Analytical performance specifications

Antonsen, S., Petersen, P. H., & Fraser, C. G. (1993). Medical need for quality specifications in clinical laboratories. Quality specifications for detection limit. Ups J Med Sci, 98(3), 317-321. http://www.ncbi.nlm.nih.gov/pubmed/7974861 

Aslan, D. (1999). Charts of operational process specifications (OPSpec charts): Quality-planning tools for analytical and medical needs. Accred. Qual. Assur., 4, 416-418. https://doi.org/10.1007/s007690050399

Boyd, J. C., & Bruns, D. E. (2001). Quality specifications for glucose meters: Assessment by simulation modeling of errors in insulin dose. Clin Chem, 47(2), 209-214. https://academic.oup.com/clinchem/article/47/2/209/5639095

Braga, F., & Panteghini, M. (2020). Derivation of performance specifications for uncertainty of serum C-reactive protein measurement according to the Milan model 3 (state of the art). Clinical Chemistry and Laboratory Medicine, 58(11), E263-E265. https://doi.org/10.1515/cclm-2020-0532 

Braga, F., & Panteghini, M. (2021). Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models. Clin Chem Lab Med, 59(8), 1362-1368. https://doi.org/10.1515/cclm-2021-0170 

Cattozzo, G., Albeni, C., Calonaci, A., & De Luca, G. (2011). Evaluation of the analytical performance of the Beckman Coulter AU680 automated analytical system based on quality specifications for allowable performance derived from biological variation. Clin Chem Lab Med, 49(9), 1563-1567. https://doi.org/10.1515/CCLM.2011.629 

Cavalier, E., Fraser, C. G., Bhattoa, H. P., Heijboer, A. C., Makris, K., Ulmer, C. Z., Vesper, H. W., Vasikaran, S., Lukas, P., Delanaye, P., Carobene, A., & Metab, I.-I. C. B. (2021). Analytical Performance Specifications for 25-Hydroxyvitamin D Examinations. Nutrients, 13(2). https://doi.org/ARTN 43110.3390/nu13020431 

Ceriotti, F., Fernandez-Calle, P., Klee, G. G., Nordin, G., Sandberg, S., Streichert, T., Vives-Corrons, J. L., & Panteghini, M. (2017). Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference. Clin Chem Lab Med, 55(2), 189-194. https://doi.org/10.1515/cclm-2016-0091 

Ceriotti, F., Fernandez-Calle, P., Klee, G. G., Nordin, G., Sandberg, S., Streichert, T., Vives-Corrons, J. L., Panteghini, M., Task, E., & Finish Group on Allocation of laboratory tests to different models for performance, s. (2016). Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2016-0091 

Clouet-Foraison, N., Marcovina, S. M., Guerra, E., Aarsand, A. K., Coskun, A., Diaz-Garzon, J., Fernandez-Calle, P., Sandberg, S., Ceriotti, F., Carobene, A., & Chem, E. F. C. (2020). Analytical Performance Specifications for Lipoprotein(a), Apolipoprotein B-100, and Apolipoprotein A-I Using the Biological Variation Model in the EuBIVAS Population. Clin Chem, 66(5), 727-736. https://doi.org/10.1093/clinchem/hvaa054 

Dalenberg, D. A., Schryver, P. G., & Klee, G. G. (2013). Analytical performance specifications: relating laboratory performance to quality required for intended clinical use. Clin Lab Med, 33(1), 55-73. https://doi.org/10.1016/j.cll.2012.11.005 

Dallas Jones, G. R. (2015). Analytical performance specifications for EQA schemes - need for harmonisation. Clin Chem Lab Med, 53(6), 919-924. https://doi.org/10.1515/cclm-2014-1268 

de Verdier, C.-H., & Groth, T. (1994). Desirable analytical quality specifications for clinical chemistry laboratories. Clin. Chem., 40, 168-169. https://doi.org/10.1093/clinchem/40.1.168  

de Verdier, C. H., Groth, T., & Hyltoft Petersen, P. (1993). Medical need for quality specifications--a NORDKEM project for selecting the appropriate quality in clinical laboratories. Scand J Clin Lab Invest, 215, 29-37. https://doi.org/10.3109/00365519309090695 

Dewenter, H., Heitmann, K. U., Treinat, L., & Thun, S. (2014). Effective ways for the transmission of infection prevention data according to German legal specifications via the medical terminology SNOMED CT used with HL7 CDA templates. Stud Health Technol Inform, 205, 1033-1037. https://www.ncbi.nlm.nih.gov/pubmed/25160345

Dybkaer, R. (1993). Medical need for quality specifications in clinical laboratories. Truth, accuracy, error and uncertainty. Ups J Med Sci, 98(3), 215-220. http://www.ncbi.nlm.nih.gov/pubmed/7974852 

Dybkaer, R. (1999). Setting quality specifications for the future with newer approaches to defining uncertainty in laboratory medicine. Scand J Clin Lab Invest, 59(7), 579-583. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10667703 

Fallest-Strobl, P. C., Olafsdottir, E., Wiebe, D. A., & Westgard, J. O. (1997). Comparison of NCEP performance specifications for triglycerides, HDL-, and LDL-cholesterol with operating specifications based on NCEP clinical and analytical goals. Clin Chem, 43(11), 2164-2168. https://www.ncbi.nlm.nih.gov/pubmed/9365403

Fasce, C. F., Jr., Rej, R., Copeland, W. H., & Vanderlinde, R. E. (1973). A discussion of enzyme reference materials: applications and specifications. Clin Chem, 19(1), 5-9. https://www.ncbi.nlm.nih.gov/pubmed/4683368 

Fraser, C. G. (1990). Quality specifications in laboratory medicine. Ups J Med Sci, 95(3), 229-232. http://www.ncbi.nlm.nih.gov/pubmed/2100399 

Fraser, C. G. (1993). Databases for facilitating work on setting quality specifications: biological variation. Ups J Med Sci, 98(3), 415-416. http://www.ncbi.nlm.nih.gov/pubmed/7974875 

Fraser, C. G. (1999a). General strategies to set quality specifications for reliability performance characteristics. Scand J Clin Lab Invest, 59(7), 487-490. http://www.ncbi.nlm.nih.gov/pubmed/10667685

Fraser, C. G. (1999b). Quality specifications in laboratory medicine - current consensus view. Accred. Qual. Assur., 4, 410-413. https://doi.org/10.1007/s007690050397

Fraser, C. G. (1999c). Quality specifications in laboratory medicine - current consensus views. Accreditation and Quality Assurance, 4(9-10), 410-413. https://doi.org/10.1007/s007690050397 

Fraser, C. G. (2005). Quality specifications for imprecision of B-type natriuretic peptide assays. Clin Chem, 51(7), 1307-1309. https://doi.org/10.1373/clinchem.2005.050393 

Fraser, C. G. (2015). The 1999 Stockholm Consensus Conference on quality specifications in laboratory medicine. Clin Chem Lab Med, 53(6), 837-840. https://doi.org/10.1515/cclm-2014-0914 

Fraser, C. G., Kallner, A., Kenny, D., & Petersen, P. H. (1999). Introduction: strategies to set global quality specifications in laboratory medicine. Scand J Clin Lab Invest, 59(7), 477-478. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10667682 

Fraser, C. G., & Petersen, P. H. (1999). Analytical performance characteristics should be judged against objective quality specifications. Clin Chem, 45(3), 321-323. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10053031 

Fraser, C. G., Petersen, P. H., Ricos, C., & Haeckel, R. (1992). Proposed quality specifications for the imprecision and inaccuracy of analytical systems for clinical chemistry. Eur J Clin Chem Clin Biochem, 30(5), 311-317. http://www.ncbi.nlm.nih.gov/pubmed/1627730 

Glibert, B., Bourleaux, V., Peeters, R., Reynolds, T., & Vranken, G. (2016). Analytical Performance Verification of the Beckman Coulter AU5800 Clinical Chemistry Analyser Against Recognized Quality Specifications Reveals Relevance of Method Harmonization. Clin Lab, 62(1-2), 57-72. https://www.ncbi.nlm.nih.gov/pubmed/27012034 

Goldschmidt, H. M. (1999). Postanalytical factors and their influence on analytical quality specifications. Scand J Clin Lab Invest, 59(7), 551-554. http://www.ncbi.nlm.nih.gov/pubmed/10667697 

Groth, T. (1999). Series analyses and quality specifications required for monitoring over time. Scand J Clin Lab Invest, 59(7), 501-508. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10667687 

Guder, W. G. (1999). Preanalytical factors and their influence on analytical quality specifications. Scand J Clin Lab Invest, 59(7), 545-549. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10667696 

Haeckel, R., & Kindler, M. (1999). Effect of current and forthcoming European legislation and standardization on the setting of quality specifications by laboratories. Scandinavian Journal of Clinical & Laboratory Investigation, 59(7), 569-573. https://www.tandfonline.com/doi/abs/10.1080/00365519950185373

Horvath, A. R., Bossuyt, P. M., Sandberg, S., John, A. S., Monaghan, P. J., Verhagen-Kamerbeek, W. D., Lennartz, L., Cobbaert, C. M., Ebert, C., Lord, S. J., Test Evaluation Working Group of the European Federation of Clinical, C., & Laboratory, M. (2015). Setting analytical performance specifications based on outcome studies - is it possible? Clin Chem Lab Med, 53(6), 841-848. https://doi.org/10.1515/cclm-2015-0214 

Hyltoft Pedersen, P. (2001). Elements of Analytical Quality and Strategies for Choosing Analytical Quality Specifications. Blood Gas News, 10(1), 31-39. https://portal.findresearcher.sdu.dk/da/publications/elements-of-analytical-quality-and-strategies-for-choosing-analyt

Hyltoft Petersen, P., Brandslund, I., Jorgensen, L., Stahl, M., de Fine Olivarius, N., & Borch-Johnsen, K. (2001). Evaluation of systematic and random factors in measurements of fasting plasma glucose as the basis for analytical quality specifications in the diagnosis of diabetes. 3. Impact of the new WHO and ADA recommendations on diagnosis of diabetes mellitus. Scand J Clin Lab Invest, 61(3), 191-204. http://www.ncbi.nlm.nih.gov/pubmed/11386606 

Hyltoft Petersen, P., Sandberg, S., Fraser, C. B., & Goldschmidt, H. (2000). A Model for Setting Analytical Quality Specifications and Design of Control for Measurements on Ordinary Scale. Clinical Chemistry and Laboratory Medicine, 38, 545-551. https://doi.org/10.1515/CCLM.2000.080

Jones, G. R. D., Albarede, S., Kesseler, D., MacKenzie, F., Mammen, J., Pedersen, M., Stavelin, A., Thelen, M., Thomas, A., Twomey, P. J., Ventura, E., Panteghini, M., & EQAS, E. T. F. G.-A. P. S. f. (2017). Analytical performance specifications for external quality assessment - definitions and descriptions. Clin Chem Lab Med, 55(7), 949-955. https://doi.org/10.1515/cclm-2017-0151 

Jorgensen, L. G., Brandslund, I., Stahl, M., Hyltoft Petersen, P., Iversen, S., Klitgaard, N., & de Fine Olivarius, N. (2002). Upper reference limit, analytical quality specifications and clinical use of haemoglobin A1C. Scand J Clin Lab Invest, 62(8), 609-622. http://www.ncbi.nlm.nih.gov/pubmed/12564619

Kallner, A. (1999). Quality specifications based on the uncertainty of measurement. Scandinavian Journal of Clinical & Laboratory Investigation, 59(7), 513-516. https://doi.org/10.1080/00365519950185256

Kallner, A. (2000). Global trends in quality specifications: a report from the Stockholm Conference. Accred Qual Assur, 5, 397-398. https://link.springer.com/article/10.1007/PL00010428

Kallner, A., McQueen, M., & Heuck, C. (1999). The Stockholm Consensus Conference on quality specifications in laboratory medicine, 25-26 April 1999. Scand J Clin Lab Invest, 59(7), 475-476. https://pubmed.ncbi.nlm.nih.gov/10667681/

Klee, G. G., Schryver, P. G., & Kisabeth, R. M. (1999). Analytic bias specifications based on the analysis of effects on performance of medical guidelines. Scand J Clin Lab Invest, 59(7), 509-512. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10667688  

Kofstad, J. (1993). Quality specifications for pH and blood gases. Ups J Med Sci, 98(3), 381-385. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=7974869 

Kouri, T., Laippala, P., Kutter, D., Gant, V., Hallander, H., & Guder, W. G. (1999). Quality specifications for ordinal scale measurements with multiproperty (multiple) urine test strips. Scand J Clin Lab Invest, 59(7), 523-526. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10667691 

Krouwer, J. S. (2013). Why specifications for allowable glucose meter errors should include 100% of the data. Clin Chem Lab Med, 51(8), 1543-1544. https://doi.org/10.1515/cclm-2013-0387 

Krouwer, J. S. (2016a). The problem with total error models in establishing performance specifications and a simple remedy. Clinical Chemistry and Laboratory Medicine, 54(8), 1299-1301. https://doi.org/10.1515/cclm-2015-1175 

Krouwer, J. S. (2016b). The problem with total error models in establishing performance specifications and a simple remedy. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2015-1175 

Krouwer, J. S., & Cembrowski, G. S. (2011). Towards more complete specifications for acceptable analytical performance - a plea for error grid analysis. Clin Chem Lab Med, 49(7), 1127-1130. https://doi.org/10.1515/CCLM.2011.610 

Laessig, R. H. (1990). Medical Need for Quality Specifications within Laboratory Medicine. Ups J Med Sci, 95(3), 233-244 https://pubmed.ncbi.nlm.nih.gov/2100400/

Larsen, M. L., Petersen, P. H., & Fraser, C. G. (1993). Quality specifications for haemoglobin A1c assays in the monitoring of diabetes. Ups J Med Sci, 98(3), 335-338. http://www.ncbi.nlm.nih.gov/pubmed/7974864 

Lin, M. J., Hoke, C., Dlott, R., Lorey, T. S., & Greene, D. N. (2013). Performance specifications of common chemistry analytes on the AU series of chemistry analyzers for miscellaneous body fluids. Clin Chim Acta, 426, 121-126. https://doi.org/10.1016/j.cca.2013.08.011 

Loh, T. P., Smith, A. F., Bell, K. J. L., Lord, S. J., Ceriotti, F., Jones, G., Bossuyt, P., Sandberg, S., & Horvath, A. R. (2021). Setting analytical performance specifications using HbA1c as a model measurand. Clinica Chimica Acta, 523, 407-414. https://doi.org/10.1016/j.cca.2021.10.016 

Lontz, J. F. (1986). Materials and their specifications for vascular prostheses. Specifications and performance standards. Artif Organs, 10(6), 443-445. https://www.ncbi.nlm.nih.gov/pubmed/3800699

Oosterhuis, W. P. (2017). Analytical performance specifications in clinical chemistry: the holy grail? Journal of Laboratory and Precision Medicine, 2, 78-. https://doi.org/0.21037/jlpm.2017.09.02;2:78 

Oosterhuis, W. P., & Sandberg, S. (2015). Proposal for the modification of the conventional model for establishing performance specifications. Clin Chem Lab Med, 53(6), 925-937. https://doi.org/10.1515/cclm-2014-1146 

Oosterhuis, W. P., & Severens, M. J. (2018). Performance specifications and six sigma theory: Clinical chemistry and industry compared. Clinical biochemistry, 57, 12-17. https://doi.org/10.1016/j.clinbiochem.2018.04.002 

Panteghini, M., Ceriotti, F., Jones, G., Oosterhuis, W., Plebani, M., Sandberg, S., Task Force on Performance Specifications in Laboratory Medicine of the European Federation of Clinical, C., & Laboratory, M. (2017). Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference. Clin Chem Lab Med, 55(12), 1849-1856. https://doi.org/10.1515/cclm-2017-0772 

Panteghini, M., & Sandberg, S. (2015). Defining analytical performance specifications 15 years after the Stockholm conference. Clin Chem Lab Med, 53(6), 829-832. https://doi.org/10.1515/cclm-2015-0303 

Petersen, P. H. (1999). Quality specifications based on analysis of effects of performance on clinical decision-making. Scand J Clin Lab Invest, 59(7), 517-521. https://www.ncbi.nlm.nih.gov/pubmed/10667690

Petersen, P. H. (2002). Importance of the choice of assumptions and models in the estimation of analytical quality specifications. Accreditation and Quality Assurance, 7(11), 488-493. https://doi.org/10.1007/s00769-002-0523-6 

Petersen, P. H., & Fraser, C. G. (2010). Strategies to set global analytical quality specifications in laboratory medicine: 10 years on from the Stockholm consensus conference. Accreditation and Quality Assurance, 15(6), 323-330. https://doi.org/10.1007/s00769-009-0630-8 

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Petersen, P. H., Fraser, C. G., Jorgensen, L., Brandslund, I., Stahl, M., Gowans, E., Libeer, J. C., & Ricos, C. (2002). Combination of analytical quality specifications based on biological within- and between-subject variation. Ann Clin Biochem, 39(Pt 6), 543-550. http://www.ncbi.nlm.nih.gov/pubmed/12564835 

Petersen, P. H., Jensen, E. A., & Brandslund, I. (2012). Analytical performance, reference values and decision limits. A need to differentiate between reference intervals and decision limits and to define analytical quality specifications. Clin Chem Lab Med, 50(5), 819-831. https://doi.org/10.1515/cclm.2011.821 

Petersen, P. H., Lund, F., Fraser, C. G., & Soletormos, G. (2016). Analytical performance specifications for changes in assay bias (Deltabias) for data with logarithmic distributions as assessed by effects on reference change values. Ann Clin Biochem. https://doi.org/10.1177/0004563216634376 

Powers, D. M., & Greenberg, N. (1999). Development and use of analytical quality specifications in the in vitro diagnostics medical device industry. Scand J Clin Lab Invest, 59(7), 539-543. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10667695 

Ricos, C., Alvarez, V., Cava, F., Garcia-Lario, J. V., Hernandez, A., Jimenez, C. V., Minchinela, J., Perich, C., & Simon, M. (2018). Desirable Specifications for Total Error, Imprecision, and Bias, derived from intra- and inter-individual biologic variation http://www.westgard.com/biodatabase1.htm .

Ricos, C., Garcia-Victoria, M., & de la Fuente, B. (2004). Quality indicators and specifications for the extra-analytical phases in clinical laboratory management. Clinical Chemistry and Laboratory Medicine, 42(6), 578-582. https://doi.org/Doi 10.1515/Cclm.2004.100 

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Sandberg, S., Fraser, C. G., Horvath, A. R., Jansen, R., Jones, G., Oosterhuis, W., Petersen, P. H., Schimmel, H., Sikaris, K., & Panteghini, M. (2015). Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med, 53(6), 833-835. https://doi.org/10.1515/cclm-2015-0067 

Sciacovelli, L., Panteghini, M., Lippi, G., Sumarac, Z., Cadamuro, J., Galoro, C. A. D., Castro, I. G. D., Shcolnik, W., & Plebani, M. (2017). Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group "Laboratory Error and Patient Safety" and EFLM Task and Finish Group "Performance specifications for the extra-analytical phases". Clinical Chemistry and Laboratory Medicine, 55(10), 1478-1488. https://doi.org/10.1515/cclm-2017-0412 

Skeie, S., Thue, G., & Sandberg, S. (2001a). Interpretation of hemoglobin A(1c) (HbA(1c)) values among diabetic patients: implications for quality specifications for HbA(1c). Clin Chem, 47(7), 1212-1217. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11427451 

Skeie, S., Thue, G., & Sandberg, S. (2001b). Patient-derived quality specifications for instruments used in self-monitoring of blood glucose. Clin. Chem., 47(1), 67-73. https://doi.org/10.1093/clinchem/47.1.67

Smith, A. F., Shinkins, B., Hall, P. S., Hulme, C. T., & Messenger, M. P. (2019). Toward a Framework for Outcome-Based Analytical Performance Specifications: A Methodology Review of Indirect Methods for Evaluating the Impact of Measurement Uncertainty on Clinical Outcomes. Clin Chem. https://doi.org/10.1373/clinchem.2018.300954 

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Thue, G., & Sandberg, S. (2015). Analytical performance specifications based on how clinicians use laboratory tests. Experiences from a post-analytical external quality assessment programme. Clin Chem Lab Med, 53(6), 857-862. https://doi.org/10.1515/cclm-2014-1280 

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Westgard, J. O., Seehafer, J. J., & Barry, P. L. (1994). European specifications for imprecision and inaccuracy compared with operating specifications that assure the quality required by US CLIA proficiency-testing criteria. Clin Chem, 40(7 Pt 1), 1228-1232. http://www.ncbi.nlm.nih.gov/pubmed/8013091

Westgard, J. O., & Wiebe, D. A. (1991). Cholesterol operational process specifications for assuring the quality required by CLIA proficiency testing. Clin Chem, 37(11), 1938-1944. http://www.ncbi.nlm.nih.gov/pubmed/1934469