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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, 6. March 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: NBS1/18month: February 2018Participant-No: 9900667date of issue: 17.02.18
17-OH-progesterone (2)
This certificate is valid until the end of August 2018.
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.
Certificate
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/www
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tifica
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=990
0667
&rv_
id=NB
S_18
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uuid=
04F6
23F4
B899
4BC9
A1E6
36C1
4E1A
70B7 We confirm that you have participated in the survey for neonatal screening.
You have met the requirements of the survey for the following analytes:
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, 6. March 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: NBS1/18month: February 2018Participant-No: 9900667date of issue: 17.02.18
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: NBS1/18month: February 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 31.4 -1.25 50.2 35.1 65.3B 3.60 -2.04 9.30 6.51 12.1
17-OH-progesterone[nmol/l]
+ 2 A 66.9 0.23 62.5 43.7 81.3B 24.8 0.83 19.8 13.8 25.8
IRT[µg/l]
± 2 A 16.5 -1.16 25.4 17.7 33.1B 48.6 -1.00 69.4 48.5 90.3
Findings NBS1/18 -February 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
8 12 16 20 24 28 32 36 40 44 48 52 56 mU/l
1 2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
2222
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
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
6633,4 mU/l4,4 mU/l13,4 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
2 1 120 11 738 2 35 1
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 10 20 30 40 50
All Kits 66 8.93 27.9 33.3 39.2 69.9
Kit Classifications
2 20 38 02 99 2 31.4 50.2 69.0 1 0 1 03 350 2 33.9 38.3 42.7 0 0 1 04 99 2 27.6 31.2 34.8 0 1 1 04 245 20 25.1 27.3 30.5 34.1 39.6 0 4 16 04 246 8 25.2 25.8 32.2 37.0 37.7 0 5 3 04 247 16 8.93 30.0 33.4 35.2 39.0 1 5 10 05 77 8 30.2 32.9 40.3 41.6 41.9 0 4 4 05 111 2 35.7 39.2 42.7 0 0 1 0
Other Kits: 1 77(1),2 2(1),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: -5.5 % -37.45 %
Findings NBS1/18 -February 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
3 4 5 6 7 8 9 10 11 12 13 14 15 mU/l
2222 16 3 61 5 49 6
2
20
54
51
24
18
10
31
13
4
36
59
45
60
23
12
7
19
40
14
38
15
47
11
28
8
34
29
21
27
37
58
41
26
53
17
9
52
33
35
25
32
43
55
62
39
46
56
57
42
30
44
50
48 65
63
64
66
1
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
669,9 mU/l1,9 mU/l19,5 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
35 32 123 22 1
1 11 1
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 5 10 15
All Kits 66 3.60 8.72 10.2 11.7 29.7
Kit Classifications
35 23 1 12 99 2 3.60 9.30 15.0 2 0 0 03 350 2 10.3 13.2 16.1 0 1 0 04 99 2 9.80 10.3 10.8 1 1 0 04 245 20 8.00 8.91 10.1 10.6 12.1 12 8 0 04 246 8 6.10 6.54 10.3 11.4 11.8 5 3 0 04 247 16 8.60 9.02 10.1 11.9 29.7 7 8 1 05 77 8 4.60 5.53 9.05 10.6 10.9 8 0 0 05 111 2 11.1 13.3 15.4 0 1 0 0
Other Kits: 1 77(1),2 2(1),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: -64.53 % -61.29 %
Findings NBS1/18 -February 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
16 28 40 52 64 76 88 100 112 124 136 148 160 nmol/l
55 37
42
36
21
41
31
14
46
67
15
51
27
1
24
53
56
44
45
64
39
4
58
40
54
17
25
34
2222
57
18
68
38
69
8
9
59
60
70
23
16
62
11
63
28
12
61
3
33
10
5
50 71
66
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
5467,1 nmol/l11,2 nmol/l16,7 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
1 118 12 2 321 4 16
1 1
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 0 50 100
All Kits 54 16.8 56.4 66.5 76.1 96.2
Kit Classifications
1 18 21 13 350 2 43.0 53.2 63.4 0 0 1 04 245 22 64.8 66.0 70.6 85.1 96.2 0 9 6 14 246 6 56.7 69.8 87.5 0 1 5 04 247 16 44.5 50.0 58.4 65.4 69.5 0 7 8 05 111 2 56.5 65.3 74.1 1 0 0 0
Other Kits: 2 9(1),2 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 NBS1/18 -February 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
14 17 20 23 26 29 32 35 38 41 44 47 50 nmol/l
51 24
21
37
42
36
56
58
64
14
39
67
1
44
46
45
31
3
15
4
16
27
69
25
38
18
60
40
41
23
59
2222
57
54
33
61
34
10
8
28
68
66
70
12
11
17
5
53
9
50
62 71 63 55
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
5424,3 nmol/l5,8 nmol/l24,1 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
33 30 18 8
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 0 10 20 30 40 50
All Kits 54 14.8 19.9 23.7 28.9 89.7
Kit Classifications
34 8 0 03 350 2 17.3 18.7 20.0 1 0 0 04 245 22 19.7 23.0 26.4 29.4 38.0 12 5 0 04 246 6 20.7 23.6 29.1 5 1 0 04 247 16 16.0 17.9 21.0 22.5 24.5 13 2 0 05 111 2 21.4 37.2 53.0 1 0 0 0
Other Kits: 2 9(1),2 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 NBS1/18 -February 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
7 9 11 13 15 17 19 21 23 25 27 29 31 µg/l
4
2
47
29
40
19
28
10
5
50
14
27
35
55
53
3
1
33
17
72
18
20
15
31
36
8
25
41
21
38
11
57
45
24
39
44
46 2222 64 51 63 48 65
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
4311,5 µg/l4,8 µg/l41,9 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
39 38
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 5 10 15 20 25 30
All Kits 43 7.45 8.50 10.0 15.2 30.0
Kit Classifications
39 0 0 02 52 3 16.5 25.4 30.0 3 0 0 04 245 15 7.45 7.82 9.00 10.4 11.1 15 0 0 04 246 5 7.80 9.30 10.5 5 0 0 04 247 14 9.00 9.18 10.6 12.0 12.0 14 0 0 05 111 2 15.3 18.5 21.7 1 0 0 0
Other Kits: 2 9(1),3 247(1),3 350(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: 65 % -35.04 %
Findings NBS1/18 -February 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
16 22 28 34 40 46 52 58 64 70 76 82 88 µg/l
55 28
2
18
29
35
19
47
11
4
40
25
14
1
10
53
36
31
5
20
3
72
57
41
15
33
24
64
50
27
8
44
45
38
17
21
39
51
2222 46 63 48 65
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
4333,8 µg/l11,5 µg/l34,0 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
39 37 1
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 20 40 60 80
All Kits 43 16.2 26.2 30.3 42.8 72.0
Kit Classifications
39 0 0 02 52 3 48.6 69.4 72.0 3 0 0 04 245 15 24.0 24.4 27.1 32.4 37.6 15 0 0 04 246 5 26.7 29.8 34.0 5 0 0 04 247 14 28.0 28.3 31.5 37.5 43.0 14 0 0 05 111 2 54.0 57.2 60.4 1 0 0 0
Other Kits: 2 9(1),3 247(1),3 350(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: 60 % -29.97 %
Findings NBS1/18 -February 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 1,6 2,2 2,8 3,4 4 4,6 5,2 5,8 6,4 7 7,6 8,2 µg/l
14
15
31
38
53
44
5
57
28
25
36
33
18
24
72
73
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
161,8 µg/l0,1 µg/l7,7 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
11 111 11 1
Kit Evaluation for Sample A
M Kit N Min 16.P 50.P 84.P Max 0,7 1,4 2,1 2,8 3,5
All Kits 16 1.60 1.61 1.89 2.00 2.00
Kit Classifications
11 1 1 02 255 3 1.87 1.90 1.96 3 0 0 04 255 12 1.60 1.63 1.86 2.00 2.00 8 1 0 0
Other Kits: 4 247(1),
Findings NBS1/18 -February 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
2 2,6 3,2 3,8 4,4 5 5,6 6,2 6,8 7,4 8 8,6 9,2 µg/l
38
31
53
25
18
5
57
24
14
72
44
33
15
36
73
28
Descriptive Statistics Statistics of classifications Statistics of Implications, related to Classificationsnone new card plasma sample other
NXMSDCV
====
162,3 µg/l0,3 µg/l12,8 %
normalCH/AGS/CF possibleCH/AGS/CF evidentother
4 48 1 71 1
Kit Evaluation for Sample B
M Kit N Min 16.P 50.P 84.P Max 0,7 1,4 2,1 2,8
All Kits 16 2.00 2.10 2.40 2.73 3.10
Kit Classifications
4 8 1 02 255 3 2.14 2.24 3.10 1 2 0 04 255 12 2.00 2.09 2.40 2.68 2.80 3 6 0 0
Other Kits: 4 247(1),
Youden plots NBS1/18, Participant No 9900667, page 1 of 2
Analyte
Method
TSHall methods
success rate 90,9 % out of range 3
No of participants 66sample/unit A BmU/lmeanstandard deviationcoefficient of variation
33.4 9.944.49 1.9513.4 19.6
Sample A [mU/l]
10 20 30 40 50M Kit N Min 16.P 50.P 84.P Max
Alle 66 8.93 27.9 33.3 39.2 69.94 245 20 25.1 27.3 30.5 34.1 39.64 246 8 25.2 25.8 32.2 37.0 37.74 247 16 8.93 30.0 33.4 35.2 39.05 77 8 30.2 32.9 40.3 41.6 41.9
M Kit N Min 16.P 50.P 84.P Max
Sample B [mU/l]
5 10 15
Alle 66 3.60 8.72 10.2 11.7 29.74 245 20 8.00 8.91 10.1 10.6 12.14 246 8 6.10 6.54 10.3 11.4 11.84 247 16 8.60 9.02 10.1 11.9 29.75 77 8 4.60 5.53 9.05 10.6 10.9
Other kits (number):1-77(1), 2-02(1), 2-09(1), > 2-99(2)<, 3-99(1), 3-247(1), 3-350(2), 4-91(1), 4-99(2), 5-111(2),
Analyte
Method
17-OH-progesteroneall methods
success rate 90,7 % out of range 1
No of participants 54sample/unit A Bnmol/lmeanstandard deviationcoefficient of variation
67.2 24.311.2 5.8716.7 24.1
Sample A [nmol/l]
0 50 100M Kit N Min 16.P 50.P 84.P Max
Alle 54 16.8 56.4 66.5 76.1 96.24 245 22 64.8 66.0 70.6 85.1 96.24 246 6 56.7 69.8 87.54 247 16 44.5 50.0 58.4 65.4 69.5
M Kit N Min 16.P 50.P 84.P Max
Sample B [nmol/l]
0 10 20 30 40 50
Alle 54 14.8 19.9 23.7 28.9 89.74 245 22 19.7 23.0 26.4 29.4 38.04 246 6 20.7 23.6 29.14 247 16 16.0 17.9 21.0 22.5 24.5
Other kits (number):2-09(1), > 2-99(1)<, 3-247(1), 3-350(2), 4-91(1), 4-99(1), 5-111(2), 6-99(1),
Youden plots NBS1/18, Participant No 9900667, page 2 of 2
Analyte
Method
IRTall methods
success rate 88,3 % out of range 0
No of participants 43sample/unit A Bµg/lmeanstandard deviationcoefficient of variation
11.6 33.84.86 11.542.0 34.1
Sample A [µg/l]
5 10 15 20 25 30M Kit N Min 16.P 50.P 84.P Max
Alle 43 7.45 8.50 10.0 15.2 30.02 52 3 16.5 25.4 30.04 245 15 7.45 7.82 9.00 10.4 11.14 246 5 7.80 9.30 10.54 247 14 9.00 9.18 10.6 12.0 12.05 111 2 15.3 18.5 21.7
M Kit N Min 16.P 50.P 84.P Max
Sample B [µg/l]
20 40 60 80
Alle 43 16.2 26.2 30.3 42.8 72.02 52 3 48.6 69.4 72.04 245 15 24.0 24.4 27.1 32.4 37.64 246 5 26.7 29.8 34.04 247 14 28.0 28.3 31.5 37.5 43.05 111 2 54.0 57.2 60.4The deviation of your results from the median of the corresponding sub-collective (kit) is:
A-35.04 %B-29.97 %
Other kits (number):2-09(1), 3-247(1), 3-350(1), 4-91(1),
