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Description

The Clarity hCG Urine Cassette Pregnancy Test includes a product insert.

The Pregnancy Rapid Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. It is designed for both professional use and OTC self-test use.

Features

Clarity hCG Urine Cassette Pregnancy Test Features

  • Sensitivity of 25 mlU/ml.
  • Specificity of 100% - no cross reaction with FSH/TSH/LH.
  • 99% overall accuracy.
  • CLIA waived.
  • 24 month dating.

Package Quantities

Clarity hCG Urine Cassette Pregnancy Test Package Quantities

  • #DTG-PLUS25: Box of 25.
  • #DTG-HCGPLUS50: Box of 50.

Frequently asked questions

Is the Clarity pregnancy test highly accurate?

Yes, the Clarity hCG Urine Cassette Pregnancy Test is designed for high performance and reliability, boasting excellent clinical metrics.

Key performance specifications include:

  • Overall Accuracy: The test achieves a high 99% overall accuracy in pregnancy determination.
  • Specificity: It offers 100% specificity, ensuring reliable results by showing no cross-reaction with other common hormones such as FSH, TSH, or LH.
  • Sensitivity: This test is highly sensitive, capable of detecting hCG at concentrations as low as 25 mIU/mL.

Furthermore, this product is CLIA waived, making it suitable for both professional laboratory use and over-the-counter self-testing applications.

Is the hCG pregnancy test CLIA waived?

Yes, the Clarity Diagnostics Clarity hCG Pregnancy Test Cassette is officially CLIA waived.

This designation is crucial for professional use as it:

  • Indicates suitability for use in a wide range of healthcare settings, including clinics and laboratories.
  • Allows for efficient rapid screening in point-of-care environments without stringent regulatory oversight.
Is the Clarity hCG cassette suitable for professional use?

Yes, the Clarity hCG Urine Cassette Pregnancy Test is explicitly designed for use in professional clinical environments as well as for consumer self-testing (OTC).

Its features ensure reliability and ease of use in point-of-care (POC) settings:

  • CLIA Waived Status: This regulatory status allows for broader usability across various clinical settings.
  • High Reliability: The test boasts an exceptional 99% overall accuracy and 100% specificity, ensuring reliable results without cross-reaction from related hormones (FSH, TSH, LH).
  • High Sensitivity: It features a sensitivity level of 25 mlU/ml for the reliable, rapid determination of the hCG hormone in urine.
  • Bulk Availability: The test is available in boxes of 25 or 50 units, catering efficiently to high-volume testing environments.
Is the test highly specific against other common hormones?

Yes, this pregnancy test boasts 100% specificity, which is a key performance feature. This ensures that the test will show no cross-reaction with related hormones, helping to prevent false positive results.nThe test specifically avoids cross-reaction with:

  • FSH (Follicle-Stimulating Hormone)
  • TSH (Thyroid-Stimulating Hormone)
  • LH (Luteinizing Hormone)
Does the test have a high sensitivity for early detection?

Yes, the Clarity hCG Urine Cassette Pregnancy Test is highly sensitive, capable of detecting hCG at concentrations as low as 25 mIU/mL, which aids in early pregnancy detection.

Does this test prevent errors from common hormone interference?

Yes, the Clarity hCG test is engineered with 100% specificity. This means it is specifically calibrated to avoid cross-reaction with other hormones, such as:

  • FSH (Follicle-stimulating hormone)
  • TSH (Thyroid-stimulating hormone)
  • LH (Luteinizing hormone)

This precise design ensures that the result you receive is focused entirely on detecting hCG, providing you with reliable and targeted diagnostic confidence.

Does the test cassette have a long shelf life?

Yes, the Clarity hCG Pregnancy Test Cassette offers a favorable shelf life. The product has a dating period of 24 months.

What package quantities are available?

The Clarity hCG Pregnancy Test Cassette is available in two convenient package options:

  • Box of 25 test cassettes
  • Box of 50 test cassettes
Is this a rapid pregnancy test?

Yes, the Clarity hCG Urine Cassette Pregnancy Test is specifically designed for the rapid determination of pregnancy.

This rapid capability ensures quick results, making the test highly efficient for professional laboratory use and convenient for over-the-counter (OTC) self-testing applications.

What is the high sensitivity level?

The Clarity hCG Urine Cassette Pregnancy Test features a high sensitivity level, capable of detecting the human chorionic gonadotropin (hCG) hormone at concentrations as low as 25 mIU/mL. This highly sensitive threshold is designed for reliable and rapid determination to aid in the detection of early pregnancy.