Lomina hCG Enhanced Sensitivity Test

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced and developed by the placenta shortly after fertilization. In a normal pregnancy, hCG can be detected in both urine and serum or plasma as early as 7 to 10 days after conception. The level of hCG continues to rise very rapidly, often exceeding 100mIU/ml by the first missed menstrual period and peaking in the range of 100,000-200,000mIU/ml at approximately 10-12 weeks of pregnancy. The occurrence of hCG in both urine and serum or plasma soon after conception and its subsequent rapid increase in concentration during early gestational growth makes it an excellent marker for early detection of pregnancy.

Intended Use:

The Lomina Pregnancy Enhanced Sensitivity Test is a rapid chromatographic immunoassay for the quantitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.

Pregnancy Enhanced Sensitivity Test:

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced and developed by the placenta shortly after fertilization. In a normal pregnancy, hCG can be detected in both urine and serum or plasma as early as 7 to 10 days after conception. The level of hCG continues to rise very rapidly, often exceeding 100mIU/ml by the first missed menstrual period and peaking in the range of 100,000-200,000mIU/ml at approximately 10-12 weeks of pregnancy. The occurrence of hCG in both urine and serum or plasma soon after conception and its subsequent rapid increase in concentration during early gestational growth makes it an excellent marker for early detection of pregnancy.

Available Packaging Variants:

Usable Biological Material:

The test is developed and tested from a human urine sample.

Urine sample

Major Parameters, Characteristics & Limits

Test duration: 3 min
Disease category: Pregnancy test

Sensitivity: 100% (95.0%CI: 47.8%-100%)
Specificity: 100% (95.0%CI: 96.5%-100%)
Accuracy: 100% (95.0%CI: 96.7%-100%)

Principle:

The Lomina Pregnancy Enhanced Sensitivity Test is a rapid one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test uses a combination of antibodies including a monoclonal anti-hCG antibody that selectively detects elevated levels of hCG. The test is performed by adding urine to a hydrophilic stick and obtaining the result from coloured lines.

Interpretation:

A. Negative test result:

A single coloured bar appears in the control area (C). No stripe appears in the test area (T). This result means that you are probably not pregnant.

B. Positive test result:

Two distinctive coloured stripes appear. One stripe should be in the control area (C) and the other in the test area (T). One stripe may be lighter than the other; they may not match. This bump means you are probably pregnant.

C. Invalid test result:

The result is invalid if no coloured stripe appears in the control area (C), even if a stripe appears in the test area (T). The most likely cause of the control area failure is insufficient sample volume or incorrect procedure. Check the procedure and repeat the test with a new test strip. If the problem persists, stop using the test kit immediately and contact your local distributor.

Download:

Document

EnglishGermanCzech

Instructions for use (IFU)

-

-

Download

CE Certificate

Download

-

-

High sensitivity and specificity of tests

Quick test
evaluation

Tested in accredited laboratories

Simple
application

Připravujeme. Již brzy!