New PCT Assay from Ortho Comes with CE Mark

Press Release Summary:

  • Helps clinicians identify sepsis and other severe bacterial infections
  • Ensures results are ready to be delivered to clinicians quickly, with 96.5% first pass yield 
  • Can aid clinical assessment in the early detection of severe bacterial infections and in making decisions regarding antibiotic therapy

Original Press Release:

Ortho's VITROS® B•R•A•H•M•S PCT Assay for Sepsis Now Available

RARITAN, New Jersey, June 11, 2020 /PRNewswire/ -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory solutions, received CE Mark for its VITROS® B•R•A•H•M•S PCT (Procalcitonin) assay, now commercially available to help clinicians identify sepsis and other severe bacterial infections. Ortho's newest assay is available on the VITROS® 3600 Immunodiagnostic System, the VITROS® 5600 and VITROS® XT 7600 Integrated Systems and the ECi/ECiQ Systems.*

Sepsis is estimated to affect more than 30 million people globally each year, potentially leading to six million deaths.1 If unrecognized or untreated, it can lead to systemic inflammation, tissue damage and organ failure or death.1 

Fast diagnosis and appropriate antimicrobial therapy are required to increase the likelihood of survival,2 and multiple clinical studies recognize PCT's role in detecting severe bacterial infections and guiding the use of antimicrobial therapy.3 

The VITROS® B•R•A•H•M•S PCT assay can aid clinical assessment in the early detection of severe bacterial infections (sepsis, community-acquired pneumonia, acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease) and in making decisions regarding antibiotic therapy.4,5 Emerging antibiotic resistance has made it extremely important to reduce the unnecessary and prolonged use of antibiotics.6

In addition, PCT continues to gain utility in COVID-19 management protocols, as an increase in PCT could indicate bacterial coinfection and progression to a more severe form of disease. 7,8

Labs running the NEW VITROS B•R•A•H•M•S PCT assay leverage both the power of B•R•A•H•M•S and the difference that only VITROS® analyzers can provide. Paired together, these VITROS® Solutions help improve patient outcomes by delivering consistently Fast, Accurate and Reliable results to the clinicians who diagnose, monitor and provide treatment. Given this VITROS benefit, labs can fulfill more requests from difficult draws with the assay's small sample size at 30μL. Further, the assay maximizes efficiency with a long calibration interval of 56 days and offers excellent analytical correlation and clinical concordance to the B•R•A•H•M•S method.5

"When minutes matter in emergency and critical care situations, fast, accurate results determine treatment and can mean the difference between life and death," said Nadav Kaufman, Senior Director of Global Marketing for Ortho's Clinical Labs Menu and Innovation. "Because Every Test Is a Life, Ortho Clinical Diagnostics is committed to providing medical teams with high-quality diagnostics that deliver accurate results that help clinicians treat their patients faster."

VITROS technology ensures results are ready to be delivered to clinicians quickly, with a 96.5% first pass yield (without user intervention).9 Proprietary MicroSensor™ technology detects and flags results with potential hemolysis, icterus and turbidity interferences, reducing the need for reviews/reruns/redraws.10 With a guaranteed uptime of 98%, these solutions improve a lab's ability to deliver better patient outcomes. 11 

Self-contained, waterless VITROS® Systems help ensure results are not impacted by water quality and go hand-in-hand with Ortho's goal to support long-term environmental sustainability.

*Not all products available in all countries.

For more information, visit https://www.orthoclinicaldiagnostics.com/global/covid19.

About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory solutions, serves the clinical laboratory and immunohematology communities.

Ortho's high-quality products and services help hospitals, hospital networks, blood banks and labs in more than 125 countries and territories deliver consistently fast, accurate, and reliable results that allow clinicians to make better-informed treatment decisions.

For more information about Ortho's solutions and services, visit www.orthoclinicaldiagnostics.com, or visit Ortho on social media: LinkedInTwitterFacebookInstagram and YouTube.

1 https://www.who.int/news-room/fact-sheets/detail/sepsis; Accessed March 25, 2020.
2 Branche A, Neeser O, Mueller B, Schuetz P. Procalcitonin to guide antibiotic decision making. Curr Opin Infect Dis. 2019 Apr;32(2):130-135.
3 Rhodes A, Evans LE, Alhazzani W, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017;43(3):304–377. doi:10.1007/s00134-017-4683-6
4 Brunkhorst, F. M., Wegscheider, K., Forycki, Z. F., & Brunkhorst, R. (1999). Procalcitonin for early diagnosis and differentiation of SIRS, sepsis, severe sepsis and septic shock. Critical Care, 3(Suppl 1), P095.  
5 Ortho Clinical Diagnostics (2020). VITROS Immunodiagnostics Products B•R•A•H•M•S PCT Reagent Pack and Calibrators Instructions For Use. GEM 1370 XUS EN. REF 690 5558. Raritan, NJ USA
6 Sager, R., Kutz, A., Mueller, B. et al. Procalcitonin-guided diagnosis and antibiotic stewardship revisited. BMC Med 15, 15 (2017). https://doi.org/10.1186/s12916-017-0795-7
7 Lippi G, Plebani M. Procalcitonin in patients with severe coronavirus disease 2019 (COVID-19): A meta-analysis. Clin Chim Acta. 2020 Mar 4;505:190-191.
8 Tsantes A. et al., The role of procalcitonin and IL-6 in discriminating between septic and non-septic causes of ALI/ARDS: a prospective observational study Clin Chem Lab Med 2013;51 (7),Jul: 1535-42.
9 An internal Ortho study validated by a third party established that the VITROS® 5600 Integrated System had an industry-leading 96.5 percent first-pass yield. Subsequent Ortho comparison studies established that the VITROS XT 7600 Integrated System met or exceeded that standard.
10 ORTHO VALUATOR℠ data from on–site studies commissioned by Ortho–Clinical Diagnostics are on file and available upon request.
11 SalesAid_OrthoCare_Guarantee_PR-05571

Ortho Clinical Diagnostics
CONTACT: Elaine Andrecovich, Ortho Clinical Diagnostics, +1 908 218 8256, elaine.andrecovich@orthoclinicaldiagnostics.com
Web Site: www.orthoclinicaldiagnostics.com

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