Product no. 4140 Reticulocytes, manual methods

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External Quality Assessment Scheme

Reticulocytes, manual methods Round 1, 2020 Specimens Please find enclosed 1 human origin blood cell suspension S001, 3 mL. Caution Quality control specimens derived from human blood must be handled with the same care as patient samples, i.e. as potential transmitters of serious diseases. The specimens are found to be HBsAg, HCVAb and HIVAgAb negative when tested with licensed reagents, but no known test method can offer complete assurance that the specimens will not transmit these or other infectious diseases. Examinations Reticulocytes Storage and use Please analyse samples on arrival day. If this is not possible, store samples in a refrigerator (+2…+8°C) and analyze as soon as possible. Let the vials warm up in room temperature at least for 15 minutes before the measurement. Gently invert the vial until the cells are completely and uniformly suspended. Don’t use mechanical mixer. Prepare staining and smear. Result reporting Please enter the results and methods via LabScala. If you can’t find your instrument or reagent from the registry, please contact the EQA Coordinator. S001: LQ711320011

2020-03-16 INSTRUCTIONS

Product no. 4140

LQ711320011/US

If the kit is incomplete or contains

damaged specimens, please report

immediately to [email protected]

____________________________

The results should be

reported no later than

April 6, 2020. _________________________

Inquiries

EQA Coordinator

Iida Silvo

[email protected]

Labquality

Kumpulantie 15

FI-00520 HELSINKI

Finland

Tel. + 358 9 8566 8200

Fax + 358 9 8566 8280

[email protected]

www.labquality.fi

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Reticulocytes, automated methods Round 1, 2020 Specimens Please find enclosed 2 blood cell suspensions 3 mL each according to your order. S002 and S003 are for Siemens Advia analyzers, S004 and S005 are for Sysmex analyzers, S006 and S007 are for Cell-Dyn 3200, 3500, 3700 and Ruby analyzers. S008 and S009 are for Coulter GenS and Coulter LH750 analyzers. S010 and S011 are for Cell-Dyn 4000, Saphire and ABX analyzers. S012 and S013 are for Mindray analysers. Caution Quality control specimens derived from human blood must be handled with the same care as patient samples, i.e. as potential transmitters of serious diseases. The specimens are found to be HBsAg, HCVAb and HIVAgAb negative when tested with licensed reagents, but no known test method can offer complete assurance that the specimens will not transmit these or other infectious diseases. Examinations Reticulocytes Storage and use Store in refrigerator (+2…+8°C), do not freeze. Allow samples to warm up at ambient room temperature about 15 minutes before mixing. Do not shake the vial or use a mechanical mixer. Gently invert the vials until the cells are completely suspended. Result reporting Please enter the results and methods via LabScala. If you can’t find your instrument or reagent from the registry, please contact the EQA Coordinator. Results should be given in absolute values.

2020-03-16 INSTRUCTIONS

Product no. 4150-4155

LQ711320012-0113/US

If the kit is incomplete or contains

damaged specimens, please report

immediately to [email protected].

____________________________

The results should be

reported no later than

April 6, 2020. _________________________

Inquiries

EQA Coordinator

Iida Silvo

[email protected]

Labquality

Kumpulantie 15

FI-00520 HELSINKI

Finland

Tel. + 358 9 8566 8200

Fax + 358 9 8566 8280

[email protected]

www.labquality.fi

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Reticulocytes, automated methods S002: LQ711320012 S008:LQ711320018

S003: LQ711320013 S009:LQ711320019

S004:LQ711320014 S010:LQ711320110

S005: LQ711320015 S011:LQ711320111

S006:LQ711320016 S012:LQ711320112

S007: LQ711320017 S013:LQ711320113

Reticulocyte count, March, 1-2020

Copyright © Labquality Oy

17.04.2020 1/3

Round Sample xpt Result diff% z-score

20/1 Sample S005 331.1 285.6 -13.8% -1.1220/1 Sample S004 55.9 46.4 -17.0% -1.4619/3 Sample S005 246.7 227.5 -7.8% -1.1919/3 Sample S004 58.1 56.1 -3.5% -0.4919/2 Sample S005 313.9 285.2 -9.1% -0.6419/2 Sample S004 299.8 267.8 -10.7% -1.4218/3 Sample S005 5.3 5.3 -0.6% -0.0718/3 Sample S004 0.7 0.8 6.9% 0.5718/1 Sample S005 6.0 5.8 -2.6% -0.2618/1 Sample S004 0.8 0.8 -3.8% -0.3017/3 Sample S005 9.0 9.1 0.9% 0.1017/3 Sample S004 1.0 0.9 -3.5% -0.37

xpt sd SEM CV% n

Sysmex XE-5000 331.1 x10E9/l 40.6 18.2 12.3 5All methods 284.3 x10E9/l 26.9 2.4 9.5 129

xpt sd SEM CV% n

Sysmex XE-5000 55.9 x10E9/l 6.5 2.9 11.6 5All methods 54.6 x10E9/l 6.6 0.6 12.1 129

Reticulocytes |XE-5000

xxxxx



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Round Sample xpt Result diff% z-score

20/1 Sample S005 275.8 277.4 0.6% 0.0820/1 Sample S004 55.0 49.9 -9.3% -0.8019/3 Sample S005 192.3 179.4 -6.7% -0.9219/3 Sample S004 49.2 46.5 -5.6% -0.65

xpt sd SEM CV% n

Sysmex XN 275.8 x10E9/l 19.1 1.9 6.9 105All methods 284.3 x10E9/l 26.9 2.4 9.5 129

xpt sd SEM CV% n

Sysmex XN 55.0 x10E9/l 6.4 0.6 11.7 105All methods 54.6 x10E9/l 6.6 0.6 12.1 129

Reticulocytes |XN1000

xxxxx



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Report info

Participants

166 participants from 20 countries.

Report info

Your own result should be compared to others using the same method. Assigned values (x , target values) are means of the results where results deviating more than +/- 3*standard deviation from the median are removed. The standard uncertainty (u) ofptthe assigned value is reported as standard error of the mean (SEM). Additionally, if the measurement uncertainty of the target value is large an automatic text is printed on the report:“The uncertainty of the assigned value is not negligible, and evaluations could be affected.”In case the client’s result is the only one in the method group, no assigned value will be calculated, no target area shown, and no statistics calculated. In case there are only a fewresults in the client’s own method group, the result can be compared to all method mean or to a group that is similar to the own method. Results reported with < or > -signs cannot be included in the statistics.

For information on report interpretation and performance evaluation, please see the " EQAS Interpretation guidelines" LabScala User instructions (top right corner ?Help link).

xxxxx



17.04.2020 1/14

Sample S001 | Reticulocytes, %

Methodics xpt Median sd CV% SEM min max Outliers n

Reticulocytes, Balanced sampling 5.4 5.2 1.1 20.7 0.3 3.6 7.0 1 13Reticulocytes, other manual counting 5.1 5.2 1.7 33.1 0.4 2.0 8.4 - 20All 5.2 5.2 1.5 28.5 0.3 2.0 8.4 1 33

Sample S001 histogram summaries in LabScala| Reticulocytes, %|



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Sample S002 | Reticulocytes, x10E9/l


Siemens / Advia 53.7 54.0 4.6 8.5 0.9 47.0 62.0 1 26All 53.7 54.0 4.6 8.5 0.9 47.0 62.0 1 26

Sample S002 histogram summaries in LabScala| Reticulocytes, x10E9/l|



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Siemens / Advia 243.5 241.0 19.3 7.9 3.9 216.0 305.0 1 26All 243.5 241.0 19.3 7.9 3.9 216.0 305.0 1 26




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Sysmex XE-2100 53.1 55.1 7.0 13.3 3.2 40.7 57.7 - 5Sysmex XE-5000 55.9 58.2 6.5 11.6 2.9 46.4 62.3 - 5Sysmex XN 55.0 54.9 6.4 11.7 0.6 36.7 69.4 - 105Sysmex XT 2000i 52.0 47.4 8.6 16.6 3.9 43.3 64.0 - 5Sysmex XT 4000, 4000i 51.2 51.7 7.2 14.1 2.4 39.6 60.5 - 9All 54.6 54.8 6.6 12.1 0.6 36.7 69.4 - 129




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Sysmex XE-2100 335.1 338.6 25.5 7.6 11.4 301.2 362.0 - 5Sysmex XE-5000 331.1 335.3 40.6 12.3 18.2 285.6 392.3 - 5Sysmex XN 275.8 273.7 19.1 6.9 1.9 240.5 325.5 - 105Sysmex XT 2000i 316.9 316.3 27.9 8.8 12.5 273.7 343.0 - 5Sysmex XT 4000, 4000i 323.3 329.2 19.2 6.0 6.4 283.6 342.1 - 9All 284.3 279.7 26.9 9.5 2.4 240.5 362.0 1 129




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Cell-Dyn Ruby 105.2 101.5 37.7 35.8 16.8 64.0 143.9 - 5All 105.2 101.5 37.7 35.8 16.8 64.0 143.9 - 5




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Cell-Dyn Ruby 300.9 305.6 59.6 19.8 26.7 213.0 381.0 - 5All 300.9 305.6 59.6 19.8 26.7 213.0 381.0 - 5




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Coulter STKS, GenS, LH750, MaxM, DxH 39.2 38.5 2.7 6.8 1.2 36.6 42.1 - 5All 39.2 38.5 2.7 6.8 1.2 36.6 42.1 - 5




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Coulter STKS, GenS, LH750, MaxM, DxH 250.7 246.5 10.1 4.0 4.5 240.8 266.0 - 5All 250.7 246.5 10.1 4.0 4.5 240.8 266.0 - 5




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ABX 64.5 64.0 8.2 12.8 4.1 55.0 75.0 - 4All 64.5 64.0 8.2 12.8 4.1 55.0 75.0 - 4




17.04.2020 11/14



ABX 193.3 196.0 5.5 2.8 2.8 185.0 196.0 - 4All 193.3 196.0 5.5 2.8 2.8 185.0 196.0 - 4




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Mindray 63.1 63.1 1.3 2.1 0.9 62.2 64.0 - 2All 63.1 63.1 1.3 2.1 0.9 62.2 64.0 - 2




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Mindray 168.7 168.7 16.3 9.7 11.5 157.2 180.2 - 2All 168.7 168.7 16.3 9.7 11.5 157.2 180.2 - 2




17.04.2020 14/14

Report info

Participants

166 participants from 20 countries.

Report info

Your own result should be compared to others using the same method. Assigned values (x , target values) are means of the results where results deviating more than +/- 3*standard deviation from the median are removed. The standard uncertainty (u) ofptthe assigned value is reported as standard error of the mean (SEM). Additionally, if the measurement uncertainty of the target value is large an automatic text is printed on the report:“The uncertainty of the assigned value is not negligible, and evaluations could be affected.”In case the client’s result is the only one in the method group, no assigned value will be calculated, no target area shown, and no statistics calculated. In case there are only a fewresults in the client’s own method group, the result can be compared to all method mean or to a group that is similar to the own method. Results reported with < or > -signs cannot be included in the statistics.

For information on report interpretation and performance evaluation, please see the " EQAS Interpretation guidelines" LabScala User instructions (top right corner ?Help link).

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Reticulocytes Round 1, 2020 Specimens All samples were blood cell suspensions. Sample S001 (LQ711320011) was for manual methods. Laboratories were asked to stain the specimen themselves. Sample S002 (LQ711320012) and sample S003 (LQ711320013) were for Siemens Advia instruments. Sample S004 (LQ711320014) and sample S005 (LQ711320015) were for Sysmex analysers. Sample S006 (LQ711320016) and sample S007 (LQ711320017) were for Cell-Dyn 3200, 3500, 3700 and Ruby analysers. Sample S008 (LQ711320018) and sample S009 (LQ711320019) were for Coulter analysers. Sample S010 (LQ711320110) and sample S011 (LQ711320111) were for ABX and Cell-Dyn 4000 and Saphire analysers. Sample S012 (LQ711320112) and sample S013 (LQ711320113) were for Mindray users. Based on the previous tests and the results of this round, the samples are homogeneous, stable and suitable for the external quality assessment scheme. The materials were sent without temperature control packaging. Report info Please see the description of the data analysis on the last page of the laboratory-specific histograms and Numerical Summary reports. Comments It is important to read the Final report first, because it contains important information of the samples and results in each round. Manual methods: In balanced sampling method (Dacie & Lewis: Practical Haematology) at least 100 reticulocytes are counted in successive fields and the count of all red cells in every tenth field. The number of all red cells should be counted in at least ten fields. The calculation is as follows (an example): Number of the reticulocytes seen in 150 fields = 100; Number of all red cells present 15 fields = 300; the approximate number of all red cells in 150 fields = 3000; the reticulocyte percentage = 100/3000 x 100 = 3.3 %.

Numerical summary, manual methods In this round the results from automated analysers were asked in absolute values. The results have been printed in unit x 10E9/L. Different analysers can give results in different units. There were many results given in wrong units, those results have been excluded from calculation. Like in previous rounds, in manual methods the variation of the results was bigger than automatic methods. End of report

2020-04-14 FINAL REPORT

Product no. 4140, 4150-4156

Samples sent 2020-03-16 Round closed 2020-04-09 Final report 2020-04-14 Request for correction

Typing errors in laboratory’s result

forms are on laboratory’s responsibility.

Labquality accepts responsibility only

for result processing. Requests must be

notified by writing within three weeks

from the date of this letter.

Authorized by

EQA Coordinator

Iida Silvo

[email protected]

Expert

Anri Tienhaara, MD, PhD

TYKSLAB,

Turku University Central Hospital

Labquality Oy

Kumpulantie 15

FI-00520 HELSINKI

Finland

Tel. + 358 9 8566 8200

Fax + 358 9 8566 8280

[email protected]

www.labquality.fi

Specimen 1 mean SD CV% n Balanced sampling 5.1 1.7 33.1 20 Other 5.4 1.1 20.7 13

Copyright © Labquality Oy Labquality does not permit any reproduction for commercial purposes of any portion of the material subject to this copyright. Labquality prohibits any use of its name, or reference to Labquality EQA program, or material in this report in any advertising, brochures or other commercial publications. Labquality EQA data do not necessarily indicate the superiority of instruments, reagents, testing equipments or materials used by participating laboratories. Use of Labquality EQA data to suggest superiority or inferiority of equipments or materials may be deceptive and misleading. Proficiency test results are handled confidentially. Labquality will not issue any statements to third parties of the performance of laboratories in external quality assessment schemes unless otherwise agreed.

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Documents

Product no. 4140 Reticulocytes, manual methods