Procleix offers a broad and growing assay portfolio that expands your testing capabilities.


Procleix Zika virus assay

The Procleix Zika virus assay1 is an investigational test currently used in the Investigational New Drug (IND) clinical study in US. Procleix Zika virus assay is an in vitro nucleic acid amplification test for the detection of Zika virus RNA. The assay is designed for the fully integrated and automated Procleix Panther system. Procleix Zika virus assay and Procleix Panther system are not FDA approved products for commercial distribution in US.

For additional information regarding the IUO/PEO availability and participation in the FDA IND (Investigational New Drug) program, please send your inquiries to: NAT@grifols.com.


Procleix Dengue virus assay

The CE-marked Procleix Dengue virus assay2 addresses global Dengue virus prevalence concerns in donated blood and plasma products. The assay detects Dengue virus (serotypes 1 - 4) in plasma and serum specimens, and from organ and tissue donors, including cadaveric (non-heartbeating) donors.


Procleix HEV assay

The qualitative Procleix HEV assay3 provides highly sensitive detection of all four genotypes of the hepatitis E virus on the fully automated Procleix Panther system.


Procleix Ultrio assay family

The Procleix assays within the Ultrio family include Procleix Ultrio Elite4, Ultrio Plus and Ultrio assays. They combine the early detection capabilities of Nucleic Acid Testing (NAT) with single-tube TMA technology to deliver simultaneous results for HIV, HCV, and HBV. Members of the Procleix Ultrio family assays run on either the Procleix Panther system or the Procleix Tigris system. Procleix Ultrio Elite assay runs on the Procleix Panther system, while both, Procleix Ultrio & Procleix Ultrio Plus assays are compatible with the Procleix Tigris system.


Procleix Parvo/HAV assay

The Procleix Parvo/HAV assay5 reduces the risk of parvovirus B19 and hepatitis A virus transmission in plasma-derived products while optimizing your NAT testing efficiency. It provides operator-assigned parvovirus B19 quantitative cut-off and ensures simultaneous quantification and qualitative detection of parvovirus B19 and HAV, respectively. This assay runs on both, the Procleix Panther system and the Procleix Tigris system.

Note: Procleix WNV assay is only FDA-approved on the Procleix Tigris system.


Procleix WNV assay

The leading CE-mark certified and FDA-approved6 Procleix WNV assay achieves proven sensitivity and specificity. This assay is compatible on both, Procleix Panther system and Procleix Tigris system.


 

Ask your local Grifols representative or contact us for more information on the Procleix assays7.

 

References:

  1. Disclaimer: The ZIKV assay will be available for use under an effective IND in US, providing all requirements for opening an investigational study are met (US regulations 21 CFR Part 312). The ZIKV assay is for Investigational Use Only. The performance characteristics of this product have not been established. The Procleix Panther system is not available for commercial use in the US. For Investigational Use Only. Performance characteristics have not been established. The information contained herein is solely for scientific discussion purpose and not for promotional use.
  2. The performance characteristics of the Procleix Dengue virus assay have not been evaluated for blood screening use in the US.
  3. The performance characteristics of the Procleix HEV assay have not been evaluated for blood screening use in the US.
  4. The performance characteristics of the Procleix Ultrio Elite assay have not been evaluated for blood screening use in the US.
  5. In the US, the Procleix Parvo/HAV assay (for use on the Procleix Tigris system) is an in-process test that is available for commercial sale. The performance specifications have not been reviewed and approved by the FDA.
  6. Procleix WNV assay is only FDA-approved on the Procleix Tigris system.
  7. Product registration and commercial availability vary. For a complete list, view the table on our Approvals page.