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CE-IVD compliant collection-through-extraction workflow for ccfDNA

The PAXgene Blood ccfDNA Tube (CE-IVD) with the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) and the QIAGEN QIAsymphony instrument (CE-IVD) have been verified and validated as an integrated CE-IVD compliant workflow. The QIAsymphony PAXgene Blood ccfDNA (CE-IVD) system is the first collection-through-extraction CE-IVD compliant workflow for ccfDNA.

In addition, we have received the In Vitro Diagnostic (IVD) EU Quality Management System (QMS) Certificate according to ISO 13485 and compliance to the new EU IVDR 2017/746 for In Vitro Diagnostic Medical Devices (IVDR) for PAXgene Blood Collection Tubes (CE-IVD) and QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD).

The QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) is revolutionizing blood sample processing for ccfDNA extraction. The complete system consists of:

  • QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD)
  • PAXgene Blood ccfDNA Tube (CE-IVD)
  • QIAsymphony SP instrument

Workflow to increase your efficiency

Workflow to increase your efficiency

The QIAsymphony PAXgene Blood ccfDNA (CE-IVD) system provides a streamlined, CE-IVD compliant workflow for extracting ccfDNA:

  • No need to separate plasma from the cellular fraction into secondary tubes
  • Just one centrifugation step prior to loading onto the QIAsymphony SP instrument
  • Direct processing of primary blood collection tubes is 3x faster than when using methods involving secondary tubes

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Increase efficiency and reduce waste

Maximize productivity, minimize waste

By not using secondary tubes, you significantly lower costs and reduce biohazardous waste by almost 80%. Without the need for sample transfer, you minimize the risk of sample misidentification and blood exposure. Ultimately, by processing primary blood collection tubes, you save time, money and resources, while reducing waste and the potential for error. The QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) – simplifying your blood sample processing, increasing your productivity.

Flexible and effective

Flexible and effective

QIAsymphony PAXgene Blood ccfDNA (CE-IVD) system provides flexibility in the sample volumes you choose to process. PAXgene Blood ccfDNA Tube (CE-IVD) handling protocols are available for sample input volumes of 2.4 ml and 4.0 ml plasma. Compared to processing methods requiring secondary tubes, the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) provides consistent and comparable high ccfDNA yields.

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Now available and CE-IVD compliant

Now available and CE-IVD compliant

With the new QIAsymphony PAXgene Blood ccfDNA (CE-IVD) system you can save time and resources, while reducing waste and costs. The CE-IVD compliant collection-through-extraction workflow for extracting ccfDNA provides flexibility in sample volumes without sacrificing performance. Explore the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) and see how it can improve your blood sample processing for ccfDNA extraction.

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Interested in the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD)?

If you would like more information on the QIAsymphony PAXgene Blood ccfDNA (CE-IVD) system, please sign up below and we’ll contact you.

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