1 1060. 2 quality and automation in the determination of the erythrocyte sedimentation rate by paolo...

10601060

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.

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.

SCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONS1. 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.

SCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC 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 Medical Laboratory 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”, Clinical Chemistry, June 2000, 46: 881-882.

SCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONS11.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”, Clinical Chemistry, 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.

SCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONS16.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).

SCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC WORKS AND PUBLICATIONSSCIENTIFIC 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.

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.

10From 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

K3EDTA @ 24hrs 4°C, K2EDTA @ 24hrs 4°C r=0.974• Sta

Test 1 ESR results at 4hrs versus 48hrs at 4°C

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

K3EDTA @ 48hrs 4°C, K2EDTA @ 48hrs 4°C r=0.964

• Sta

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

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.

From NCCLS, 4rd ed., Vol. 20, No. 27, December From NCCLS, 4rd ed., Vol. 20, No. 27, December 20002000

Acceptable values comparing EDTA with citrate collected Acceptable values comparing EDTA with citrate collected samplessamples

EDTAEDTAFixedFixed

20 4320 43

CitrateCitrateVariablesVariables

5-17 17-355-17 17-35

202021212222232324242525262627272828--

36363737383839394040414142424343

5-17 5-17 6-176-176-186-186-196-197-197-197-207-208-218-218-218-219-229-22

--13-2913-2913-3013-3014-3014-3014-3114-3115-3215-3215-3315-3316-3416-34

17-3517-35

sample

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.

t=0t=0 t=1ht=1hWESTERGRENWESTERGREN

t=12 ht=12 hor or

CentrifugationCentrifugation

NormalNormal

PathologicalPathological

ESR – HEMATOCRITESR – HEMATOCRITESR – HEMATOCRITESR – HEMATOCRIT

35%35%Normal Normal HematocritHematocritrangerange

ESR 1hESR 1hESR 1hESR 1hSAMPLESAMPLESAMPLESAMPLE

20% Area requested 20% Area requested for well mixingfor well mixing

THE CLASSICAL ESRTHE CLASSICAL ESR THE CLASSICAL ESRTHE CLASSICAL ESR

AgglomerinAgglomerin

ESR is a phyisical phenomenon circumscribed on ESR is a phyisical phenomenon circumscribed on time time ESR is a phyisical phenomenon circumscribed on ESR is a phyisical phenomenon circumscribed on time time

From NCCLS: From NCCLS: recognised curve is a recognised curve is a sigmoid type helped sigmoid type helped by the presence of by the presence of specific proteins specific proteins called called agglomerinsagglomerins

Without these agglomerins there is no sedimentation Without these agglomerins there is no sedimentation Without these agglomerins there is no sedimentation Without these agglomerins there is no sedimentation

• 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

ESR values increaseESR values increase

• Pathologies– dehydration, hepatic necrosis, Thrichinosis,

polycythemia, fibrinogenopenia and iperfibrinogenemia, cachexy, anticoagulants

• Drugs– salicylates, cortisone, ACTH, Cyclophosphamide

(chemotherapeutic agent), chinin, oxalate

ESR values decreaseESR values decrease

Westergren method and use of Sodium Citrate show: (from NCCLS 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

VACUTAINER TUBE IN CITRATEVACUTAINER TUBE IN CITRATEVACUTAINER TUBE IN CITRATEVACUTAINER TUBE IN CITRATE

Exceeding level of bloodExceeding level of blood(fresh tubes)(fresh tubes)

NO RATIO RESPECTEDNO RATIO RESPECTED

Correct level of bloodCorrect level of bloodDilution ratio 1:4Dilution ratio 1:4

RATIO RESPECTEDRATIO RESPECTED

insufficient level of insufficient level of bloodblood

(old tubes)(old tubes)NO RATIO RESPECTEDNO RATIO RESPECTED

NONO OKOK NONO

Errors in the dilution phaseErrors in the dilution phaseErrors in the dilution phaseErrors in the dilution phase

Correct LevelCorrect Level

THE IMPORTANCE OF HEMATOCRITTHE IMPORTANCE OF HEMATOCRITDIFFERENT RESULTS OF THE SAME SAMPLE DILUTEDDIFFERENT RESULTS OF THE SAME SAMPLE DILUTED

WITH AUTOLOGOUS PLASMAWITH AUTOLOGOUS PLASMA

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).

Hct of 26Hct of 26 Hct of 28Hct of 28 Hct of 34Hct of 34 Hct of 45Hct of 45

TIME (minutes)TIME (minutes)

100100

120120

140140

00 2020 4040 6060 8080 100100 120120 140140 160160 180180 200200

LOW INFLUENCE OF HEMATOCRIT ON TEST 1

LOW INFLUENCE OF HEMATOCRIT ON TEST 1From From Thomas L.Fabry, Thomas L.Fabry, Mechanism of Erythrocyte Aggregation and Mechanism of Erythrocyte Aggregation and

Sedimentation, BloodSedimentation, Blood, Vol. 70, No. 5 (Nov.), 1987: pp 1572-1576., Vol. 70, No. 5 (Nov.), 1987: pp 1572-1576.

Fabry’s Formula to adjust the value Fabry’s Formula to adjust the value of ESRof ESR

Example of adjustment for a sample with hematocrit Example of adjustment for a sample with hematocrit 30.330.3 - Correct value = 69.2

- WG non corrected value = 114- TEST 1 = 6767

Example of adjustment for a sample with Example of adjustment for a sample with hematocrit 26.3hematocrit 26.3 - Correct value = 66.3

- WG non corrected value = 127- TEST 1 = 6767

LOW HEMATOCRITLOW HEMATOCRITLOW HEMATOCRITLOW HEMATOCRIT

The instrument indicates The instrument indicates with an asterics (*), near with an asterics (*), near the result, the samples the result, the samples with a low hematocrit with a low hematocrit value.value.

In the example reported In the example reported the hematocrit value is the hematocrit value is lowlow

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.

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.

29/01/2003 29/01/2003 29/01/2003 29/01/200312.07.am 12.18am 12.28am 15.38 pm

ESR 2 3 4 238 41 44 4276 79 79 7414 13 13 152 3 3 4

15 16 16 1442 44 40 417 8 7 9

26 25 22 2316 16 16 1711 11 10 1152 50 47 4519 17 20 1859 57 55 5822 22 23 24

TEST 1 REPRODUCIBILITY DURING THE SAME DAYSamples collected on January 28th and processed on January 29th

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.

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

TEST 1 REPRODUCIBILITY DURING THE SAME DAYfig 1

Samples collected on January 28thand processed on January 29th

29/01/2003 29/01/2003 29/01/2003 29/01/200312.07.am 12.18am 12.28am 15.38 pm

ESR 2 3 4 238 41 44 4276 79 79 7414 13 13 152 3 3 4

15 16 16 1442 44 40 417 8 7 9

26 25 22 2316 16 16 1711 11 10 1152 50 47 4519 17 20 1859 57 55 5822 22 23 24

y = 1,0066x + 0,0901

R2 = 0,9944y = 0,9798x + 0,4054

R2 = 0,9831

y = 0,9446x + 1,2142

R2 = 0,988

0 20 40 60 80

R = 0.99

CORRELATION CHARTCORRELATION CHART CORRELATION CHARTCORRELATION CHART

29/01/2003 30/01/2003 30/01/2003 12.07am 9.21am 9.32am

ESR 2 2 238 36 4176 77 7514 11 122 2 2

15 12 1242 35 397 8 8

26 22 2016 14 1511 9 1052 43 4419 20 2059 56 5522 22 22

REPRODUCIBILITY AFTER 48 HOURSSamples 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

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.

R = 0.99 correlation between columns B- columns C R2 0,9832

R = 0.99 correlation between columns B- columns D R2 0,9844

29/01/2003 30/01/2003 30/01/2003 12.07am 9.21am 9.32am

ESR 2 2 238 36 4176 77 7514 11 122 2 2

15 12 1242 35 397 8 8

26 22 2016 14 1511 9 1052 43 4419 20 2059 56 5522 22 22

y = 0,9557x - 0,9483

R2 = 0,9832

y = 0,9519x - 0,3137

R2 = 0,9844

0 10 20 30 40 50 60 70 80 R = 0.99

CORRELATION CHARTCORRELATION CHART CORRELATION CHARTCORRELATION CHART

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.

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%.

Stability StudyStability Study

STATISTICAL QUALITY CONTROL DATA REPORTSTATISTICAL QUALITY CONTROL DATA REPORTSTATISTICAL QUALITY CONTROL DATA REPORTSTATISTICAL QUALITY CONTROL DATA REPORT

Print out dateScale of values

Value of cumulative average (black circle)Value of daily average O (white circle)

STD S. cumulative standard deviationSTD 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

For Range 2-120 mm/h and 2-30 mm/h

STATISTICAL QUALITY CONTROL DATA REPORTSTATISTICAL QUALITY CONTROL DATA REPORTSTATISTICAL QUALITY CONTROL DATA REPORTSTATISTICAL QUALITY CONTROL DATA REPORT

For control of population to obtain internal normal range

STABILITY OF VACUTAINER TUBE IN STABILITY OF VACUTAINER TUBE IN EDTAEDTA

THETHE EDTAEDTA COLLECTED COLLECTED SAMPLE REFRIGERATED AT SAMPLE REFRIGERATED AT +4°C CAN BE TESTED EVEN +4°C CAN BE TESTED EVEN

AFTERAFTER 24 HOURS24 HOURS FROM FROM BLOOD COLLECTIONBLOOD COLLECTION

From Clinical Chemistry, Vol. 47, No. 6, Supplement 2001, p. 162 - Internal quality control for erythrocyte sedimentation rate (ESR) measured by TEST 1 analyzer by D. Giavarina, S. Capuzzo, M. Carta, F. Caoduro, G. Soffiati, Clin. Chem. & Hematol Lab - San Bortolo Hospital: Vicenza, Italy

Technical advantages

SAVE of time money

SAVE of waste money (expired tube – tube volume)

SAVE of stock money

Quality improvements

The unique method for Lab Accreditation

The unique characteristics of ALIFAX ESR analyzers provides a Statistical Internal Quality The unique characteristics of ALIFAX ESR analyzers provides a Statistical Internal Quality Control useful to the certification of the lab.Control useful to the certification of the lab.The new ISO9001/UNI EN ISO 9001 – Ed. 2000 certification is used for the validation of the The new ISO9001/UNI EN ISO 9001 – Ed. 2000 certification is used for the validation of the lab test in which the lab instrumentation, controls and, in general, the analysis system can lab test in which the lab instrumentation, controls and, in general, the analysis system can have the recognition of a value and its maximum validation to guarantee operation have the recognition of a value and its maximum validation to guarantee operation functionality and reliability of the results. functionality and reliability of the results.

TEST1 TH new software offers:TEST1 TH new software offers:• Control of the functionality of reading sensors for each washing Control of the functionality of reading sensors for each washing • Data control by a statistical quality system based on the control validity of Data control by a statistical quality system based on the control validity of the collected data of a populationthe collected data of a population• Control of the daily value relative to a population of 6000 memorized data Control of the daily value relative to a population of 6000 memorized data in the instrumentin the instrument• Control of the single result scanned 1000 times by our system for each Control of the single result scanned 1000 times by our system for each analysisanalysis• Control of sample reproducibility on samples tested the day after Control of sample reproducibility on samples tested the day after • Control of data reproducibility at R value equivalent to 0.98-0.99Control of data reproducibility at R value equivalent to 0.98-0.99• Control for samples improper to the test below the normal hematocrit values Control for samples improper to the test below the normal hematocrit values < 20< 20• Control of data transmission to LIS.Control of data transmission to LIS.

New software benefits for

LAB ACCREDITATION

• Autodiagnostics• Internal or external bar code reader• Interfacing through RS232• QUERY HOST Software for PC LAB management• No dedicated tubes• Compatible with cell counter racks (Bayer, Beckman Coulter, Sysmex, Abbott,

ABX, etc.)• Capacity of 60 samples random batch access• 180 samples/hr• Automatic sample mixing• Blood collection according to the ICSH recommendations• Flow control to check of eventual clots• Minimum Blood Volume > 1 ml• Working volume 150 µL of blood

TECHNICAL CHARACTERISTICSTECHNICAL CHARACTERISTICS

• Cell measure volume 1 µL• Thermostation 37°C • First result after 3 minutes and 20 seconds• Low influence of hematocrit < 35 HCT• No carryover• Autowashing• Safe-control closed cycle system• Automatic reading and print out of the results• Totally safe waste volume tank• Waste production reduced (Test 1=3 L, others=1.000L)• Waste disposal costs reduced• Statistical internal quality control of population for normal values• Safety check card• Electronic calibration for alignment of results

TECHNICAL CHARACTERISTICSTECHNICAL CHARACTERISTICS

What is TEST 1

• The only instrument in the world which can

MEASURE the ESR values

• Remember that all other instruments on the market are simply READERS

• Test 1 measures the kinetics of blood sedimentation phenomenon

• all the other instruments simply read the final result of this phenomenon, that is why they need more time to give results

TEST1TEST1

ESRESR

TELEMETRYTELEMETRY

TEST1TEST1

ESRESR

TELEMETRYTELEMETRY

CAPACITY OF SEDIMENTATION AND CAPACITY OF SEDIMENTATION AND AGGREGATION AGGREGATION

Aggregation startingt = 0

Aggregation after 1000 scanst = 20 sec.

TEST 1 studies the sedimentation and aggregation capacity TEST 1 studies the sedimentation and aggregation capacity of the blood red cells via optical densityof the blood red cells via optical density

Every sample is read 1000 times in 20 seconds verifying the Every sample is read 1000 times in 20 seconds verifying the aggregation and sedimentation capacity of the blood red aggregation and sedimentation capacity of the blood red

cellscells

Light beambefore

Light beamafter

Normal Status

Lag phase

Time (minutes)

Inflammation Status

Lag phase

Precipitation phase

Packaging phase

Time (minutes)

Agglomerine

20 seconds

MyelomaExample of collapsed sample for ESR

Lag phasePrecipitation phase

Packaging phase

Time (minutes)

Example of a collapsed sample

From 200 mm to the ratio in percentage 100

Westergrenpipet

200 mm

Corpuscular

Part 35 Hematocrit or PCV

100 mm

65 ESR

MyelomaExample of collapsed sample for ESR

Lag phase Precipitationphase

Packagingphase

Time (minutes)

+-- -+ +

+ ++-- -

+ ++--

+-- -+ +

+ ++---

+ ++-- -

+ ++--

Westergren pipet

200 mm

Corpuscular

Part 35 Hematocrit or PCV

100 mm

65 ESR

+-- -+ +

+ ++-- -

+ ++--

+-- -+ +

+ ++---

+ ++-- -

+ ++--

These blood samples without “ Agglomerins” do not

express a ESR value with a “sigmoid” tract, but

collapse to the level of the Hematocrit. Final point

of reading.

The mathematical algorithm converts the results The mathematical algorithm converts the results from optical density tofrom optical density to

ERYTHROCYTE SEDIMENTATION RATEERYTHROCYTE SEDIMENTATION RATEof the microvolume analyzedof the microvolume analyzed

fromfromsample optical densitysample optical density

totomm/hr Westergrenmm/hr Westergren

CALCULATION METHODOLOGY OF CALCULATION METHODOLOGY OF RESULTSRESULTS

Test-1 ESR

expresses the vitality of aggregation also 12, 24, 48

hr after collection, according to the sigmoid curve

of the classic graph, that is the only curve

described and represented.

PATENT

The world patent of Test-1 concerns

the mathematic algorithm that

expresses the same sigmoid function

of the ESR

A synthetic control with no active electrical charge and

with no agglomerins that induce and activate the

sedimentation process is not recognized by Test-1 as

these controls give no signals of vitality because they

are not part of the “sigmoid sedimentation”, but a

mixture of water – sand and not a measure of control.

• The Test 1 technology is PATENTED

30 µL of blood30 µL of bloodsuitable for pediatric usesuitable for pediatric use

• Micro Test 1 can work with fresh blood, as soon as it has been collected, without need of anticoagulant or preservatives

The only instrument that works without preservant

Methodology advantages and characteristics

• Quality Control

• Urgent diagnosis can be fulfilled

• Pediatric use

• No anticoagulant use- fresh blood for MicroTest1

• Test 1 Measures ESR, it is not a Reader

Test 1 is an Analyzer !!!!

METHODOLOGY ADVANTAGES

• Capillary• Microvolume 150 or 30 microliters (T1 or MicroT1)

• Photometric-kinetic• Scanning rate -total scans 1000 for sample in 20 sec.• Not influenced from hematocrit• Rapidity of response correlated to Westergren• Reproducibility• Stability during time (EDTA-48 hours against Na

Citrate 4 hours)

==> Time sec.==> Time sec.

During 20 sec. the sample is scanned 1000 timesDuring 20 sec. the sample is scanned 1000 times

Ident. 05483311Ident. 05483311

ESR = 118 mm/hrESR = 118 mm/hr

Ident. 05725053Ident. 05725053

Ident. 05725044Ident. 05725044

==> Time sec.==> Time sec. ==> Time sec.==> Time sec.

11 It starts from 0 time to 20 sec. following and measuring the It starts from 0 time to 20 sec. following and measuring the evolutionevolution of the sed rate curves.of the sed rate curves.

22 It measures the optical density related to the concentration It measures the optical density related to the concentration of the of the erythrocytes/aggregates present at the moment of the erythrocytes/aggregates present at the moment of the analysis.analysis.

33 Kinetics following the evolution of the curves with a Kinetics following the evolution of the curves with a frequency of 50frequency of 50 measures per second.measures per second.

44 The capillary system simulates a invivo situation and The capillary system simulates a invivo situation and guarantees guarantees minimal optical paths in blood subject to sedimentation which minimal optical paths in blood subject to sedimentation which enableenable the detection of small variations.the detection of small variations.

METHODOLOGY CHARACTERISTICSMETHODOLOGY CHARACTERISTICS

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””..

CORRELATION TEST 1-WESTERGRENCORRELATION TEST 1-WESTERGRENCORRELATION TEST 1-WESTERGRENCORRELATION TEST 1-WESTERGREN

From Clinical Chemistry and Laboratory From Clinical Chemistry and Laboratory Medicine, February 2003, 41(2)Medicine, February 2003, 41(2)

“… “… the correlation coefficient was the correlation coefficient was 0.98…”0.98…”

COMPARATIVE SCHEDULE WEIGHT OF WASTE DISPOSAL

COMPANY TYPE OF PRODUCED

WASTE PRODUCED FOR EACH TESTING

WASTE PRODUCED FOR 20.000 TESTING

IN KG.

DIESSE DEDICATED TUBE + BLOOD

gr. 12 Kg. 240

BD TUBE WITH BLOOD gr. 10 Kg. 200

ALIFAX ON A COLLECTION TANK

CAPACITY 2.000 TESTING

gr. 0,25 Kg. 5

Slides from Customers

ESR value RangeCV%TEST 1 13.1 12-14 4.86Westergren 8.0 8.0-109.68

TEST 1 29 27-32 5.30Westergren 25 21-308.45

TEST 1 54.7 51-58 3.37Westergren 57.1 51-605.04

Imprecision of TEST 1 and WestergrenImprecision of TEST 1 and Westergren

• It preserves the red blood morphology.• Does not interfere with mechanisms that lead to erythrocyte sedimentation.• Increases specimen stability.• Does not incur problems related to

sample dilution with sodium citrate.

ADVANTAGES OF EDTA AS AN ANTICOAGULANTADVANTAGES OF EDTA AS AN ANTICOAGULANT

Specimens anticoagulated with EDTA:• Are suitable for internal quality control programs.• Allow the creation of a unique workstation for measuring ESR and performing other hematological tests (erythrocyte, leukocyte, reticulocyte counts and differential analysis in a single specimen).

ADVANTAGES OF EDTA AS AN ANTICOAGULANTADVANTAGES OF EDTA AS AN ANTICOAGULANT

Reference limits, 2.5th and 97.5th pervcentiles and their 95% confidence intervals (CI) for SRB

in undiluted EDTA-anticoagulant blood. Variation with age and sex

Reference limits, 2.5th and 97.5th pervcentiles and their 95% confidence intervals (CI) for SRB

in undiluted EDTA-anticoagulant blood. Variation with age and sex

Age n Sex 2.5 percentiles 97.5 percentiles (year) and 95%CI and 95%CI

0-14 80 W and M 2 (2-2) 34 (26-41)15-50 190 Women 2 (2-2) 37 (36-39)15-50 150 Men 2 (2-2) 28 (20-30)51-70 120 Women 2 (2-3) 39 (38-45)51-70 130 Men 2 (2-2) 37 (31-44)>70 170 W and M 3 (3-3) 46 (45-55)

Clin Chem Lab Med 2001;39(5):451-4.

150 µL of 150 µL of bloodblood

TEST 1 THTEST 1 TH

ROLLER

TEST 1TEST 1THTH works by loading works by loading cell counter racks directly, eg.: cell counter racks directly, eg.: Bayer, Sysmex, Beckman Coulter, Bayer, Sysmex, Beckman Coulter, Abbott, ABX, etc…Abbott, ABX, etc…

Any kind of vacutainer tube Any kind of vacutainer tube available on the market can available on the market can be used to perform the ESR, be used to perform the ESR, e.g.:e.g.:

TEST 1TH RACKTEST 1TH RACK

TUBES LOCKTUBES LOCK

Tubes lockTubes lock Tubes unlockTubes unlock

SAMPLE ID WITH EXTERNAL BAR-CODE READER

Tube identificationTube identificationWith the bar code reader the ID With the bar code reader the ID

patient is automatically assigned patient is automatically assigned to the ESR resultto the ESR result

Tube introduction into the rackTube introduction into the rack

Internal Bar Code ReaderInternal Bar Code Reader

AUTOMATIC ID PATIENT WITH QUERY HOST SOFTWARE

Sample Identification with Sample Identification with automatic selection of the tubes automatic selection of the tubes requiring the ESR test both with requiring the ESR test both with dedicated racks.dedicated racks.

Racks used:Racks used:

WORKFLOWWORKFLOWRack blockingRack blocking

Tubes are blocked Tubes are blocked with an elliptic movementwith an elliptic movement

Rack loadingRack loadingOpen the front door and insert the Open the front door and insert the

rack into the instrument.rack into the instrument.Close the front door and press the Close the front door and press the

START key.START key.

RACK ADAPTOR FOR BECKMAN COULTERRACK ADAPTOR FOR BECKMAN COULTER

RACK ADAPTOR FOR BAYERRACK ADAPTOR FOR BAYER

RACK ADAPTOR FOR SYSMEX - ABBOTT - ABXRACK ADAPTOR FOR SYSMEX - ABBOTT - ABX

The most recent work made by an Hospital in Verona, Italy, is an important example of TLA (Total Lab Automation), published at Euromedlab, Barcelona 2003, in which the author declares what you can see in the poster (500 tubes of ESR per day not using, as in the past, a dedicated sodium citrate tube).

The picture of the lab shows an integration of Sysmex cell counter and 2 TEST1 connected to the LIS. For the purpose of this automation the workflow is now available to perform the ESR test using directly the cell counter racks of Abbott, ABX, Beckman Coulter, Bayer and Sysmex. Thus, TEST1 is loaded with special rack adaptors to contain the original hematology racks with an internal bar code reader selecting the ESR test connected to LIS.

I remind you no other author, as far as I can know, has published anything new with the old method and with the old reader systems.

INSTRUMENTS IN THE WORLDINSTRUMENTS IN THE WORLDupdated 26.04.04

102102

INSTRUMENTS IN THE WORLDINSTRUMENTS IN THE WORLDINSTRUMENTS IN THE WORLDINSTRUMENTS IN THE WORLD

103103

TTOOTTAALL

734734

TEST1 MicroTEST1 Roller 20 Country

308 75 8 Italy

48 42 14 South Africa

75 10 3 Spain

55 6 Korea

21 41 Brasil

31 17 2 Turkey

17 32 China

41 3 3 Belgium

40 1 Portugal

21 5 Australia

20 Germany

13 13 1 Colombia

12 1 2 Ireland/UK

9 Israel

5 3 New Zealand

6 4 2 Slovenia

1 5 Uruguay

9 Costa Rica

4 Malaysia

1 3 Guatemala

3 Nederlands

1 1 India

1 1 Hungary

2 Syria

1 Norway

2 2 U.S.A.

1 Nicaragua

1 El Salvador

1 Panama

1 Greece

1 Indonesia

1 Singapore

1 Vietnam

1 1 Chile

1 3 Japan

TEST 1TEST 1TEST 1TEST 1

TTOOTTAALL

285285

Micro Micro TEST 1TEST 1Micro Micro

TEST 1TEST 1

104104104

Sales of TEST 1 tests

819.000

2.218.000

3.058.500

4.580.500

7.104.000

10.161.000

2.000.000

4.000.000

6.000.000

8.000.000

10.000.000

12.000.000

1998 1999 2000 2001 2002 2003

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