CERTIFICATE OF CALIBRATION Aspartate aminotransferase (AST) Standardization laboratory Cert. 04-16 September 5 th, 2016 Measurement procedure: IFCC reference measurement procedure (Clin Chem Lab Med. 2002;40: 725-33) Measurements performed: 2016, August 31, September 1 and 2. Day 1 0.545 (0.008) 32.7 (0.49) Day 2 0.551 (0.008) 33.0 (0.50) 0.55 ± 0.014 33.0 ± 0.82 Day 3 0.554 (0.012) 33.2 (0.70) Day 1 1.707 (0.005) 102.4 (0.32) Day 2 1.715 (0.014) 102.9 (0.85) 1.707 ± 0.043 102.4 ± 2.56 Day 3 1.701 (0.015) 102.0 (0.76) EQAS Clinical Chemistry, Bio-Rad, lot# 211403 06 09, Cycle 15 exp. 2017-07-31 Day 1 3.607 (0.036) 216.4 (2.15) Day 2 3.581 (0.009) 214.9 (0.52) 3.593 ± 0.090 215.6 ± 5.39 Day 3 3.590 (0.019) 215.4 (1.15) EQAS Clinical Chemistry, Bio-Rad, lot# 211402 05 10, Cycle 15 exp. 2017-07-31 (*) Day 1 4.997 (0.020) 299.8 (1.21) Day 2 5.047 (0.051) 302.8 (3.07) 5.029 ± 0.126 301.7 ± 7.54 Day 3 5.042 (0.027) 302.5 (1.63) (*) measurements performed on sample diluted 1:2 with saline.
CERTIFICATE OF CALIBRATION Potassium Standardization laboratory Cert. 03-16 August 26 th, 2016 Measurement procedure: Flame emission photometry, bracketing technique Measurements performed: 2016, August 24, 25, 26 Day 1 1.90 (0.018) Day 2 1.91 (0.011) 1.91 ± 0.04 Day 3 1.90 (0.004) Day 1 3.00 (0.012) Day 2 2.98 (0.014) 2.98 ± 0.06 Day 3 2.95 (0.030) EQAS Clinical Chemistry, Bio-Rad, lot# 211403 06 09, Cycle 15 exp. 2017-07-31 Day 1 4.85 (0.025) Day 2 4.75 (0.018) 4.80 ± 0.10 Day 3 4.81 (0.029) EQAS Clinical Chemistry, Bio-Rad, lot# 211402 05 10, Cycle 15 exp. 2017-07-31 Day 1 6.29 (0.017) Day 2 6.21 (0.010) 6.25 ± 0.12 Day 3 6.25 (0.033)
CERTIFICATE OF CALIBRATION Lactate Dehydrogenase (LDH) Standardization laboratory Cert. 05-16 September 5 th, 2016 Measurement procedure: IFCC reference measurement procedure (Clin Chem Lab Med. 2002;40: 643-8) Measurements performed: 2016, August 31, September 1 and 2. Day 1 2.80 (0.036) 167.9 (2.15) Day 2 2.80 (0.014) 167.8 (0.84) 2.78 ± 0.083 166.9 ± 5.0 Day 3 2.75 (0.031) 165.0 (1.85) Day 1 6.00 (0.090) 359.8 (5.43) Day 2 6.01 (0.086) 360.8 (5.19) 5.97 ± 0.179 358.5 ± 10.8 Day 3 5.91 (0.021) 354.9 (1.24) EQAS Clinical Chemistry, Bio-Rad, lot# 211403 06 09, Cycle 15 exp. 2017-07-31 (*) Day 1 11.35 (0.104) 681.2 (6.26) Day 2 11.13 (0.068) 667.9 (4.06) 11.21 ± 0.336 672.5 ± 20.2 Day 3 11.14 (0.122) 668.4 (7.33) EQAS Clinical Chemistry, Bio-Rad, lot# 211402 05 10, Cycle 15 exp. 2017-07-31 (*) Day 1 15.31 (0.154) 918.6 (9.22) Day 2 15.38 (0.042) 923.0 (2.49) 15.32 ± 0.46 919.1 ± 27.6 Day 3 15.26 (0.245) 915.8 (14.7) (*) Measurements performed on samples diluted 1:2 with saline.
CERTIFICATE OF CALIBRATION Sodium Standardization laboratory Cert. 02-16 August 26 th, 2016 Measurement procedure: Flame emission photometry, bracketing technique Measurements performed: 2016, August 24, 25, 26 Day 1 125.4 (0.48) Day 2 126.2 (0.26) 125.3 ± 1.75 Day 3 124.5 (0.81) Day 1 133.6 (0.44) Day 2 133.5 (0.38) 133.6 ± 1.87 Day 3 133.7 (1.98) EQAS Clinical Chemistry, Bio-Rad, lot# 211403 06 09, Cycle 15 exp. 2017-07-31 Day 1 147.3 (1.07) Day 2 145.4 (0.67) 146.1 ± 2.04 Day 3 145.5 (1.27) EQAS Clinical Chemistry, Bio-Rad, lot# 211402 05 10, Cycle 15 exp. 2017-07-31 Day 1 157.1 (0.83) Day 2 153.6 (0.90) 155.3 ± 2.33 Day 3 155.1 (0.74)
Standardization laboratory Cholesterol Reference Method Laboratory Network Laboratory #504 Cert. 01-16 August 22 nd, 2016 CERTIFICATE OF CALIBRATION TOTAL CHOLESTEROL Measurement procedure: Abell Kendall method according to the CDC, Atlanta. Triplicate measurements in four different days. Measurements performed: 2016, August 1, 2, 3, 4 mg/dl mg/dl Day 1 93.1 (0.22) 2.41 (0.006) Day 2 91.9 (0.34) 2.38 (0.009) 92.2 ± 1.2 2.385 ± 0.031 Day 3 91.4 (0.24) 2.36 (0.006) Day 4 92.4 (0.61) 2.39 (0.016) mg/dl mg/dl Day 1 158.0 (0.39) 4.09 (0.010) Day 2 156.4 (0.80) 4.05 (0.021) 156.7 ± 2.0 4.054 ± 0.052 Day 3 156.4 (0.23) 4.05 (0.006) Day 4 156.1 (0.42) 4.04 (0.011) EQAS Clinical Chemistry, Bio-Rad, lot# 211403 06 09, Cycle 15 exp. 2017-07-31 mg/dl mg/dl Day 1 259.9 (0.48) 6.72 (0.013) Day 2 258.2 (0.25) 6.68 (0.007) 258.4 ± 3.1 6.682 ± 0.080 Day 3 257.6 (0.49) 6.66 (0.013) Day 4 257.7 (0.27) 6.66 (0.007) EQAS Clinical Chemistry, Bio-Rad, lot# 211402 05 10, Cycle 15 exp. 2017-07-31 mg/dl mg/dl Day 1 342.9 (0.67) 8.87 (0.017) Day 2 340.6 (0.57) 8.81 (0.015) 341.3 ± 3.75 8.827 ± 0.097 Day 3 340.5 (1.07) 8.81 (0.028) Day 4 341.2 (0.50) 8.82 (0.013)
Kalibrierlaboratorium I, Bonn, für klinisch-chemische Messgrößen Calibration laboratory I, Bonn, for clinical chemical quantities akkreditiert durch die / accredited by the Deutsche Akkreditierungsstelle GmbH als Kalibrierlaboratorium im / as calibration laboratory in the Deutschen Kalibrierdienst Kalibrierschein Kalibrierzeichen 1856 D-K- 15117-01-00 Calibration Certificate Calibration mark 2016-06 Gegenstand / Object Messgröße / Measurand Hersteller / Manufacturer Bezeichnung, Lot-Nr. Level 1 Auftraggeber / Customer Auftragsnummer / Order No. Anzahl der Seiten des Kalibrierscheins Number of pages of the certificate 2 Serum, lyophilized Creatinine in serum 211404; 211407; 211411 Bio-Rad RL1 2016/8 Dieser Kalibrierschein dokumentiert die Rückführung auf nationale Normale zur Darstellung der Einheiten in Übereinstimmung mit dem Internationalen Einheitensystem (SI). Die DAkkS ist Unterzeichner der multilateralen Übereinkommen der European co-operation for Accreditation (EA) und der International Laboratory Accreditation Cooperation (ILAC) zur gegenseitigen Anerkennung der Kalibrierscheine. Für die Einhaltung einer angemessenen Frist zur Wiederholung der Kalibrierung ist der Benutzer verantwortlich. This calibration certificate documents the traceability to national standards, which realize the units of measurement according to the International System of Units (SI). The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of the International Laboratory Accreditation Cooperation (ILAC) for the mutual recognition of calibration certificates. Datum der Kalibrierung Date of calibration 06-08-16 The user is obliged to have the object recalibrated at appropriate intervals. Dieser Kalibrierschein darf nur vollständig und unverändert weiterverbreitet werden. Auszüge oder Änderungen bedürfen der Genehmigung sowohl der Deutschen Akkreditierungsstelle als auch des ausstellenden Kalibrierlaboratoriums. Kalibrierscheine ohne Unterschrift haben keine Gültigkeit. This calibration certificate may not be reproduced other than in full except with the permission of both the German Accreditation Body and the issuing laboratory. Calibration certificates without signature are not valid. Datum Leiter des Kalibrierlaboratoriums Bearbeiter Date Head of the calibration laboratory Person in charge 06-08-16 Dr. C. Ritter-Sket J. Westhues Referenzinstitut für Bioanalytik - Friesdorfer Straße 153-53175 Bonn
Seite 1856 Page 2 D-K- 15117-01-00 2016-06 Description: Measurand: Calibration procedure: The object of calibration is Serum, lyophilized Concentration of Creatinine in serum Determination of the concentration of Creatinin im Serum by Isoptope dilution mass spectrometry (IDMS) Options of measurement: All values are referring to the temperature of 20 C. Results: Concentration of Creatinin im Serum Date 1. Value 2. Value 30.05.2016 (Vial 7) 314.7 317.8 01.06.2016 (Vial 11) 315.8 319.0 03.06.2016 (Vial 4) 314.9 319.3 07.06.2016 (Vial 7) 312.8 315.3 Reference procedure value: 316.2 Expanded uncertainty: 3.162 Relative expanded uncertainty: 1.0 % Coverate factor k: Effective degrees of freedom v(eff): 2.4 7 The uncertainty stated is the expanded uncertainty obtained by multiplying the standard uncertainty by the coverage factor k. At a t-distribution with v(eff) effective degrees of freedom the value of the measurand lies within the assigned range of values with a probabilityy of 95 %. It has been determined in accordance with DAkkS-DKD-3. The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of the International Laboratory Accreditatoin Cooperation (ILAC) for the mutual recognition of calibration certificates. The other signatories in and outside Europe can be seen on the Website of EA (www.european-accreditation.org) and ILAC (www.ilac.org). Referenzinstitut für Bioanalytik - Friesdorfer Straße 153-53175 Bonn
Kalibrierlaboratorium I, Bonn, für klinisch-chemische Messgrößen Calibration laboratory I, Bonn, for clinical chemical quantities akkreditiert durch die / accredited by the Deutsche Akkreditierungsstelle GmbH als Kalibrierlaboratorium im / as calibration laboratory in the Deutschen Kalibrierdienst Kalibrierschein Kalibrierzeichen 1857 D-K- 15117-01-00 Calibration Certificate Calibration mark 2016-06 Gegenstand / Object Messgröße / Measurand Hersteller / Manufacturer Bezeichnung, Lot-Nr. Level 4 Auftraggeber / Customer Auftragsnummer / Order No. Anzahl der Seiten des Kalibrierscheins Number of pages of the certificate 2 Serum, lyophilized Creatinine in serum 211402; 211405; 211410 Bio-Rad RL1 2016/8 Dieser Kalibrierschein dokumentiert die Rückführung auf nationale Normale zur Darstellung der Einheiten in Übereinstimmung mit dem Internationalen Einheitensystem (SI). Die DAkkS ist Unterzeichner der multilateralen Übereinkommen der European co-operation for Accreditation (EA) und der International Laboratory Accreditation Cooperation (ILAC) zur gegenseitigen Anerkennung der Kalibrierscheine. Für die Einhaltung einer angemessenen Frist zur Wiederholung der Kalibrierung ist der Benutzer verantwortlich. This calibration certificate documents the traceability to national standards, which realize the units of measurement according to the International System of Units (SI). The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of the International Laboratory Accreditation Cooperation (ILAC) for the mutual recognition of calibration certificates. Datum der Kalibrierung Date of calibration 06-08-16 The user is obliged to have the object recalibrated at appropriate intervals. Dieser Kalibrierschein darf nur vollständig und unverändert weiterverbreitet werden. Auszüge oder Änderungen bedürfen der Genehmigung sowohl der Deutschen Akkreditierungsstelle als auch des ausstellenden Kalibrierlaboratoriums. Kalibrierscheine ohne Unterschrift haben keine Gültigkeit. This calibration certificate may not be reproduced other than in full except with the permission of both the German Accreditation Body and the issuing laboratory. Calibration certificates without signature are not valid. Datum Leiter des Kalibrierlaboratoriums Bearbeiter Date Head of the calibration laboratory Person in charge 06-08-16 Dr. C. Ritter-Sket J. Westhues Referenzinstitut für Bioanalytik - Friesdorfer Straße 153-53175 Bonn
Seite 1857 Page 2 D-K- 15117-01-00 2016-06 Description: Measurand: Calibration procedure: The object of calibration is Serum, lyophilized Concentration of Creatinine in serum Determination of the concentration of Creatinin im Serum by Isoptope dilution mass spectrometry (IDMS) Options of measurement: All values are referring to the temperature of 20 C. Results: Concentration of Creatinin im Serum Date 1. Value 2. Value 30.05.2016 (Vial 2) 83.39 82.04 01.06.2016 (Vial 5) 82.54 82.80 03.06.2016 (Vial 10) 83.18 84.04 07.06.2016 (Vial 2) 84.01 82.76 Reference procedure value: 83.10 Expanded uncertainty: 0.831 Relative expanded uncertainty: 1.0 % Coverate factor k: Effective degrees of freedom v(eff): 2.4 7 The uncertainty stated is the expanded uncertainty obtained by multiplying the standard uncertainty by the coverage factor k. At a t-distribution with v(eff) effective degrees of freedom the value of the measurand lies within the assigned range of values with a probabilityy of 95 %. It has been determined in accordance with DAkkS-DKD-3. The DAkkS is signatory to the multilateral agreements of the European co-operation for Accreditation (EA) and of the International Laboratory Accreditatoin Cooperation (ILAC) for the mutual recognition of calibration certificates. The other signatories in and outside Europe can be seen on the Website of EA (www.european-accreditation.org) and ILAC (www.ilac.org). Referenzinstitut für Bioanalytik - Friesdorfer Straße 153-53175 Bonn