Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 1 of 15 Paroxysmal Nocturnal Haemoglobinuria Sample - 087 Distribution - 161702 Participant ID - Date Issued - 26 July 2016 Closing Date - 15 August 2016 Trial Comments This trial was issued to 163 participants. Sample Comments This sample was manufactured from stabilised whole blood spiked with stabilised PNH material from a consented patient. Results and Performance Your Results Your Results Consensus Result Cell Population Present Clone Absent Red Blood Cells PNH Clone Monocytes PNH Clone Present Clone Present Granulocytes PNH Clone Present Clone Present Your Performance Performance Status Classification Over 12 Sample Period Critical Performance Status for this Trial Satisfactory Cell Population Critical 2 1 Red Blood Cells PNH Clone Satisfactory 2 1 Monocytes PNH Clone Satisfactory 3 0 Granulocytes PNH Clone N/A = Not Applicable Percentage Value Results Your Results (%) Cell Population Upper Quartile (%) Median Result (%) Lower Quartile (%) 0.81 Red Blood Cells PNH Clone 0.01 0.00 0.05 5.30 Monocytes PNH Clone 55.00 45.70 58.77 7.00 Granulocytes PNH Clone 8.50 7.77 9.80 Uncontrolled Copy
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Paroxysmal Nocturnal Haemoglobinuria Sample - 087Report.pdf · paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. Cytometry B. Clin. Cytom. 78, 211-30 (2010)
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Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 1 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 087
Distribution - 161702 Participant ID -
Date Issued - 26 July 2016 Closing Date - 15 August 2016
Trial CommentsThis trial was issued to 163 participants.
Sample CommentsThis sample was manufactured from stabilised whole blood spiked with stabilised PNH material from a consented patient.
Results and Performance
Your Results
Your Results Consensus ResultCell Population
Present Clone AbsentRed Blood Cells PNH Clone
Monocytes PNH Clone Present Clone Present
Granulocytes PNH Clone Present Clone Present
Your Performance
Performance Status Classification Over 12 Sample Period
Critical
Performance Status for this
Trial Satisfactory
Cell Population
Critical 2 1Red Blood Cells PNH Clone
Satisfactory 2 1Monocytes PNH Clone
Satisfactory 3 0Granulocytes PNH Clone
N/A = Not Applicable
Percentage Value Results
Your Results (%)Cell Population Upper Quartile (%)Median Result (%) Lower Quartile (%)
0.81Red Blood Cells PNH Clone 0.01 0.00 0.05
5.30Monocytes PNH Clone 55.00 45.70 58.77
7.00Granulocytes PNH Clone 8.50 7.77 9.80
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mfletcher
Sticky Note
The unique number of the sample issued in the trial that this report relates to. Each sample will have it's own sequence of sheets.
mfletcher
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The name of the programme that this report relates to.
mfletcher
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Your unique participant number, designed to guarantee confidentiality.
mfletcher
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The date that the trial closed.
mfletcher
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The date that the trial issued.
mfletcher
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Distribution number of the trial, the first four digits relate to the financial year and the final two digits to the trial within that financial year.
mfletcher
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Comments form UKNEQAS LI specific to this distribution.
mfletcher
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Comments form UKNEQAS LI specific to this sample.
mfletcher
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PNH cell population
mfletcher
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Your results for this distribution with regards to clone present/clone absent.
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The consensus opinion of results returned.
mfletcher
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Your performance status when compared to the consensus opinion.
mfletcher
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Your performance classification over a 12 sample period.
mfletcher
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Your results for total PNH clone size for each cell population.
mfletcher
Sticky Note
Median percentage value of all results returned.
mfletcher
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Lower quartile values (%) based on results returned.
mfletcher
Sticky Note
Upper quartile values (%) based on results returned.
Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 2 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 087
Histograms of Percentage Results
Red Blood Cells PNH Clone Percentage PopulationPlease note ▼ denotes your result
0
10
20
30
40
50
60
70
0-5
16
-25
26
-35
36
-45
6-1
5
46
-55
56
-65
66
-75
76
-85
86
-95
96
-10
0
Centile
Re
turn
s
Monocytes PNH Clone Percentage PopulationPlease note ▼ denotes your result
0
10
20
30
0-5
6-1
5
16
-25
26
-35
36
-45
46
-55
56
-65
66
-75
76
-85
86
-95
96
-10
0
Centile
Re
turn
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Histograms depicting where your result falls in comparison to the centile ranges for each cell population
Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 3 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 087
Granulocytes PNH Clone Percentage PopulationPlease note ▼ denotes your result
0
10
20
30
0-5
6-1
5
16
-25
26
-35
36
-45
46
-55
56
-65
66
-75
76
-85
86
-95
96
-10
0
Centile
Re
turn
s
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Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 4 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 087
Flow Cytometer Specific Statistics(Please note only groups of >20 returns are displayed)
Red Blood Cell PNH Clone
ReturnsFlow Cytometer Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Laboratories Reporting
Clone Absent
Median
Clone Size
(%)
Lower
Quartile
(%)
Facs Canto II 67 0.1030 37 0.000.01
Navios 25 0.0513 12 0.000.01
Monocytes PNH Clone
ReturnsFlow Cytometer Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Laboratories Reporting
Clone Absent
Median
Clone Size
(%)
Lower
Quartile
(%)
Facs Canto II 61 59.0059 2 55.60 48.30
Navios 23 56.8522 1 52.20 38.02
Granulocytes PNH Clone
ReturnsFlow Cytometer Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Median
Clone Size
(%)
Lower
Quartile
(%)
Laboratories Reporting
Clone Absent
Facs Canto II 77 9.5075 8.54 7.902
Navios 26 9.6926 8.22 7.460
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Flow cytometer specific statistics for each cell population. 20 or more returns are required for robust statistics.
Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 5 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 087
Gating Antibodies Used Statistics(Please note only groups of >20 returns are displayed)
Red Blood Cell PNH Clone
ReturnsGating Strategy Used Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Laboratories Reporting
Clone Absent
Median
Clone Size
(%)
Lower
Quartile
(%)
CD235a 99 0.0444 55 0.01 0.00
Monocytes PNH Clone
ReturnsGating Strategy Used Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Median
Clone Size
(%)
Lower
Quartile
(%)
Laboratories Reporting
Clone Absent
CD33 23 59.6023 57.00 54.900
CD33/CD45 35 60.2235 57.30 54.280
Granulocytes PNH Clone
ReturnsGating Strategy Used Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Median
Clone Size
(%)
Lower
Quartile
(%)
Laboratories Reporting
Clone Absent
CD15 34 8.7534 8.16 7.430
CD15/CD45 35 8.8534 8.10 7.501
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Gating antibody statistics for each cell population. 20 or more data sets are required for robust statistic generation.
Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 6 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 087
GPI Linked Antibodies Used Statistics(Please note only groups of >20 returns are displayed)
Red Blood Cell PNH Clone
ReturnsGPI Linked Antibodies
Combination Used
Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Laboratories Reporting
Clone Absent
Median
Clone Size
(%)
Lower
Quartile
(%)
CD59 101 0.0442 59 0.00 0.00
Monocytes PNH Clone
ReturnsGPI Linked Antibodies
Combination Used
Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Median
Clone Size
(%)
Lower
Quartile
(%)
Laboratories Reporting
Clone Absent
CD14/FLAER 66 59.7864 55.75 49.382
Granulocyte PNH Clone
ReturnsGPI Linked Antibodies
Combination Used
Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Median
Clone Size
(%)
Lower
Quartile
(%)
Laboratories Reporting
Clone Absent
CD24/FLAER 74 9.0073 8.40 7.811
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mfletcher
Sticky Note
GPI linked antibody statistics for each cell population. shown as the most commonly used combinations, 20 or more data sets are required for robust statistic generation.
Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 7 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 087
GPI Linked Antibodies Specific Statistics
Red Blood Cell PNH Clone
Laboratories using as
part of their panel*
Laboratories Reporting
Clone Absent
Laboratories Reporting
Clone Present
GPI Linked Antibody
CD55 710 17
CD59 6952 121
* Please note the numbers in the above tables will not match the number of laboratories enrolled in the programme as each centre uses a panel with multiple antibodies
Monocytes PNH Clone
Laboratories using as
part of their panel*
Laboratories Reporting
Clone Absent
Laboratories Reporting
Clone Present
GPI Linked Antibody
CD14 279 81
CD157 015 15
CD24 03 3
^CD55 010 10
^CD59 010 10
FLAER 296 98
* Please note the numbers in the above tables will not match the number of laboratories enrolled in the programme as each centre uses a panel with multiple antibodies
Granulocyte PNH Clone
Laboratories using as
part of their panel*
Laboratories Reporting
Clone Absent
Laboratories Reporting
Clone Present
GPI Linked Antibody
CD157 014 14
CD24 297 99
^CD55 012 12
^CD59 014 14
CD66b 020 20
FLAER 2115 117
* Please note the numbers in the above tables will not match the number of laboratories enrolled in the programme as each centre uses a panel with multiple antibodies
^ Antigens marked above are not considered best practice and laboratories should avoid using these for
leucocytes. Please see Borowitz, M. J. et al. Guidelines for the diagnosis and monitoring of
paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. Cytometry B. Clin.
Cytom. 78, 211-30 (2010) or Sutherland, D. R., Keeney, M. & Illingworth, A. Practical guidelines for
the high-sensitivity detection and monitoring of paroxysmal nocturnal hemoglobinuria clones by
flow cytometry. Cytom. Part B - Clin. Cytom. 82 B, 195-208 (2012) for further explanation.
Uncon
trolle
d Cop
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mfletcher
Sticky Note
GPI linked antibody statistics for each cell population shown as individual antigens. 20 or more data sets are required for robust statistic generation.
mfletcher
Sticky Note
This section will display any useful or new references.
Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 8 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 088
Distribution - 161702 Participant ID - 40003
Date Issued - 26 July 2016 Closing Date - 15 August 2016
Trial CommentsThis trial was issued to 163 participants.
Sample CommentsThis sample was manufactured from stabilised whole blood
Results and Performance
Your Results
Your Results Consensus ResultCell Population
Absent Clone AbsentRed Blood Cells PNH Clone
Monocytes PNH Clone Absent Clone Absent
Granulocytes PNH Clone Absent Clone Absent
Your Performance
Performance Status Classification Over 12 Sample Period
Critical
Performance Status for this
Trial Satisfactory
Cell Population
Satisfactory 3 1Red Blood Cells PNH Clone
Satisfactory 3 1Monocytes PNH Clone
Satisfactory 4 0Granulocytes PNH Clone
N/A = Not Applicable
Percentage Value Results
Your Results (%)Cell Population Upper Quartile (%)Median Result (%) Lower Quartile (%)
0.00Red Blood Cells PNH Clone 0.00 0.00 0.00
0.00Monocytes PNH Clone 0.00 0.00 0.00
0.00Granulocytes PNH Clone 0.00 0.00 0.00
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Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 9 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 088
Histograms of Percentage Results
Red Blood Cells PNH Clone Percentage Population
Due to the Median, Lower Quartile and Upper Quartile values for this sample being 0, Histograms are not displayed.
Monocytes PNH Clone Percentage Population
Due to the Median, Lower Quartile and Upper Quartile values for this sample being 0, Histograms are not displayed.
Granulocytes PNH Clone Percentage Population
Due to the Median, Lower Quartile and Upper Quartile values for this sample being 0, Histograms are not displayed.
Uncon
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d Cop
y
Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 10 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 088
Flow Cytometer Specific Statistics(Please note only groups of >20 returns are displayed)
Red Blood Cell PNH Clone
ReturnsFlow Cytometer Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Laboratories Reporting
Clone Absent
Median
Clone Size
(%)
Lower
Quartile
(%)
Facs Canto II 67 0.002 65 0.000.00
Navios 24 0.001 23 0.000.00
Monocytes PNH Clone
ReturnsFlow Cytometer Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Laboratories Reporting
Clone Absent
Median
Clone Size
(%)
Lower
Quartile
(%)
Facs Canto II 60 0.003 57 0.00 0.00
Navios 23 0.000 23 0.00 0.00
Granulocytes PNH Clone
ReturnsFlow Cytometer Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Median
Clone Size
(%)
Lower
Quartile
(%)
Laboratories Reporting
Clone Absent
Facs Canto II 75 0.004 0.00 0.0071
Navios 26 0.000 0.00 0.0026
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Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 11 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 088
Gating Antibodies Used Statistics(Please note only groups of >20 returns are displayed)
Red Blood Cell PNH Clone
ReturnsGating Strategy Used Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Laboratories Reporting
Clone Absent
Median
Clone Size
(%)
Lower
Quartile
(%)
CD235a 97 0.004 93 0.00 0.00
Monocytes PNH Clone
ReturnsGating Strategy Used Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Median
Clone Size
(%)
Lower
Quartile
(%)
Laboratories Reporting
Clone Absent
CD33 22 0.001 0.00 0.0021
CD33/CD45 35 0.000 0.00 0.0035
Granulocytes PNH Clone
ReturnsGating Strategy Used Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Median
Clone Size
(%)
Lower
Quartile
(%)
Laboratories Reporting
Clone Absent
CD15 34 0.001 0.00 0.0033
CD15/CD45 35 0.000 0.00 0.0035
Uncon
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Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 12 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 088
GPI Linked Antibodies Used Statistics(Please note only groups of >20 returns are displayed)
Red Blood Cell PNH Clone
ReturnsGPI Linked Antibodies
Combination Used
Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Laboratories Reporting
Clone Absent
Median
Clone Size
(%)
Lower
Quartile
(%)
CD59 100 0.004 96 0.00 0.00
Monocytes PNH Clone
ReturnsGPI Linked Antibodies
Combination Used
Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Median
Clone Size
(%)
Lower
Quartile
(%)
Laboratories Reporting
Clone Absent
CD14/FLAER 65 0.001 0.00 0.0064
Granulocyte PNH Clone
ReturnsGPI Linked Antibodies
Combination Used
Upper
Quartile
(%)
Laboratories Reporting
Clone Present
Median
Clone Size
(%)
Lower
Quartile
(%)
Laboratories Reporting
Clone Absent
CD24/FLAER 73 0.000 0.00 0.0073
Uncon
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Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 13 of 15
Paroxysmal Nocturnal Haemoglobinuria Sample - 088
GPI Linked Antibodies Specific Statistics
Red Blood Cell PNH Clone
Laboratories using as
part of their panel*
Laboratories Reporting
Clone Absent
Laboratories Reporting
Clone Present
GPI Linked Antibody
CD55 170 17
CD59 1174 121
* Please note the numbers in the above tables will not match the number of laboratories enrolled in the programme as each centre uses a panel with multiple antibodies
Monocytes PNH Clone
Laboratories using as
part of their panel*
Laboratories Reporting
Clone Absent
Laboratories Reporting
Clone Present
GPI Linked Antibody
CD14 801 81
CD157 150 15
CD24 30 3
^CD55 100 10
^CD59 100 10
FLAER 962 98
* Please note the numbers in the above tables will not match the number of laboratories enrolled in the programme as each centre uses a panel with multiple antibodies
Granulocyte PNH Clone
Laboratories using as
part of their panel*
Laboratories Reporting
Clone Absent
Laboratories Reporting
Clone Present
GPI Linked Antibody
CD157 140 14
CD24 981 99
^CD55 120 12
^CD59 140 14
CD66b 200 20
FLAER 1152 117
* Please note the numbers in the above tables will not match the number of laboratories enrolled in the programme as each centre uses a panel with multiple antibodies
^ Antigens marked above are not considered best practice and laboratories should avoid using these for
leucocytes. Please see Borowitz, M. J. et al. Guidelines for the diagnosis and monitoring of
paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. Cytometry B. Clin.
Cytom. 78, 211-30 (2010) or Sutherland, D. R., Keeney, M. & Illingworth, A. Practical guidelines for
the high-sensitivity detection and monitoring of paroxysmal nocturnal hemoglobinuria clones by
flow cytometry. Cytom. Part B - Clin. Cytom. 82 B, 195-208 (2012) for further explanation.
Uncon
trolle
d Cop
y
Report Issue Date: 20 Oct 2016 ; Distribution: PNH2 161702; Version: 1.0.0 Page 14 of 15
Paroxysmal Nocturnal Haemoglobinuria
Information with respect to compliance with standards BS EN ISO/IEC 17043:2010
4.8.2 a) The proficiency testing provider for this programme is: