Atellica VTLi sepsis biomarker sample comparison study

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host
response to infection caused by bacterial, viral, and fungal pathogens.

Sepsis is very time-sensitive and can rapidly progress to organ failure and
death, every hour of delay in treatment can increase mortality by 7% (Kumar,
2006). Using this POC IVD analyzer, results for key sepsis biomarkers can be
obtained in as little as 10 minutes from a venipuncture or fingerstick.
Compared to the longer waiting time and higher volumes necessary to receive
similar results from hospital laboratories, this Investigational Device can aid
in the rapid diagnosis of sepsis, resulting in potentially significant patient
benefit for those who suffer from this life-threatening disease.

Apart from blood derived biomarkers, other vital parameters make the diagnosis
sepsis more/less likely. These parameters are included in scores, such as the
SIRS Criteria or the qSOFA criteria.

Data collected in this clinical study is primarily intended to derive sample
equivalence information in the development phase of the Sepsis tests.

Primary Objective:
Compare Atellica VTLi Sepsis biomarker values from capillary whole blood from
fingerstick with anticoagulated whole blood and plasma from venipuncture.

Secondary Objectives:
Correlate the blood and plasma outcomes on the Atellica VTLi Sepsis tests as
function of the currently used assay platforms.
Correlate the blood and plasma outcomes on the Atellica VTLi Sepsis test as
function of the corresponding hematocrit (Hct) values.

The purpose of the Atellica VTLi Sepsis Biomarker study is to evaluate the
equivalence between the different sample types for testing Sepsis blood
biomarkers on the Atellica VTLi system according to CLSI EP09c.

This is an In Vitro Diagnostic Observational Study.
Capillary whole blood samples from fingerstick, anticoagulated venous whole
blood and anticoagulated venous plasma samples will be collected at the
Catharina hospital emergency/ICU department. Up to 150 valid sample biomarker
results, covering the entire measuring range for the different sepsis analytes,
will be collected in each matrix claimed (i.e. venous whole blood and plasma
and capillary blood). More patients might be screened to fill the desired
concentration ranges. We aim at an equal distribution of biomarker levels.
Patients sample matrix types need to be collected as matched sets for this
study. Per patient set, a single lot of each cartridge type will be used.
Multiple cartridge configurations may be tested to cover multiple sepsis
biomarkers. Part of testing will be done near the bedside of the patient and
part will be done at the local laboratory.

Per patient, the following sample sources are collected:
• Capillary whole blood with an uncoated transfer device
• Anticoagulated venous whole blood
• Anticoagulated venous plasma

The time that the blood is taken and tested will be recorded for each sample.

Samples will be collected across the measurement range for the different
biomarkers, targeted at 1/3th in the low range, 1/3th in the intermediate range
and 1/3th in the high range.

When a certain range is completed, the sample collection can continue until the
required ranges are filled. Including more samples in the ranges that are
already completed is acceptable and expected.

All Sepsis biomarker results from the different sample types within the
measuring range will be recorded and used for data analysis. In case of no or
*invalid* results, retesting will be performed, if sample volume allows. No and
invalid results will be reported.

For this study no personal data will be collected, other than for screening of
the in- and exclusion criteria. The Atellica VTLi Sepsis test results will not
be used for patient diagnosis or treatment, but only for study purposes.

Hematocrit values will be obtained from the medical record (or measured in
Li-Heparin venous tube). If available, also sepsis biomarker levels will be
obtained from the laboratory data.

Left-over plasma from samples will be aliquoted, stored and transferred to
Siemens Eindhoven for additional biomarker assay analysis

This is a low risk IVD study. All blood samples will be collected using
standard blood collection techniques used for venipuncture and fingerstick.
Some of the patients will have an indwelling cannula from which blood samples
are drawn. In most cases an additional venipuncture is required to be performed
as part of this study. The fingerstick sample - taken only for study purposes -
may result in a small pain at the side of the fingertip, but this pain is
usually of short duration and tolerated very well.

Potential benefits of the Sepsis test include increased survival rates in
septic patients due to earlier detection, but also reduction of unnecessary
antibiotic use in patients with low levels of biomarkers due to early result
reporting. Sepsis is a very time-sensitive, life-threatening disease in where
every hour of delay in treatment can increase mortality by 7% (Kumar, 2006).
Using this POC analyzer, biomarker results can be obtained within 10 minutes,
aiding in the early diagnosis of sepsis.