www.alphalabs.co.uk 11 Sepsis is a clinical syndrome caused by the body’s immune and coagulation systems being switched on by the presence of an infection - bacterial, viral, or fungal. Severe sepsis is defined as: Organ dysfunction Tissue hypoperfusion Sepsis Septic shock is a life-threatening condition that is characterised by: Low blood pressure despite adequate fluid replacement Organ dysfunction Sepsis The UK Sepsis Trust estimates that 37,000 people die from sepsis in the UK every year, with the most common causes of severe sepsis in adults being pneumonia and bowel perforation. The current definitions of sepsis and severe sepsis were established in critical care and paediatric critical care, which does not simply translate into diagnostic pathways for initial diagnosis and management since sepsis presentation can vary from patient to patient. Whilst early treatment of sepsis is associated with improved outcomes, it is clinically challenging to diagnose sepsis, especially in those who are critically ill. This means that sepsis can rapidly progress to organ dysfunction and death despite immediate and aggressive medical therapies. Current standard practice varies on the clinical experience of the physician or practitioner making the initial assessment. Identification relies on non-specific physiological criteria and culture-based pathogen detection. Due to the broad-spectrum indications, such as tachycardia, fever, chills, rash and an increase in inflammatory markers such as CRP, there can be delays in diagnosis and treatment, as well as misuse and overuse of antibiotics. Blood culture analysis is currently the gold standard for the identification of bacteria or fungi that cause infection. However, this method is slow and it can take several days to obtain blood culture results. Therefore, this method cannot significantly influence the initial management of patients. There are also issues with the detection of microbes in the sample and false negatives results due to contamination of the sample. Antibiotic Resistance This leads to patients receiving prolonged exposure to broad-spectrum antibiotics, which leads to the increase in bacterial antibiotic resistance. There is therefore a need for rapid, broad-based detection of pathogens causing the infection. Molecular Diagnostics Molecular diagnostics is defined as the detection of genomic variants, aiming to facilitate detection, diagnosis, subclassification, prognosis, and monitoring response to therapy. Panel-based molecular diagnostic assays are now available for direct testing of positive blood culture bottles (BCBs), leading to more timely results than conventional blood culture analysis. Faster identification and resistance characterisation of pathogens may lead to: Earlier administration of directed antimicrobial therapy Earlier de-escalation of broad-spectrum agents Potential for better outcomes Fewer antibiotic-associated adversities Less emergence of antimicrobial-resistant organisms Trials involving rapid multiplex PCR (rmPCR) based blood culture identification, such as Banerjee et al (2015), illustrate that the use of rmPCR can reduce the time to diagnosis and can optimise antibiotic prescribing for bloodstream infections. BCID2 Aids Early Bacterial Identification BioFire® FilmArray® Blood Culture Identification 2 (BCID2) Panels aid in the early identification and treatment of sepsis. With 43 targets, the BCID2 Panel detects pathogens and antimicrobial resistance genes directly from positive blood cultures, to shorten the time to optimal treatment. The Clinical Challenges of Sepsis Emerging Technologies for Molecular Diagnostics First-of-its-kind quality control designed to meet the standards for verifying the entire analytical process of BioFire BCID2 sepsis assays from sample lysis to result reporting Simultaneously tests a single positive blood culture sample to giving results for 33 different organisms and organism groups that cause bloodstream infections and 10 antimicrobial resistance genes – one of the largest testing panels currently on the market Cost savings – MDx-Chex for BCID2 only uses 2 BioFire BCID2 panel pouches to deliver complete target coverage ISO15189 compliance - Can be used as a 3rd party quality control. Routine use of MDx-Chex for BCID2 as a full process quality control can help identify variations in the test system that can lead to incorrect results Allows for continued verification to ensure accurate Rapid Multiplex PCR–Based Blood Culture Identification for sepsis Contains stabilised blood components, blood culture media components, and inactivated micro-organisms resulting in a full-process, cellular-based control for the BioFire BCID2 Panel Use of full-process cellular controls evaluates the entire analytical process: sample lysis, nucleic acid isolation and purification, amplification, detection, and analysis, as well as the impact of PCR inhibitors and pre-analytical variables Quality control for BioFire® FilmArray 2.0® and FilmArray® Torch systems Storage conditions - 2 C to 25 C MDx-Chex™ Control for BCID2 Find out more and view the best practice video here: alphalabs.co.uk/mdx-chex
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