Flexible hCG Testing for Professional Use

The NOVAtest® One Step hCG Combo Test is a rapid immunochromatographic in vitro diagnostic test for the qualitative detection of human chorionic gonadotropin (hCG) in human serum and urine specimens as an aid in the early detection of pregnancy.

The test employs a highly specific double-antibody sandwich immunoassay and provides visually interpretable results in approximately 5 minutes, with a detection sensitivity of 25 mIU/mL hCG.

Available in strip and cassette formats, the test is designed for professional use in laboratories, clinics, and other appropriate healthcare settings.

Dual-Specimen Compatibility

The NOVAtest® supports hCG detection in both serum and urine specimens, allowing healthcare professionals to select the appropriate specimen type according to the clinical setting and testing workflow.

High Sensitivity for hCG Detection

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

Rapid 5-Minute Results

Clear visual results are available in approximately 5 minutes, supporting efficient testing and timely clinical assessment.

Reliable Double-Antibody Technology

The test utilizes a highly specific double-antibody sandwich immunoassay designed to provide reliable qualitative detection of hCG.

The test demonstrates more than 99% relative sensitivity for pregnancy detection based on the applicable performance evaluation.

Flexible Strip and Cassette Formats

Available in both strip and cassette formats, the product can accommodate different professional testing workflows and operational preferences.

Manual Testing Without Dedicated Instrumentation

The test is designed for manual operation without dedicated analytical instrumentation, providing a straightforward testing procedure for appropriate professional settings.

Support Professional Pregnancy Assessment

Rapid hCG detection can provide healthcare professionals with timely information to support the initial assessment of suspected pregnancy and determine whether further clinical evaluation may be appropriate.

Supporting Flexible Professional Pregnancy Testing

The NOVAtest® One Step hCG Combo Test combines serum and urine compatibility, 25 mIU/mL detection sensitivity, rapid 5-minute results, and flexible strip and cassette formats in one professional IVD solution.

Designed for professional use, the test provides healthcare professionals with a practical and flexible approach to qualitative hCG detection across different specimen types and testing environments.

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.

hCG can be detected in both blood and urine during pregnancy, but specimen selection may vary depending on the testing environment and clinical workflow.

Serum specimens can be used in professional laboratory and clinical settings, while urine specimens provide an alternative specimen type for appropriate professional testing applications.

Supporting both specimen types within one testing solution gives healthcare professionals greater flexibility when selecting a testing approach. This can be particularly useful across different clinical workflows where specimen availability and testing requirements may vary.

The ability to use either serum or urine also helps provide a more adaptable testing solution without requiring separate product platforms for different specimen types.

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