The objective of this pilot study is to assess whether transportation of the sample via a pneumatic tube system (PTS) has any detrimental effects on the recovery of presepsin levels, when compared to traditional hand-delivery. This research will be…
ID
Source
Brief title
Condition
- Infections - pathogen unspecified
Synonym
Research involving
Sponsors and support
Intervention
- In-vitro diagnostic
N.a.
Outcome measures
Primary outcome
<p>The slope of the linear regression line of the presepsin concentrations measured after the two transport methods should be within a clinically reasonable range (slope 1.00 ± 0.15, and/or the correlation (Pearson’s r) > 0.900). After evaluating the results of the first 45 samples (equally distributed between the three concentration ranges), if the outcome is negatively conclusive, the study can stop, otherwise the collection of samples shall continue until up to 130 results approximately equally distributed between the given sample ranges are reached. Due to the desire for an even distribution, a maximum of 200 subjects are included.</p>
Secondary outcome
<figure class="table"><table><tbody><tr><td><strong><img src="https://www.toetsingonline.nl/icons/ecblank.gif" alt="" width="1" height="1"></strong></td><td>The measured concentrations of presepsin immediately after arrival are compared with the measured concentrations of presepsin at two time points the next day. This determines the stability at room temperature.<br><br>Stability is determined by:<br>Absolute deviation: recovery concentration Presepsin ≤ 500 pg/mL: +/- 50 pg/mL<br>Relative deviation: Presepsin > 500: +/- 10%</td></tr></tbody></table></figure>
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Background summary
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The Elecsys® Presepsin assay is an immunoassay utilizing the electrochemiluminescence »ECLIA« technology for the quantitative in vitro measurement of presepsin in human serum and plasma. The test uses two monoclonal antibodies specifically directed against presepsin. This study is being conducted to obtain information on transport and temperature stability at room temperature as part of the technical validation to be able to obtain future approval for use of Elecsys® Presepsin in clinical practice by the regulatory authorities. |
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Study objective
The objective of this pilot study is to assess whether transportation of the sample via a pneumatic tube system (PTS) has any detrimental effects on the recovery of presepsin levels, when compared to traditional hand-delivery. This research will be carried out in three types of materials (serum, heparin plasma and EDTA plasma), of each type two tubes will be collected.
The secondary (optional) objective is to test the room temperature stability of presepsin.
Study design
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Prospective, non-interventional, observational, multicenter study enrolling patients with no, beginning or clear signs of infection/sepsis. |
Intervention
Measuring Presepsin from collected serum and plasma during planned collection.
Study burden and risks
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The burden amounts to taking a maximum of 2x 30 ml during two planned bloodwithdrawls during regular care. The only risks of the study are the possible side effects of a venipunture. |
N Geerts
Michelangelolaan 2
Eindhoven 5623 EJ
Netherlands
498856603565
christine.schaef@roche.com
N Geerts
Michelangelolaan 2
Eindhoven 5623 EJ
Netherlands
498856603565
christine.schaef@roche.com
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Signed Informed Consent
Age > 18 yrs
Exclusion criteria
Self-declared pregnancy or breast-feeding women
Dependent of sponsor or investigator
known/self-declared anemia
Congnitive impairment
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87568.000.24 |
| Research portal | NL-005325 |