Automated Nucleic Acid Test (NAT) System Screens Blood Donors for Malaria
By LabMedica International staff writers Posted on 10 Jun 2022 |
Plasmodium is a mosquito-borne parasite that causes malaria and is responsible for more than 240 million infections and 620,000 deaths annually. The protozoan parasite creates a significant risk for both blood safety and availability. Screening blood donors can reduce the risk of transfusion-transmitted malaria (TTM) and enhance blood availability by reducing the number of donors rejected and deferred due to malaria risk. Now, a nucleic acid test (NAT) for blood donor screening detects the presence of Plasmodium to improve blood safety.
Grifols’ (Barcelona, Spain) Procleix Plasmodium Assay, designed for NAT, uses magnetic-based target capture, Transcription-Mediated Amplification (TMA) and chemiluminescence to detect the presence of specific ribosomal RNA sequences of five species of Plasmodium parasites that cause malaria in humans (P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax) in whole blood specimens from blood donors. The high sensitivity and specificity of the Procleix technology enables pathogen detection to reduce the risk of transfusing infected blood or blood components, 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 widely adopted Procleix Panther System, an automated NAT instrument from Grifols.
Currently, risk for malaria in blood donors is typically evaluated using a questionnaire in which donors who declare having traveled to or prior residence in malaria-endemic areas are temporarily deferred. Blood banks and collection centers could decide that deferrals could be unnecessary if donors were tested and found negative using the Procleix Plasmodium Assay. The assay has obtained the CE mark, the first for an automated NAT system specifically validated for screening blood donors for malaria, and will be available in all markets accepting the CE mark certification.
"We are excited to announce the CE mark certification of an additional Procleix assay, demonstrating Grifols' continued commitment to transfusion safety," said Antonio Martínez, President, Grifols Diagnostic Business Unit. "Certification of the Procleix Plasmodium Assay enhances the ability of blood banks in Europe to provide safer blood transfusions."
Related Links:
Grifols
Latest Molecular Diagnostics News
- Blood Test Accurately Predicts Lung Cancer Risk and Reduces Need for Scans
- Unique Autoantibody Signature to Help Diagnose Multiple Sclerosis Years before Symptom Onset
- Blood Test Could Detect HPV-Associated Cancers 10 Years before Clinical Diagnosis
- Low-Cost Point-Of-Care Diagnostic to Expand Access to STI Testing
- 18-Gene Urine Test for Prostate Cancer to Help Avoid Unnecessary Biopsies
- Urine-Based Test Detects Head and Neck Cancer
- Blood-Based Test Detects and Monitors Aggressive Small Cell Lung Cancer
- Blood-Based Machine Learning Assay Noninvasively Detects Ovarian Cancer
- Simple PCR Assay Accurately Differentiates Between Small Cell Lung Cancer Subtypes
- Revolutionary T-Cell Analysis Approach Enables Cancer Early Detection
- Single Genetic Test to Accelerate Diagnoses for Rare Developmental Disorders
- Upgraded Syndromic Testing Analyzer Enables Remote Test Results Access
- Respiratory and Throat Infection PCR Test Detects Multiple Pathogens with Overlapping Symptoms
- Blood Circulating Nucleic Acid Enrichment Technique Enables Non-Invasive Liver Cancer Diagnosis
- First FDA-Approved Molecular Test to Screen Blood Donors for Malaria Could Improve Patient Safety
- Fluid Biomarker Test Detects Neurodegenerative Diseases Before Symptoms Appear