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bioMérieux receives FDA clearance to extend platelet shelf life to 7 days with Large Volume Delayed Sampling strategy using BACT/ALERT® 3D and BACT/ALERT® VIRTUO® culture systems.22 May, 2020
bioMérieux announces that its BACT/ALERT® BPA and BPN culture bottles have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Large Volume Delayed Sampling (LVDS) of leukocyte-reduced apheresis platelets (LRAP) and leukocyte-reduced whole blood platelet concentrates (LRWBPC) with BACT/ALERT®3D and BACT/ALERT® VIRTUO® systems.
Durham, NC – bioMérieux, a world leader in the field of in vitro diagnostics, announces that its BACT/ALERT® BPA and BPN culture bottles have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Large Volume Delayed Sampling (LVDS) of leukocyte-reduced apheresis platelets (LRAP) and leukocyte-reduced whole blood platelet concentrates (LRWBPC) with BACT/ALERT®3D and BACT/ALERT® VIRTUO® systems.
In September 2019, the FDA released its final guidance regarding “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion”. This guidance officially recognizes LVDS as an effective strategy to control the risk of bacterial contamination in platelets and extend their shelf life to 7 days with a single-step approach. This results in improved safety as well as increased availability of these life-saving products.
Platelets are particularly prone to contamination since they are stored at room temperature. Therefore, routine testing for bacterial contamination is critical to detect those units that are contaminated and could potentially cause harm to transfused patients.
LVDS has already been implemented in several countries as an effective risk reduction measure to increase safety of the platelet supply while eliminating the need for further testing. Recent analyses have suggested that LVDS is a cost-effective approach when compared to other proposed strategies, and that extending platelet shelf life to 7 days may reduce unnecessary discarding of platelets.1
“The FDA clearance for LVDS when using either of our two culture systems is an important step towards increasing patient safety and availability of precious life-saving platelets. As we continually face a shortage of blood products, especially now due to the COVID-19 pandemic, extending platelet shelf life with a single-step bacterial screening approach is critical and highly beneficial for patients in need” said Dr. Mark Miller, Executive Vice President, Chief Medical Officer of bioMérieux.
Patient safety is at the heart of bioMérieux’s innovations to detect specific pathogenic bacteria in platelets in order to enhance their safety and increase their availability. BACT/ALERT® BPA and BPN culture bottles support the growth of aerobic and anaerobic microorganisms in three types of leukocyte reduced platelet units: apheresis platelet units, and both single and pools of up to six units of whole blood platelet concentrates.
The BACT/ALERT® technology is in routine use by blood collection and transfusion facilities in over 25 countries worldwide and has a long proven track record for reliably testing platelets.
A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. In 2019, revenues reached €2.7 billion, with over 90% of sales outside of France.
bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
1. Kacker S, Katz LM, Ness PM, et al. Financial analysis of large-volume delayed sampling to reduce bacterial contamination of platelets. Transfusion. 2020 Apr. DOI: 10.1111/trf.15773.
PRN 056409 Rev01.A