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14th April 2021  Product update: rapidvirology staff writer

Detect HIV & Hepatitis in Blood for Transfusion with CE-marked Nucleic Acid Assay


Grifols has announced its Procleix UltrioPlex E assay has received CE-marking.

The Procleix UltrioPlex E Assay is a nucleic acid test (NAT) designed to improve blood safety by detecting the presence of human immunodeficiency virus type 1 (HIV-1), HIV type 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and hepatitis E virus (HEV) in a single, simultaneous test from human serum or plasma.

It was first commercially launched in August 2020 in Japan and represents a significant advance in streamlining a laboratory’s NAT testing operations by allowing for increased screening of viruses from a single-donor specimen without the need for any additional equipment.

The Procleix UltrioPlex E Assay also helps produce less waste with higher results throughput and greater walk-away time for laboratory staff when compared with running current screening solutions separately.

The Procleix UltrioPlex E  will be available in all markets accepting the CE mark after completion of any additional registration and notification requirement.

UltrioPlex E Assay Specifications:

The Procleix UltrioPlex E Assay is a nucleic acid test (NAT) that uses Transcription-Mediated Amplification (TMA) to detect the presence of specific nucleic acid sequences for HIV-1, HIV-2, HBV, HCV, and HEV in serum or plasma of donated blood.

Because of the high sensitivity and specificity of the amplification technology, detection of the targeted pathogens can be achieved within the early stages of infection, thereby helping in preventing infected blood or blood components to be transfused even when the donor does not exhibit symptoms and traditional screening techniques are not able to detect the presence of the pathogen, or the antibodies against it.

The assay runs on the Procleix Panther System, a fully automated NAT instrument launched by Grifols in the EU market in 2012 and currently widely adopted in laboratories globally.

Please use the 'Request Information' button provided below for more details on pricing and availability. 


    

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Date Published: 14th April 2021

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Note: This content has been edited by a rapidvirology.com staff writer for style and content.


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