The medical device EndoMark® H1A kit for endocan
EndoMark® H1A or EMH1A is a ready-to-use sandwich-type immunoassay. It can analyze1 1 to 45 samples, either manually or on an automated platform developed by Biothelis.
This medical device is manufactured by Biothelis, according to European Directive 98/79 / CE.
The endocan measurement is reimbursed by the French Social Security (RIHN, code K305, BHN200)
Download the EndoMark® H1A Brochure
Assay characteristics
Limit of quantification: 0.16 ng / mL
Range: 0.62 to 60 ng / mL
Within-run repeatability (% CV): <8%
Inter-series reproducibility (% CV): <12%
No interference observed with hemolyzed, lactescent or icteric plasma
Indications for the dosage of endocan
| Event to be screened for | Target population | Dosage prescription | threshold values | Examples of possible pre-emptive treatments |
|---|---|---|---|---|
| Respiratory failure | ICU patients | On admission then daily | If < 5.5 ng / mL on admission | Corticosteroid therapy Fluid restriction Other |
| Postoperative pneumonia | Cardiac Surgical Patients | Before and 6 hours after the operation | If > 15 ng / mL 6 hours after the operation | Rapid microbiological analysis Digestive decontamination Antibioprophylaxis, other … |
| Nosocomial pneumonia | Ventilated patients | After intubation then every day | If > 9 ng / mL | Rapid microbiological analysis Antibioprophylaxis Other .. |
Diagnostic performance of the endocan assay
Screening for respiratory failure in severe septic conditions
| Threshold | < 2,5 ng/mL | < 5,5 ng/mL |
|---|---|---|
| Area under the curve | 0.93 | 0.93 |
| Sensitivity | 0.45 | 1.00 |
| Specificity | 1.00 | 0.77 |
| Positive predictive value | 1.00 | 0.44 |
| Negative predictive value | 0.91 | 1.00 |
Mikkelsen M et al, Lower serum endocan levels are associated with the development of acute lung injury after major trauma. J Crit Care. 2012
Palud A, et al, Evaluation of endothelial biomarkers as predictors of organ failures in septic shock patients. Cytokine. 2015
Ioakeimidou A et al, Increase of circulating endocan over sepsis follow-up is associated with progression into organ dysfunction. Eur J Clin Microbiol Infect Dis. 2017
Gaudet A et al, Low endocan levels are predictive of Acute Respiratory Distress Syndrome in severe sepsis and septic shock. J Crit Care. 2018 Oct; 47: 121-126
Post-operative pneumonia screening
Threshold | Pre-operative threshold > 3 ng/mL | 6h postoperative 15 ng/mL |
|---|---|---|
Area under the curve (AUC) | 0.70 | 0.75 |
| Sensitivity | 0.88 | 0.41 |
| Specificity | 0.57 | 0.95 |
| Positive predictive value | 0.17 | 0.47 |
| Negative predictive value | 0.98 | 0.94 |
Perrotti A, et al. Relevance of Endothelial Cell-Specific Molecule 1 (Endocan) Plasma Levels for Predicting Pulmonary Infection after Cardiac Surgery in Chronic Kidney Disease Patients: The Endolung Pilot Study. Cardiorenal Med. 2017 Dec;8(1):1-8. Perrotti A, et al. Is Endocan a Diagnostic Marker for Pneumonia After Cardiac Surgery? The ENDOLUNG Study. Ann Thorac Surg. 2018 Feb;105(2):535-541. NCT02542423 De Freitas Caires N et al. Endocan, sepsis, pneumonia, and acute respiratory distress syndrome. Crit Care. 2018 Oct 26;22(1):280.