First Covid-19 severity score

IDENTIFY COVID-19 PATIENTS AT RISK OF DETERIORATION

The clinical need to assess the SOFA score in Covid-19 patients: get the cSOFA score in 5 minutes

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Today’s Covid-19 pandemic has made it extremely challenging for healthcare professionals to perform efficient clinical assessments, especially given the critical time constraints and lack of resources experienced by most hospitals.

The sequential organ failure assessment score (SOFA score) is used to track a patient’s status in intensive care units (ICU) to determine the extent of organ function or rate of failure. The score is however long and complex to establish and is based on six different sub-scores from the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems that only ICUs have resources to obtain.

Abionic has developed an exclusive cSOFA score (Covid-19 Sequential Organ Failure Assessment), offering physicians the solution they need to accurately identify patients at risk of subsequent deterioration and mortality. This will optimise clinical management from prehospital care, all the way through to emergency departments, hospital wards and ICUs.

 

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The cSOFA score is a 5-minute Covid-19 severity score to immediately assess your patient’s clinical deterioration and to support your medical decision. The combination of a simple respiratory score (RESP) along with the blood biomarker Pancreatic Stone Protein (PSP), defines the cSOFA score, allowing for the severity assessment of an ongoing SARS-CoV-2 infection.

PSP is easily quantified in 5 minutes from a single drop of blood using the CE marked IVD test on the abioSCOPE®.1

The cSOFA score is composed of two easy-to-measure parameters and correlates well with SOFA

Icon 1 A simplified respiratory component (RESP)

The RESP component is derived from the more complex SOFA score, which is used to track the status of a patient in the ICU and to determine the extent of organ function or rate of failure. However, this score is based on six different sub-scores making it complex to obtain and inaccessible outside of the ICU.

Icon 2PSP blood biomarker on the abioSCOPE® device

PSP is characterised by its diagnostic accuracy in predicting sepsis and/or multiple organ dysfunction in various types of critically ill patients2. As of today more than 20 publications demonstrate that PSP correlates well with several sub-scores of SOFA. Preliminary data from the first European wave of SARS-CoV-2 infections shows a strong link between PSP concentration and the severity of these patients.

Table 1. Score table combining RESP score with PSP score to obtain cSOFA. An increasing score correlates with increasing severity, up to a maximum of 10.
Figure 2

The combination of PSP and the RESP component, gives the cSOFA score which enables a rapid and accurate assessment of the severity of the patient.

THE FASTEST COVID-19 SEVERITY SCORE FACILITATING PATIENT TRIAGE

cSOFA as Covid-19 Sequential Organ Failure Assessment

Patient Journey

CLINICAL EVIDENCES

Figure 1. Distribution of control (healthy non-Covid-19 patients), mild, moderate, and severe Covid-19 patient groups against cSOFA scores, computed from the PSP values and the RESP score.Figure 1
Figure 2. The cSOFA and SOFA score demonstrate a good correlation on 96 Covid-19 patients admitted to the ICU between March and April 2020. Each point is the average of the cSOFA and SOFA score over the entire length of stay.Figure 2

The PSP test and the RESP score combined into the cSOFA score, enables the discrimination between non-severe and severe SARS-CoV-2 infection among adults, with a p-value <0.0001.

Table 2. Diagnostic performances of cSOFA at a cut-off of 0 to determine patient non-hospitalisation. SP stands for specificity, SN for sensitivity.Table 1
Table 3. Diagnostic performances of cSOFA at a cut-off of 3 to determine Covid-19 patients’ severity. SP stands for specificity, SN for sensitivity.Table 2

Overall, the fast and highly accurate severity cSOFA score enables healthcare professionals to efficiently assess Covid-19 patients within 5 minutes to measure the likelihood of clinical deterioration. This facilitates patient triaging and assignment to the appropriate level of care right from admission, whilst also liberating vital clinical resources, key to optimising patient management.

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References 1) Putallaz L, van den Bogaard P, Laub P, Rebeaud R. Nanofluidics Drives Point-of-care Technology for on the Spot Protein Marker Analysis with Rapid Actionable Results. J Nanomed Nanotech. 2019 Oct;10(5):536; 2) Eggimann P, Que YA, Rebeaud F. Measurement of pancreatic stone protein in the identification and management of sepsis. Biomark Med. 2019 Feb;13(2):135-145; 3) Ginsburg A S, Klugman K P. COVID-19 pneumonia and the appropriate use of antibiotics. The Lancet Global Health. 2020 Nov; Volume 8, Issue 12, E1453-E1454.

Nanofluidic technology

Nanofluidics is defined as the study and application of fluid flow in and around structures with features that measure less than 100 nm (1 nm = 10-9 m) in one or more directions. Fluids confined in these structures exhibit physical behaviours not observed in larger structures, such as those of micrometre dimensions and above.

Nanofluidics is becoming a major field of research and has been applied in microfluidic systems allowing for DNA manipulation, protein separation, sample pre-concentration and single molecule detection. The majority of current nanofluidic research is intended for bioengineering and biotechnology applications.1

Abionic succeeded in bringing together nanoengineering, biochemical and medical sciences, and to develop an unparalleled nanofluidic technology-based platform to offer patients the fastest point-of-care testing solutions using principles of traditional capture ELISAs.

Figure 1. Integration of a fluorescent immunoassay (cross-section through a nanofluidic biosensor)
Figure 1

Homogeneous nanofluidic immunoassays rely on the enhanced bimolecular interactions occurring inside the nanochannel.

Analytes bound to fluorescent detecting antibodies are captured with very high efficiency on the reading area of the sensor.

A washing step is not needed as the surface over volume ratio is extremely high, and non-specific background is negligible.

Figure 2 shows the dose-dependent increase of fluorescent signal in the kinetic measurements of the ferritin in biosensors.

In less than two minutes the kinetic curves reach mass transfer equilibrium for all doses spanning the clinically relevant range needed to perform iron deficiency diagnostics.2

Figure 2. Signal uptake of ferritin versus assay time for various ferritin concentrations spanning the clinically relevant range in nanofluidic biosensors.

A rapid signal uptake is observed in the abioSCOPE® device once the sample is deposited onto the capsule containing the sensors. Figure 2 shows a dose-dependent signal increase over time.

A plateau is reached after approximately 90 seconds, demonstrating the ultra-fast binding reaction between the capture area and the targeted analyses present at very low concentration.

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References 1) Durand, N.; Biomolecular Diffusion in Nanofluidics. EPFL, Lausanne, 2010.2) Putallaz L, Sprunger Y van den Bogaard P, “Nanofluidic technology enables decentralized and rapid diagnostic testing”, Poster presented at the 2nd Swiss POCT Symposium, 2018

Analytical performances

Novel nanofluidic allergy (IgE) assay versus a reference method: a real-world comparison

A pivotal study published by Rothlisberger, S et al. demonstrated that the diagnostic decision taken by allergy expert was the same in 94.6 percent of the cases when the IgE serologic assays were performed on the abioSCOPE® device versus a reference laboratory method. This study demonstrated the clinical utility of Abionic's point-of-care IgE solutions to revolutionise the diagnosis workup of patients suffering from allergic disease.3

Table 1. Positive and negative percent agreements calculated in function of diagnostic made by allergy experts’ panel

The impact of using the point-of-care abioSCOPE® device in comparison with sending out blood samples to a clinical laboratory to measure IgE on a reference method was found to be negligible.

The agreement in the diagnostic decision was remarkably the same in more than 94 percent of the cases.

Table 1
Excellent correlation between test results on the abioSCOPE® device and a laboratory reference method

The scope of this study is to demonstrate the agreement of whole blood sample measurements on the abioSCOPE® with corresponding plasma sample measurements on the laboratory reference method ImmunoCAP total IgE (ThermoFisher Scientific) and to estimate the precision of the abioSCOPE® platform.4

Figure 3. Method comparison: total IgE on the abioSCOPE® (whole blood) vs ImmunoCAP (plasma)
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Sixty-nine whole blood and corresponding plasma samples were analysed for total IgE on the abioSCOPE® device and a laboratory reference method (ImmunoCAP, ThermoFisher Scientific, Uppsala, Sweden).

Deming statistics were applied on the dataset. An excellent correlation was found between the two methods (Figure 3): the goodness of the fit was R2=0.91, the slope of the regression line was 0.93 and the intercept -0.49 in the range 2 to 1500 IU/mL of total IgE.

Pancreatic stone protein (PSP) has significant potential as ‘early marker’ for sepsis detection

Sepsis is one of the leading causes of death in the world. It is a life-threatening condition caused by a dysregulated host response to infection. The pancreatic stone protein (PSP) is a host protein biomarker produced by the pancreas in response to a sepsis-related organ dysfunction and has shown a great potential in the early identification of septic patients. Abionic has succeeded in bringing together an ultra-rapid nanofluidic based diagnostic platform and the PSP biomarker to offer a unique simple bedside test for the earliest and immediate detection of sepsis.4

Figure 4. PSP levels raise up early in the development of sepsis

Sepsis is a medical emergency and requires prompt answer – every hour counts!

Early detection of sepsis with timely, appropriate interventions increases the likelihood of survival. Unfortunately, sepsis manifests through various clinical signs and its early diagnosis is therefore still a major challenge for clinicians.

PSP level raises up to 24 hours before sepsis diagnosis early in the development of sepsis.

Its availability near the patient thanks to the abioSCOPE® will enable timely initiation of the optimal treatments upon recognition of septic patients and potentially save millions of lives.

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References 3) Roethlisberger S.; Novel Nanofluidic IgE Assay versus a Reference Method: A Real-World Comparison. Int Arch Allergy Immunol. 2019 Jun 12 4) Abionic internal evaluation study report (data on file)

Abionic Symposium - Early Identification of Sepsis

Early Identification of Sepsis: Serial point-of-care measurements of Pancreatic Stone Protein (PSP) in the critically ill.

Re-watch our online symposium from November 17th 2020 to learn how the biomarker Pancreatic Stone Protein (PSP) enables the early identification of sepsis in the critically ill. Discover data demonstrating the clinical benefit of serial bedside PSP measurements presented by an international panel including Dr. Bruno François, Dr. Giacomucci and Dr. Eggiman, moderated by Pr. Steven Opal.