CLIA CRP wide-range

Description

C-reactive protein (CRP) is an acute inflammatory protein that increases up to 1,000-fold at sites of infection or inflammation. CRP is accepted in clinical use as a major, although rather non-specific, marker of local or systemic inflammation, bacterial infection, and sepsis.

Changes in the concentration of CRP are used to help evaluate for acute bacterial or fungal infections, identify postoperative complications, and monitor chronic inflammatory conditions such as autoimmune diseases, certain types of arthritis, and IBD. They also help evaluate the response to antibiotic treatment of bacterial infections and therapy in people with chronic inflammation.

In patients with COVID-19, admission CRP correlated with disease severity and tended to be a good predictor of adverse outcomes.

The inflammation process plays a key role in the pathogenesis of atherosclerosis, development of arterial hypertension, heart failure, valvular disease, and atrial fibrillation. The formation of cholesterol-rich plaque inside arteries is the root cause of most heart attacks and strokes.

CRP has long been recognized as an inflammatory marker and suspected of playing a role in the atherosclerotic process. Recent guidelines recommend high sensitivity CRP testing for primary CVD prevention, stratifying CVD risk groups, and select patients for statin therapy. It can also be used to prognosticate complications of CVD itself and to evaluate treatment efficacy. The CDC/AHA guidelines support the use of CRP in primary prevention and set cutoff points according to relative risk categories: low risk (<1.0 mg/L), average risk (1.0-3.0 mg/L), and high risk (>3.0 mg/L).

Technical data

• Assay time: 15 min
• Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
• Sample matrix: Serum
• Sample volume: 15 μL
• Measuring range: 0,5–360 mg/l
• Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
• Note: The kits are CE-IVD certified and intended for professional use.

Specifications

• Catalog Number: CL-CRP100
• Size: 100 tests
• Regulatory status: CE IVD
• Clinical topic: Sepsis & Inflammation
• Diagnostic panel: COVID-19 SIRS, Sepsis, and Severe Viral Infection
• Producer: TestLine Clinical Diagnostics s.r.o.

References

• 10595891,29706967,16962952,12578424,24878684,17159015,32445579,33027044,21712404,24222018,26987494,12551853,12551878,30452612,32639518,31350553,33357526
• Clyne B, Olshaker JS. The C-reactive protein. J Emerg Med. 1999 Nov- Dec;17(6):1019-25. doi: 10.1016/s0736-4679(99)00135-3. PMID: 10595891.
• Nehring SM, Goyal A, Bansal P, Patel BC. C Reactive Protein. 2020 Jun 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan–. PMID: 28722873.
• Sproston NR, Ashworth JJ. Role of C-Reactive Protein at Sites of Inflammation and Infection. Front Immunol. 2018 Apr 13;9:754. doi: 10.3389/fimmu.2018.00754. PMID: 29706967; PMCID: PMC5908901.
• Vanderschueren S, Deeren D, Knockaert DC, Bobbaers H, Bossuyt X, Peetermans W. Extremely elevated C-reactive protein. Eur J Intern Med. 2006 Oct;17(6):430-3. doi: 10.1016/j.ejim.2006.02.025. PMID: 16962952.
• Zimmerman MA, Selzman CH, Cothren C, Sorensen AC, Raeburn CD, Harken AH. Diagnostic implications of C-reactive protein. Arch Surg. 2003 Feb;138(2):220-4. doi: 10.1001/archsurg.138.2.220. PMID: 12578424.
• Santonocito C, De Loecker I, Donadello K, Moussa MD, Markowicz S, Gullo A, Vincent JL. C-reactive protein kinetics after major surgery. Anesth Analg. 2014 Sep;119(3):624-9. doi: 10.1213/ANE.0000000000000263. PMID: 24878684.
• Shadick NA, Cook NR, Karlson EW, Ridker PM, Maher NE, Manson JE, Buring JE, Lee IM. C-reactive protein in the prediction of rheumatoid arthritis in women. Arch Intern Med. 2006 Dec 11-25;166(22):2490-4. doi: 10.1001/archinte.166.22.2490. PMID: 17159015.
• Luo X, Zhou W, Yan X, Guo T, Wang B, Xia H, Ye L, Xiong J, Jiang Z, Liu Y, Zhang B, Yang W. Prognostic Value of C-Reactive Protein in Patients With Coronavirus 2019. Clin Infect Dis. 2020 Nov 19;71(16):2174-2179. doi: 10.1093/cid/ciaa641. PMID: 32445579; PMCID: PMC7314209.
• Thompson S, Bohn MK, Mancini N, Loh TP, Wang CB, Grimmler M, Yuen KY, Mueller R, Koch D, Sethi S, Rawlinson WD, Clementi M, Erasmus R, Leportier M, Kwon GC, Menezes ME, Patru MM, Gramegna M, Singh K, Najjar O, Ferrari M, Lippi G, Adeli K, Horvath AR; IFCC Taskforce on COVID-19. IFCC Interim Guidelines on Biochemical/Hematological Monitoring of COVID-19 Patients. Clin Chem Lab Med. 2020 Oct 7;58(12):2009-2016. doi: 10.1515/cclm-2020-1414. PMID: 33027044.
• European Association for Cardiovascular Prevention & Rehabilitation, Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28. PMID: 21712404.
• Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D’Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O’Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PW, Jordan HS, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S49-73. doi: 10.1161/01.cir.0000437741.48606.98. Epub 2013 Nov 12. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S74-5. PMID: 24222018.
• Adukauskienė D, Čiginskienė A, Adukauskaitė A, Pentiokinienė D, Šlapikas R, Čeponienė I. Clinical relevance of high sensitivity C-reactive protein in cardiology. Medicina (Kaunas). 2016;52(1):1-10. doi: 10.1016/j.medici.2015.12.001. Epub 2016 Jan 15. PMID: 26987494.
• Ridker PM. Clinical application of C-reactive protein for cardiovascular disease detection and prevention. Circulation. 2003 Jan 28;107(3):363-9. doi: 10.1161/01.cir.0000053730.47739.3c. PMID: 12551853.
• Pearson TA, Mensah GA, Alexander RW, Anderson JL, Cannon RO 3rd, Criqui M, Fadl YY, Fortmann SP, Hong Y, Myers GL, Rifai N, Smith SC Jr, Taubert K, Tracy RP, Vinicor F; Centers for Disease Control and Prevention; American Heart Association. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation. 2003 Jan 28;107(3):499-511. doi: 10.1161/01.cir.0000052939.59093.45. PMID: 12551878.
• Ridker PM, Koenig W, Kastelein JJ, Mach F, Lüscher TF. Has the time finally come to measure hsCRP universally in primary and secondary cardiovascular prevention? Eur Heart J. 2018 Dec 7;39(46):4109-4111. doi: 10.1093/eurheartj/ehy723. PMID: 30452612.
• Puri R, Nissen SE, Arsenault BJ, St John J, Riesmeyer JS, Ruotolo G, McErlean E, Menon V, Cho L, Wolski K, Lincoff AM, Nicholls SJ. Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial. JAMA Cardiol. 2020 Jul 8;5(10):1–8. doi: 10.1001/jamacardio.2020.2413. Epub ahead of print. PMID: 32639518; PMCID: PMC7344788.
• Pellicori P, Zhang J, Cuthbert J, Urbinati A, Shah P, Kazmi S, Clark AL, Cleland JGF. High-sensitivity C-reactive protein in chronic heart failure: patient characteristics, phenotypes, and mode of death. Cardiovasc Res. 2020 Jan 1;116(1):91-100. doi: 10.1093/cvr/cvz198. PMID: 31350553.
• Beyhoff N, Cao D, Mehran R, Dangas G, Baber U, Sartori S, Blum M, Roumeliotis A, Chandiramani R, Goel R, Zhang Z, Kovacic J, Krishnan P, Barman N, Kapur V, Sweeny J, Sharma SK, Kini A. Prognostic Impact of High-Sensitivity C-Reactive Protein in Patients Undergoing Percutaneous Coronary Intervention According to BMI. JACC Cardiovasc Interv. 2020 Dec 28;13(24):2882-2892. doi: 10.1016/j.jcin.2020.09.024. PMID: 33357526.

• Reagent Cartridge with specific reagents for the assay
• magnetic particles
• calibrators