Page 318 – Clinical Laboratory int.

Terumo BCT’s Mirasol shows efficacy against SARS-COV-2 in plasma and platelets

, 26 August 2020/in Corona News, Featured Articles /by 3wmedia

Data from a new study suggests that a medical device that uses vitamin B2 and ultraviolet light for treating human blood products is effective against the virus that causes COVID-19. The study results, generated by Terumo BCT in collaboration with researchers from Colorado State University, have been accepted for publication by Vox Sanguinis, a peerreviewed medical journal covering hematology. While there is no evidence that blood transfusions transmit COVID-19, some blood centres are using Mirasol to treat platelets and plasma as an additional layer of safety. Some healthcare providers also treat convalescent plasma with Mirasol. The International Society for Blood Transfusion (ISBT) Global Blood Safety Working Party recommends, where feasible, pathogen inactivation of plasma to control residual risks of transfusion transmitted infection diseases and to allay concern about possible superinfections with SARS-CoV-2.
Using riboflavin (vitamin B2) and ultraviolet light, Mirasol is designed to reduce the pathogen load of various disease-causing agents such as viruses, parasites and bacteria in blood products before they are transfused to patients. Mirasol also inactivates white blood cells to help reduce certain transfusion reactions.
Mirasol is CE marked for platelets, plasma and whole blood and is in routine use in more than 20 countries throughout Europe, the Middle East, Africa, Asia and Latin America. The system is not approved for sale in the U.S. and Canada.

Siemens Healthineers molecular Fast Track Diagnostics SARS-CoV-2 Assay test kit available for use in Europe

, 26 August 2020/in Corona News, Featured Articles /by 3wmedia

Siemens Healthineers molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit is ready for immediate rollout for diagnostic use in Europe. This follows registration of the test kit for diagnostic use with the Luxembourg Ministry of Health. The test kit was released for research use only (RUO) on April 2, 2020.
The test has shown 100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity. Sample-to-answer time, including extraction and generating the result, takes 2-3 hours, depending on the molecular system and lab resources employed. Up to 32 patient samples can be analysed per kit.
The company plans to ship more than 1.3 million tests per month worldwide as production capacity increases in May 2020. The FTD SAR-CoV-2 Assay can be run in laboratories simultaneously with FTD Respiratory Pathogens 21 and FTD FLU/HRSV, molecular syndromic testing panels from Siemens Healthineers that identify a wide range of pathogens that can cause acute respiratory infections.
Deepak Nath, PhD, President, Laboratory Diagnostics, Siemens Healthineers, commented: “Having our molecular assay available for diagnostic use throughout the European Union is a major step forward in our contribution to the fight against the global pandemic. I am grateful for the work and achievement of our Siemens Healthineers teams under difficult circumstances, and I hope our clinical test will help the healthcare professionals who are working on the frontlines of the pandemic and those affected by COVID-19.”
The company is also working to expand its infectious disease testing capabilities to address the COVID-19 pandemic in other areas of diagnostics. On April 23, the company announced it is developing a SARS-CoV-2 serology assay to detect IgM and IgG antibodies in blood, helping indicate whether a person has developed immunity against SARS-CoV-2.
Siemens Healthineers anticipates availability of the total antibody test by late May 2020. Planned expanded production in the company’s Walpole, Massachusetts manufacturing facility will accommodate more than 25 million tests per month in June and beyond. The company is pursuing Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) as well as the CE Mark.
The test will be available on the Atellica Solution immunoassay analyzer, which can run up to 440 tests per hour and will enable a result in just 14 minutes. In addition, the serology test also is expected to be available on the company’s expansive installed base of ADVIA Centaur XP and XPT analysers, which deliver up to 240 tests per hour, with a result in 18 minutes. Availability of this test on these industry leading platforms ensures more patients are tested in a shorter time.