Dual-Level hCG Assessment in a Single Test

The NOVAtest® One Step hCG Advanced Urine Test is a rapid immunochromatographic in vitro diagnostic test designed for the semi-quantitative assessment of human chorionic gonadotropin (hCG) in urine.

The test features a highly specific double-antibody sandwich immunoassay and a dual-test-line configuration. The two test lines provide different levels of hCG indication:

· T1 line: indicates an hCG level range associated with approximately 1–3 weeks of pregnancy

· T2 line: indicates a higher hCG level range associated with approximately 3 weeks or more of pregnancy

Results can be visually interpreted in approximately 5 minutes, without the need for dedicated analytical instrumentation.

The test is designed for professional use and provides a simple approach to assessing changes in urinary hCG levels through a single test device.

One Test. Two hCG Levels. More Information.

Unlike conventional qualitative pregnancy tests that use a single test line, the NOVAtest® One Step hCG Advanced Urine Test incorporates two test lines with different hCG response thresholds.

As urinary hCG levels increase, the test can provide a visual indication of progression between the predefined detection ranges.

T1 — Lower hCG Range

The T1 line is designed to indicate an hCG level associated with approximately 1–3 weeks of pregnancy.

T2 — Higher hCG Range

The T2 line is designed to indicate a higher hCG level associated with approximately 3 weeks or more of pregnancy.

This two-level configuration provides more information than a conventional single-threshold qualitative test while maintaining a simple visual interpretation.

Important: The relationship between hCG concentration and gestational age can vary significantly between individuals. T1/T2 results should therefore be interpreted as an indication of predefined hCG ranges rather than an exact determination of gestational age.

Dual-Level Semi-Quantitative Assessment

The two-test-line configuration provides an indication of two predefined hCG level ranges, offering more information than a conventional qualitative pregnancy test.

Simple Two-Line Differentiation

The T1 and T2 lines provide a straightforward visual indication of the detected hCG level range, allowing professional users to assess the result without dedicated analytical instrumentation.

High Sensitivity for Early hCG Detection

With a detection sensitivity as low as 25 mIU/mL hCG, the test is designed to support sensitive detection of pregnancy-related hCG.

Rapid Results in Approximately 5 Minutes

Results are available in approximately 5 minutes, supporting efficient professional pregnancy testing and timely assessment.

Reliable Double-Antibody Technology

The test utilizes a highly specific double-antibody sandwich immunoassay, with hCG detection traceable to the 5th WHO International Standard, supporting consistent analytical performance.

Manual Testing Without Dedicated Instrumentation

The test is designed for manual operation and visual interpretation, providing a straightforward testing workflow for appropriate professional settings.

Support Pregnancy Assessment

By providing an indication of urinary hCG level ranges, the test can provide additional information to support professional assessment alongside other clinical information and diagnostic methods.

Supporting More Informed Professional Pregnancy Testing

The NOVAtest® One Step hCG Advanced Urine Test combines a dual-test-line semi-quantitative design, 25 mIU/mL sensitivity, rapid 5-minute results, and instrument-free manual testing in a single professional IVD solution.

By providing an indication of two predefined urinary hCG ranges, the test goes beyond a simple positive or negative result while maintaining a straightforward visual testing workflow.

For complete information regarding intended use, specimen requirements, testing procedures, performance characteristics, limitations, and result interpretation, please refer to the product's Instructions for Use.

During early pregnancy, hCG levels generally increase substantially, but the actual concentration can vary considerably between individuals and across different stages of pregnancy.

A conventional pregnancy test answers an important question:

Is hCG detected?

However, when additional information about the detected hCG level is useful, a semi-quantitative approach can provide greater context.

The NOVAtest® One Step Advanced Urine Test uses two predefined hCG response thresholds to provide an indication of whether the detected urinary hCG level falls within a lower or higher range.

This additional information can support professional assessment of early pregnancy when considered together with clinical history, symptoms, and other diagnostic findings.

Importantly, hCG level alone should not be used to determine exact gestational age or pregnancy viability. Where clinically indicated, healthcare professionals may use quantitative serum hCG testing, ultrasound, and other diagnostic assessments for further evaluation.

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