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Description

The Clarity Diagnostics Clarity hCG Pregnancy Test Strip (#DTG-HCG25 / 25 per Box) consists of a pregnancy test pouch containing a test strip and desiccant.

The Clarity hCG Pregnancy Test Strip is a visual in vitro diagnostic tool that employs an immunochromatographic assay method for quickly determining the presence of human chorionic gonadotropin (hCG) in urine, which aids in detecting pregnancy. This test is designed for both professional usage and over-the-counter self-testing.

Under normal conditions, hCG can be found in urine 1 to 2 weeks after conception. The Clarity Pregnancy One Step Rapid Test uses special antibodies to detect increased hCG levels. Positive samples form a colored line on the test membrane, while the absence of this line usually indicates a negative result. The test maintains its accuracy even in the presence of related hormones at high levels.

Features

Clarity Diagnostics Clarity hCG Pregnancy Test Strip Features

  • One-step.
  • 99% overall accuracy.
  • 24 month dating.
  • Room temperature storage.
  • Built-in quality control.

Frequently asked questions

Is this test approved for over-the-counter home use?

Yes, the Clarity hCG Pregnancy Test Strip is explicitly designed for both professional in vitro diagnostic use and over-the-counter (OTC) self-testing.

This makes it an excellent choice for home use due to its combination of reliability and simplicity:

  • High Accuracy: It offers 99% overall accuracy in detecting hCG.
  • Ease of Use: It utilizes a rapid, one-step testing procedure.
  • Regulatory Status: The test is classified as CLIA Waived, meaning it meets federal standards for simple, low-risk tests suitable for non-laboratory settings.
  • Built-in Quality Control: Features an integrated mechanism to help ensure reliable results every time.
Does this test include built-in quality control?

Yes, the Clarity Diagnostics Clarity hCG Pregnancy Test Strip includes built-in quality control. This feature is designed to ensure the test’s reliability and accuracy, providing greater confidence in the results.

Does the test provide rapid results?

Yes, the Clarity Diagnostics hCG Pregnancy Test Strip is designed to deliver rapid results. It utilizes a one-step visual immunochromatographic assay for a quick determination of pregnancy status, ensuring convenient and fast testing.

What components are in each test pouch?

Each Clarity hCG Pregnancy Test is supplied in an individually sealed pouch to ensure stability and moisture protection. The pouch contains the following components:

  • One pregnancy test strip
  • One desiccant for maintaining the dry environment necessary for accuracy.
Is this rapid test CLIA Waived for broad usability?

Yes, the Clarity hCG Pregnancy Test Strip is officially CLIA Waived.

This designation confirms its simplicity and accuracy, making it suitable for both professional in vitro diagnostic use and over-the-counter self-testing by consumers.

The test utilizes a reliable, one-step immunochromatographic assay with a 99% overall accuracy. It also features a built-in quality control mechanism to ensure dependable results with every use.

Is the Clarity hCG test highly accurate?

Yes, the Clarity hCG Pregnancy Test Strip is designed for highly reliable detection.

  • Exceptional Accuracy: This test boasts 99% overall accuracy in detecting elevated levels of human chorionic gonadotropin (hCG) in urine.
  • Reliable Testing: It uses a rapid, one-step immunochromatographic assay and includes a built-in quality control mechanism to help ensure dependable performance.
Can this test be stored at room temperature?

Yes, the Clarity hCG Pregnancy Test Strip is designed for easy and reliable storage at room temperature, which simplifies inventory and preparation.

For optimal performance, the test strips should be stored within the specific range:

  • 36°F to 86°F
  • 2°C to 30°C

Additionally, the product has a long 24-month dating period.

What is the test strip's dating period?

The Clarity Diagnostics Clarity hCG Pregnancy Test Strip features 24-month dating (shelf life). This allows for long-term storage, which is further simplified by the ability to store the test strips conveniently at room temperature.

When can hCG be detected?

The Clarity hCG Pregnancy Test Strip is designed to detect the presence of human chorionic gonadotropin (hCG) in urine. This hormone is the primary indicator of pregnancy.

  • Detection Window: hCG levels typically become detectable in urine 1 to 2 weeks following conception.
  • Accuracy: This rapid, one-step test offers 99% overall accuracy.
  • Technology: It utilizes an immunochromatographic assay with specialized antibodies to ensure reliable detection of elevated hCG concentrations.
How soon can this test detect pregnancy?

The Clarity Diagnostics hCG Pregnancy Test Strip detects human chorionic gonadotropin (hCG) in urine.HCG is the hormone produced during pregnancy and generally becomes detectable in urine samples approximately 1 to 2 weeks following conception.The test is highly reliable, offering 99% overall accuracy.