Participation certificate 2018_3.pdf · Participation certificate We confirm that you have...
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Referenzinstitut für Bioanalytik Survey directors Prof. Dr. C. Knabbe Prof. Dr. Dr. K.P. Kohse Prof. Dr. M. Neumaier Head of RfB Dr. W. J. Geilenkeuser Dr. A. Kessler Bonn, 15. August 2018 Referenzinstitut für Bioanalytik - Friesdorfer Str. 153 - D-53175 Bonn Tel. 0228 / 926895 - 0 - Fax 0228 / 926895-29 - Web: www.rfb.bio - E-Mail: [email protected] Tijen Tanyalcin MD,PH Tanyalcin Tip laboratuvari Kizilkanat Sag lik Sitisi B Blok kat 1 1359 sokak no 4/3 35220 ALSANCAK, IZMIR TURKEY Survey: NBS3/18 month: July 2018 Participant-No: 9900667 date of issue: 28.07.18 TSH (2) 17-OH-progesterone (2) IRT (2) The number in parentheses characterizes the analytical method used. The assignment of the number to the respective method and/or the respective instrument is to be taken from the total evaluation. Participation certificate We confirm that you have participated in the survey for neonatal screening. The analytes determined by you are as follows:
Transcript of Participation certificate 2018_3.pdf · Participation certificate We confirm that you have...
Referenzinstitut für Bioanalytik
Survey directorsProf. Dr. C. Knabbe
Prof. Dr. Dr. K.P. KohseProf. Dr. M. Neumaier
Head of RfBDr. W. J. Geilenkeuser
Dr. A. Kessler
Bonn, 15. August 2018
Referenzinstitut für Bioanalytik - Friesdorfer Str. 153 - D-53175 BonnTel. 0228 / 926895 - 0 - Fax 0228 / 926895-29 - Web: www.rfb.bio - E-Mail: [email protected]
Tijen Tanyalcin MD,PHTanyalcin Tip laboratuvariKizilkanat Sag lik Sitisi B Blok kat 11359 sokak no 4/335220 ALSANCAK, IZMIRTURKEY
Survey: NBS3/18month: July 2018Participant-No: 9900667date of issue: 28.07.18
TSH (2) 17-OH-progesterone (2) IRT (2)
The number in parentheses characterizes the analytical method used.The assignment of the number to the respective method and/or the respective instrumentis to be taken from the total evaluation.
Participation certificateWe confirm that you have participated in the survey for neonatal screening.
The analytes determined by you are as follows:
Survey: NBS3/18month: July 2018Participant-No: 9900667
Listing and Evaluation of all your results
Explanations
CertificateA certificate is issued (given) for an analyte only if the basis for an evaluation of the accuracy is given by the guidelines of theGerman Medical Association and/or if an evaluation is possible in analogy to these guidelines (see comments on the evaluation)and, if both results for an analyte are within the given acceptance limits. (marked as '+' below C)
Certificate of participationIn the participation certificate all analytes which are included in the list on this page are listed.If all analytes are listed on the certificate no participation certificate is printed.
C M R D/Dmax T LL UL
Legend: C=Certification, M=No of method, R=your result, D=difference (R-T)Dmax= maximum allowable amount of difference in measurement, partly given byannax 1 of the guideline of the BÄK (Dt. Ärzteblatt 111, Heft 38, 19.9.2014).T = target value, either reference method value or assigned value, LL | UL = lower resp. upper limit
Certification: + = fulfilled ( quotient | D/Dmax | <= 1.0 )- = not fulfilled (quotient | D/Dmax | > 1.0± = certification cancelled because of technicaland/or analytical reasons
TSH[mU/l]
± 2 A 3.85 -1.91 9.03 6.32 11.8B 13.5 -1.42 23.7 16.5 30.9
17-OH-progesterone[nmol/l]
± 2 A 20.4 0.70 16.8 11.7 21.9B 142 1.26 103 72.1 134
IRT[µg/l]
± 2 A 47.5 -1.14 72.3 50.6 94.0B 7.60 -1.80 16.8 11.7 21.9
Findings NBS3/18 -July 2018-Neonatal - Screening, TSH, Sample A
Participant No 9900667
Legend: NXMSDCVM
=====
number of resultsmean valuestandard deviationcoefficient of variationmethod number
r n
r n r n
r n r n
=
=
=
result box/result code no.
normal | CH/AGS/CF possible
CH/AGS/CF evident | other
= 16. bis 84. percentile with medianCH = congenital hypothyroidismAGS = adrenogen. syndromeCF = cystic fibrosisr n = marks your result box
3 4 5 6 7 8 9 10 11 12 13 14 15 mU/l
11 2 3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69 70
71
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
707,7 mU/l1,5 mU/l19,5 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
49 47 115 14
1 1
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 5 10
All Kits 70 3.85 6.44 7.65 9.35 12.1
Kit Classifications
49 15 0 12 9 2 8.20 9.03 9.86 0 1 0 02 99 2 3.85 7.93 12.0 2 0 0 03 99 2 7.94 8.33 8.71 1 0 0 04 91 2 5.90 6.81 7.71 1 0 0 04 245 22 6.75 7.17 7.85 8.75 11.6 18 5 0 04 246 9 6.50 6.68 7.80 9.28 9.70 7 2 0 04 247 18 6.00 6.50 7.38 9.48 9.80 11 7 0 05 77 8 4.40 4.81 6.03 8.18 8.49 7 0 0 05 111 2 9.79 10.2 10.6 1 0 0 0
Other Kits: 1 77(1),3 247(1),4 99(1),The deviation of your result from the total median M M Muand from the median of the corresponding sub-collective (kit) Mu is: -49.67 % -51.42 %
Findings NBS3/18 -July 2018-Neonatal - Screening, TSH, Sample B
Participant No 9900667
Legend: NXMSDCVM
=====
number of resultsmean valuestandard deviationcoefficient of variationmethod number
r n
r n r n
r n r n
=
=
=
result box/result code no.
normal | CH/AGS/CF possible
CH/AGS/CF evident | other
= 16. bis 84. percentile with medianCH = congenital hypothyroidismAGS = adrenogen. syndromeCF = cystic fibrosisr n = marks your result box
13 15 17 19 21 23 25 27 29 31 33 35 37 mU/l
11 6
8
13
11
24
19
30
22
51
14
56
54
39
17
16
29
31
52
23
18
20
28
37
46
27
21
15
33
42
61
44
32
45
3
41
34
2
71
26
36
57
25
60
58
55
35
47
9
43
63
12
5
65
53
62
4
38
49
10
59
40
68
64
48
7
66
67 69 50 70
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
7020,3 mU/l2,9 mU/l14,6 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
44 35 918 17
3 3
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 10 20 30
All Kits 70 13.5 17.8 20.2 23.0 41.5
Kit Classifications
0 44 18 32 9 2 22.7 23.7 24.6 0 0 1 02 99 2 13.5 27.5 41.5 0 2 0 03 99 2 20.6 21.0 21.5 0 1 0 04 91 2 15.0 17.0 19.0 0 0 1 04 245 22 17.2 18.1 20.0 23.4 28.9 0 16 7 04 246 9 15.1 16.8 20.5 25.2 30.5 0 6 3 04 247 18 15.0 17.1 19.4 22.1 23.0 0 13 5 05 77 8 20.0 20.2 22.2 23.7 24.3 0 5 0 25 111 2 23.8 25.6 27.4 0 0 1 0
Other Kits: 1 77(1),3 247(1),4 99(1),The deviation of your result from the total median M M Muand from the median of the corresponding sub-collective (kit) Mu is: -33.42 % -51.05 %
Findings NBS3/18 -July 2018-Neonatal - Screening, 17-OHP, Sample A
Participant No 9900667
Legend: NXMSDCVM
=====
number of resultsmean valuestandard deviationcoefficient of variationmethod number
r n
r n r n
r n r n
=
=
=
result box/result code no.
normal | CH/AGS/CF possible
CH/AGS/CF evident | other
= 16. bis 84. percentile with medianCH = congenital hypothyroidismAGS = adrenogen. syndromeCF = cystic fibrosisr n = marks your result box
11 13 15 17 19 21 23 25 27 29 31 33 35 nmol/l
21 25 49
72
63
69
14
15
8
12
17
33
61
18
5
24
9
11
65
32
73
19
31
4
7
40
29
58
57
64
37
53
56
48
47
34
3
60
50
46
44
28
41
38
59
67
11
51
52
39
74
75
30
68
10 76
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
5517,2 nmol/l2,9 nmol/l17,1 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
44 42 11 1
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 5 10 15 20 25 30
All Kits 55 11.2 14.0 16.8 20.4 25.0
Kit Classifications
44 1 0 04 245 23 13.9 15.9 18.0 20.7 25.0 18 1 0 04 246 7 11.2 14.5 20.9 7 0 0 04 247 16 12.3 13.9 15.2 16.5 20.0 15 0 0 05 111 2 17.0 18.5 20.0 1 0 0 0
Other Kits: 2 9(1),2 99(1),3 99(1),3 247(1),4 91(1),4 99(1),6 99(1),The deviation of your result from the total median M M Muand from the median of the corresponding sub-collective (kit) Mu is:
Findings NBS3/18 -July 2018-Neonatal - Screening, 17-OHP, Sample B
Participant No 9900667
Legend: NXMSDCVM
=====
number of resultsmean valuestandard deviationcoefficient of variationmethod number
r n
r n r n
r n r n
=
=
=
result box/result code no.
normal | CH/AGS/CF possible
CH/AGS/CF evident | other
= 16. bis 84. percentile with medianCH = congenital hypothyroidismAGS = adrenogen. syndromeCF = cystic fibrosisr n = marks your result box
70 82 94 106 118 130 142 154 166 178 190 202 214 nmol/l
21 24
30
63
56
31
25
59
65
14
9
15
61
33
17
18
11
32
67
73
29
7
69
58
52
34
74
37
72
64
41
12
8
3
4
51
60
75
28
40
68
47
46
49
19
5
39
57
38
44 48
76
11 10 50 53
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
55106,0 nmol/l19,7 nmol/l18,6 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
1 19 5 4
33 6 22 41 1
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 50 100 150
All Kits 55 70.3 89.0 103 121 176
Kit Classifications
1 9 33 14 245 23 90.6 101 112 130 176 0 3 14 14 246 7 70.3 101 167 0 2 5 04 247 16 76.3 85.8 91.8 101 106 0 4 11 05 111 2 98.1 102 105 1 0 0 0
Other Kits: 2 9(1),2 99(1),3 99(1),3 247(1),4 91(1),4 99(1),6 99(1),The deviation of your result from the total median M M Muand from the median of the corresponding sub-collective (kit) Mu is:
Findings NBS3/18 -July 2018-Neonatal - Screening, IRT, Sample A
Participant No 9900667
Legend: NXMSDCVM
=====
number of resultsmean valuestandard deviationcoefficient of variationmethod number
r n
r n r n
r n r n
=
=
=
result box/result code no.
normal | CH/AGS/CF possible
CH/AGS/CF evident | other
= 16. bis 84. percentile with medianCH = congenital hypothyroidismAGS = adrenogen. syndromeCF = cystic fibrosisr n = marks your result box
21 37 53 69 85 101 117 133 149 165 181 197 213 µg/l
30 11 49 67
64
12
11
51
70
17
24
21
16
77
66
15
44
33
52
23
63
28
27
39
37
8
50
56
54
48
68
58
42
31
20
19
25
57
60
46
59
34
69
18
65
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
4496,3 µg/l19,9 µg/l20,6 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
3 2 119 6 1 1218 1 16
1 1
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 50 100 150 200
All Kits 44 21.7 78.6 98.8 112 127
Kit Classifications
3 19 18 12 52 3 47.5 85.0 94.1 2 1 0 04 245 16 90.7 92.0 99.9 117 124 0 11 6 04 246 5 89.5 100 110 0 2 2 14 247 14 76.9 82.5 99.9 122 127 0 4 10 05 111 2 72.5 72.6 72.7 0 1 0 0
Other Kits: 2 9(1),3 99(1),3 247(1),4 91(1),The deviation of your result from the total median M M Muand from the median of the corresponding sub-collective (kit) Mu is: -51.95 % -44.18 %
Findings NBS3/18 -July 2018-Neonatal - Screening, IRT, Sample B
Participant No 9900667
Legend: NXMSDCVM
=====
number of resultsmean valuestandard deviationcoefficient of variationmethod number
r n
r n r n
r n r n
=
=
=
result box/result code no.
normal | CH/AGS/CF possible
CH/AGS/CF evident | other
= 16. bis 84. percentile with medianCH = congenital hypothyroidismAGS = adrenogen. syndromeCF = cystic fibrosisr n = marks your result box
3 5 7 9 11 13 15 17 19 21 23 25 27 µg/l
51 77
52
37
27
44
11
24
54
60
50
39
57
34
68
20
16
59
19
25
42
12
23
48
21
15
69
17
65
46
33
31
28
63
11
56
58
18
8
67
64
49 30 66 70
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
447,4 µg/l3,5 µg/l47,6 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
41 40
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 0 5 10 15
All Kits 44 4.50 5.00 6.35 9.58 19.5
Kit Classifications
41 0 0 02 52 3 7.60 18.6 19.5 3 0 0 04 245 16 4.50 4.79 5.90 7.08 7.40 17 0 0 04 246 5 5.10 5.80 7.70 5 0 0 04 247 14 5.00 5.40 6.40 7.78 10.0 14 0 0 05 111 2 10.2 10.3 10.4 1 0 0 0
Other Kits: 2 9(1),3 99(1),3 247(1),4 91(1),The deviation of your result from the total median M M Muand from the median of the corresponding sub-collective (kit) Mu is: 19 % -59.14 %
Findings NBS3/18 -July 2018-Neonatal - Screening, PAP, Sample A
Participant No 9900667
Legend: NXMSDCVM
=====
number of resultsmean valuestandard deviationcoefficient of variationmethod number
r n
r n r n
r n r n
=
=
=
result box/result code no.
normal | CH/AGS/CF possible
CH/AGS/CF evident | other
= 16. bis 84. percentile with medianCH = congenital hypothyroidismAGS = adrenogen. syndromeCF = cystic fibrosisr n = marks your result box
0 0,2 0,4 0,6 0,8 1 1,2 1,4 1,6 1,8 2 2,2 2,4 µg/l
12 17
28
65
77
11
59
48
69
68
44
8
78
63
21
42
33
39
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
180,9 µg/l0,1 µg/l16,2 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
16 16
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 0,5 1 1,5
All Kits 18 0.560 0.834 0.985 1.10 1.22
Kit Classifications
16 0 0 02 255 3 0.833 0.970 1.00 3 0 0 04 255 15 0.560 0.828 1.00 1.14 1.22 13 0 0 0
Other Kits:
Findings NBS3/18 -July 2018-Neonatal - Screening, PAP, Sample B
Participant No 9900667
Legend: NXMSDCVM
=====
number of resultsmean valuestandard deviationcoefficient of variationmethod number
r n
r n r n
r n r n
=
=
=
result box/result code no.
normal | CH/AGS/CF possible
CH/AGS/CF evident | other
= 16. bis 84. percentile with medianCH = congenital hypothyroidismAGS = adrenogen. syndromeCF = cystic fibrosisr n = marks your result box
0 0,2 0,4 0,6 0,8 1 1,2 1,4 1,6 1,8 2 2,2 2,4 µg/l
12 44
11
59
48
28
65
68
21
69
77
63
17
42
78
8
33
39
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
181,1 µg/l0,1 µg/l11,4 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
16 16
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 0,5 1 1,5 2
All Kits 18 0.920 1.00 1.14 1.30 1.41
Kit Classifications
16 0 0 02 255 3 1.04 1.10 1.17 3 0 0 04 255 15 0.920 1.00 1.20 1.30 1.41 13 0 0 0
Other Kits:
Youden plots NBS3/18, Participant No 9900667, page 1 of 2
Analyte
Method
TSHall methods
success rate 85,7 % out of range 1
No of participants 70sample/unit A BmU/lmeanstandard deviationcoefficient of variation
7.73 20.41.51 2.9819.5 14.7
Sample A [mU/l]
5 10M Kit N Min 16.P 50.P 84.P Max
Alle 70 3.85 6.44 7.65 9.35 12.14 245 22 6.75 7.17 7.85 8.75 11.64 246 9 6.50 6.68 7.80 9.28 9.704 247 18 6.00 6.50 7.38 9.48 9.805 77 8 4.40 4.81 6.03 8.18 8.49
M Kit N Min 16.P 50.P 84.P Max
Sample B [mU/l]
10 20 30
Alle 70 13.5 17.8 20.2 23.0 41.54 245 22 17.2 18.1 20.0 23.4 28.94 246 9 15.1 16.8 20.5 25.2 30.54 247 18 15.0 17.1 19.4 22.1 23.05 77 8 20.0 20.2 22.2 23.7 24.3
Other kits (number):1-77(1), 2-09(2), > 2-99(2)<, 3-99(2), 3-247(1), 4-91(2), 4-99(1), 5-111(2),
Analyte
Method
17-OH-progesteroneall methods
success rate 83,6 % out of range 0
No of participants 55sample/unit A Bnmol/lmeanstandard deviationcoefficient of variation
17.2 1062.96 19.817.2 18.6
Sample A [nmol/l]
5 10 15 20 25 30M Kit N Min 16.P 50.P 84.P Max
Alle 55 11.2 14.0 16.8 20.4 25.04 245 23 13.9 15.9 18.0 20.7 25.04 246 7 11.2 14.5 20.94 247 16 12.3 13.9 15.2 16.5 20.0
M Kit N Min 16.P 50.P 84.P Max
Sample B [nmol/l]
50 100 150
Alle 55 70.3 89.0 103 121 1764 245 23 90.6 101 112 130 1764 246 7 70.3 101 1674 247 16 76.3 85.8 91.8 101 106
Other kits (number):2-09(1), > 2-99(1)<, 3-99(1), 3-247(1), 4-91(1), 4-99(1), 5-111(2), 6-99(1),
Youden plots NBS3/18, Participant No 9900667, page 2 of 2
Analyte
Method
IRTall methods
success rate 84,0 % out of range 0
No of participants 44sample/unit A Bµg/lmeanstandard deviationcoefficient of variation
96.3 7.4319.9 3.5420.7 47.6
Sample A [µg/l]
50 100 150 200M Kit N Min 16.P 50.P 84.P Max
Alle 44 21.7 78.6 98.8 112 1272 52 3 47.5 85.0 94.14 245 16 90.7 92.0 99.9 117 1244 246 5 89.5 100 1104 247 14 76.9 82.5 99.9 122 1275 111 2 72.5 72.6 72.7
M Kit N Min 16.P 50.P 84.P Max
Sample B [µg/l]
0 5 10 15
Alle 44 4.50 5.00 6.35 9.58 19.52 52 3 7.60 18.6 19.54 245 16 4.50 4.79 5.90 7.08 7.404 246 5 5.10 5.80 7.704 247 14 5.00 5.40 6.40 7.78 10.05 111 2 10.2 10.3 10.4The deviation of your results from the median of the corresponding sub-collective (kit) is:
A-44.18 %B-59.14 %
Other kits (number):2-09(1), 3-99(1), 3-247(1), 4-91(1),
