Two Viral Blood Screening Assays Get FDA Clearance
By LabMedica International staff writers Posted on 11 Jul 2018 |
Image: The Procleix Panther system, a fully integrated and automated nucleic acid technology system for blood and plasma screening (Photo courtesy of Grifols Diagnostics).
Hello,
A global producer of plasma-derived medicines and a developer of diagnostic solutions announced today that it has received approval from the U.S. Food & Drug Administration (FDA, Silver Springs, MD, USA) for two blood screening assays.
One assay that allows for increased blood safety by screening and delivering simultaneous results for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) as well as detecting HIV type 2 (HIV-2). The Procleix Ultrio Elite assay can be used to test pools of plasma composed of up to 96 individual donations from donors of source plasma. Procleix WNV assay is a highly sensitive, qualitative in vitro nucleic acid assay for the detection of West Nile virus RNA in plasma and serum of human blood donors.
Both assays will run on the fully automated nucleic acid testing (NAT) blood screening platform Grifols’ Procleix Panther system. The device is an integrated nucleic acid testing system that fully automates all necessary steps to perform Procleix assays, from sample processing through amplification, detection, and data reduction. The Procleix Panther system was created to be a fully automated sample-to-result instrument that eliminates the need for batch processing. Grifols will begin commercializing the Procleix Ultrio Elite and Procleix WNV assays in the USA later this year.
The system received CE marking and launched in Europe in 2012 and in 2016, the FDA allowed blood centers to use the Grifols’ Procleix Zika virus assay with the Procleix Panther system under an Investigational New Drug (IND) study protocol to screen donated blood nationwide. The firm has since launched an IND Babesia screening test on the platform.
Carsten Schroeder, BA, MBA, the president of Grifols' diagnostic division, said, “The addition of the Procleix Panther system with these assays will allow blood centers to efficiently screen for infectious diseases on one simple, automated platform while adapting to changes in donation volume and regulatory requirements.”
Related Links:
U.S. Food & Drug Administration
A global producer of plasma-derived medicines and a developer of diagnostic solutions announced today that it has received approval from the U.S. Food & Drug Administration (FDA, Silver Springs, MD, USA) for two blood screening assays.
One assay that allows for increased blood safety by screening and delivering simultaneous results for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) as well as detecting HIV type 2 (HIV-2). The Procleix Ultrio Elite assay can be used to test pools of plasma composed of up to 96 individual donations from donors of source plasma. Procleix WNV assay is a highly sensitive, qualitative in vitro nucleic acid assay for the detection of West Nile virus RNA in plasma and serum of human blood donors.
Both assays will run on the fully automated nucleic acid testing (NAT) blood screening platform Grifols’ Procleix Panther system. The device is an integrated nucleic acid testing system that fully automates all necessary steps to perform Procleix assays, from sample processing through amplification, detection, and data reduction. The Procleix Panther system was created to be a fully automated sample-to-result instrument that eliminates the need for batch processing. Grifols will begin commercializing the Procleix Ultrio Elite and Procleix WNV assays in the USA later this year.
The system received CE marking and launched in Europe in 2012 and in 2016, the FDA allowed blood centers to use the Grifols’ Procleix Zika virus assay with the Procleix Panther system under an Investigational New Drug (IND) study protocol to screen donated blood nationwide. The firm has since launched an IND Babesia screening test on the platform.
Carsten Schroeder, BA, MBA, the president of Grifols' diagnostic division, said, “The addition of the Procleix Panther system with these assays will allow blood centers to efficiently screen for infectious diseases on one simple, automated platform while adapting to changes in donation volume and regulatory requirements.”
Related Links:
U.S. Food & Drug Administration
Latest Microbiology News
- Integrated Solution Ushers New Era of Automated Tuberculosis Testing
- Automated Sepsis Test System Enables Rapid Diagnosis for Patients with Severe Bloodstream Infections
- Enhanced Rapid Syndromic Molecular Diagnostic Solution Detects Broad Range of Infectious Diseases
- Clinical Decision Support Software a Game-Changer in Antimicrobial Resistance Battle
- New CE-Marked Hepatitis Assays to Help Diagnose Infections Earlier
- 1 Hour, Direct-From-Blood Multiplex PCR Test Identifies 95% of Sepsis-Causing Pathogens
- Mouth Bacteria Test Could Predict Colon Cancer Progression
- Unique Metabolic Signature Could Enable Sepsis Diagnosis within One Hour of Blood Collection
- Groundbreaking Diagnostic Platform Provides AST Results With Unprecedented Speed
- Simple Blood Test Combined With Personalized Risk Model Improves Sepsis Diagnosis
- Blood Analysis Predicts Sepsis and Organ Failure in Children
- TB Blood Test Could Detect Millions of Silent Spreaders
- New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours
- New Tuberculosis Test to Expand Testing Access in Low- and Middle-Income Countries
- Rapid Test Diagnoses Tropical Disease within Hours for Faster Antibiotics Treatment
- Rapid Molecular Testing Enables Faster, More Targeted Antibiotic Treatment for Pneumonia