An evaluation of the StaRRsed Compact
Contents
1. Standardisation in Haematology ICSH 1973 Reference Method for the Erythrocyte Sedimentation Rate ESR Test on Human Blood British Journal of Haematology 24 671 International Committee for Standardisation in Haematology Expert panel on Blood Rheology 1988 Guidelines on selection of laboratory tests for monitoring the acute phase response J Clin Pathol 41 1203 International Committee for Standardisation in Haematology Expert panel on Blood Rheology 1993 ICSH recommendations for measurement of erythrocyte sedimentation rate J Clin Pathol 46 1993 Rogers R 1994 The development of 30 minute ESR s on the StaRRsed ESR Analyser Medical Laboratory World April 1994 Manley RW 1957 The effect of room temperature on erythrocyte sedimentation rate and its correction J Clin Pathol 10 1957 354 Garvey B Mahon A Parker Williams J 1999 ESR Chex control material for erythrocyte sedimentation determination MDA 99 28 MDA Evaluation Report StaRRsed Compact ESR Analyser 33 MDA Evaluation Report StaRRsed Compact ESR analyser 31 APPENDIX u Manufacturers Comments me VITECH 3S SCIENTIFIC Ltd Huffwood Trading Estate Partridge Green West Sussex RH13 8AU 7W 01403 710479 FA X 01403 710382 rf rra vule deuda pps com wea ade np Pesce vitacisonpm cem ul 18 August 2000 UK NEQAS H P O Box 14 Walford WDI 8FJ Dear Sir Mechatronics the Dutch Manufacturer have asked us as UK D2. and the technology employed by these instruments 1s often dissimilar Some instruments report the Westergren ESR based on a 20 or 30 minute sedimentation extrapolated to one hour whilst other instruments allow the user to choose between a 1 hour or a 2 hour value The StaRRsed Compact is the latest in a line of instruments from Mechatronics which produces a true Westergren result The ESR is probably the second most frequently ordered haematology test but is undoubtedly the worst controlled Despite the many factors known to influence the result of the ESR a consistent commercial whole blood control material has only recently become available Mechanism of red cell sedimentation The rate of sedimentation is not influenced by a single factor but by a number of interrelated factors These combine and cause to a greater or lesser extent a difference in the specific gravity between red cells and plasma and dictate the degree to which the red cells form rouleaux Rouleaux being large clumps of cells sediment more rapidly than single cells and formation increases with progressively higher concentrations of acute phase proteins fibrinogen in particular but is retarded by albumin The acute phase proteins are a heterogeneous group which include haptoglobins ceruloplasmins C reactive protein and y globulins These proteins are synthesised in increased amounts in response to acute tissue damage chronic inflammation chronic infection and p
3. codes and the patient identification has to be entered manually Throughput is also dependent on the samples being well mixed prior to analysis and 1s obviously lower if samples have to be individually mixed prior to sampling The most efficient way to operate the analyser is to group the samples into large batches and to operate the instrument in the 30 minute program This would prevent slowing down the generation of reports for distribution to wards and medical staff as an ESR often goes hand in hand with a full blood count and most haematology analysers are capable of producing over 100 results per hour User acceptability The StaRRsed Compact is extremely easy to use and appears to be very reliable It was not necessary to call in engineers during the time of the evaluation However it takes 45 minutes to perform the shutdown sequence which the instrument carries out automatically Weekly and monthly maintenance can take considerably longer but is partly automated In a laboratory with only one instrument it will need to be organised to complement the rest of the instrument maintenance in the laboratory MDA Evaluation Report StaRRsed Compact ESR analyser 24 Technical assessment The Compact does have the distinct advantage over other systems in that it makes use of the EDTA sample so there are no extra costs for specially prepared tubes and the possibility of dilution error is reduced Training and instruction manual Trainin
4. evaluating disease processes are developed it does remain a useful marker of disease change particularly in cases of rheumatoid arthritis and is of great value in the rapid diagnosis of temporal arthritis and polymyalgia rheumatica Nowadays the manual technique devised by Westergren 1s almost universally used Blood that has been anticoagulated with KSEDTA or KsEDTA is diluted with 32 8 g L tri sodium citrate 109 mmol L in the proportion of one part citrate to four parts of blood The pipette is filled with the suitably diluted blood set perfectly upright and the numerical value in mm is obtained by measuring the distance from the surface to the upper limit of the red cell layer in the column of blood after exactly 60 minutes MDA Evaluation Report StaRRsed Compact ESR analyser 7 The nternational Council for Standards in Haematology ICSH in 1993 published a method for the control of ESR measurements using non citrated EDTA blood Based on the Westergren method it is generally agreed that the method is too laborious for routine use and is not widely used however it still remains as the ICSH Reference method and any new techniques should be evaluated against it Current interest in ESR methodology has focused mainly on the development of automated closed systems that allow in most cases the sedimentation rate to be determined in the blood collection tube Most of these automated methods do not support the use of the CSH Reference Method
5. plasma found Differential between a filled and empty pipette too small Only one meniscus found Only a separation between red cells and plasma found Too many borders found More than three borders found possibly air bubbles ESR probably gt 140mm Extreme high ESR value Poor meniscus found Meniscus at the top of the column too small fill amp clean sequence needs to be performed Column height nmm Column height must be between 190 amp 210mm nmm the actual column height The operator can accept the error messages by pressing the ESC key on the keypad The alarm will be cancelled until another error 1s found During the time of the evaluation the only error message generated was too many borders found due to the presence of bubbles in the column of cells due to short sampling There are two other messages which may appear which do not cause the alarm to be initialised They appear in the report format The evaluators found that an occasional sample gave a dilution out of range indication in this case greater than 10 However when the sample was repeated the dilution was within range and both results were the same EDTA The number refers to the percentage of over followed by a number or under dilution compared to the ideal 100 This can be set by the user from zero to 20 MDA Evaluation Report StaRRsed Compact ESR analyser 20 Technical assessment Hazy lt 10mm lt 25mm gt 25mm e Syst
6. ARRSED AUTOMATED ESR ANALYSER STARRSED ESR Analyser complete with Citrate Addition COMPACT VITACOVER Two preventative maintenance visits per year VITASURE Total Service Support All labour and parts excluding consumables in the event of a breakdown during normal use also two preventative maintenance visits per year VTTACOVER Full contract fee is payable on completion of the first scheduled visit of each contract year VITASURE Full contract fee is payable annually in advance ALL PRICES ARE EXCLUSIVE OF V A T MDA Evaluation Report StaRRsed Compact ESR analyser 28 Costings The manufacturer has provided the following information relating to the actual running costs of the instrument and the costs per test Costings of Starrsed Compact ESR Analyser Costings have been calculated as per the ICSH recommendations The Analyser has been fully amortised over 5 years although based on the experience of other Starrsed Analysers the Compact should operate satisfactorily for up to 10 years It is assumed that the manual ESR method takes 4 minutes per test as per CAP and Welcan measurements and that this can be halved when using Compact less Phlebotomists time and less Laboratory time reading and writing down results Labour costs have been calculated at 9 per hour The cost of titrated blood collection tubes for the manual method has been assumed to be 15p each The Supplier of Compact provides two alternative Se
7. August 2000 Looo E NUMBER DEVICES i scENcy Evaluation Report MDA 00050 The StaRRsed Compact automated ESR analyser o A g 9 3 a lt C e t e e e lt Q a Crown Copyright An evaluation of the StaRRsed Compact automated ESR analyser B J Garvey I J Mackie A Mahon C Gardiner J Parker Williams S J Machin MDA Evaluation Centre Department of Haematology UK NEQAS H University College London Watford General Hospital PO Box 14 Watford London Summary Introduction Technical assessment Materials Comparability Comparison of timed methods Reproducibility Sample stability Comparison with ICSH standardised method Carry over sampling error messages System messages Safety Efficiency assessment User acceptability Training amp instruction manual Costings Acknowledgements References Appendix Manufacturer s comments Declaration of conformity with European directives Examples of report formats How to obtain MDA evaluation reports Contents 15 16 18 18 20 21 22 23 23 24 24 25 27 31 33 35 35 36 a 39 Summary The StaRRsed Compact is a fully automated ESR analyser which is based on the well tried functions of earlier models of StaRRsed and performs according to the Westergren method As the name implies it is smaller than previous models and consists of a single bench top unit The analyser can a
8. ED CORRECTEO 9 E S R E S R 5 35 100 90 90 80 30 85 70 60 80 25 50 75 40 70 30 20 20 65 10 60 MDA Evaluation Report StaRRsed Compact ESR analyser 11 ESR measurement principle The automatic reading of the Westergren sedimentation pipettes is carried out by moving a sensor along the pipettes and measuring the absorption of infrared light While the sensor is moving a reading is made every 0 25mm From these readings values at a number of absorbance levels are determined as shown in figure 3 The red cell interface is taken to be the point where the maximum change in absorbence occurs All absorbence figures are relative to the darkest and lightest reading darkest 100 and the lightest 0 absorbence respectively By definition the levels are 87 5 cells plasma separation 75 0 haze detection 50 0 meniscus detection Figure 3 Absorbence readings dynamicaly determined 22235523333 3 Advantages of automation of ESR s hazy 10 mm sedimentations 110mm height The manufacturer states that advantages of automating the Westergren method of ESR determination using the StaRRsed Compact are as follows The pipettes are always filled to the correct level Using closed sample tubes reduces the possibility of contamination for the operator and the environment Standard glass Westergren pipettes are used in which the measurement can be corrected to a constant temperature MDA Evaluation Repo
9. StaRRsed Compact ESR analyser 23 Technical assessment Before analysing the samples the room was blacked out and an ultra violet lamp shone on the analyser and su rrounding area to ensure no background contamination was present The spiked samples were analysed by the StaRRsed Compact and the instrument was re examined with the ultra violet lamp to identify any possible areas of contamination A swab was taken from a sample to act as a positive control and one from an area away from the instrument as a negative control Swabs were also taken from the outer needle sleeve the sample inlet valve and the sample exit valve The swabs were cultured in nutrient broth for 48hrs at 35 C The positive control swab and the swab from the outer needle sleeve demonstrated bacterial growth This is due to the fact that the outer needle sleeve punctures the sample lid and does not have a built in cleaning mechanism Therefore it is necessary to include cleaning of the outer needle case with disinfectant as part of the routine daily maintenance Electrical safety The StaRRsed Compact is CE marked with respect to the Machinery Directive 89 392 EEC and a declaration of compliance is shown in the Appendix Efficiency assessment The StaRRsed Compact has a throughput of approximately 80 samples per 50 minutes in the 30 minute program and 80 samples in Ihr 20 minutes in the I hour program This throughput is slightly lower if the samples have illegible bar
10. arry over was nil and washing and drying of the tubes was more than adequate Sample stability studies showed that for up to 6 hrs samples are equally stable at room temperature or 4 C but samples left overnight should be stored at 4 C for maximum stability This applies to both EDTA and pre diluted samples however refrigerated EDTA samples show slightly better stability than refrigerated citrated samples Overall the StaRRsed Compact was found to be a reliable instrument easy to use and maintain It works most efficiently when large numbers of samples can be batched and the use of the 30 minute program would be useful in a busy laboratory especially if the analyser was part of an automated system MDA Evaluation Report StaRRsed Compact ESR analyser 4 Introduction The StaRRsed Compact ESR analyser is a fully automated analyser for the haematology laboratory made by Mechatronics Manufacturing BV in the Netherlands and marketed in the UK by Vitech Scientific Ltd Huffwood Trading Estate Partridge Green West Sussex RH13 SAU Tel no 01403 710479 Instrument description Figure 1 StaRRsed Compact ESR analyser MDA Evaluation Report StaRRsed Compact ESR analyser 5 The StaRRsed Compact is a fully automated erythrocyte sedimentation rate ESR analyser based on the well tried functions of earlier models of StaRRsed ESR analysers It produces a true Westergren result and conforms to the ICSH recommendations The instrument c
11. ccept either EDTA blood or pre citrated blood there being a function available to switch off the citrate diluter on the instrument However the main analysis mode is for whole blood ami coagulated with EDTA 1e making use of the Full Blood Count sample thus cutting down on the expense of purchasing special pre citrated tubes for ESR samples The analyser can also be attached in series to up to three other analysers for dealing with a very large workload and is able to interface with fully automated haematology systems It requires 2ml of blood to ensure that the analyser has a sufficient sample for testing Two hundred and thirty EDTA samples from patients with a range of clinical conditions some containing potential interfering substances were analysed on the StaRRsed Compact and the results were compared with the corresponding pre citrated samples analysed on a Vesmatic in routine use The StaRRsed gave a higher percentage of lower results than the Vesmatic however it must be pointed out that the technologies involved are completely different In a separate study 43 samples were selected at random and the results from the StaRRsed Compact compared with those obtained using the ICSH standardised method The StaRRsed Compact performed well Comparison between the 30 minute and one hour method of analysis showed excellent agreement Reproducibility studies over a range of results from 2 110 mm fall gave a spread of values of only Imm C
12. e The samples were first tested using the 30 minute method and then by the one hour method MDA Evaluation Report StaRRsed Compact ESR analyser 16 Technical assessment The one hour method was taken as the standard as this 1s the method promoted by the manufacturer The results of the comparison of the two methods can be seen in figure 5 with the difference plot shown in figure 6 In this case the difference is the 30 minute method minus the one hour method The values of the two methods were compared using paired t tests Data from 84 samples Mean difference between the 30 min amp Ihr method 0 63 Standard deviation 2 59 T critical two tale value 1 98 P T t two tail 0 03 Figure 5 Comparison between 1hr and 30 minute methods 110 we Bo 3a 7 2 99 a0 x y Technical assessment MDA Evaluation Report StaRRsed Compact ESR analyser 17 Figure 6 Difference between 1hr and 30 minute methods Reproducibility For the purposes of the evaluation samples were selected to cover the following ranges 2 17 mm fall in Ihr 18 65 mm fall in 1hr and 65 110 mm fall in Ihr Each sample was analysed three times in succession using the 1hour program Results are shown below in table 1 Table 1 Reproducibility ESR mm fall in 1hr Spread of results 1865mm 65 110mm The instrument gave reproducible results over the full range of ESR results Sample stability Short term sample stability S
13. ed laboratories and the temperature in the evaluation laboratory was adjusted to that of the room in the haematology department The results of the comparability can be seen in figure 4 and the differences between the StaRRsed and the mean of the results from the two instruments in figure 5 Ideally this difference plot should show minimal scatter about the horizontal line The values from the two instruments were compared using paired t tests The following results were obtained Data from 230 samples were obtained Mean difference between the StaRRsed Compact and the Vesmatic 6 15 Standard deviation 8 88 T critical two tale value 1 970 P T t two tail lt 0 001 The results from the two systems were comparable although the Vesmatic read consistently higher than the StaRRsed Compact MDA Evaluation Report StaRRsed Compact ESR analyser 15 Technical assessment Figure 4 Comparison of StaRRsed Compact vs Vesmatic wa ddr M abii V Y amp 8 8 48 8 Figure 4 Difference plot StaRRsed Compact vs Vesmatic Comparison of timed methods The StaRRsed Compact offers the choice of two programs for ESR measurement one hour which is recommended by the manufacturer and 30 minutes The results of the 30 minute program are corrected by the software to give the result expected if the one hour method had been used For the purposes of the evaluation 84 samples were tested to give as wide a range of results as possibl
14. em messages The StaRRsed Compact will present the operator actual performance of the instrument Waiting tube e Printer failure Reagents level empty Waste full Test messages This is generated when the red cell interface is difficult to define with the following messages relating to the this is caused by a filled pipette being at the measuring position before the elapsed time is finished No more samples can be aspirated until the pipette has been read and the results passed to the printer This is generated in response to the switch printer on message Data will be stored in the buffer and can be printed afterwards All reagent bottles have level detectors and the LCD screen will identify which reagent bottle is empty The waste container also has a level detector If the waste container becomes full the analyser will stop and will not continue working until the waste has been emptied and the fatal error cleared using menu 6 During the start up sequence all positioning sensors are tested If incorrect a system error will be generated These are explained in detail in the User s manual Vacuum errors dilution errors and fill time out error messages are detailed 1n the User s manual Safety Microbiological safety Spores of Bacillus subtilis var Niger and Uvitex a liquid optical brightener were diluted in ten EDTA samples according to the method of Kennedy et al 1998 MDA Evaluation Report
15. emperature Results EDTA RT Initial Mean ESR 28 Initial Mean ESR 19 EDTA RT 24hrs Mean ESR 14 24hrs Mean ESR 11 EDTA 4 C Initial Mean ESR 12 Initial Mean ESR 9 EDTA 4 C 24hrs Mean ESR 13 24hrs Mean ESR 6 MDA Evaluation Report StaRRsed Compact ESR analyser 19 Technical assessment From the results obtained it can be seen that the ESR results on samples received too late 1n the working day to be analysed are best stored overnight in the refrigerator There is only a slight difference between results obtained from EDTA samples diluted by the instrument and pre diluted citrate samples Comparison with ICSH standardised method ICSH 1993 recommend that for validation of new methods of ESR estimation the new methodology should be compared with the standardised method The standardised method is performed on undiluted blood the PC V of which has been corrected to 0 33 0 03 using autologous plasma in a Westergren tube under standardised conditions The results are compared with those on the chart below which has been issued to replace the use of the original formula Figure 8 ICSH chart for verification of working method ESR values nmi fer verification of comparaluliry of toorking Fouce method uth JOSH nandardited method Workmy erkiny Workmy xis Mrhad 75 T7 TT 74 20 NH B 3 4 a5 6 6 en rad 9 Fi 3 p LL 98 a 100 101 102 103 104 105 Stan sr ned mtih
16. eport StaRRsed Compact ESR analyser 35 How to obtain MDA evaluation reports MDA evaluation reports are published by the Medical Devices Agency an Executive Agency of the Department of Health They are available free of charge to the UK National Health Service and are for sale to commercial organisations and other interested parties A free catalogue can be obtained from the Orders Department or downloaded from the MDA s web site www medical devices gov uk Ordering Send your order to the address given below stating the reference number title and quantity of each report required Your reports will be despatched by second class post the following working day If you are not a representative of the NHS you will be invoiced separately Non NHS customers are reminded that it is not possible to offer refunds for reports ordered in error Orders Department Room 1207 Medical Devices Agency Hannibal House Elephant amp Castle LONDON SEI6TQ Tel 0207 7972 8181 Fax 0207 7972 8105 E mail dep medical devices gov uk Enquiries General enquires should be directed to the Orders Department as above Technical enquires should be addressed to Mrs Anne Mahon at the Evaluation Centre Tel 01923 217878 Fax 01923 217879 E mail anne haem neqas eval demon co uk MDA Evaluation Report StaRRsed Compact ESR analyser 36
17. g was completed in less than one hour of the instrument being set up ready for use As with all customers the site was revisited two weeks after receiving the instrument to see 1f any problems had arisen The User s manual is well presented clearly formatted and easy to follow MDA Evaluation Report StaRRsed Compact ESR analyser 25 MDA Evaluation Report StaRRsed Compact ESR analyser 26 Costings The manufacturer quotes the following prices for the instrument and the service charges Cost of instrument PRICE LIST Automated ESR Analyser ST ARRSED COMPACT ESR Analyser including 84 Precision Glass Tubes conforming to Westergren Dimensions Automatic Sample Aspirator and Citrate dilution Reading and Flushing Washing Station Sample D Keyboard Double RS232 Interface Printer Built in Vacuum Pump with separator Microbiological and activated charcoal filters provided Automatic Bar Code Reader Liquid level sensors Automatic Disinfecting of Waste lines and Waste bottle Gives temperature corrected ESR results and reports abnormal results Automatically dilutes blood with citrate in ratio 1 4 eliminates need for dedicated citrated blood collection tubes for ESR test Accepts EDTA blood samples with bar coded labels Competitive Lease Terms over 5 6 or 7 years available Prices exclusive of VAT amp Delivery January 1999 MDA Evaluation Report StaRRsed Compact ESR analyser 27 Costings Cost of service ST
18. hort term sample stability was defined as stability over one working day Ten patients chosen at random from the phlebotomy clinic were counselled and then samples were taken in duplicate into K 3 EDTA The samples were identified by number only no patients details were taken The samples were analysed 15 minutes after taking to allow equilibration One set of samples was stored at 4 C between analysis times being allowed to warm up to room temperature before being tested The other set of samples was kept at room temperature 18 C for the duration of the test Results can be seen in figure 7 MDA Evaluation Report StaRRsed Compact ESR analyser 18 Technical assessment Figure 7 Short term sample stability Long term sample stability Long term sample stability was defined as stability over 24hrs Twenty patients chosen at random from the phlebotomy clinic were counselled and then samples were taken in duplicate into K3 EDTA The samples were identified by number only no patients details were taken One set of samples was diluted with 3 sodium citrate using calibrated positive displacement pipettes to mimic samples which may be received in the laboratory already pre diluted The samples were analysed 15 minutes after taking to allow equilibration after dilution The groups were then further divided into two and one group from each type of sample was stored in the refrigerator overnight while the other group was left at room t
19. iming and language selection Menu 4 functions related to the Bar code reader measure unit and pipette position Menu 5 functions related to RS232 communication and also access to the 30 minute function MDA Evaluation Report StaRRsed Compact ESR analyser 9 Menu 6 functions relating to the handling of errors There are three further menus which can only be accessed by use of a password Menu 7 functions related to service and handling Menu this is not in use at the present time Menu 9 functions relating to solenoid valves and valve actuators Menu 10 functions relating to peristaltic pumps and vacuum pumps Processing of samples On the main menu no 1 select 1 Run mode Insert a sample tube after mixing gently at least eight times ICSH recommendation in the tube adapter with the bar code label to the left and press the Fill key this last step can be omitted 1f the auto sample mode is selected The bar code details will be accepted by the analyser s software and the sampling sequence will take place For sample tubes without details on a bar code the patient identification is keyed in using the keypad press the Fill key and the sampling sequence will take place In the EDTA sample mode a sensor detects the rate at which the blood is being drawn up and a diluter unit situated at the right hand side of the analyser adds citrate at the appropriate rate to produce a 1 4 dilution If the EDTA
20. istributor to respond to the this evaluation We would like to thank UK NEQAS H and especially Anne Mahon for carrying out this evaluation It is gratifying to note that these independent findings confirm our own view and the views reached by existing users around the World that the Starrsed Compact makes a useful contribution to the automation of the ESR test We are sure this report will be useful to new users in the future The Reproducibility data looks excellent although we would have liked to see rather more data points per sample However we understand the practical and ethical limitations of collecting large enough amounts of blood particularly samples with a raised ESR The fact that Vesmatic result were consistently higher than Compact results does not come as a surprise Mechatronics have strived to ensure that all Starrsed ESR Analysers conform to the Westergren method in every detail and your own comparison between Compact and the ICSH Standardised Method confirms this to be the case Yours faithfully D aors P J CHOOPEZ C S BUN Reqisiored OF ice a shot Retisteterl No 1630061 E elaml Peter Hooper Managing Director valuation Report StaRRsed Compact ESR analyser 32 Apendix Declaration of conformity with European directives Mechatronics Instruments B V mechatronics E C DECLARATOIN OF CONFORMITY FOR MACHINERY Directive 89 392 EEC Annex II sub A Mechatronics Instruments B V De Fact
21. mentation pipette number number on the pipette belt 8 Sedimentation time in minutes 9 Temperature in degrees Centigrade 10 Error message if the StaRRsed Compact detects an error 11 EDTA mode LLLI REPORT EXAMPLE SSS SSS not to scale StaRRsed Date 20 05 97 time 15 28 1 3 4 5 WM 8 9 10 11 Manual Patient sedi Corr Aspect aspect Tube Time Temp Error 972005001 83 75 Clear V7 60 23 EDTA 972005002 14 13 Hazy 10mm 18 60 23 EDTA 972005003 23 21 Hazv lt 25mm 19 60 23 EDTA 972005004 67 61 Hazy gt 25mm 20 60 23 EDTA Sample result with a manual aspect where the manual aspect is shown as a number 3 972005005 4 4 Clear 3 2 60 23 EDTA Sample result with a dilution error if a dilution is out of range more than 10 or 10 the rate will be printed as example EDTA 079 This means that the current sample has a dilution failure of 21 972005006 5 5 Clear 22 60 23 EDTA 079 If the text EDTA is not printed at the end of the result line the diluter was switched off and current sample was done in the Citrate mode sample result of a pipette possibly filled with air bubbles 972005007 Too many borders found MDA Evaluation Report StaRRsed Compact ESR analyser 34 Appendix 9 2 30 minute mode 1 Patient number 2 The actual half hour result 3 ES R value normal 60 minute method 4 Sedimentation in millimetres corrected for 18 C If the temperature correction is not activated then this colum
22. mode is not selected then this dilution process 1s bypassed Although the manufacturer states that the analyser uses only ml of whole blood it 1s advisable to have 1 2ml of blood in the sample tube to ensure adequate filling of the glass tubes After each glass tube is filled with diluted blood the fill line is back flushed with isotonic saline and air to avoid carry over to the next sample The analyser stores information about the sample allowing its progress during testing to be investigated either by tube number or patient number MDA Evaluation Report StaRRsed Compact ESR analyser 10 After either 1 hour or half an hour if shortened time selected the belt will have migrated round to the measure position where a read head moves up the tube producing a result every 0 25mm This provides enough data to determine exactly where the plasma red cell interface is This is especially useful for samples which give a hazy plasma cell interface The ESR result corrected to one hour if the shortened time has been used and the temperature are downloaded to a laboratory printer or a host computer together with the patient identification number Examples of the report formats can be seen in the Appendix The analyser has a built in function which corrects the ESR measurement to 18 3 C which falls within the ICSH recommended temperature range giving consistency of results This correction factor is shown below ROOM TEMP F SC OBSERV
23. mpact Method 4 5 6 8 8 10 25 10 13 14 14 31 16 17 20 58 26 49 27 31 34 56 1 12547 46 66 Bss SL 59 36 63 63 63 68 105 67 104 83 102 64 100 100 All the StaRRsed Compact values fell within the corresponding working method limits showing agreement with the ICSH standardised method Carry over The method of Broughton et al was used to assess carry over by which a high level sample is analysed in triplicate followed by a low level sample For this procedure the 30 minute program was used A high level sample was aspirated in triplicate and the analyser allowed to complete the program The carousel was then moved using menu 4 so that the same pipettes could be reused and a low level sample was aspirated in triplicate The analyser was allowed to complete the program Results There was no evidence of carry over The cleaning and drying of the pipettes appears adequate MDA Evaluation Report StaRRsed Compact ESR analyser 21 Technical assessment Sampling error messages Generally the message clear indicates a normal ESR sampling and reading however if errors are found during the measurement of samples the StaRRsed Compact will give an audible alarm The message is displayed on the LCD screen and sent to the printer The following error messages may be reported No meniscus found No differential found between the top of the blood column and empty pipette No cells or
24. n will remain empty 9 Aspect clear hazy 6 Manually entered code number 7 Sedimentation pipette number number on the pipette belt 8 Sedimentation time in minutes 9 Temperature in degrees Centigrade 10 Error message if the StaRRsed Compact detects an error 11 EDTA mode REPORT EXAMPLE not to scale StaRRsed Date 20 05 97 time 15 28 1 2 6 4 5 6 7 8 9 10 11 Manual Patient Hh Sedi Corr Aspect aspect Tube Time Temp Error 972005001 42 84 75 Clear 17 60 23 EDTA 0 5 14 13 Hazy lt 10mm 18 60 23 EDTA 1 8 22 21 Hazy lt 25mm 19 60 23 EDTA 972005004 32 67 61 Hazy gt 25mm 20 60 23 EDTA Sample result with a manual aspect where the manual aspect is shown as a number 3 d 972005005 2 5 4 Clear 3 21 60 23 EDTA Sample result with a dilution error if a dilution is out of range more than 10 or 10 the rate will be printed as example EDTA 079 This means that the current sample has a dilution failure of 21 972005006 2 5 5 Clear 22 60 23 EDTA 079 If the text EDTA is not printed at the end of the result line the diluter was switched off and current sample was done in the Citrate mode sample result of a pipette possibly filled with air bubbles U Too many 972005007 borders found 9 3 Reporting messages If errors are found during the measurement the StaRRsed will give an audible alarm The message is displayed on the LCD screen and sent to the printer MDA Evaluation R
25. nly performed laboratory test with a long history John Hunter as far back as 1797 is credited with first noting that the speed of red cell sedimentation was increased in individuals suffering from non specific inflammatory lesions and that the speed of sedimentation varied according to the severity of the infection However whilst others also noted the phenomenon it was not until 1917 that interest in the test was renewed and the basic factors influencing the sedimentation rate gradually became understood In 1920 Linzenmeir developed the first technique for the measurement of the ESR In 1921 Westergren introduced a satisfactory method using a glass pipette some 200mm in length 2 5mm internal diameter and graduated in mm Wintrobe in 1935 then developed his method whereby a special tube 100mm in length and 3mm internal diameter is graduated on one side from 0 to 10cm in Imm divisions and on the other side from 10cm to 0 in Imm divisions Once the ESR had been measured using the 0 to 1 Ocm scale the contents of the tube were centrifuged until packing of the red cells was complete and the packed cell volume of the blood was read using the 10cm to 0 scale Although the test rapidly became a simple and popular test and has remained so ever since there has always been a lack of consensus about the role of the ESR as a non specific indicator of inflammation and tissue injury Even though the usefulness of the test 1s decreasing as other methods of
26. od EDTA antcoagulauw d but undiluied whole blood of hsemarourn of 0 35 of eas Working method 4 vols EDTA blood phus voi citrate diluent The value ibcorpoeiie a correcoon for dilution of blood by citrate in the working Method Propoted working method valid if 5 of rexulu are Wilh indicaued limits Forty three out patients who were having ESR samples taken as part of their blood test were selected at random and two extra EDTA samples were taken and one sample was analysed on the StaRRsed Compact and then analysed on a Sysmex K1000 haematology analyser to ascertain the PCV The PCVs were then adjusted using autologous plasma from the matching EDTA sample which had been centrifuged at 3500 rpm for 30 minutes The plasma was measured using positive displacement pipettes for accuracy and then the adjusted sample re analysed to confirm that the adjusted PCV was within the recommended limits before testing by the ICSH standardised method Comparison of the results from the StaRRsed Compact and the ICSH method can be seen in Table 2 the StaRRsed Compact is the working method The working MDA Evaluation Report StaRRsed Compact ESR analyser 20 Technical assessment method limits are those quoted by the ICSH for specific values as measured by the standardised method in the range 15 105 mm Table 2 StaRRsed Compact results compared with ICSH standardised method ICSH StaRRsed ICSH i StaRRsed Standardised Compact Standardised Co
27. onsists of the following a basic unit with a belt holding 84 precision bore glass Westergren pipettes a closed or open tube sampling unit measuring unit pipette wash station Bar code reader with positive sample identification serial parallel interface built in vacuum unit complete accessories kit Space and service requirements The dimensions of the instrument are Width 750mm Height 800mm Depth 360mm Total weight 45kg Noise 1 metre lt 45dB Electrical requirements Mains voltage 100 240V Power consumption 60VA in standby 500VA maximum Interface serial male 9 pin sub D Parallel female 25 pin sub D The analyser is CE marked with respect to EEC directive 89 336 EEC and low voltage directive 73 23 EEC MDA Evaluation Report StaRRsed Compact ESR analyser 6 e Environmental requirements Operational temperature is not restricted as the instrument incorporates temperature correction software that corrects the ESR to a temperature of 18 3 C This feature may be switched off if not required The noise level quoted by the manufacturer is less than 45db Waste is collected in a 2 51 waste container 0 lml of disinfectant is added to the waste line per sample The waste can be disposed of down a sink with running water or plumbed directly into the the sink waste pipe Microbiological filters protect the entire system e Historical perspectives The erythrocyte sedimentation rate ESR is a commo
28. orij 12a 1689AL Zwaag The Netherlands Herewith declares that Automatic E S R analyser StaRRsed Compact Isin compliance with the Machinery Directive 89 392 EEC as amended 91 368 EEC 93 44 EEC 93 68 EEC Is in conformity with the provisions of the following other EEC directives 73 23 EEC 89 336 EEC 93 68 EEC The following harmonized standards have been applied EN 292 1 EN 292 2 EN 294 EN 349 EN 60204 1 De F 24 P O la as Banker ABN Amwo Swill node ABM ANL 2A 1889 AL 1420 AE MOGORN Account number 4200 28 905 The heaherlands Ths Hinthaara VAT A Cost me NL 8040 22 879 801 Tal 39 01220 2339064 Fax 31 0 229 24184 ipl CHO tula unir nd Conditions By tha ORGALIME GENERAL CONDITIONS 82 of October 1992 Any other condlong ara Nerewiin axplicitty rejecimd Dy ut 36 MDA Evaluation Report StaRRsed Compact ESR analyser MDA Evaluation Report StaRRsed Compact ESR analyser 33 Appendix Examples of report formats taken from User s Manual 9 1 60 minute mode Depending on the StaRRsed Compact working mode 60 or 30 minute the printer report will be as follows Normal 60 minute mode 1 Patient number 2 Only in use if 30 minute mode is active 3 ES R value normal 60 minute method 4 Sedimentation in millimetres corrected for 18 C If the temperature correction is not activated then this column will remain empty 9 Aspect clear hazy 6 Manually entered code number 7 Sedi
29. ow or the waste becomes full If the waste container becomes full the alarm will sound and the analyser will stop all functions until the waste container has been emptied or replaced In order to restart the analyser it is necessary to clear the fatal error Menu 6 select 1 press enter MDA Evaluation Report StaRRsed Compact ESR analyser 14 Technical assessment Materials Controls ESR Chex whole blood Sed rate control was used daily The control was supplied by Alpha Labs and consisted of two levels Level had a value of 4 20mm fall in hour and Level 2 had a value of 39 63mm fall in 1 hour Both levels of controls were analysed daily with the first batch of samples and reproducibility over the length of the evaluation was excellent Patient samples Patients samples were collected into 4ml K3 EDTA vacutainer tubes supplied by Beckton Dickinson Analysis of samples was carried out within 2 hours of receipt in the laboratory except in the case of ageing studies EDTA samples were collected from the main haematology laboratory on those patients who had had an ESR requested by their doctor Comparability 230 EDTA samples were analysed on the StaRRsed Compact using the 1 hour method and the results were compared against the results from the method in routine use in the diagnostic haematology laboratory which is the Vesmatic The Vesmatic is operated in the 30 minute mode Both instruments were situated in air condition
30. regnancy Principles of operation The system is based on the traditional one hour Westergren method although there is an optional 30 minute method The instrument contains a rotating belt which holds 84 precision bore glass Westergren tubes These are non disposable and are cleaned automatically in situ with 8ml of a low foam detergent followed by a drying cycle The instrument incorporates on line citrate dilution allowing the ESR to be performed on routine EDTA samples There is however a facility to analyse pre citrated samples on the instrument if necessary MDA Evaluation Report StaRRsed Compact ESR analyser 8 The instrument will accept open or sealed tubes with a pierceable rubber septum and uses double needle aspiration The Compact has a built in bar code reader however patient identification can also be entered manually using the keypad Figure 2 The StaRRsed Compact keypad fi The StaRRsed Compact has a menu controlled operating system Each menu can be selected by pressing the menu key first main menu and scrolling using the arrow keys Functions are displayed on the LCD screen and are easily accessible In addition to showing functions the LCD screen also shows error messages and system information JC Je Je e Je Jf Je LU Jl Ji There are six menus available to users Menu 1 functions related to the sampling sequence Menu 2 functions relating to the fluid system Menu 3 functions related to t
31. rt StaRRsed Compact ESR analyser 12 Even small abnormalities can be detected over a longer period of time irrespective of where and when the blood sample was taken Every measurement is directly linked to an identified sample so a manual worksheet is not necessary Patient identification errors are reduced to a minimum by using the barcode reader Data processing can be linked to a host or personal computer system The used sedimentation pipettes are automatically washed and dried In the EDTA mode the accuracy of the dilution of the EDTA blood with citrate 1s considerably better than manual dilution achieved by tipping off or using pre filled evacuated blood tubes The ESR s are read at exactly one hour so there is consistency in results however a 30 minute method is available on the instrument Using a newly developed automatic sample feed called the Interliner it 1s possible to incorporate the analyser into a fully automated system capable of accepting racks on a continuous basis and also to link up to four StaRRsed Compacts in parallel Reagents The manufacturer recommends that only the reagent containers which are part of the instrument when delivered are used Bulk reagents to replenish the containers on the instrument are supplied with plastic taps to avoid spillage and contamination Users have the option of preparing their own reagents by the use of concentrates obtained from the manufacturer The instrument incorpora
32. rvice Contracts Vitasure a fully comprehensive contract providing full service cover including two preventative maintenance visits per annum and a cheaper more basic contract Vitacover which provides the two preventative maintenance visits only Both types of Contract have been costed Tests Time per year Consumables Cost per test per day hours cost per year Manual Compact Manual Compact Manual Compact VS Compact VC 10 170 90 390 250 0 75 2 67 2 12 30 520 260 1170 250 0 75 1 09 091 50 860 430 1950 250 0 75 0 78 0 66 100 1720 860 3900 250 0 75 0 54 048 300 5200 2600 11700 250 0 75 0 38 0 36 On this basis any Laboratory doing more than 50 ESRs a day should find it a worthwhile test to fully automate by means of a Starrsed Compact MDA Evaluation Report StaRRsed Compact ESR analyser 29 Acknowledgements Acknowledgements The evaluators would like to acknowledge the assistance given by the phlebotomists in the Out Patients Department at Watford General Hospital in obtaining samples for the evaluation We should also like to thank the biomedical scientists 1n the Haematology Department at Watford General Hospital for their assistance and patience at the interruptions caused in the search for samples for the comparability studies We are also grateful to Alpha Laboratories who provided their ESR Chex free of charge MDA Evaluation Report StaRRsed Compact ESR analyser 30 References International Committee for
33. tes five solutions and a waste container Rinse solution This is used for rinsing the Westergren pipettes Approximately 8ml is used for each sample Saline Isotonic saline is used for cleaning the needle and fill nozzle assembly Each sample uses approximately 3ml MDA Evaluation Report StaRRsed Compact ESR analyser 13 Diluent 3 2 sodium citrate is used for diluting EDTA samples Approximately 500 Cl is used for each sample The prime cycle on the instrument uses 2 5ml If the solution becomes turbid it must be discarded and the container cleaned with 10 sodium hypochlorite solution and rinsed in distilled water before refilling De ionised water Deionised water is used for rinsing the fill nozzle using approximately 500DI After 10 aspirations the outside of the metal fill nozzle is washed automatically Disinfectant This is used to disinfect the waste system using approximately 500DI after each pipette rinse The manufacturer recommends the use of Virkon however users who prefer to use sodium hypochlorite either in the form of household bleach or laboratory grade sodium hypochlorite must ensure that concentrations of available chlorine quoted by the manufacturer in the user s manual are adhered to Detergent water saline disinfectant and waste bottles are all protected by level sensors which give an audible warning which requires manual intervention to cancel it This occurs either when reagent levels become too l
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