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Description

The Clarity Diagnostics Clarity hCG Combo Urine/Serum Pregnancy Test Cassette (50 / Box) includes individually packed test devices, package insert, and disposable pipettes. Clinicians can use this test to detect the presence of the hCG hormone in urine to determine a patient's pregnancy status.

Features

Clarity Diagnostics Clarity hCG Combo Urine/Serum Pregnancy Test Cassette Features

  • 24 month dating.
  • Specificity: 100%.
  • 99% overall accuracy.
  • Room temperature storage.
  • Sensitivity: 20mI U/ml urine or serum.

Configurations

Clarity Diagnostics Clarity hCG Combo Urine/Serum Pregnancy Test Cassette Configurations

  • #DTG-COMBO: CLIA Waived.
  • #CLA-COMBO10: Standard.

Frequently asked questions

Is this hCG test highly accurate?

Yes, the Clarity hCG Combo Cassette offers high clinical performance for professional use, capable of testing both urine and serum samples. The test provides exceptional reliability, validated by the following specifications:

  • Overall Accuracy: 99%
  • Specificity: 100% (indicating no false positives)
  • High Sensitivity: The test detects the hCG hormone at a concentration down to 20mI U/ml in both urine and serum samples.
Does this test accept both urine and serum samples?

Yes, the Clarity hCG Combo Cassette is specifically designed for dual sample compatibility, offering clinicians the versatility to test both urine and serum specimens to determine pregnancy status. This high level of utility is ideal for various clinical settings.

This test provides excellent clinical performance across both sample types:

  • Overall Accuracy: 99%
  • Specificity: 100%
  • High Sensitivity: It detects hCG down to a concentration of 20mI U/ml for both urine and serum samples.

Furthermore, the cassettes are designed for easy inventory management, featuring a 24-month shelf life and only requiring simple room temperature storage.

Does this test feature an extended shelf life?

Yes, these Clarity Diagnostics hCG Combo Test Cassettes are designed for convenient inventory management and usage, featuring both an extended shelf life and simple storage requirements:

  • Extended Shelf Life: The tests have a generous 24-month dating period, which is ideal for long-term inventory storage.
  • Convenient Storage: They only require storage at room temperature, simplifying logistics and handling in various clinical settings.
Does this test have high sensitivity?

Yes, the Clarity hCG Combo Test offers optimal sensitivity for reliable clinical diagnosis of pregnancy.

  • Sensitivity Threshold: The test can detect hCG concentrations down to 20mI U/ml in samples.
  • Sample Compatibility: This high sensitivity is achieved whether testing urine or serum specimens, providing excellent versatility.

Furthermore, the test boasts superior clinical performance, offering 99% overall accuracy and perfect (100%) specificity.

What items are included in the box of 50 tests?

The Clarity Diagnostics hCG Combo Test is supplied in a box containing 50 complete testing units intended for professional clinical use. To ensure sterility and convenience, each box includes the following components:<ul><li>50 individually packed test devices (cassettes)</li><li>Disposable pipettes for accurate sample handling</li><li>A comprehensive package insert detailing instructions for use</li></ul>

Is the test CLIA Waived?

Yes, this pregnancy test is available in different configurations to suit specific clinical regulatory requirements.

The test comes in two main options:

  • CLIA Waived Configuration (Model #DTG-COMBO): This option is certified as CLIA Waived, making it ideal for simple and rapid point-of-care diagnostics.
  • Standard Configuration (Model #CLA-COMBO10): This variant is available for facilities requiring a standard diagnostic configuration.
Does the Clarity hCG test offer 100% specificity?

Yes, the Clarity hCG Combo Pregnancy Test is engineered for superior clinical performance, boasting 100% specificity.

This high level of diagnostic performance ensures maximum reliability by correctly identifying samples that truly do not contain the hCG hormone.

Other key specifications and advantages include:

  • Overall Accuracy: The test achieves a high 99% overall accuracy rate.
  • Optimal Sensitivity: It detects hCG concentrations down to 20 mI U/ml in both urine and serum samples.
  • Dual Sample Use: Provides versatility as it is compatible with both urine and serum matrices.
  • Inventory Management: Features a 24-month shelf life and requires only convenient room temperature storage.
  • Configurations: Available in both CLIA Waived and Standard options to meet various clinical needs.
Can these tests be conveniently stored at room temperature?

Yes, these Clarity hCG Combo Cassettes are designed for optimal convenience and long-term storage in clinical settings.

  • Storage Condition: The tests only require room temperature storage.
  • Shelf Life: They feature an excellent 24-month dating period (shelf life) from the date of manufacture, simplifying inventory management.
Are there different test configurations available?

Yes, the Clarity hCG Combo Test Cassette is available in two distinct configurations to accommodate various clinical and regulatory requirements:

  • CLIA Waived Configuration (Model #DTG-COMBO): This option is designated as CLIA Waived, making it suitable for point-of-care (POC) diagnostics in facilities seeking minimal regulatory complexity.
  • Standard Configuration (Model #CLA-COMBO10): This configuration is the standard option typically used in general clinical settings and laboratories.
What essential components are included in the box?

The box provides 50 complete, individually packaged test units, along with all necessary accessories for immediate use in a clinical setting:

  • 50 Individually packed test devices (cassettes)
  • Disposable pipettes for accurate sample handling
  • A package insert containing instructions and detailed product information