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Isaeva O.V.

Central Research Institute of epidemiology Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing;
Mechnikov Research Institute of Vaccines and Sera

Potemkin I.A.

Central Research Institute of epidemiology Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing;
Mechnikov Research Institute of Vaccines and Sera

Deliy I.V.

JSC «Vector-Best»

Bezuglova L.V.

JSC «Vector-Best»

Kyuregyan K.K.

Central Research Institute of epidemiology Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing;
Mechnikov Research Institute of Vaccines and Sera

Verification of the precision of enzyme immunoassay detection of HBsAg in «Vectohep B — HBs-antigen» reagent kits

Authors:

Isaeva O.V., Potemkin I.A., Deliy I.V., Bezuglova L.V., Kyuregyan K.K.

More about the authors

Journal: Laboratory Service. 2024;13(2): 13‑19

DOI: 10.17116/labs20241301113

Read: 794 times

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Table of contents

VERIFICATION OF THE PRECISION OF ENZYME IMMUNOASSAY DETECTION OF HBSAG IN «VECTOHEP B — HBS-ANTIGEN» REAGENT KITS
VERIFICATION OF THE PRECISION OF ENZYME IMMUNOASSAY DETECTION OF HBSAG IN «VECTOHEP B — HBS-ANTIGEN» REAGENT KITS

To cite this article:

Isaeva OV, Potemkin IA, Deliy IV, Bezuglova LV, Kyuregyan KK. Verification of the precision of enzyme immunoassay detection of HBsAg in «Vectohep B — HBs-antigen» reagent kits. Laboratory Service. 2024;13(2):13‑19. (In Russ.)
https://doi.org/10.17116/labs20241301113

Подписка 2025 Лабораторная служба (Laboratory Service)
МСФ на ЯМ
Использование инфографики авторами научных работ
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Abstract:

A condition for ensuring the quality of laboratory examination procedures before its addition into everyday use is the verification declared by the manufacturer functional characteristics. The article presents the results of the verification of examination procedure for precision using practical tools from the Clinical and Laboratory Standards Institute document CLSI EP15-A3 [1]. Evaluation was carried out on example of enzyme immunoassay detection of hepatitis B virus surface antigen (HBsAg) in the «Vectohep B — HBs-antigen» reagent kits for qualitative determination of the marker for screening of patient samples (human blood serum). The obtained the repeatability and intra-laboratory precision parameters corresponded to the specifications validated by the manufacturer for the «Vectohep B — HBs-antigen» reagent kit with a detection limit of 0.05 IU/ml and published earlier [2]. It was shown that the examination procedure, which was evaluated in laboratory conditions according to ISO 15189 requirements [3], have been verified for precision.

Keywords:

laboratory tests
precision verification
enzyme immunoassay detection of HBsAg

Authors:

Isaeva O.V.

Central Research Institute of epidemiology Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing;
Mechnikov Research Institute of Vaccines and Sera

Potemkin I.A.

Central Research Institute of epidemiology Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing;
Mechnikov Research Institute of Vaccines and Sera

Deliy I.V.

JSC «Vector-Best»

Bezuglova L.V.

JSC «Vector-Best»

Kyuregyan K.K.

Central Research Institute of epidemiology Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing;
Mechnikov Research Institute of Vaccines and Sera

Received:

29.06.2023

Accepted:

24.04.2024

Close metadata

References:

  1. CLSI EP15-A3: User verification of precision and correctness. The approved manual is the third edition. Institute of Clinical and Laboratory Standards. Publication date 11.09.14. (In Russ.).
  2. Bezuglova LV, Deliy IV, Uvarova LA, Gulakova MV, Cherepanova NS. Interlaboratory evaluation of the precision of enzyme immunoassay detection of HBsAg in a set of reagents «Vectohep B — HBs-antigen» according to the standard CLSI EP05-A3:2014. Handbook of the head of CDL. 2023;(4):25-36. (In Russ.). https://e.zavkdl.ru/articleprint?aid=1021078.
  3. GOST R ISO 15189—2015 Medical laboratories. Particular requirements for quality and competence. Date of introduction 01.06.16. (In Russ.).
  4. Menshikov VV, Emanuel AV, Pervushin YuV, Tsvirenko SV. Ensuring the clinical safety of obtaining and using laboratory information. Clinical recommendations. M.: Association of specialists and organizations of laboratory services «Federation of Laboratory Medicine»; 2013. (In Russ.).
  5. GOST R ISO 53022.2—2008 Clinical laboratory technologies. Requirements for quality of clinical laboratory tests. Part 2. Assessment of analytical reliability methods (accuracy, sensitivity, specificity). Date of introduction 01.01.10. (In Russ.).
  6. Pum J. A practical guide to validation and verification of analytical methods in the clinical laboratory. Adv Clin Chem. 2019;(90):215-281.  https://doi.org/10.1016/bs.acc.2019.01.006
  7. CLSI C24-Ed4: Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions, 4th Edition. Clinical and Laboratory standards institute. Publication date 29.09.2016. (In Russ.).
  8. Netesova IG, Yaroslavtseva OA. Conducting intra-laboratory quality control of low-quality methods of enzyme immunoassay in the presence and absence of control materials. Handbook of the head of the CDL. 2015;7:29-36. (In Russ.).
  9. Netesova IG, Mostovich LA, Bezuglova LV, Bobkova MR, Tarasenko OA. Organization and conduct of in-laboratory quality control of non-quantitative methods of immunochemical analysis when using medical devices for in vitro diagnostics of the 3rd risk class for the detection of immunological markers of infectious diseases. Information and methodological guide. Novosibirsk: Vector-Best; 2019. (In Russ.).
  10. Criteria for identifying emissions for the normal distribution (Outlier tests for the normal distribution). An online resource developed by Concert Software. https://contchart.com/outliers.aspx
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