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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, 23. May 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: NBS2/18month: May 2018Participant-No: 9900667date of issue: 05.05.18
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: NBS2/18month: May 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 3.40 -1.02 5.85 3.45 8.25B 36.2 -0.40 41.2 28.8 53.6
17-OH-progesterone[nmol/l]
± 2 A 30.8 -1.26 49.5 34.6 64.4B 15.2 -0.52 18.0 12.6 23.4
IRT[µg/l]
± 2 A 79.2 -0.68 99.7 69.7 130B 15.3 -1.17 23.6 16.5 30.7
Findings NBS2/18 -May 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 3,8 4,6 5,4 6,2 7 7,8 8,6 9,4 10,2 11 11,8 12,6 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
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
696,9 mU/l1,4 mU/l20,2 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
57 54 15 52 2
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 2 4 6 8 10 12
All Kits 69 3.40 6.00 6.83 7.86 154
Kit Classifications
57 5 2 03 99 3 6.44 7.41 154 1 0 1 03 350 2 6.90 9.85 12.8 1 0 0 04 91 2 6.40 6.73 7.05 1 0 0 04 245 22 5.50 5.84 6.50 7.23 47.7 20 1 1 04 246 7 5.40 6.32 8.65 6 1 0 04 247 19 5.10 5.82 7.00 7.50 8.00 17 2 0 05 77 8 6.00 6.10 7.01 11.2 12.8 7 0 0 05 111 2 8.29 8.79 9.29 1 0 0 0
Other Kits: 1 77(1),2 2(1),2 99(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:
Findings NBS2/18 -May 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
8 14 20 26 32 38 44 50 56 62 68 74 80 mU/l
69 68 66
5
2
7
37
18
15
11
13
31
56
16
53
23
28
17
29
11
6
4
12
8
26
47
33
52
14
19
27
63
9
22
45
32
38
55
44
59
35
50
21
41
46
20
51
36
3
25
57
42
54
30
24
43
48
10
49
40
62
65
60
39
67
58
34
61 64
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
6940,0 mU/l5,6 mU/l14,0 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
1 120 11 843 2 37 2
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 20 40 60
All Kits 69 8.20 34.4 39.3 45.4 56.4
Kit Classifications
1 20 43 03 99 3 8.20 35.2 42.8 1 1 0 03 350 2 49.0 49.4 49.8 0 0 1 04 91 2 39.9 42.0 44.0 0 0 1 04 245 22 15.7 32.2 37.5 40.3 50.6 0 6 16 04 246 7 32.0 35.3 42.3 0 4 3 04 247 19 31.2 35.3 39.3 44.1 49.0 0 6 13 05 77 8 30.6 33.9 41.8 51.5 56.4 0 2 5 05 111 2 47.7 51.3 55.0 0 0 1 0
Other Kits: 1 77(1),2 2(1),2 99(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:
Findings NBS2/18 -May 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
6 18 30 42 54 66 78 90 102 114 126 138 150 nmol/l
68
65
11
8
24
6
22
70
21
66
40
43
13
38
17
54
51
56
52
60
2
9
71
48
47
39
49
34
35
15
7
19
50
27
14
31
72
44
18
29
32
42
30
33
73
46
37
63
69
59
36
41
20
61
64 67 74
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
5749,2 nmol/l12,3 nmol/l25,1 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
3 328 24 3 114 4 9
1 1
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 0 50 100
All Kits 57 6.84 43.2 49.5 58.4 87.0
Kit Classifications
3 28 14 13 350 2 47.9 61.9 75.8 0 0 1 04 91 2 35.4 43.3 51.2 0 1 0 04 245 23 6.84 44.5 51.0 61.0 87.0 1 13 2 14 246 6 42.5 50.4 58.2 0 2 4 04 247 18 33.4 40.1 45.6 51.1 54.0 0 10 7 05 111 2 8.02 36.4 64.8 1 0 0 0
Other Kits: 2 99(1),3 99(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 NBS2/18 -May 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
2 6 10 14 18 22 26 30 34 38 42 46 50 nmol/l
65 8
21
67
47
70
2
24
6
54
73
11
56
71
40
22
43
52
51
17
15
60
72
9
37
44
39
66
18
29
27
48
7
34
19
31
32
38
14
50
36
49
69
46
30
35
13
64
42
63
20
33
41
59
61 74 68
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
5718,3 nmol/l5,1 nmol/l28,0 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
44 42 12 2
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 0 10 20 30 40 50
All Kits 57 2.74 14.6 18.0 21.0 41.2
Kit Classifications
45 2 0 03 350 2 13.6 15.7 17.8 1 0 0 04 91 2 14.1 15.7 17.3 1 0 0 04 245 23 17.2 18.0 19.5 25.0 41.2 16 2 0 04 246 6 14.0 17.1 21.3 6 0 0 04 247 18 12.5 13.6 16.0 18.7 21.0 17 0 0 05 111 2 2.74 15.1 27.4 1 0 0 0
Other Kits: 2 99(1),3 99(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 NBS2/18 -May 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
6 26 46 66 86 106 126 146 166 186 206 226 246 µg/l
69 11 32
44
17
65
35
7
22
26
75
62
37
31
33
61
28
29
45
16
8
14
6
34
63
40
41
50
27
21
24
43
68
52
42
47
67
51
11
38
56
54 59
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
43131,7 µg/l15,5 µg/l11,8 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
1 112 7 528 2 3 22
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 50 100 150 200
All Kits 43 6.92 114 132 144 167
Kit Classifications
1 12 28 02 52 2 79.2 99.7 120 0 2 0 04 91 2 99.4 119 139 0 1 0 04 245 16 114 117 131 144 167 0 5 11 04 246 4 100 130 147 0 1 3 04 247 15 96.4 116 139 150 157 0 3 12 05 111 2 109 117 125 0 0 1 0
Other Kits: 3 99(1),3 350(1),The deviation of your result from the total median M M Muand from the median of the corresponding sub-collective (kit) Mu is: -40 % -20.56 %
Findings NBS2/18 -May 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
4 4,8 5,6 6,4 7,2 8 8,8 9,6 10,4 11,2 12 12,8 13,6 µg/l
7 44 50 37
16
27
11
34
41
67
75
45
24
68
59
17
35
38
56
28
29
51 21
6
31
33
22
26
42
14
32
52
47
54
40
63
8
43
61
65 11
62
69
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
437,3 µg/l1,5 µg/l20,6 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
40 38 11 1
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 5 10
All Kits 43 4.50 5.90 7.30 9.50 37.3
Kit Classifications
40 1 0 02 52 2 15.3 23.6 31.9 2 0 0 04 91 2 4.95 5.68 6.40 1 0 0 04 245 16 4.50 5.84 6.50 7.93 9.50 16 0 0 04 246 4 5.50 5.75 6.50 4 0 0 04 247 15 7.00 7.47 8.00 9.22 10.0 15 0 0 05 111 2 10.3 10.7 11.2 1 0 0 0
Other Kits: 3 99(1),3 350(1),The deviation of your result from the total median M M Muand from the median of the corresponding sub-collective (kit) Mu is: 110 % -35.17 %
Findings NBS2/18 -May 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
1 1,2 1,4 1,6 1,8 2 2,2 2,4 2,6 2,8 3 3,2 3,4 µg/l
50 38 75
42
43
33
54
40
41
22
52
76
59
63
31
35 37
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
171,4 µg/l0,1 µg/l11,6 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
14 141 1
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 0,5 1 1,5 2 2,5
All Kits 17 1.10 1.38 1.50 1.68 1.83
Kit Classifications
14 1 0 02 255 3 1.21 1.40 1.50 3 0 0 04 255 14 1.10 1.40 1.50 1.70 1.83 11 1 0 0
Other Kits:
Findings NBS2/18 -May 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
4 4,4 4,8 5,2 5,6 6 6,4 6,8 7,2 7,6 8 8,4 8,8 µg/l
50
42
33 41 75
63
31
43
76
22
52
35
40
54 59 37
38
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
174,7 µg/l0,4 µg/l8,6 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
1 17 1 67 7
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 2 4 6 8
All Kits 17 4.00 4.26 4.74 5.24 5.43
Kit Classifications
1 7 7 02 255 3 4.30 4.50 5.43 0 2 1 04 255 14 4.00 4.24 4.77 5.17 5.40 1 5 6 0
Other Kits:
Youden plots NBS2/18, Participant No 9900667, page 1 of 2
Analyte
Method
TSHall methods
success rate 88,4 % out of range 2
No of participants 69sample/unit A BmU/lmeanstandard deviationcoefficient of variation
6.92 40.11.40 5.6220.2 14.0
Sample A [mU/l]
2 4 6 8 10 12M Kit N Min 16.P 50.P 84.P Max
Alle 69 3.40 6.00 6.83 7.86 1543 99 3 6.44 7.41 1544 245 22 5.50 5.84 6.50 7.23 47.74 246 7 5.40 6.32 8.654 247 19 5.10 5.82 7.00 7.50 8.005 77 8 6.00 6.10 7.01 11.2 12.8
M Kit N Min 16.P 50.P 84.P Max
Sample B [mU/l]
20 40 60
Alle 69 8.20 34.4 39.3 45.4 56.43 99 3 8.20 35.2 42.84 245 22 15.7 32.2 37.5 40.3 50.64 246 7 32.0 35.3 42.34 247 19 31.2 35.3 39.3 44.1 49.05 77 8 30.6 33.9 41.8 51.5 56.4
Other kits (number):1-77(1), 2-02(1), > 2-99(1)<, 3-350(2), 4-91(2), 4-99(1), 5-111(2),
Analyte
Method
17-OH-progesteroneall methods
success rate 87,7 % out of range 0
No of participants 57sample/unit A Bnmol/lmeanstandard deviationcoefficient of variation
49.2 18.312.4 5.1525.2 28.1
Sample A [nmol/l]
0 50 100M Kit N Min 16.P 50.P 84.P Max
Alle 57 6.84 43.2 49.5 58.4 87.04 245 23 6.84 44.5 51.0 61.0 87.04 246 6 42.5 50.4 58.24 247 18 33.4 40.1 45.6 51.1 54.0
M Kit N Min 16.P 50.P 84.P Max
Sample B [nmol/l]
0 10 20 30 40 50
Alle 57 2.74 14.6 18.0 21.0 41.24 245 23 17.2 18.0 19.5 25.0 41.24 246 6 14.0 17.1 21.34 247 18 12.5 13.6 16.0 18.7 21.0
Other kits (number):> 2-99(1)<, 3-99(1), 3-350(2), 4-91(2), 4-99(1), 5-111(2), 6-99(1),
Youden plots NBS2/18, Participant No 9900667, page 2 of 2
Analyte
Method
IRTall methods
success rate 83,7 % out of range 3
No of participants 43sample/unit A Bµg/lmeanstandard deviationcoefficient of variation
132 7.3715.6 1.5211.8 20.7
Sample A [µg/l]
50 100 150 200M Kit N Min 16.P 50.P 84.P Max
Alle 43 6.92 114 132 144 1672 52 2 79.2 99.7 1204 91 2 99.4 119 1394 245 16 114 117 131 144 1674 246 4 100 130 1474 247 15 96.4 116 139 150 1575 111 2 109 117 125
M Kit N Min 16.P 50.P 84.P Max
Sample B [µg/l]
5 10
Alle 43 4.50 5.90 7.30 9.50 37.32 52 2 15.3 23.6 31.94 91 2 4.95 5.68 6.404 245 16 4.50 5.84 6.50 7.93 9.504 246 4 5.50 5.75 6.504 247 15 7.00 7.47 8.00 9.22 10.05 111 2 10.3 10.7 11.2The deviation of your results from the median of the corresponding sub-collective (kit) is:
A-20.56 %B-35.17 %
Other kits (number):3-99(1), 3-350(1),
