abioSCOPE® PANCREATIC STONE PROTEIN (PSP)

abioSCOPE® POC

Rapid turnaround time
5 minutes from blood sampling to
actionable results

Easy to use
Simple 4 steps with a blood volume
of 30 µl from a fingerstick
Connectivity options
HL7, Ethernet to HIS/LIS, barcode
scanner and QR code

Laboratory quality results
Laboratory equivalent
performances

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Description

abioSCOPE® POC  SEPSIS APPLICATION

  • The revolutionary in vitro diagnostic (IVD)
    point-of-care platform
  • PATENTED NANOFLUIDIC TECHNOLOGY

Forcing molecules into a nanochannel, limiting the travel distance to a few hundred nanometres and reducing incubation time to 2 minutes.

  • UNPARALLELED IMMUNOASSAY PANEL SOLUTIONS
  • Disrupting today’s blood-testing standards, bringing laboratory quality tests close to patients and analysing up to 14 parameters at the same time from a single drop of blood in just 5 minutes instead of hours.
  • device enables a PSP test on the earliest detection of sepsis in just 5 minutes with adrop of blood from a fingerstick, and has the potential to save millions of lives.
  • Early sepsis diagnosis is a major challenge for clinicians because there is no single sign or symptom to recognize sepsis… Everybody can get sepsis, no matter how healthy or how good in shape you are.
  • Sepsis affects more than 30 million people worldwide every year, potentially leading to 9 million deaths.1Every 3 seconds someone dies of sepsis globally.
  • Sepsis is #1 killer at hospitals, it claims more lives than prostate cancer, breast cancer and AIDS combined.

Sepsis is a medical emergency and requires immediate diagnosis7

  • Risk of mortality increases 8% every hour that the treatment is delayed.8
  • With early detection of sepsis and appropriate treatment in the first hour, the patient has more than 80% survival rate. 9

Many sepsis survivors are left with physical, mental and emotional challenges

  • Up to 60% of sepsis survivors experience worsened cognitive and/or physical function 10
  • Older sepsis survivors experience on average 1 to 2 new limitations (e.g: bathing, dressing, managing money…) on their daily activities 10
  • Every day there are an average of 38 amputations in the U.S. as the result of sepsis 10

PSP test on the abioSCOPE® enables the earliest detection of sepsis in just 5 minutes with a drop of blood from a fingerstick, and has the potential to save millions of lives.

Pancreatic Stone Protein (PSP) has significant potential as ‘early marker’ for sepsis detection 12

PSP (REG1A) is a type I subclass member of the regenerating protein family mostly produced by pancreas, its blood level increases early in the onset of sepsis.12,13

Multiple clinical studies demonstrated PS’s superior diagnostic accuracy compared to procalcitonin (PCT) and C-reactive protein (CRP) for the detection of sepsis.14

In addition, PSP is correlated with disease severity, sepsis, septic shock, and prediction of mortality.14

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PSP test on the abioSCOPE® diagnose sepsis 24 hours earlier than today’s standard of care 15 

abioSCOPE® POC COVID SEVERITY SCORE

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

Figure 1

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.

 

Figure 2

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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References1) 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.

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Download the abioSCOPE® Technical datasheet

abioSCOPE® POC Technical_Data_Sheet_JGA

Pipette instructions

abioSCOPE® POC QRG_Laborytory_Micropipette_V1.1_EN_JGA

 

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