ROLLER 20 LC
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20” Of gENIuS Results highly correlated to the Westergen reference method In accordance with CLSI requirements* 1.000 readings for each sample Use of the same EDTA tube coming from the CBC 175 μl of blood Self-cleaning without contamination Self-checking of reading sensors and physical obstacles Data transmission to LIS Efficiency and precision Standardization and reproducibility Certainty of results SCIENTIFIC PUBLICATIONS 1. CH Cha, CJ Park, YJ Leunda Kim, DH C. Galiano, G. Nalbandian and B. Miller (Iris HS Chi, DS Lee, HI Cho 1. G. Scott, T. Nguyen, S.Cha, HK Ostolaza, Kim, Honghoon, JH Bae, JS Jung, S Jang, Diagnostics, Chatsworth, (Department of Laboratory Medicine, University of Ulsan College of Medicine CA CA) “Roller 20PN and Westergren Correlation” White Paper 2012 Chatsworth, and Gangneung Asan Hospital, Gangneung, Korea) “Erythrocyte Sedimentation Rate Measurements by TEST 1 Better Reflect Inflammation Than Do 2. CH Cha, CJ Park, YJ Cha, HK Kim, DH Kim, Honghoon, JH Bae, JS Jung, S Jang, HS Chi, DS Lee, HI Cho Those by the Westergren Method in Patients With Malignancy, Autoimmune Disease, or Infection” Am J Clin Pathol. (Department of Laboratory Medicine, University of Ulsan College of Medicine and Gangneung Asan Hospital, Gan2009 Feb;131(2):189-94 gneung, Korea) “Erythrocyte Sedimentation Rate Measurements by TEST 1 Better Reflect Inflammation Than Do Those by the Westergren Method in Patients With Malignancy, IAutoimmune Disease, or Infection” Am Elena Cancer 2. B Frollano, G Cigliana, G Vitelli, R Fontinovo, S Giommi, Cordone (Clinical Pathology, Regina J Clin Pathol. 2009 Feb;131(2):189-94 “Capillary Erythrocyte Sedimentation Rate (ESR) in oncological patients: low haematocrit Institute, IFO, Rome – Italy) pitfalls and sample collection optimization in a certified quality system laboratory” SIBioC National Congress 28-31 3. B Frollano, G Cigliana, G Vitelli, R Fontinovo, S Giommi, I Cordone (Clinical Pathology, Regina Elena Cancer October 2008, Rimini, Italy. Institute, IFO, Rome – Italy) “Capillary Erythrocyte Sedimentation Rate (ESR) in oncological patients: low haematocrit pitfalls and sample collection optimization in a certified quality system laboratory” SIBioC National Congress 28-31 3. R. Pajola, E. Piva, B. Robecchi, F. Tosato, M. Plebani. (Dep. of Laboratory Medicine, Padua University School of October 2008, Rimini, Italy. Erythrocyte Sedimentation Rate (ESR): an old test with new contents” SIBioC National Medicine, Padua, Italy) “The Congress 28-31 October 2008, Rimini, Italy. 4. R. Pajola, E. Piva, B. Robecchi, F. Tosato, M. Plebani. (Dep. of Laboratory Medicine, Padua University School of Medicine, Padua, Italy) “The Cunha, F Valido (Clinical Pathology Department, IPO Coimbra; Francisco Gentil, EPE, 4. J Reis, J Diamantino, N Erythrocyte Sedimentation Rate (ESR): an old test with new contents” SIBioC National Congress 28-31 October 2008, Rimini, Italy. blood a comparison of theTest 1 ESR system with the ICSH reference Portugal),“Erythrocyte sedimentation rate in method. Clinical Chemistry and Laboratory Medicine 2007 June; 45, Special Supplement, p.S118, MO77. 5. J Reis, J Diamantino, N Cunha, F Valido (Clinical Pathology Department, IPO Coimbra; Francisco Gentil, EPE, Portugal),“Erythrocyte Temporin, M Plebaniin bloodof Laboratory Medicine, University-Hospital, Padova, Italy) “A new 5. E Piva, R Pajola, V sedimentation rate (Dept. a comparison of theTest 1 ESR system with the ICSH reference method. Clinical Chemistry and Laboratory Medicine 2007 the erythrocyte sedimentation rate measurement” Clinical turbidimetric standard to improve the quality assurance of June; 45, Special Supplement, p.S118, MO77. Biochemistry 2007 Apr; 40(7):491-5. Epub 2007 Jan 8. 6. E Piva, R Pajola, V Temporin, M Plebani (Dept. of Laboratory Medicine, University-Hospital, Padova, Italy) “A new turbidimetricAkalin N. (Biochemistry Department, Baskent University, Ankara, Turkey) “Comparison of the erythrocyte 6. Arikan S, standard to improve the quality assurance of the erythrocyte sedimentation rate measurement” Clinical Biochemistry 2007 measured by the Micro Test 1 Jan 8. sedimentation rate Apr; 40(7):491-5. Epub 2007 sedimentation analyzer and the conventional Westergren method” Ann Saudi Med 2007; 27(5): 362-365. 7. Arikan S, Akalin N. (Biochemistry Department, Baskent University, Ankara, Turkey) “Comparison of the erythrocyte sedimentation rate G Feng, SFby the (Dep of Clinical Laboratory, Sixth People’s the conventional Westergren Jiaotong 7. LY Li, WB Chen, measured Shen Micro Test 1 sedimentation analyzer and Hospital Affiliated to Shangai method” Ann Saudi Shangai 200233, 362-365. University, Med 2007; 27(5): China) “Evaluation of the Microtest 1 ESR analyzer and investigation of the reference value” Chin J Lab Med, March 2007, Vol 30, N 3 (article in Chinese) 8. LY Li, WB Chen, G Feng, SF Shen (Dep of Clinical Laboratory, Sixth People’s Hospital Affiliated to Shangai Jiaotong University, Shangai 200233, China)M Gultekin (Clinical Biochemistry Unit, Medical and investigation of the reference 8. S Ozdem, HS Akbas, L Donmez, “Evaluation of the Microtest 1 ESR analyzer Faculty, Central Laboratory, Akdevalue” Chin J Lab Med, March 2007, Vol 30, TEST 1 within Chinese) niz University, Antalya,Turkey) Comparison of N 3 (article SRS 100 and ICSH reference method for the measurement of the length of sedimentation reaction in blood. Clin Chem Lab Med. 2006;44(4):407-12 9. S Ozdem, HS Akbas, L Donmez, M Gultekin (Clinical Biochemistry Unit, Medical Faculty, Central Laboratory, AkdenizNE Ajubi, AJ Bakker, GA van den Berg of TEST 1 with SRS 100 and ICSH reference method for the measurement 9. University, Antalya,Turkey) Comparison (Stichting KCL, Dept. of Clinical Chemistry, Leeuwarden, The Netherlanof the length of sedimentation reaction in blood. Clin Chem Lab Med.using the Test 1 system: comparison with the ds), “Determination of the length of sedimentation reaction in blood 2006;44(4):407-12 Sedimatic 100 method, turbidimetric fibrinogen levels and the influence of M proteins” Clin Chem Lab Med 2006, 10. NE Ajubi, AJ Bakker, GA van den Berg (Stichting KCL, Dept. of Clinical Chemistry, Leeuwarden, The Netherlan44 (7): 904-906 ds), “Determination of the length of sedimentation reaction in blood using the Test 1 system: comparison with the Sedimatic 100 method, S Ito, S Makino, N Miyake (Clinical the influence of Eijuproteins” Clin Chem Lab Med 2006, 10. Y Kagawa, N Ikeda, turbidimetric fibrinogen levels and Test Section of M Hospital, Finggal Link Co. and Dept. 44Clinical Pathology of Juntendo University),“Evaluation for ESR automated measuring instrument with EDTA”, 36th of (7): 904-906 Japan Society for Clinical Laboratory Automation, 30 September 2004, Japan. 11. Y Kagawa, N Ikeda, S Ito, S Makino, N Miyake (Clinical Test Section of Eiju Hospital, Finggal Link Co. and Dept. of Clinical Pathology of C Musa, J Aldunate (Servicio Laboratorio Clínico, Hospital Universidad de Chile),“Estudio 11. B Rosas, P Díaz, Juntendo University),“Evaluation for ESR automated measuring instrument with EDTA”, 36th Japan Society for Clinical Laboratory Automation, 30 Vesmatic”, XII Congreso Chileno de Tecnologia Medica, 20–22 Comparativo de 2 equipos que realizan VHS, Test1 y September 2004, Japan. October 2004, Santiago, Chile (article in Spanish). 12. B Rosas, P Díaz, C Musa, J Aldunate (Servicio Laboratorio Clínico, Hospital Universidad de Chile),“Estudio Comparativo deP D’Altoé, V Temporin, VHS, Test1Buttarello, M Sanzari, (Dept. of Laboratory Medicine, University12. M Plebani, 2 equipos que realizan E Piva, M y Vesmatic”, XII Congreso Chileno de Tecnologia Medica, 20–22 October 2004, Santiago, Chile (article in Spanish). ed Interindividuale della Velocità di Eritrosedimentazione”, 36th Hospital, Padova, Italy),“Variabilità Biologica Intra SIBioC, 8-11 June 2004, Padova, Italy (article in Italian). 13. M Plebani, P D’Altoé, V Temporin, E Piva, M Buttarello, M Sanzari, (Dept. of Laboratory Medicine, UniversityHospital, Padova, Italy),“Variabilità Biologica Intra ed Interindividuale della klinično kemijo in biokemijo) “Nov način 13. E Melkič, M Piskar, P Lenart (Klinični center Ljubljana, Klinični intitut za Velocità di Eritrosedimentazione”, 36th SIBioC, 8-11 June 2004, Padova, Italy (article in Italian). Test1 Alifax”, 2 Kongres Hematologov in Transfuziologov merjenja hitrosti sedimentacije eritrocitov z analizatorjem Slovenije z Mednarodno UbeleÏbo, 23–24 April 2004, Portoroz, Slovenia (article in Slovenian). 14. E Melkič, M Piskar, P Lenart (Klinični center Ljubljana, Klinični intitut za klinično kemijo in biokemijo) “Nov način merjenja hitrosti sedimentacije eritrocitov z analizatorjem Test1 Alifax”, 2 Kongres Hematologov in Transfuziologov 14. B Olivera Alonso, M Sirvent Monerris, MT Rotella Belda,V Ballenilla Antón, G Vidal (M Laboratorio Hospital San Slovenije z Mednarodno UbeleÏbo, 23–24 April 2004, Portoroz, Slovenia (article in Slovenian). V.S.G.: Repercusiones Vicente y Area Sanitaria 18.Alicante, Spain),“Cambio De Método Para La Determinación De Sobre La Fase Preanalítica”, Generalitat Valenciana - Conselleria De Sanitat (for Valencia Government – MOH), Spain 15. B Olivera Alonso, M Sirvent Monerris, MT Rotella Belda,V Ballenilla Antón, G Vidal (M Laboratorio Hospital San 2004 (poster in Spanish). Vicente y Area Sanitaria 18.Alicante, Spain),“Cambio De Método Para La Determinación De V.S.G.: Repercusiones Sobre La Fase Preanalítica”, Generalitat Valenciana - Conselleria De Sanitat (for Valencia Government – MOH), Spain 2004 (poster in Spanish). EACH SAMPLE IS READ 1000 TIMES IN 20 SECONDS TEST 1 is the only analyzer capable to give ESR results in 20 seconds by measuring the kinetic of red cells aggregation. TEST 1 CAPILLARY PHOTOMETRY TECHNOLOGY overcomes the variables and limitations of the sedimentation method also listed in the CLSI document*. Aggregation Start Aggregation after 20 seconds CAPILLARY PHOTOMETRY Temperature variability 25. D Smith D Spedding, (Dade Behring Diagnostics, New Zealand), “Evaluation of Agreement between the TEST1 24. and Starrsed Automated ESR Analysers”, November 2001, private communication. 26. D Giavarina, S Capuzzo, M Carta, F Cauduro, G Soffiati (Clin. Chem. & Hematol. Lab., San Bortolo Hospital, 25. Soffiati Vicenza, Italy), “Internal Quality Control for Erythrocyte Sedimentation Rate (ESR) measured by TEST-1 Analyzer”, Clinical Chemistry, June 2001, 47: 162. 27. E Piva, MC Sanzari, G Servidio M Plebani (Dept. of Laboratory Medicine, University-Hospital, Padova, Italy), 26. “Length of Sedimentation Reaction in Undiluted Blood (Erythrocyte Sedimentation Rate): Variations with Sex and Age and Reference Limits”, Clinical Chemistry and Laboratory Medicine, May 2001, 39: 451-454. 28. N de Jonge, I Sewkaransing, J Slinger, JJM Rijsdijk (Dept. Clinical Chemistry, Leyenburg Hospital, The Netherlan27. ds) Erythrocyte Sedimentation Rate by Test-1 Analyzer Clinical Chemistry, June 2000, 46: 881-882. 29. M Plebani, S De Toni, MC Sanzari, D Bernardi, E Stockreiter (Department of Laboratory Medicine, University28. Hospital of Padua, Italy) The TEST 1 automated system: a new method for measuring the erythrocyte sedimentation rate. Am J Clin Pathol. 1998 Sep;110(3):334-40. 30. G Soffiati (Clinical Chemistry and Hematology Laboratory, San Bortolo Hospital, Vicenza, Italy), “Nuovo Metodo 29. Soffiati per la Determinazione della Velocità di Eritrosedimentazione (VES)”, August 1998, private communication. 31. N Cirilli, Z Abu Asy, N Giacchè, F Bordicchia, S Paolucci, M Tocchini (Dept. of Laboratory Medicine, G. Salesi 30. Hospital, Ancona, Italy), “TEST1: Un Nuovo Metodo per la Determinazione della VES”, Biochimica Clinica, Vol. 22, N. 5-6, 1998, p. 339. High reproducibility New ESR system generation Instruments and latex controls are FDA registred and 510K exempted *Clinical Laboratory and Standard Institute (formerly NCCLS) Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard - Fifth Edition H02-A5, Vol.31 No.11 2011 24. M Plebani, E Piva (Dept. of Laboratory Medicine, University-Hospital, Padova, Italy), “Erythrocyte Sedimentation 23. Rate. Use of Fresh Blood for Quality Control”, American Journal of Clinical Pathology, 2002, 117:621-626. Latex Controls and Calibrators available Poor reproducibility 23. E Piva, P Fassina, M Plebani (Dept. of Laboratory Medicine, University-Hospital, Padova, Italy), “Determination of 22. the length of sedimentation reaction (erythrocyte sedimentation rate) in non-anticoagulated blood with the Microtest 1” Clin Chem Lab Med. 2002 Jul;40(7):713-7. Automated mixing step Controls and Calibrators lack 22. BH Lee, J Choi, MS Gee, KK Lee, H Park (Dept. of Laboratory Medicine,Kangbuk Samsung Hospital, Sungkyun21. kwan University School of Medicine, Seoul, Korea), “Basic Evaluation and Reference Range Assessment of TEST1 for the Automated Erythrocyte Sedimentatioon Rate” Journal of Clinical Pathology and Quality Control, Vol. 24, No. 1, 2002 (article in Korean). No influence of vibration or other external factors Not standardized sample mixing 21. E Heverin (Galway-Mayo Institute of Technology, Ireland), “Comparison of the Westergren method versus the 20. TEST1 technique for determining the Erythrocyte Sedimentation Rate” May 2002, private communication. Use of the same capillary for all samples Vibrations and pipettes verticality 20. D Giavarina, S Capuzzo, F Cauduro, M Carta, G Soffiati (Clin. Chem. & Hematol. Lab., San Bortolo Hospital, 19. Soffiati Vicenza, Italy), “Internal Quality Control for Erythrocyte Sedimentation Rate Measured Test 1 Analyzer” Clinical Laboratory 2002, 48:459-462. No dilution, use of EDTA tube Inadequate materials and pipettes variability 19. A Romero, M Muñoz, G Ramirez (Dept. of Haematology, H.C.U. “Virgen de la Victoria”, Málaga & *GIEMSA, 18. School of Medicine, University of Málaga, Spain), “Determination of the Length of Sedimentation Reaction in Blood: a Comparison of the Test1 ESR System with the ICSH Reference Method and the Sedisystem”, Clinical Chemistry and Laboratory Medicine 2003, 41 (2). Independent from Hematocrit value Dilution problems using Sodium Citrate 18. M Plebani (Dept. of Laboratory Medicine, University-Hospital, Padova, Italy), “Erythrocyte Sedimentation Rate: 17. Innovative Techniques for an Obsolete Test?”, Clinical Chemistry and Laboratory Medicine, 2003, 41 (2): 115-116. Hematocrit influence 17. M Nicoli, E Lanzoni, A Massocco, (Laboratory of Clinical Chemistry and Haematological Analysis, Ospedale Civile 16. Maggiore,Verona, Italy) “Integrated Haematology and Coagulation Laboratory”, Poster, Euromedlab Congress, 1-5 June 2003, Barcelona, Spain. 16. P Galiano, “Quality and Automation in the Determination of the Erythrocyte Sedimentation Rate”, Symposium 15. 046, 22nd World Congress of Pathology & Laboratory Medicine, 30 August- September 2003, Busan, Korea. ALIFAX S.p.A. Via F. Petrarca,2/1 35020 Polverara - Padova, ITALY Tel. +39 049 0992000 Fax +39 049 5855434 info@alifax.com www.alifax.com S.r.l. Via F. Petrarca, 2/1 35020 Polverara ITALY Tel. +39 049 0992000 Fax +39 049 5855434 info@alifax.com www.alifax.com Entered in Entered incompanies register