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1060. QUALITY AND AUTOMATION IN THE DETERMINATION OF THE ERYTHROCYTE SEDIMENTATION RATE by Paolo Galiano. In the last 5 years many scientific works on the TEST1 system have been published by different authors, many of them Italian, but others from The Netherlands, New Zealand, Korea, Spain.

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1060

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  1. 1060

  2. QUALITY AND AUTOMATION IN THE DETERMINATION OF THE ERYTHROCYTE SEDIMENTATION RATE by Paolo Galiano

  3. In the last 5 years many scientific works on the TEST1 system have been published by different authors, many of them Italian, but others from The Netherlands, New Zealand, Korea, Spain. The state of the art of these articles provides a view of the new state of the art of the Erythrocyte Sedimentation Rate in the world.

  4. SCIENTIFIC WORKS AND PUBLICATIONS 1. M. Plebani, S. De Toni, M.C. Sanzari, E. Stockreiter, D. Bernardi (Dept. of Laboratory Medicine, University-Hospital, Padova, Italy), “The TEST 1 Automated System: A New Method for Measuring for Erythrocyte Sedimentation Rate”, American Journal of Clinical Pathology, 1998, 110:334-340. 2. N. Cirilli, Z. Abu Asy, N. Giacchè, F. Bordicchia, S. Paolucci, M. Tocchini (Dept. of Laboratory Medicine, G. Salesi Hospital, Ancona, Italy), “TEST1: Un Nuovo Metodo per la Determinazione della VES”, Biochimica Clinica, Vol. 22, N. 5-6, 1998, p. 339. 3. M. Plebani, S. De Toni, M.C. Sanzari, E. Stockreiter, D. Bernardi, F. Floriani (Dept. of Laboratory Medicine, University-Hospital, Padova, Italy), “Il Sistema Automatizzato TEST1: un Nuovo Metodo per la Determinazione della Velocità di Eritrosedimentazione”, Medicina di Laboratorio, Vol. 6, N. 2, June 1998, pp. 166-172. 4. G. Soffiati (Clinical Chemistry and Hematology Laboratory, San Bortolo Hospital, Vicenza, Italy), “Nuovo Metodo per la Determinazione della Velocità di Eritrosedimentazione (VES)”, August 1998, private communication. 5. L. Germagnoli, S. Lopez-Silva, M. Murone, S. Vazzana, L. Grassini, L. Calloni, V. Gioia (Dept. of Laboratory Medicine, Scientific Institute San Raffaele, Milan, Italy), “Evaluation of the Automatic System TEST1™ for Measurement of the Erythrocyte Sedimentation Rate (ESR)”, issued as scientific poster on Clinical Chemistry, July 1999.

  5. SCIENTIFIC WORKS AND PUBLICATIONS 6. K. S. Shin, J.S. Kim, B.R. Son (Dept. of Clinical Pathology, College for Medicine Chungbuk National University, Cheongju, Korea): “Evaluation of the TEST 1 for Measuring Erythrocyte Sedimentation Rate” Journal of Clinical Pathology and Quality Control, Vol. 21, No. 1, 1999, pp. 223-228. 7. John Robert "Erythrocyte Sedimentation. A New Solution to an Old Problem", (Hitech Pathology, Melbourne, Australia) issued on the official publication of the New Zealand Institute of MedicalLaboratory Science and Australian Institute of Medical Scientists, South Pacific Congress, Christchurch, New Zealand, 23-27 August 1999, sponsored by Dade Behring Diagnostics. 8. C. Gasparoli, D. Pulè, A. Fusco (Dept. of Laboratory Medicine, Istituto Dermopatico Immacolata – IRCCS, Rome), “Sostituzione di un Metodo Tradizionale per la Misurazione delle VES con il Nuovo Metodo Automatico TEST1”, October 1999, private communication. 9. K. Taylor (Canterbury Health Laboratories, Christchurch, New Zealand), “TEST1 Evaluation Report”, December 1999, private communication. 10. N. de Jonge, I. Sewkaransing, J. Slinger, J.J.M. Rijsdijk (Dept. Clinical Chemistry, Leyenburg Hospital, The Netherlands), “Erythrocyte Sedimentation Rate by Test-1 Analyzer”, ClinicalChemistry, June 2000, 46: 881-882.

  6. SCIENTIFIC WORKS AND PUBLICATIONS 11. M. Plebani, E. Piva, M.C. Sanzari, G. Servidio (Dept. of Laboratory Medicine, University-Hospital, Padova, Italy), “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. 12. D. Giavarina, S. Capuzzo, M. Carta, F. Cauduro, G. Soffiati (Clin. Chem. & Hematol. Lab., San Bortolo Hospital, Vicenza, Italy), “Internal Quality Control for Erythrocyte Sedimentation Rate (ESR) measured by TEST-1 Analyzer”, ClinicalChemistry, June 2001, 47: 162. 13. D. Spedding, D. Smith (Dade Behring Diagnostics, New Zealand), “Evaluation of Agreement between the TEST1 and Starrsed Automated ESR Analysers”, November 2001, private communication. 14. M. Plebani, E. Piva (Dept. of Laboratory Medicine, University-Hospital, Padova, Italy), “Erythrocyte Sedimentation Rate. Use of Fresh Blood for Quality Control”, American Journal of Clinical Pathology, 2002, 117:621-626. 15. E. Heverin (Galway-Mayo Institute of Technology, Ireland), “Comparison of the Westergren method versus the TEST1 technique for determining the Erythrocyte Sedimentation Rate”, May 2002, private communication.

  7. SCIENTIFIC WORKS AND PUBLICATIONS 16. P. Napoli, B. Montaruli, S. Plateroti, A. Martini, A. Sacchi, A. Toja. M. Saitta (Analysis Lab, CIOV, Evangelico Valdese Hospital, Turin, Italy), “Sistema Automatizzato TEST1: Controllo di Qualità Interno per la Determinazione della VES”, Biochimica Clinica, Vol. 26, N. 3, 2002, p. 215. 17.B.H. Lee, J. Choi, M.S. Gee, K.K. Lee, H. Park (Dept. of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan 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. 18.D. Giavarina, S. Capuzzo, F. Cauduro, M. Carta, G. Soffiati (Clin. Chem. & Hematol. Lab., San Bortolo Hospital, Vicenza, Italy), “Internal Quality Control for Erythrocyte Sedimentation Rate Measured Test 1 Analyzer”, Clinical Laboratory 2002, 48: 459-462. 19. Romero A., Muñoz M., Ramirez G. (Dept. of Haematology, H.C.U. "Virgen de la Victoria", Málaga & *GIEMSA, 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).

  8. SCIENTIFIC WORKS AND PUBLICATIONS • 20. M. Plebani (Dept. of Laboratory Medicine, University-Hospital, Padova, Italy), “Erythrocyte Sedimentation Rate: Innovative Techniques for an Obsolete Test?”, Clinical Chemistry and Laboratory Medicine, 2003, 41 (2): 115-116. • 21. Nicoli M., Lanzoni E., Massocco A., Franceschini C.* (Laboratory of Clinical Chemistry and Haematological Analysis, Ospedale Civile Maggiore, Verona, Italy & *Dasit, Cornaredo, Italy), “Integrated Haematology and Coagulation Laboratory”, Poster, Euromedlab Congress, Barcelona, Spain, 1-5 June 2003. • 22. P. Galiano, “Quality and Automation in the Determination of the Erythrocyte Sedimentation Rate, Symposium 046, 22nd World Congress of Pathology & Laboratory Medicine, 30 August-2 September 2003, Busan, Korea. • 23. J.M. Jou, “La VSG: còmo, cuàndo y para qué puede ser ùtil”,  (Hospital Clinic University of Barcelona), AEHH/SETH Hematology Society National Congress, 23-25 October 2003, Santiago de Compostela, Spain. • 24. B. Olivera Alonso, M. Sirvent Monerris, M.T. Rotella Belda,V. Ballenilla Antón,García Vidal (M Laboratorio Hospital San 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.

  9. Heverin from Galway-Mayo Institute of Technology, in describing the reproducibility of the TEST1, verifies a very important point, “temperature”. To perform a reliable internal quality control it is absolutely needed to keep the samples into the refrigerator and to allow them to reach room temperature the day after before testing them again. I remind you that from NCCLS 4th edition, approved May 2001, ESR cannot be calibrated.

  10. Stability after 24 hours at 4°C K3EDTA @ 24hrs 4°C, K2EDTA @ 24hrs 4°C  r=0.974 From E. Heverin (Galway-Mayo Institute of Technology, Ireland), “Comparison of the Westergren method vs the TEST1 technique for determining the Erythrocyte Sedimentation Rate”, May 2002

  11. From E. Heverin (Galway-Mayo Institute of Technology, Ireland), “Comparison of the Westergren method vs the TEST1 technique for determining the Erythrocyte Sedimentation Rate”, May 2002 Test 1 ESR results at 4hrs versus 48hrs at 4°C Stability after 48 hours at 4°C K3EDTA @ 48hrs 4°C, K2EDTA @ 48hrs 4°C  r=0.964

  12. From E. Heverin (Galway-Mayo Institute of Technology, Ireland), “Comparison of the Westergren method vs the TEST1 technique for determining the Erythrocyte Sedimentation Rate”, May 2002

  13. From E. Heverin (Galway-Mayo Institute of Technology, Ireland), “Comparison of the Westergren method vs the TEST1 technique for determining the Erythrocyte Sedimentation Rate”, May 2002

  14. Now let me make a brief list of the reference subjects described by the National Committee for Clinical Laboratory Standards. All the topics belong to sodium citrate collected samples.

  15. From NCCLS, 4rd ed., Vol. 20, No. 27, December 2000 Acceptable values comparing EDTA with citrate collected samples 20 21 22 23 24 25 26 27 28 - 36 37 38 39 40 41 42 43 5-17  6-17 6-18 6-19 7-19 7-20 8-21 8-21 9-22 - 13-29 13-30 14-30 14-31 15-32 15-33 16-34  17-35 s a m e s a m p l e Citrate Variables 5-17 17-35 EDTA Fixed 20 43

  16. Just from one of the points you can read from the original document, I use page 8 to see the limits of all citrate methods and instruments using this type of preservant (sodium citrate). TEST1 has a big advantage: it works with EDTA,considered to be the best blood preservant. In fact, if you see this slide, the variation of citrate is intrinsic to the list shown above offering an acceptable range, but variable against a fixed value offered by EDTA samples.

  17. THE CLASSICAL ESR SAMPLE ESR 1h ESR – HEMATOCRIT 20% Area requested for well mixing Normal Agglomerin Pathological 35% Normal Hematocrit range t=0 t=1h WESTERGREN t=12 h or Centrifugation

  18. ESR is a phyisical phenomenon circumscribed on time From NCCLS: recognised curve is a sigmoid type helped by the presence of specific proteins called agglomerins Without these agglomerins there is no sedimentation

  19. ESR values increase • Pathologies • leukaemia, rheumatic polimialgy, rheumatoid arthritis, thromboflebitis, subacute endocarditis, pneumoniae, colangitis, osteomyelitis, SLE, pyelonephritis, post cardiosurgery, acute hearth stroke, lung stroke, linphoma, rheumatic fever, viral hepatitis, glomerular nephritis, infectious mononucleosis, breast cancer, lung cancer, hepatic metastatis, ipernephroma, uremia, acute meningithis, ictus, sarcoidosis, pelvic infections (gonococcus and others), tubercolosis, Crohn’s disease, burns, bone fracture, anemia, arthrosis, gout, cholecystitis, typhus, mumps, acute allergy, ulcerative colitis, pregnancy, postpartum, menstruation, Cytomegalovirus infection, Toxoplasmosis, Rickettsiosis, fever, appendicitis. • Drugs • contraceptive , A Vitamin • others: B Hepatitis vaccination 32

  20. ESR values decrease • Pathologies • dehydration, hepatic necrosis, Thrichinosis, polycythemia, fibrinogenopenia and iperfibrinogenemia, cachexy, anticoagulants • Drugs • salicylates, cortisone, ACTH, Cyclophosphamide (chemotherapeutic agent), chinin, oxalate 33

  21. Westergren method and use of Sodium Citrate show: (fromNCCLS Vol.20 No.27 H2-A4) - errors in the dilution step • poor temperature control • problems connected to vibrations,verticality,diameter of pipets • test must be run within 4 hours from blood collection • PCV adjustment (<0.35) • No control available - plastic tubes may interfere with red cells surface charges due to the plastic material

  22. VACUTAINER TUBE IN CITRATE Errors in the dilution phase Correct Level insufficient level of blood (old tubes) NO RATIO RESPECTED Exceeding level of blood (fresh tubes) NO RATIO RESPECTED NO OK NO Correct level of blood Dilution ratio 1:4 RATIO RESPECTED

  23. THE IMPORTANCE OF HEMATOCRIT DIFFERENT RESULTS OF THE SAME SAMPLE DILUTED WITH AUTOLOGOUS PLASMA 140 120 100 80 SEDIMENTATION (mm) 60 40 20 0 0 20 40 60 80 100 120 140 160 180 200 TIME (minutes) Hct of 45 Hct of 26 Hct of 28 Hct of 34 Sedimentation as a function of time with different Hct values artificially obtained adding autologous plasma (Blood, Vol. 70, No 5, Nov. 1987: pp 1572-1576).

  24. LOW INFLUENCE OF HEMATOCRIT ON TEST 1 From Thomas L.Fabry, Mechanism of Erythrocyte Aggregation and Sedimentation, Blood, Vol. 70, No. 5 (Nov.), 1987: pp 1572-1576. Fabry’s Formula to adjust the value of ESR Example of adjustment for a sample with hematocrit 30.3 - Correct value = 69.2 - WG non corrected value = 114 - TEST 1 =67 Example of adjustment for a sample with hematocrit 26.3 - Correct value = 66.3 - WG non corrected value = 127 - TEST 1 =67

  25. LOW HEMATOCRIT The instrument indicates with an asterics (*), near the result, the samples with a low hematocrit value. In the example reported the hematocrit value is low

  26. Moreover, the commercial quality controls offered and pushed by our competitors, as you can see again, show the great variations of these values, improperly offered under this name: ranges and limits suggested in the figure show how low level is indicated from 1 to14 and high level from 15 to 55.

  27. TEST1 offers much closer reproducibility as many authors have described using internal samples of their labs, tested 24 and 48 hours later. The correlations you see on the data are comparable to normal clinical chemistry controls and, finally, our statistical quality control gives you a method based on statistical data of your population. The cumulative data of any day (white circles) can be compared with the black one, that are the statistical data collected by the instrument during a month and these collected data can be considered as a standard when you have in the black circle values at least from 500-1000 results. The cumulative black circle maintains a revolving number of 6000 samples as a standard.

  28. TEST 1 REPRODUCIBILITY DURING THE SAME DAY Samples collected on January 28th and processed on January 29th R = 0,99 in the correlation between column B- column C = R2 0,9944 R = 0,99 in the correlation between column B- column D = R2 0,9831 R = 0,99 in the correlation between column B- column E = R2 0,988 Samples were properly stored in the refrigerator (4°C) and let them get room temperature taking them out of the refrigerator 30-40 minutes before running the tests performed with Test 1 Instrument. Samples are properly mixed in Test 1, thus aggregated cells are re-suspended in the plasma and ESR is consequently correctly measured. The 4 columns represent the results obtained in 4 different moments (12,07 am; 12,18 am; 12,28 am; 15,38 pm). Results were obtained alive during the training! The red column is the reference towards which the correlations of columns C, D and E have been calculated.

  29. CORRELATION CHART R = 0.99

  30. REPRODUCIBILITY AFTER 48 HOURS Samples collected on 28/1/2003 and processed on 30/1/2003 SAMPLES HAVE BEEN STORED AT +4°C DURING THE TIME LAPSE BETWEEN 29 AND 30 JANUARY R = 0.99 correlation between columns B- columns CR2 0,9832 R = 0.99 correlation between columns B- columns DR2 0,9844 The following day we took out from the refrigerator the 15 samples tested the day before and let them get room temperature for about 30-40 minutes. Then we put samples into Test 1 and the working session started. After 3 minutes of mixing cycle the measurement of ESR begun. The results of two running sessions are reported on columns C and D. Column B has been copied and pasted from the previous Excel sheet in order to have an immediate comparison among reproducibility of Test 1 and good quality of results.

  31. CORRELATION CHART R = 0.99

  32. I specified that the value of our control is to be interpreted upon the reproducibility of the correlation value R=0,99 and this is a real reproducibility as a clinical chemistry control, not based on the possible variation of a sample that may also give not so reproducible results the day after. This is not so frequent but if it occurred you would be able to give the correct answer: it is the reproducibility R that creates the stability of control. Moreover, I graphically represented the normal, pathological and myeloma conditions to show the time and curve typology of the myeloma-ESR case. I have intentionally begun a discussion in which, as a first topic, I have reminded the audience that the representation of a myeloma-ESR curve is not even reported by the NCCLS, as this organisation describes only a Sigmoid-like curve to represent a physical condition, in this case the ESR testing, and not a curve that remains plain for many minutes and then precipitates.

  33. Stability Study Storage of blood sample at 4°C for up 24 hours caused a decrease in ESR values obtained with the TEST1: the mean difference was 2.86 ( 95% CI, 2.41-3.31) and 2.28 (95% CI, 1.90-2.65) respectively for two different analyzers with the same samples (n=1.140). The decreases were of 9% and 11%.

  34. STATISTICAL QUALITY CONTROL DATA REPORT For Range 2-120 mm/h and 2-30 mm/h Print out date Scale of values Value of cumulative average (black circle) Value of daily average O (white circle) STD S. cumulative standard deviation STD D. daily standard deviation N.B. The values printed are only examples not to be considered as absolute but only indicative. (black circle ) = 6000 data of cumulative values are equivalent to your statistical population, which can be considerd a Standard

  35. STATISTICAL QUALITY CONTROL DATA REPORT For control of population to obtain internal normal range

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