ГОСТ Р ИСО 21151-2021. Национальный стандарт Российской Федерации. Медицинские изделия для диагностики in vitro. Требования к международным протоколам гармонизации установления метрологической прослеживаемости значений, приписываемых калибраторам и образцам биологического материала человека

[1]

ISO 18113-2

In vitro diagnostic medical devicess - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (Медицинские приборы для инвитро диагностики. Информация, предоставленная производителем (маркировка). Часть 2. Диагностические реагенты инвитро для профессионального использования)

[2]

Danilenko U et al., An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials. Clin Chem Lab Med 2020; 58 pp. 368 - 374.

[3]

CLSI Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition. CLSI document EP05-A3. Wayne PA: Clinical and Laboratory Standards Institute. 2014

[4]

CLSI Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Third Edition. CLSI document EP09-A3. Wayne PA: Clinical and Laboratory Standards Institute. 2013

[5]

Miller W.G. et al., Roadmap for harmonization of clinical laboratory measurement procedures. Clin. Chem. 2011, 57 (8) pp. 1108 - 1117

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Thienpont LM et al. Traceability to a common standard for protein measurements by immunoassay for in-vitro diagnostic purposes. Clin Chim Acta. 2010;411(23 - 24):2058-61.

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Van Uytfanghe K. et al., A "Step-Up" approach for harmonization. Clin. Chim. Acta. 2014, 432 pp. 62 - 67

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Van Houcke S.K. et al., Harmonization of immunoassays to the all-procedure trimmed mean - proof of concept by use of data from the insulin standardization project. Clin. Chem. Lab. Med. 2013, 51 (5) pp. e103 - e105

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D. et al., A statistical basis for harmonization of thyroid stimulating hormone assays using a robust factor analysis model. Clin. Chem. Lab. Med. 2014, 52 (7) pp. 965 - 972

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Thienpont L.M. et al., Harmonization of serum thyroid-stimulating hormone measurements paves the way for the adoption of a more uniform reference interval. Clin. Chem. 2017, 63 (7) pp. 1248 - 1260

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Miller W.G., Harmonization: its time has come. Clin. Chem. 2017, 63 (7) pp. 1184 - 1186

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Panteghini M. et al., Defining analytical performance goals - 15 years after the Stockholm Conference. Clin. Chem. Lab. Med. 2015, 53 (6) pp. 829 - 958

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Panteghini M. et al., Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference. Clin. Chem. Lab. Med. 2017, 55 (12) pp. 1849 - 1856

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Miller W.G. et al., IFCC Working Group Recommendations for Assessing Commutability Part 1: General Experimental Design. Clin. Chem. 2018, 64 (3) pp. 447 - ,454

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Miller W.G. et al., Proficiency Testing/External Quality Assessment: Current Challenges and Future Directions. Clin. Chem. 2011, 57 (12) pp. 1670 - 1680

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De Grande L.A.C. et al., Monitoring the stability of the standardization status of FT4 and TSH assays by use of daily outpatient medians and flagging frequencies. Clin. Chim. Acta. 2017, 467 pp. 8 - 14

УДК 57.085.2:006.354

ОКС 11.100.10

Ключевые слова: медицинские изделия МИ IVD, международный протокол гармонизации, метрологическая прослеживаемость, значения, приписываемые калибраторам, образцы биологического материала