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IB10 sphingotest® PCT


IB10 sphingotest® PCT is a rapid point-of-care (POC) immunoassay for the quantitative in vitro determination of Procalcitonin (PCT) in the concentration range of 0.3 μg/L to 10 μg/L in human EDTA whole blood or plasma.

The test is designed for professional use only and may be used on sites where near patient testing is practiced.

Cat. No. IVR-IB65 | Procalcitonin (package of 10 discs)

Clinical Significance

Sepsis is the most common cause of death in intensive care units (ICU) with a mortality rate up to 50% depending on severity. The earlier sepsis is identified and treated, the better the prognosis (1,2). PCT levels in sepsis are often greater than 1 μg/L and reach values of 10 μg/L or even higher with severe sepsis and septic shock. As the septic infection resolves, the PCT levels also return to ranges < 0.5 μg/L, with a half-life of 24 hours. The IB10 sphingotest® PCT is only intended for the diagnosis of sepsis, the assessment of the degree of severity, and monitoring of the change of sepsis severity (3). This assay is neither suitable nor intended for other applications and/or uses.

Expected Values

All measurements with EDTA whole blood samples collected from 100 apparently healthy individuals were found as < 0.3 μg/L for the IB10 sphingotest® PCT.

Diagnosis of Sepsis (1,4)

PCT (μg/L)Analysis
< 0.5Local bacterial infection is possible. Systemic infection (sepsis) is not likely.
Low risk for progression to severe systemic infection (severe sepsis).
Levels below 0.5 μg/L do not exclude an infection, because localized infections (without systemic signs) may be associated with such low levels.
≥ 0.5 and ≤ 2Systemic infection (sepsis) is possible, but various conditions are known to induce PCT as well.
Moderate risk for progression to severe systemic infection (severe sepsis). The patient should be closely
monitored both clinically and by re-assessing PCT within 6-24 hours.
> 2 and ≤ 10Systemic infection (sepsis) is likely, unless other causes are known.
High risk for progression to severe systemic infection (severe sepsis).
> 10Important systemic inflammatory response, almost exclusively due to severe bacterial sepsis or septic shock.
High likelihood of severe sepsis or septic shock.

 


 

Whole Blood vs. Plasma Comparison

All our assays correlate with r=0.9. For more detailed information please read the IFUs or connect with our sales representatives.

 


 

Key Features

Easy Handling
Sample Type EDTA whole blood or plasma samples
Time to Result20 minutes
Measuring Range 0.3 - 10 μg/L
Limit of Detection0.3 μg/L
No High Dose Hook Effectup to 10,000 μg/L
Analyte Stability for IB10 Measurement 24 hours for whole blood

 

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IB10 sphingotest® PCT is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of Procalcitonin.

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References

(1) Gregoriano C et al. Role of procalcitonin use in the management of sepsis. J Thorac Dis. 2020 Feb;12(Suppl 1):S5-S15.

(2) Kondo Y et al. Diagnostic value of procalcitonin and presepsin for sepsis in critically ill adult patients: a systematic review and meta-analysis. J Intensive Care. 2019;7:22.

(3) De Oro N et al. The use of procalcitonin as a sepsis marker in a community hospital. J Appl Lab Med. 2019;3(4):545-552.

(4) Meisner M, Procalcitonin (PCT) - biochemistry and clinical diagnosis, First Edition Uni-med, 2010. ISBN: 978-3-8374-1241-3