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 |
|---|---|
| < 0.5 | Local 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 ≤ 2 | Systemic 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 ≤ 10 | Systemic infection (sepsis) is likely, unless other causes are known. |
| High risk for progression to severe systemic infection (severe sepsis). | |
| > 10 | Important 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 Result | 20 minutes |
| Measuring Range | 0.3 - 10 μg/L |
| Limit of Detection | 0.3 μg/L |
| No High Dose Hook Effect | up 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.
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