FULLY AUTOMATED ANALYZERS FOR THE

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ESR IN 20 SECONDSESRFULLY AUTOMATED ANALYZERSFOR THE DETERMINATIONOF THE ERYTHROCYTESEDIMENTATION RATE20SECONDSwww.alifax.com

ESR IN 20 SECONDS BY RED CELLAGGREGATIONEACH SAMPLE is read1000 times in 20 seconds201sechCAPILLARY PHOTOMETRYSEDIMENTATION ESRTemperature control 37 CTemperature variabilityIndependent from Hematocrit valueHematocrit influenceNo dilution, use of EDTA tubeDilution problems using Sodium CitrateUse of the same capillary for all samplesInadequate materials and pipettes variabilityNo influence of vibration or other external factorsVibrations and pipettes verticalityAutomated mixing stepNot standardized sample mixingLatex Controls and Calibrators availableControls and Calibrators lackHigh reproducibilityPoor reproducibilityTEST1 CAPILLARY PHOTOMETRY TECHNOLOGY OVERCOMES THE MAJORITYOF THE VARIABLES AND LIMITATIONS OF THE SEDIMENTATION METHOD (ICSHRECOMMENDATIONS) (4).Alifax technology is classified by CLSI guidelines as an alternative method for ESR (H02-A5 Vol. 31, N.11)YOUNGJOO CHAMD, Department of LaboratoryMedicine, Chung-Ang UniversityHospital, Seoul, Korea"ESR measurements by TEST1 reflect inflammation better than do those bythe Westergen method in patients with malignancy, autoimmune disease,or infection"Clin Chem Lab Med 2010;48(7):1043–1048

TEST1Direct loading from originalcell blood counter rackTEST1 BCLSI 195.220/BCL60 cmUp to 60 samples per session withALIFAX green plastic racks.Up to 48 samples per session with BeckmanCoulter Series LH 700 CBC racksTEST1 SDLSI 195.230/SDLUp to 40 samples per session withALIFAX yellow plastic racks.Up to 40 samples per session with SysmexSeries SF, SE, XE CBC racksTEST1 YDL54cmSI 195.240/YDL49 cmUp to 40 samples per session withALIFAX blue plastic racks.Up to 40 samples per session with SiemensSeries ADVIA 120 CBC racksTEST1 THLSI 195.210/THLTEST1 MDLSI 195.250/MDL NEW AUTOMATIC WASHING SYSTEM175 μl EDTA blood sample per testOnly 800 μl sample requested in the tubeCapacity up to 60 samplesDirect loading of CBC racksThroughput up to 150 samples/hourInternal bar code readerBidirectional connection to LISUp to 40 samples per session withBeckman CoulterSeries LH 500 CBC racksTEST1 XDLSI 195.260/XDLUp to 40 samples per sessionwith Beckman CoulterSeries DxH 800 CBC racks

ROLLERManual tube loading alsofor uncapped and low volume samplesROLLER 20PNROLLER 20MCDouble circuit forautomatic and manualsamplingManual samplingSI R20-PNOnly 30 µl EDTAblood sample LCD touch screen User-friendlysoftware External barcodereader 46 cm 17524 cm39cmROLLER 10PNROLLER 20LCSI R10-PNSI R20-LCManual sampling MixAutomaticsamplingOnly 30 µl EDTA blood samplerotor with 10 positionsfor standardized mixing procedure LCD touch screen User-friendly software External barcode reader Internal175 µl EDTA bloodsample per test 800 µl samplerequested in the tube 18 samples Simplified needlereplacement Automated washing 58 cmInternal rotor with 20 positionsµl EDTA blood sampleautomated withdrawal per test 100 µl sample requested in thetube for manual withdrawal LCD touch screen User-friendly software Automatic washing system External barcode readerSI R20-MC32 cm56cm

JO PLUSOn line ESR SYSTEMfor total laboratory automationJo Plus is conceived for megalaboratories with high routinevolumes equipped with LaboratoryAutomation System (LAS).Jo Plus is based on the sameTest1 family technology.42 cm94 cm30cmJO PLUSSI 804.100 120 samples processedin about 1 hour 175 μl EDTA blood sample per test Results available in 30 secondsPower supply: 115-230 VAC (SMPS), 50/60 HzPower consumption: 66VASize: 94 x 30 x 42 cm (W,D,H)Weight: 16 Kg

LATEX CONTROLSEQE KITThree levels to guarantee:precision, accuracy, repeatabilityExternal Quality Evaluationkit Specific for all Alifax ESRanalyzers6 TESTS30 TESTSSI 305.100-A (Greiner tubes)SI 305.102-A (Sarstedt tubes)SI 305.300-A (Greiner tubes)SI 305.302-A (Sarstedt tubes)Third parties international programsavailable: CAP LABQUALITY NEQAS ONEWORLD ACCURACY APISHELF LIFE: From production: 6 months. From the 1st piercing: 6 weeksSTORAGE CONDITIONS: From production: 4-25 C. From the 1st piercing: 4-8 Cnext introduction graphic layoutSMART CARDEnvironmentally friendlycards save storage andtransport costs.Only pay for a testwhen needed.1.0004.00010.000 20.000teststestscode SI 195.901code SI 195.904code SI 195.910code SI 195.920code SI 804.910code SI 804.920testsTEST1ROLLERJO PLUS-tests-

COMPARATIVE CHARTTEST1ROLLER 20 PNROLLER 20 LCROLLER 10 PNROLLER 20 MCPositionsUp to 60Up to 20Up to 18Up to 10 - for mix SamplingAutomaticdirect loadingof 4 CBC racksAutomaticand ManualAutomaticManualManualThroughputUp to 150/hUp to 120/hUp to 100/h ��Min Volume800 µl800 µl (auto)100 µl (manual)800 µl100 µl100 µlTesting volume175 µl175 µl (auto)100 µl (manual)175 µl30 µl30 µlInternal mixingVVVVxThermostatation 37 CVVVInternal washingVVVVxVxBarcode readerV(ext. optional)(ext. optional)(ext. optional)(ext optional)PrinterVVVVVVV49 x 54 x 6024 x 39 x 4632 x 56 x 5824 x 39 x 4624 x 39 x 46Weight (Kg)471623,213,511Daily maintenance5’5’5’5’5’Maintenance1 yearor 30.000 tests1 yearor 30.000 tests1 yearor 30.000 tests1 yearor 30.000 tests1 yearor 30.000 testsOperator time1’ 2’ 2’30’ / sample30’ / sampleLIS bidirectional connectionDimensions (cm) W,D,HVClass I - FDA registered - Device listing number D116930VV

ESR BRO001 ESR LINE 03 01 190919 ENI N S I D E I N N O V AT I O NNEW ESR SYSTEM GENERATIONERYTHROCYTE SEDIMENTATION RATE1. Lapić I, Piva E, Spolaore F, Tosato F, Pelloso M, Plebani M; Automated measurementof the erythrocyte sedimentation rate: method validation and comparison. Clin ChemLab Med. 2019 Apr 22. Kim M, Ju YS, Lee EJ, Lee E, Jeon K, Lee J, Kang HJ, Kim HS, Lee JS, Kim HJ, Lee YK;Erythrocyte sedimentation rate measured using microhemagglutination is not elevaed in monoclonal gammopathy compared with other diseases. Int J Lab Hematol.2018Oct;40(5):540-5483. Sonmez C, Dogan OC, Kaymak AO, Akkaya N, Akin KO, Guntas G; Test-1 analyzerand conventional Westergren method for erythrocyte sedimentation rate: Acomparative study between two laboratories. J Clin Lab Anal. 2018 Jun;32(5).4. Kratz A, Plebani M, Peng M, Lee YK, McCafferty R, Machin SJ; ICSH recommendationsfor modified and alternate methods measuring the erythrocyte sedimentation rate.Int J Lab Hematol. 2017 Oct;39(5):448-457.5. Cha CH, Cha YJ, Park CJ, Kim HK, Cha EJ, Kim DH, Honghoon, Jung JS, Kim MJ, Jang S,Chi HS, Lee DS; Evaluation of the TEST 1 erythrocyte sedimentation rate system andintra- and inter-laboratory quality control using new latex control materials. ClinChem Lab Med 2010;48(7):1043–10486. Scott G, Nguyen T, Leunda Ostolaza S, Galiano C, Nalbandian G and Miller B; Roller20PN and Westergren Correlation. White Paper 2012 Chatsworth, CA7. Cha CH, Park CJ, Cha YJ, Kim HK, Kim DH, Honghoon, Bae JH, Jung JS, Jang S, ChiHS, Lee DS, Cho HI; Erythrocyte Sedimentation Rate Measurements by TEST 1Better Reflect Inflammation Than Do Those by the Westergren Method inPatients With Malignancy, Autoimmune Disease, or Infection. Am J Clin Pathol. 2009Feb;131(2):189-948. Frollano B, Cigliana G, Vitelli G, Fontinovo R, Giommi S, Cordone I; CapillaryErythrocyte Sedimentation Rate (ESR) in oncological patients: low haematocritpitfalls and sample collection optimization in a certified quality system laboratory.SIBioC National Congress 28-31 October 2008, Rimini, Italy.9. Pajola R, Piva E, Robecchi B, Tosato F, Plebani M; The Erythrocyte SedimentationRate (ESR): an old test with new contents. SIBioC National Congress 28-31 October2008, Rimini, Italy.10. Reis J, Diamantino J, Cunha N, Valido F; Erythrocyte sedimentation rate in blooda comparison of theTest 1 ESR system with the ICSH reference method. ClinicalChemistry and Laboratory Medicine 2007 June; 45, Special Supplement, p.S118,MO77.11. Piva E, Pajola R, Temporin V, Plebani M; A new turbidimetric standard to improvethe quality assurance of the erythrocyte sedimentation rate measurement. ClinicalBiochemistry 2007 Apr; 40(7):491-5. Epub 2007 Jan 8.12. Arikan S, Akalin N. (Biochemistry Department, Baskent University, Ankara,Turkey) “Comparison of the erythrocyte sedimentation rate measured by theMicro Test 1 sedimentation analyzer and the conventional Westergren method”Ann Saudi Med 2007; 27(5): 362-365.13. Li LY, Chen WB, Feng G, Shen SF; Evaluation of the Microtest 1 ESR analyzer andinvestigation of the reference value. Chin J Lab Med, March 2007, Vol 30, N 314. Ozdem S, Akbas HS, Donmez L, Gultekin M; Comparison of TEST 1 with SRS100 and ICSH reference method for the measurement of the length ofsedimentation reaction in blood. Clin Chem Lab Med. 2006;44(4):407-1215. Ajubi NE, Bakker AJ, van den Berg GA; Determination of the length ofsedimentation reaction in blood using the Test 1 system: comparison withthe Sedimatic 100 method, turbidimetric fibrinogen levels and the influence of Mproteins. Clin Chem Lab Med 2006, 44 (7): 904-90616. Kagawa Y, Ikeda N, Ito S, Makino S, Miyake N; Evaluation for ESR automated measuringinstrument with EDTA. 36th Japan Society for Clinical Laboratory Automation, 30September 2004, Japan.17. Rosas B, Díaz P, Musa C, Aldunate J; Estudio Comparativo de 2 equipos querealizan VHS, Test1 y Vesmatic”, XII Congreso Chileno de Tecnologia Medica.20–22 October 2004, Santiago, Chile18. Plebani M, D’Altoé P, Temporin V, Piva E, Buttarello M, Sanzari M; VariabilitàBiologica Intra ed Interindividuale della Velocità di Eritrosedimentazione. 36thSIBioC, 8-11 June 2004, Padova, Italy19. Melkič E, Piskar M, Lenart P; Nov način merjenja hitrosti sedimentacije eritrocitovz analizatorjem Test1 Alifax. 2 Kongres Hematologov in TransfuziologovSlovenije z Mednarodno UbeleÏbo, 23–24 April 2004, Portoroz, Slovenia20. Olivera Alonso B, Sirvent Monerris M, Rotella Belda MT, Ballenilla Antón V, VidalG; Cambio De Método Para La Determinación De V.S.G.: Repercusiones SobreLa Fase Preanalítica. Generalitat Valenciana - Conselleria De Sanitat (forValencia Government – MOH), Spain 200421. Galiano P; Quality and Automation in the Determination of the ErythrocyteSedimentation Rate”, Symposium 046, 22nd World Congress of Pathology &Laboratory Medicine, 30 August- 1 September 2003, Busan, Korea.22. Nicoli M, Lanzoni E, Massocco A; Integrated Haematology and CoagulationLaboratory. Poster, Euromedlab Congress, 1-5 June 2003, Barcelona, Spain23. Plebani M; Erythrocyte Sedimentation Rate: Innovative Techniques for anObsolete Test? Clinical Chemistry and Laboratory Medicine, 2003, 41 (2): 115-11624. Romero A, Muñoz M, Ramirez G; Determination of the Length of SedimentationReaction in Blood: a Comparison of the Test1 ESR System with the ICSHReference Method and the Sedisystem", Clinical Chemistry and LaboratoryMedicine 2003, 41 (2)25. Giavarina D, Capuzzo S, Cauduro F, Carta M, Soffiati G; Internal Quality Controlfor Erythrocyte Sedimentation Rate Measured Test 1 Analyzer. ClinicalLaboratory 2002, 48:459-46226. Heverin E; Comparison of the Westergren method versus the TEST1technique for determining the Erythrocyte Sedimentation Rate. May 2002,private communication27. Lee BH, Choi J, Gee MS, Lee KK, Park H; Basic Evaluation and ReferenceRange Assessment of TEST1 for the Automated Erythrocyte SedimentatioonRate. Journal of Clinical Pathology and Quality Control, Vol. 24, No. 1, 200228. Piva E, Fassina P, Plebani M; Determination of the length of sedimentationreaction (erythrocyte sedimentation rate) in non-anticoagulated blood with theMicrotest 1. Clin Chem Lab Med. 2002 Jul;40(7):713-729. Plebani M, Piva E; Erythrocyte Sedimentation Rate. Use of Fresh Blood forQuality Control. American Journal of Clinical Pathology, 2002, 117:621-62630. Smith D, Spedding D; Evaluation of Agreement between the TEST1 and StarrsedAutomated ESR Analysers. November 2001, private communication31. Giavarina D, Capuzzo S, Carta M, Cauduro F, Soffiati G; Internal Quality Controlfor Erythrocyte Sedimentation Rate (ESR) measured by TEST-1 Analyzer. ClinicalChemistry, June 2001, 47: 16232. Piva E, Sanzari MC, Servidio G, Plebani M; Length of Sedimentation Reaction inUndiluted Blood (Erythrocyte Sedimentation Rate): Variations with Sex and Ageand Reference Limits. Clinical Chemistry and Laboratory Medicine, May 2001, 39:451-45433. de Jonge N, Sewkaransing I, Slinger J, Rijsdijk JJM; Erythrocyte SedimentationRate by Test-1 Analyzer Clinical Chemistry. June 2000, 46: 881-88234. Plebani M, De Toni S, Sanzari MC, Bernardi D, Stockreiter E; The TEST 1automated system: a new method for measuring the erythrocyte sedimentationrate. Am J Clin Pathol. 1998 Sep;110(3):334-4035. Soffiati G; Nuovo Metodo per la Determinazione della Velocità diEritrosedimentazione (VES), August 1998, private communication36. Cirilli N, Abu Asy Z, Giacchè N, Bordicchia F, Paolucci S, Tocchini M; TEST1: UnNuovo Metodo per la Determinazione della VES. Biochimica Clinica, Vol. 22, N.5-6, 1998, p. 339Due to regulatory requirements, the products listed herein are available for sale in anyrelevant Country territory provided that they have been registered according to theapplicable domestic law. The products listed herein may have incurred changes withrespect to the last available edition.“ Copyright 2019. Alifax S.r.l. (Italy). All rights reserved. No part of this document maybe disclosed to any third party, reproduced, stored in a retrieval system or transmittedin any form or by any means, electronic, mechanical, photocopied, recorded, orotherwise, without the prior written permission of Alifax S.r.l and shall at all times remainthe property of Alifax S.r.l. The Recipient shall treat as confidential, all ConfidentialInformation included in this and shall not use such Confidential Information for anypurpose other than in connection with the document purpose.”ALIFAX S.r.l.Via Petrarca, 2/1 - Polverara (PD) - Italy - ( 39) 049 0992000 info@alifax.com www.alifax.comEntered in Padova companies register at the n. 04337640280. Company stock 10.000.000 entirelydeposited Company with single partner and subjected to direction and coordination of Alifax Holding

of the erythrocyte sedimentation rate: method validation and comparison. Clin Chem Lab Med. 2019 Apr 2 2. Kim M, Ju YS, Lee EJ, Lee E, Jeon K, Lee J, Kang HJ, Kim HS, Lee JS, Kim HJ, Lee YK; Erythrocyte sedimentation rate measured using microhemagglutination is not eleva ed in monoclonal gammopathy compared with other diseases. Int J Lab Hematol.

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