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

<ul>
<li><strong>Overall Accuracy:</strong> 99%</li>
<li><strong>Specificity:</strong> 100% (indicating no false positives)</li>
<li><strong>High Sensitivity:</strong> The test detects the hCG hormone at a concentration down to <strong>20mI U/ml</strong> in both urine and serum samples.</li>
</ul>
Does this test accept both urine and serum samples?
<p>Yes, the Clarity hCG Combo Cassette is specifically designed for <strong>dual sample compatibility</strong>, offering clinicians the versatility to test both <strong>urine and serum specimens</strong> to determine pregnancy status. This high level of utility is ideal for various clinical settings.</p>

<p>This test provides excellent clinical performance across both sample types:</p>

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

<p>Furthermore, the cassettes are designed for easy inventory management, featuring a <strong>24-month shelf life</strong> and only requiring simple <strong>room temperature storage</strong>.</p>
Does this test feature an extended shelf life?
<p>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:</p>

<ul>
<li><strong>Extended Shelf Life:</strong> The tests have a generous <strong>24-month dating period</strong>, which is ideal for long-term inventory storage.</li>
<li><strong>Convenient Storage:</strong> They only require storage at <strong>room temperature</strong>, simplifying logistics and handling in various clinical settings.</li>
</ul>
Does this test have high sensitivity?
<p>Yes, the Clarity hCG Combo Test offers <strong>optimal sensitivity</strong> for reliable clinical diagnosis of pregnancy.</p>

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

<p>Furthermore, the test boasts superior clinical performance, offering 99% overall accuracy and perfect (100%) specificity.</p>
What items are included in the box of 50 tests?
<p>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:&lt;ul&gt;&lt;li&gt;<strong>50 individually packed test devices</strong> (cassettes)&lt;/li&gt;&lt;li&gt;<strong>Disposable pipettes</strong> for accurate sample handling&lt;/li&gt;&lt;li&gt;A comprehensive <strong>package insert</strong> detailing instructions for use&lt;/li&gt;&lt;/ul&gt;</p>
Is the test CLIA Waived?
<p>Yes, this pregnancy test is available in different configurations to suit specific clinical regulatory requirements.</p>

<p>The test comes in two main options:</p>

<ul>
<li><strong>CLIA Waived Configuration (Model #DTG-COMBO):</strong> This option is certified as CLIA Waived, making it ideal for simple and rapid point-of-care diagnostics.</li>
<li><strong>Standard Configuration (Model #CLA-COMBO10):</strong> This variant is available for facilities requiring a standard diagnostic configuration.</li>
</ul>
Does the Clarity hCG test offer 100% specificity?
<p>Yes, the Clarity hCG Combo Pregnancy Test is engineered for <strong>superior clinical performance</strong>, boasting <strong>100% specificity</strong>.</p>

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

<p>Other key specifications and advantages include:</p>

<ul>
<li><strong>Overall Accuracy:</strong> The test achieves a high <strong>99% overall accuracy</strong> rate.</li>
<li><strong>Optimal Sensitivity:</strong> It detects hCG concentrations down to <strong>20 mI U/ml</strong> in both urine and serum samples.</li>
<li><strong>Dual Sample Use:</strong> Provides versatility as it is compatible with both <strong>urine and serum</strong> matrices.</li>
<li><strong>Inventory Management:</strong> Features a 24-month shelf life and requires only convenient room temperature storage.</li>
<li><strong>Configurations:</strong> Available in both <strong>CLIA Waived</strong> and Standard options to meet various clinical needs.</li>
</ul>
Can these tests be conveniently stored at room temperature?
<p>Yes, these Clarity hCG Combo Cassettes are designed for optimal convenience and long-term storage in clinical settings.</p>

<ul>
<li><strong>Storage Condition:</strong> The tests only require <strong>room temperature</strong> storage.</li>
<li><strong>Shelf Life:</strong> They feature an excellent <strong>24-month dating period</strong> (shelf life) from the date of manufacture, simplifying inventory management.</li>
</ul>