Reference laboratories and methods

Kessler A, Siekmann L, Weykamp C , Geilenkeuser WJ , Dreazen O, Jonathan Middle J, Schumann G. The IFCC external quality assessment scheme for reference laboratories – review of 8 years’ experience. Clin Chem Lab Med. 2013;51: 997-1005 https://doe.org/10.1515/cclm-2012-0722

Siekmann L. Requirements for reference (calibration) laboratories in laboratory medicine. Clin Biochem Rev 2007; 28: 149-54 https://pubmed.ncbi.nlm.nih.gov/18392129/

Bais R , Armbruster D , Jansen RTP, Klee G, Panteghini M, Passarelli J, Sikaris KA. Defining acceptable limits for the metrological traceability of specific measurands. Clin Chem Lab Med. 2013; 51: 973-979 https://doi.org/10.1515/cclm-2013-0122

Belyus, P. S., Burgess, T. E., & Walsh, P. R. (1986). Quality assurance in a large reference laboratory. Clin Lab Med, 6(4), 745-754. http://www.ncbi.nlm.nih.gov/pubmed/3791912 

Bennett, S. T., Eckfeldt, J. H., Belcher, J. D., & Connelly, D. P. (1992). Certification of Cholesterol Measurements by the National Reference Method Laboratory Network with Routine Clinical Specimens - Effects of Network Laboratory Bias and Imprecision. Clin Chem, 38(5), 651-657. http://clinchem.aaccjnls.org/content/clinchem/38/5/651.full.pdf 

Burnett, R. W. (2001). IFCC Reference Measurement Procedure for Substance Concentration Determination of Total Carbon Dioxide in Blood, Plasma or Serum. International Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med, 39(3), 283-288. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11350028 

Büttner, J. (1994). Reference materials and reference methods in laboratory medicine. A challenge to international cooperation. Eur. J. Clin. Chem. Clin. Biochem., 32, 571-577 https://pubmed.ncbi.nlm.nih.gov/7819427/  

Cali, J. P. (1979). Role of Reference Materials in the Analytical Laboratory. Fresenius Zeitschrift Fur Analytische Chemie, 297(1), 1-3. https://doi.org/10.1007/Bf00487739  

Centers for Disease, C., & Prevention. (1994). Clinical laboratory measurements traceable to the National Reference System for Cholesterol. MMWR Morb Mortal Wkly Rep, 43(8), 149-151. http://www.ncbi.nlm.nih.gov/pubmed/8309465 

D'Angelo, A. (1995). Reference materials and reference measurement systems in laboratory medicine. Prothrombin time standardization: the problem of the control plasma. Eur J Clin Chem Clin Biochem, 33(12), 1019-1022. https://www.ncbi.nlm.nih.gov/pubmed/8845419 

Deming, S. N. (1991). Proficiency testing of clinical chemistry laboratories: the role of the reference laboratory. Clin Chem, 37(4), 483. http://www.ncbi.nlm.nih.gov/pubmed/2015658 

Dybkaer, R. (1995). Reference materials and reference measurement systems in laboratory medicine. Harmonization of nomenclature and definitions in reference measurement systems. Eur J Clin Chem Clin Biochem, 33(12), 995-998. http://www.ncbi.nlm.nih.gov/pubmed/8845435 

Dybkaer, R. (2001a). Metrology in laboratory medicine - Reference measurement systems. Accred Qual Assur, 6(1), 16-19. https://doi.org/10.1007/Pl00010430 

Dybkaer, R. (2001b). Metrology in laboratory medicine - Reference measurement systems. Accreditation and Quality Assurance, 6(1), 16-19. https://doi.org/10.1007/Pl00010430 

Ellison, S. L. R., Burke, S., Walker, R. F., Heydorn, K., Mansson, M., Pauwels, J., Wegscheider, W., & Nijenhuis, B. T. (2001). Uncertainty for reference materials certified by interlaboratory study: Recommendations of an international study group. Accreditation and Quality Assurance, 6(6), 274-277. https://doi.org/10.1007/s007690100341 

Fuentes-Arderiu, X., & Rigo-Bonnin, R. (2012). Metrological reference values for estimating measurement bias in clinical laboratory sciences. Accred Qual Assur, 17, 549-551 https://link.springer.com/article/10.1007/s00769-012-0891-5

Helander, A., Wielders, J. P., Jeppsson, J. O., Weykamp, C., Siebelder, C., Anton, R. F., Schellenberg, F., Whitfield, J. B., & Transferrin, I. W. G. o. S. o. C.-D. (2010). Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: II. Performance of a laboratory network running the HPLC candidate reference measurement procedure and evaluation of a candidate reference material. Clin Chem Lab Med, 48(11), 1585-1592. https://doi.org/10.1515/CCLM.2010.322 

Hibbert, D. B., & Westwood, S. (2003). The external review committee on pure reference materials at the National Analytical Reference Laboratory. Accreditation and Quality Assurance, 8(9), 434-435. https://doi.org/10.1007/s00769-003-0641-9 

Hoffmann, R. G., Waid, M. E., & Henry, J. B. (1961). Clinical specimens and reference samples for the quality control of laboratory accuracy. Am J Med Technol, 27, 309-317. https://www.ncbi.nlm.nih.gov/pubmed/13908141 

IFCC. (2008). IFCC External Quality Assessment Scheme for Reference (calibration) Laboratories in Laboratory Medicine (RELA). http://www .dgkl-rfb.de:81/IFCC_EQAS_ProcManual.pdf 

International Federation of Clinical, C., Laboratory Medicine Working Group for Standardization of Thyroid Function, T., Van Houcke, S. K., Van Uytfanghe, K., Shimizu, E., Tani, W., Umemoto, M., & Thienpont, L. M. (2011). IFCC international conventional reference procedure for the measurement of free thyroxine in serum: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group for Standardization of Thyroid Function Tests (WG-STFT)(1). Clin Chem Lab Med, 49(8), 1275-1281. https://doi.org/10.1515/CCLM.2011.639 

Jackson, C. M., White, G. C., 2nd, Barrowcliffe, T., Esnouf, M. P., Jespersen, J., Kluft, C., Lenahan, J., Joint Committee of the, I. S. D., the, I. S., & Standardization, C. (2002). A reference system approach to future standardization of laboratory tests for hemostasis. A position paper of the Joint Committee of the IFCC Scientific Division and the ISTH Scientific and Standardization Committee. Thromb Haemost, 87(1), 165-169. https://www.ncbi.nlm.nih.gov/pubmed/11848447 

Jackson, C. M., White, G. C., Barrowcliffe, T., Esnouf, M. P., Jespersen, J., Kluft, C., Lenahan, J., & Standar, C. I. S. D. I. S. (2002). A reference system approach to future standardization of laboratory tests for hemostasis. Thrombosis and Haemostasis, 87(1), 165-169 https://pubmed.ncbi.nlm.nih.gov/11848447  

Johnson, A. M. (1995). Reference materials and reference measurement systems in laboratory medicine. Transfer of values to reference materials. Eur J Clin Chem Clin Biochem, 33(12), 1009-1011. http://www.ncbi.nlm.nih.gov/pubmed/8845417 

Johnson, A. M. (2010). Necessity for high-quality reference materials in the harmonization of laboratory assays. Clin Chem Lab Med, 48(6), 747-748. https://doi.org/10.1515/CCLM.2010.180 

Kimberly, M. M. (2004). Reference material needs in clinical laboratory science. Accreditation and Quality Assurance, 9(4-5), 239-241. https://doi.org/10.1007/s00769-004-0765-6 

Kimberly, M. M., Leary, E. T., Cole, T. G., & Waymack, P. P. (1999). Selection, validation, standardization, and performance of a designated comparison method for HDL-cholesterol for use in the cholesterol reference method laboratory network. Clin Chem, 45(10), 1803-1812. https://www.ncbi.nlm.nih.gov/pubmed/10508128

Kimberly, M. M., Myers, G. L., & Little, R. R. (2004). Clinical laboratory reference networks. Accreditation and Quality Assurance, 9(1-2), 18-23. https://doi.org/10.1007/s00769-003-0701-1 

Lasky, F. (1992). Proficiency testing linked to the national reference system for the clinical laboratory: a proposal for achieving accuracy. Clin Chem, 38, 1260-1267 https://pubmed.ncbi.nlm.nih.gov/1623591/  

Lee, J. I., Kim, J. Y., Choi, J. Y., Kim, H. K., Jang, H. W., Hur, K. Y., Kim, J. H., Kim, K. W., Chung, J. H., & Kim, S. W. (2010). Differences in serum thyroglobulin measurements by 3 commercial immunoradiometric assay kits and laboratory standardization using Certified Reference Material 457 (CRM-457). Head Neck, 32(9), 1161-1166. https://doi.org/10.1002/hed.21308 

Loeliger, E. A., & van Halem-Visser, L. P. (1979). Results of calibration by the Dutch National Reference Laboratory of the thromboplastins included in the ICTH/ICSH collaborative study of prothrombin time standardization. Thromb Haemost, 42(4), 1128-1131. https://www.ncbi.nlm.nih.gov/pubmed/542925 

Margolis, S. A., Vangel, M., & Duewer, D. L. (2003). Certification of standard reference material 970, ascorbic acid in serum, and analysis of associated interlaboratory bias in the measurement process. Clin Chem, 49(3), 463-469. https://doi.org/10.1373/49.3.463 

McQueen, M. J., Roberts, H. R., & Siest, G. (1995a). Reference Materials and Reference Measurement Systems in Laboratory Medicine - A major international meeting organized by the International Federation of Clinical Chemistry (IFCC), Geneva, October 5-7, 1994 - Introduction. European Journal of Clinical Chemistry and Clinical Biochemistry, 33(12), 977-979 https://pubmed.ncbi.nlm.nih.gov/8845431/

McQueen, M. J., Roberts, H. R., & Siest, G. (1995b). Reference materials and reference measurement systems in laboratory medicine--a major international meeting organized by the International Federation of Clinical Chemistry (IFCC), Geneva, October 5-7, 1994. Eur J Clin Chem Clin Biochem, 33(12), 977-979. http://www.ncbi.nlm.nih.gov/pubmed/8845431 

Moss, D. W., & Whicher, J. T. (1995). Reference materials and reference measurement systems in laboratory medicine. Commutability and the problem of method-dependent results. Eur J Clin Chem Clin Biochem, 33(12), 1003-1007. http://www.ncbi.nlm.nih.gov/pubmed/8845416 

Muller, M. M. (2000). Implementation of reference systems in laboratory medicine. Clin Chem, 46(12), 1907-1909 https://pubmed.ncbi.nlm.nih.gov/11106321/  

Nakamura, M., Iso, H., Kitamura, A., Imano, H., Kiyama, M., Yokoyama, S., Kayamori, Y., Koyama, I., Nishimura, K., Nakai, M., Dasti, M., Vesper, H. W., Teramoto, T., & Miyamoto, Y. (2015). Total cholesterol performance of Abell-Levy-Brodie-Kendall reference measurement procedure: Certification of Japanese in-vitro diagnostic assay manufacturers through CDC's Cholesterol Reference Method Laboratory Network. Clin Chim Acta, 445, 127-132. https://doi.org/10.1016/j.cca.2015.03.026 

Phillips, S., Setford, S. J., Shearer, D. M., Smith, A., & Ross, J. N. (2020). Precision Evaluation of Clinical Laboratory Glucose Reference Systems. Diabetes, 69. https://doi.org/10.2337/db20-916-P 

Ross, J. W., Miller, G., Myers, G. L., & Praestgaard, J. (1998). The accuracy of laboratory measurements in clinical chemistry - A study of 11 routine chemistry analytes in the College of American Pathologists Chemistry Survey with fresh frozen serum, definitive methods, and reference methods. Arch Pathol Lab Med, 122(7), 587-608 https://pubmed.ncbi.nlm.nih.gov/9674541/  

Schiele, F., Muller, J., Colinet, E., Siest, G., Arzoglou, P., Brettschneider, H., Calam, D. H., Ceriotti, F., Ferard, G., Frei, J., & et al. (1992). Interlaboratory study of the IFCC method for alanine aminotransferase performed with use of a partly purified reference material. Clin Chem, 38(12), 2365-2371. https://www.ncbi.nlm.nih.gov/pubmed/1458569 

Schumann, G., Bonora, R., Ceriotti, F., Ferard, G., Ferrero, C. A., Franck, P. F., Gella, F. J., Hoelzel, W., Jorgensen, P. J., Kanno, T., Kessner, A., Klauke, R., Kristiansen, N., Lessinger, J. M., Linsinger, T. P., Misaki, H., Panteghini, M., Pauwels, J., Schiele, F., . . . Laboratory, M. (2002). IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C. International Federation of Clinical Chemistry and Laboratory Medicine. Part 6. Reference procedure for the measurement of catalytic concentration of gamma-glutamyltransferase. Clin Chem Lab Med, 40(7), 734-738. https://doi.org/10.1515/CCLM.2002.126 

Siekmann, L. (2006). Networks of reference measurement laboratories in laboratory medicine - activities of the Joint Committee on Traceability (JCTLM, WG-2). Accreditation and Quality Assurance, 11(5), 224-230. https://doi.org/10.1007/s00769-006-0120-1 

Siekmann, L. (2007). Requirements for reference (calibration) laboratories in laboratory medicine. Clin Biochem Rev, 28(4), 149-154. https://www.ncbi.nlm.nih.gov/pubmed/18392129 

Siekmann, L., Doumas, B. T., Thienpont, L., & Schumann, G. (1995). Reference materials and reference measurement systems in laboratory medicine. Networks of Reference Laboratories. Eur J Clin Chem Clin Biochem, 33(12), 1013-1017. http://www.ncbi.nlm.nih.gov/pubmed/8845418 

Stamm, D. (1982). A new concept for quality control of clinical laboratory investigations in the light of clinical requirements and based on reference method values. J Clin Chem Clin Biochem, 20, 817-824 https://doi.org/10.1515/cclm.1982.20.11.817  

Tate, J. R., Berg, K., Couderc, R., Dati, F., Kostner, G. M., Marcovina, S. M., Rifai, N., Sakurabayashi, I., & Steinmetz, A. (1999). International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Standardization Project for the Measurement of Lipoprotein(a). Phase 2: selection and properties of a proposed secondary reference material for lipoprotein(a). Clin Chem Lab Med, 37(10), 949-958. https://doi.org/10.1515/CCLM.1999.140 

Thorpe, S. M., & Koenders, A. (1986). Standardization of steroid receptor assays in human breast cancer--III. Selection of reference material for intra- and inter-laboratory quality control. Eur J Cancer Clin Oncol, 22(8), 939-944. https://www.ncbi.nlm.nih.gov/pubmed/3770051

Uldall, A. (1984). Apparent Interlaboratory Variation Using Different Types of Reference Sera. Scandinavian Journal of Clinical & Laboratory Investigation, 44, 163-171 https://pubmed.ncbi.nlm.nih.gov/6599517/  

van den Besselaar, A. M., Hermans, J., van der Velde, E. A., Bussemaker-Verduyn den Boer, E., van Halem-Visser, L. P., Jansen-Gruter, R., & Loeliger, E. A. (1986). The calibration of rabbit tissue thromboplastins: experience of the Dutch Reference Laboratory for anticoagulant control. Journal of Biological Standardization, 14(4), 305-317. https://www.ncbi.nlm.nih.gov/pubmed/3558415 

van den Besselaar, A. M., van Halem-Visser, L. P., Hoekstra-Schuman, M., van der Marel-van Nieuwkoop, W., & Loeliger, E. A. (1980). Simplified thromboplastin calibration. Further experience of the Dutch Reference Laboratory for Anticoagulant Control. Thromb Haemost, 43(1), 53-57. https://www.ncbi.nlm.nih.gov/pubmed/7404478 

Wetzel, H. (1995). Reference materials and reference measurement systems in laboratory medicine. Transportation of reference material. Eur J Clin Chem Clin Biochem, 33(12), 993-994. http://www.ncbi.nlm.nih.gov/pubmed/8845434 

Xia, C., Tong, Q., Wang, Q., Tang, Z., Qi, L., Chi, S., Zhang, M., Wang, X., Li, H., & Xu, G. (2010). Application of five frozen human-pooled serum samples assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference procedure in a traceability investigation of gamma-glutamyltransferase catalytic concentration measurements in China. Ann Clin Biochem, 47(Pt 3), 189-194. https://doi.org/10.1258/acb.2009.009210

Zhang, R., & Wang, Q. T. (2020). Comparability of four clinical laboratory measurement methods for GGT and commutability of candidate reference materials. Journal of clinical laboratory analysis. https://doi.org/ARTN e2355710.1002/jcla.23557