 For each test, open one Status hCG pouch, and label the Status device with the patient ID.

STEP 2 Holding the dropper in a vertical position, add 3 drops of sample into the Sample well (S).

STEP 3 Read the results at 35 minutes. Do not interpret the results after 5 minutes.