Clinical Utility of Recently Food and Drug Administration-Approved IntelliSep Test (Sepsis Biomarker) for Early Diagnosis of Sepsis: Comparison with Other Biomarkers
Abstract
:1. Introduction
2. Materials and Methods
3. Results
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
- Singer, M.; Deutschman, C.S.; Seymour, C.W.; Shankar-Hari, M.; Annane, D.; Bauer, M.; Bellomo, R.; Bernard, G.R.; Chiche, J.D.; Coopersmith, C.M.; et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016, 315, 801–810. [Google Scholar] [CrossRef] [PubMed]
- Rudd, K.E.; Johnson, S.C.; Agesa, K.M.; Shackelford, K.A.; Tsoi, D.; Kievlan, D.R.; Colombara, D.V.; Ikuta, K.S.; Kissoon, N.; Finfer, S.; et al. Global, regional, and national sepsis incidence and mortality, 1990–2017: Analysis for the Global Burden of Disease Study. Lancet 2020, 395, 200–211. [Google Scholar] [CrossRef] [PubMed]
- Gonzalez, M.D.; Chao, T.; Pettengill, M.A. Modern Blood Culture: Management Decisions and Method Options. Clin. Lab. Med. 2020, 40, 379–392. [Google Scholar] [CrossRef]
- Nguyen, H.B.; Rivers, E.P.; Knoblich, B.P.; Jacobsen, G.; Muzzin, A.; Ressler, J.A.; Tomlanovich, M.C. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit. Care Med. 2004, 32, 1637–1642. [Google Scholar] [CrossRef] [PubMed]
- Garcia-Alvarez, M.; Marik, P.; Bellomo, R. Sepsis-associated hyperlactatemia. Crit. Care 2014, 18, 503. [Google Scholar] [CrossRef] [PubMed]
- Vincent, J.L.; Bakker, J. Blood lactate levels in sepsis: In 8 questions. Curr. Opin. Crit. Care 2021, 27, 298–302. [Google Scholar] [CrossRef] [PubMed]
- Maigari, I.M.; Jibrin, Y.B.; Gwalabe, S.A.; Dunga, J.A.; Abdu, A.; Umar, M.S.; Hassan, H.F.; Ballah, A.M.; Sulaiman, M.H. Diagnostic usefulness of serum procalcitonin in patients with bacterial sepsis. Niger. J. Clin. Pract. 2023, 26, 1436–1443. [Google Scholar] [CrossRef] [PubMed]
- Assicot, M.; Gendrel, D.; Carsin, H.; Raymond, J.; Guilbaud, J.; Bohuon, C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet 1993, 341, 515–518. [Google Scholar] [CrossRef] [PubMed]
- Athhan, F.; Akagunduz, B.; Genel, F.; Bak, M.; Can, D. Procalcitonin: A marker of neonatal sepsis. J. Trop. Pediatr. 2002, 48, 10–14. [Google Scholar] [CrossRef]
- Simon, L.; Gauvin, F.; Amre, D.K.; Saint-Louis, P.; Lacroix, J. Serum procalcitonin and C-reactive protein levels as markers of bacterial infection: A systematic review and meta-analysis. Clin. Infect. Dis. 2004, 39, 206–217. [Google Scholar] [CrossRef]
- Agnello, L.; Bivona, G.; Vidali, M.; Scazzone, C.; Giglio, R.V.; Iacolino, G.; Iacona, A.; Mancuso, S.; Ciaccio, A.M.; Lo Sasso, B.; et al. Monocyte distribution width (MDW) as a screening tool for sepsis in the Emergency Department. Clin. Chem. Lab. Med. 2020, 58, 1951–1957. [Google Scholar] [CrossRef] [PubMed]
- O’Neal, H.R., Jr.; Sheybani, R.; Caffery, T.S.; Musso, M.W.; Hamer, D.; Alwood, S.M.; Berlinger, M.S.; Jagneaux, T.; LaVie, K.W.; O’Neal, C.S.; et al. Assessment of a Cellular Host Response Test as a Sepsis Diagnostic for Those With Suspected Infection in the Emergency Department. Crit. Care Explor. 2021, 3, e0460. [Google Scholar] [CrossRef] [PubMed]
- Hollenbeak, C.S.; Henning, D.J.; Geeting, G.K.; Ledeboer, N.A.; Faruqi, I.A.; Pierce, C.G.; Thomas, C.B.; O’Neal, H.R., Jr. Costs and Consequences of a Novel Emergency Department Sepsis Diagnostic Test: The IntelliSep Index. Crit. Care Explor. 2023, 5, e0942. [Google Scholar] [CrossRef] [PubMed]
- O’Neal, H.R., Jr.; Sheybani, R.; Janz, D.R.; Scoggins, R.; Jagneaux, T.; Walker, J.E.; Henning, D.J.; Rosenman, E.; Mahler, S.A.; Regunath, H.; et al. Validation of a Novel, Rapid Sepsis Diagnostic for Emergency Department Use. Crit. Care Explor. 2024, 6, e1026. [Google Scholar] [CrossRef] [PubMed]
- Zheng, X.L. ADAMTS13 and von Willebrand factor in thrombotic thrombocytopenic purpura. Annu. Rev. Med. 2015, 66, 211–225. [Google Scholar] [CrossRef] [PubMed]
- Chan, M.; Zhao, X.; Zheng, X.L. Low ADAMTS13 predicts adverse outcomes in hospitalized patients suspected with heparin-induced thrombocytopenia. Res. Pract. Thromb. Haemost. 2021, 5, e12581. [Google Scholar] [CrossRef] [PubMed]
- Sui, J.; Cao, W.; Halkidis, K.; Abdelgawwad, M.S.; Kocher, N.K.; Guillory, B.; Williams, L.A.; Gangaraju, R.; Marques, M.B.; Zheng, X.L. Longitudinal assessments of plasma ADAMTS13 biomarkers predict recurrence of immune thrombotic thrombocytopenic purpura. Blood Adv. 2019, 3, 4177–4186. [Google Scholar] [CrossRef] [PubMed]
- Zhang, Q.; Bignotti, A.; Yada, N.; Ye, Z.; Liu, S.; Han, Z.; Zheng, X.L. Dynamic Assessment of Plasma von Willebrand Factor and ADAMTS13 Predicts Mortality in Hospitalized Patients with SARS-CoV-2 Infection. J. Clin. Med. 2023, 12, 7174. [Google Scholar] [CrossRef] [PubMed]
- Wagner, D.D.; Bonfanti, R. von Willebrand factor and the endothelium. Mayo Clin. Proc. 1991, 66, 621–627. [Google Scholar] [CrossRef]
- Madarati, H.; Singh, K.; Sparring, T.; Andrisani, P.; Liaw, P.C.; Fox-Robichaud, A.E.; Kretz, C.A. Reviewing the Dysregulation of Adamts13 and Vwf in Sepsis. Shock 2024, 61, 189–196. [Google Scholar] [CrossRef] [PubMed]
- Singh, K.; Kwong, A.C.; Madarati, H.; Kunasekaran, S.; Sparring, T.; Fox-Robichaud, A.E.; Liaw, P.C.; Kretz, C.A. Characterization of ADAMTS13 and von Willebrand factor levels in septic and non-septic ICU patients. PLoS ONE 2021, 16, e0247017. [Google Scholar] [CrossRef] [PubMed]
- Agnello, L.; Vidali, M.; Lo Sasso, B.; Giglio, R.V.; Gambino, C.M.; Scazzone, C.; Ciaccio, A.M.; Bivona, G.; Ciaccio, M. Monocyte distribution width (MDW) as a screening tool for early detecting sepsis: A systematic review and meta-analysis. Clin. Chem. Lab. Med. 2022, 60, 786–792. [Google Scholar] [CrossRef]
- Sporn, L.A.; Chavin, S.I.; Marder, V.J.; Wagner, D.D. Biosynthesis of von Willebrand protein by human megakaryocytes. J. Clin. Investig. 1985, 76, 1102–1106. [Google Scholar] [CrossRef]
- Plautz, W.E.; Matthay, Z.A.; Rollins-Raval, M.A.; Raval, J.S.; Kornblith, L.Z.; Neal, M.D. Von Willebrand factor as a thrombotic and inflammatory mediator in critical illness. Transfusion 2020, 60 (Suppl. S3), S158–S166. [Google Scholar] [CrossRef]
- Ruggeri, Z.M. Structure of von Willebrand factor and its function in platelet adhesion and thrombus formation. Best Pract. Res. Clin. Haematol. 2001, 14, 257–279. [Google Scholar] [CrossRef]
- Kremer Hovinga, J.A.; Zeerleder, S.; Kessler, P.; Romani de Wit, T.; van Mourik, J.A.; Hack, C.E.; ten Cate, H.; Reitsma, P.H.; Wuillemin, W.A.; Lammle, B. ADAMTS-13, von Willebrand factor and related parameters in severe sepsis and septic shock. J. Thromb. Haemost. 2007, 5, 2284–2290. [Google Scholar] [CrossRef] [PubMed]
- Bernardo, A.; Ball, C.; Nolasco, L.; Moake, J.F.; Dong, J.F. Effects of inflammatory cytokines on the release and cleavage of the endothelial cell-derived ultralarge von Willebrand factor multimers under flow. Blood 2004, 104, 100–106. [Google Scholar] [CrossRef] [PubMed]
- Cao, W.J.; Niiya, M.; Zheng, X.W.; Shang, D.Z.; Zheng, X.L. Inflammatory cytokines inhibit ADAMTS13 synthesis in hepatic stellate cells and endothelial cells. J. Thromb. Haemost. 2008, 6, 1233–1235. [Google Scholar] [CrossRef] [PubMed]
- Dong, J.F.; Moake, J.L.; Nolasco, L.; Bernardo, A.; Arceneaux, W.; Shrimpton, C.N.; Schade, A.J.; McIntire, L.V.; Fujikawa, K.; Lopez, J.A. ADAMTS-13 rapidly cleaves newly secreted ultralarge von Willebrand factor multimers on the endothelial surface under flowing conditions. Blood 2002, 100, 4033–4039. [Google Scholar] [CrossRef]
- Moake, J.L. Thrombotic microangiopathies. N. Engl. J. Med. 2002, 347, 589–600. [Google Scholar] [CrossRef]
- Zheng, X.; Majerus, E.M.; Sadler, J.E. ADAMTS13 and TTP. Curr. Opin. Hematol. 2002, 9, 389–394. [Google Scholar] [CrossRef] [PubMed]
- Bianchi, V.; Robles, R.; Alberio, L.; Furlan, M.; Lammle, B. Von Willebrand factor-cleaving protease (ADAMTS13) in thrombocytopenic disorders: A severely deficient activity is specific for thrombotic thrombocytopenic purpura. Blood 2002, 100, 710–713. [Google Scholar] [CrossRef] [PubMed]
- Levi, M.; Scully, M.; Singer, M. The role of ADAMTS-13 in the coagulopathy of sepsis. J. Thromb. Haemost. 2018, 16, 646–651. [Google Scholar] [CrossRef] [PubMed]
High Probability of Sepsis | Low Probability of Sepsis |
---|---|
≥18 years old | ≥18 years old |
Two or more of the systemic inflammatory response syndrome (SIRS) criteria, in which one must be temperature or WBC criterion. | CBC ordered |
Prescribed antimicrobials (antibiotics or antivirals). | ED discharged |
Admitted to hospital or has an admission order placed. | None |
Demographic | Count |
---|---|
Female | 23 |
Male | 21 |
Age range (years) | 19–97 |
Asian | 1 |
Black or African American | 17 |
White or Caucasian | 24 |
Other | 2 |
Case# | Enrolment Criteria | ISI | Interpretation Band (ISI Score) | Comments |
---|---|---|---|---|
1 | High probability | 3.8 | Band 1 (3.8) | Sepsis confirmed, lactate 1.3 mmol/L, MDW: 22.2 |
2 | High probability | 3.3 | Band 1 (3.3) | No sepsis, lactate: 1.9 mmol/L, MDW: 19.5 |
3 | High probability | 4.4 | Band 1(3.3) | No sepsis, lactate 6.2 mmol/L |
4 | High probability | 4.9 | Band 1 (4.4) | No sepsis, lactate 4.3 mmol/L, MDW 18.0 |
Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content. |
© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Share and Cite
Sarani, N.; Dasgupta, A.; Enders, M.; Rowan, L.; Elsarraj, H.; Gralnek, S.; Shay, M.; Lemar, L.R.; Simpson, S.Q.; Cunningham, M.T.; et al. Clinical Utility of Recently Food and Drug Administration-Approved IntelliSep Test (Sepsis Biomarker) for Early Diagnosis of Sepsis: Comparison with Other Biomarkers. J. Clin. Med. 2024, 13, 4852. https://doi.org/10.3390/jcm13164852
Sarani N, Dasgupta A, Enders M, Rowan L, Elsarraj H, Gralnek S, Shay M, Lemar LR, Simpson SQ, Cunningham MT, et al. Clinical Utility of Recently Food and Drug Administration-Approved IntelliSep Test (Sepsis Biomarker) for Early Diagnosis of Sepsis: Comparison with Other Biomarkers. Journal of Clinical Medicine. 2024; 13(16):4852. https://doi.org/10.3390/jcm13164852
Chicago/Turabian StyleSarani, Nima, Amitava Dasgupta, Maria Enders, Lauren Rowan, Hanan Elsarraj, Sarah Gralnek, Madison Shay, Lucas R. Lemar, Steven Q. Simpson, Mark T. Cunningham, and et al. 2024. "Clinical Utility of Recently Food and Drug Administration-Approved IntelliSep Test (Sepsis Biomarker) for Early Diagnosis of Sepsis: Comparison with Other Biomarkers" Journal of Clinical Medicine 13, no. 16: 4852. https://doi.org/10.3390/jcm13164852