Lot-to-lot reagent verification: challenges and possible solutions
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Tze Ping Loh
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Sverre Sandberg
Abstract
Lot-to-lot verification is an important laboratory activity that is performed to monitor the consistency of analytical performance over time. In this opinion paper, the concept, clinical impact, challenges and potential solutions for lot-to-lot verification are exained.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Not applicable.
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Ethical approval: Not applicable.
References
1. Hicks, AJ, Carwardine, ZL, Hallworth, MJ, Kilpatrick, ES. Using clinical guidelines to assess the potential value of laboratory medicine in clinical decision-making. Biochem Med (Zagreb). 2021;31:010703. https://doi.org/10.11613/BM.2021.010703.Search in Google Scholar
2. Sikaris, K, Pehm, K, Wallace, M, Picone, D, Frydenberg, M. Review of serious failures in reported test results for prostate-specific antigen (PSA) testing of patients by SA Pathology. Available from: http://www.sapathology.sa.gov.au/wps/wcm/connect/1fa1d43f-08ab-49e0-9875-369da73bc731/Final+Report+-+SA+PSA+Review+-+July+2016.pdf?MOD=AJPERES [Accessed 2 Feb 2022].Search in Google Scholar
3. Algeciras-Schimnich, A, Bruns, DE, Boyd, JC, Bryant, SC, La Fortune, KA, Grebe, SK. Failure of current laboratory protocols to detect lot-to-lot reagent differences: findings and possible solutions. Clin Chem 2013;59:1187–94. https://doi.org/10.1373/clinchem.2013.205070.Search in Google Scholar
4. Chai, JH, Ma, S, Heng, D, Yoong, J, Lim, WY, Toh, SA, et al.. Impact of analytical and biological variations on classification of diabetes using fasting plasma glucose, oral glucose tolerance test and HbA1c. Sci Rep 2017;7:13721. https://doi.org/10.1038/s41598-017-14172-8.Search in Google Scholar
5. Larsen, ML, Fraser, CG, Petersen, PH. A comparison of analytical goals for haemoglobin A1c assays derived using different strategies. Ann Clin Biochem 1991;28:272–8. https://doi.org/10.1177/000456329102800313.Search in Google Scholar
6. Petersen, PH, Jørgensen, LG, Brandslund, I, De Fine Olivarius, N, Stahl, M. Consequences of bias and imprecision in measurements of glucose and hba1c for the diagnosis and prognosis of diabetes mellitus. Scand J Clin Lab Invest Suppl 2005;240:51–60. https://doi.org/10.1080/00365510500236135.Search in Google Scholar
7. Petersen, PH, Klee, GG. Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits. Clin Chim Acta 2014;430:1–8. https://doi.org/10.1016/j.cca.2013.12.014.Search in Google Scholar
8. Koerbin, G, Liu, J, Eigenstetter, A, Tan, CH, Badrick, T, Loh, TP. Missed detection of significant positive and negative shifts in gentamicin assay: implications for routine laboratory quality practices. Biochem Med (Zagreb) 2018;28:010705. https://doi.org/10.11613/BM.2018.010705.Search in Google Scholar
9. Hammarsten, O, Jacobsson, CE, Widegren, M, Danylchenko, T, Jaffe, AS. Long-time quality assessment of the Elecsys Troponin T hs assay. Clin Biochem 2013;46:1055–7. https://doi.org/10.1016/j.clinbiochem.2013.03.022.Search in Google Scholar
10. Apple, FS, Jaffe, AS. Clinical implications of a recent adjustment to the high-sensitivity cardiac troponin T assay: user beware. Clin Chem 2012;58:1599–600. https://doi.org/10.1373/clinchem.2012.194985.Search in Google Scholar
11. Wildi, K, Twerenbold, R, Jaeger, C, Rubini Giménez, M, Reichlin, T, Stoll, M, et al.. Clinical impact of the 2010–2012 low-end shift of high-sensitivity cardiac troponin T. Eur Heart J Acute Cardiovasc Care 2016;5:399–408. https://doi.org/10.1177/2048872616642952.Search in Google Scholar
12. Solsvik, AE, Kristoffersen, AH, Sandberg, S, Gidske, G, Stavelin, AV, Eikeland, J, et al.. A national surveillance program for evaluating new reagent lots in medical laboratories. Clin Chem Lab Med 2022;60:351–60. https://doi.org/10.1515/cclm-2021-1262.Search in Google Scholar
13. Hickman, PE, Koerbin, G, Badrick, T, Oakman, C, Potter, JM. The importance of low level QC for high sensitivity troponin assays. Clin Biochem 2018;58:60–3. https://doi.org/10.1016/j.clinbiochem.2018.05.007.Search in Google Scholar
14. Clinical and Laboratory Standards Institute. CLSI document EP26-A. Wayne, PA, USA: CLSI; 2013. User evaluation of between-reagent lot variation; Approved guideline.Search in Google Scholar
15. Liu, J, Tan, CH, Badrick, T, Loh, TP. Moving sum of number of positive patient result as a quality control tool. Clin Chem Lab Med 2017;55:1709–14. https://doi.org/10.1515/cclm-2016-0950.Search in Google Scholar
16. Liu, J, Tan, CH, Loh, TP, Badrick, T. Detecting long-term drift in reagent lots. Clin Chem 2015;61:1292–8. https://doi.org/10.1373/clinchem.2015.242511.Search in Google Scholar
17. Thompson, S, Chesher, D. Lot-to-Lot Variation. Clin Biochem Rev. 2018;39:51–60. PMC6223607.Search in Google Scholar PubMed
18. van Schrojenstein Lantman, M, Çubukçu, HC, Boursier, G, Panteghini, M, Bernabeu-Andreu, F, Milinković, N, et al.. An approach for determining allowable between reagent lot variation. Clin Chem Lab Med 2022;60:681–8.10.1515/cclm-2022-0083Search in Google Scholar PubMed
19. Stavelin, A, Riksheim, BO, Christensen, NG, Sandberg, S. The importance of reagent lot registration in external quality assurance/proficiency testing schemes. Clin Chem 2016;62:708–15. https://doi.org/10.1373/clinchem.2015.247585.Search in Google Scholar
20. van der Hagen, EAE, Weykamp, C, Sandberg, S, Stavelin, AV, MacKenzie, F, Miller, WG. Feasibility for aggregation of commutable external quality assessment results to evaluate metrological traceability and agreement among results. Clin Chem Lab Med 2020;59:117–25. https://doi.org/10.1515/cclm-2020-0736.Search in Google Scholar
21. Miller, WG. Time to pay attention to reagent and calibrator lots for proficiency testing. Clin Chem 2016;62:666–7. https://doi.org/10.1373/clinchem.2016.255802.Search in Google Scholar
22. Badrick, T, Bietenbeck, A, Cervinski, MA, Katayev, A, van Rossum, HH, Loh, TP, et al.. Patient-based real-time quality control: review and recommendations. Clin Chem 2019;65:962–71. https://doi.org/10.1373/clinchem.2019.305482.Search in Google Scholar
23. Duan, X, Wang, B, Zhu, J, Zhang, C, Jiang, W, Zhou, J. Regression-adjusted real-time quality control. Clin Chem 2021;67:1342–51. https://doi.org/10.1093/clinchem/hvab115.Search in Google Scholar
24. Goossens, K, Van Uytfanghe, K, Twomey, PJ, Thienpont, LM, Laboratories Participating. Monitoring laboratory data across manufacturers and laboratories—a prerequisite to make “Big Data” work. Clin Chim Acta 2015;445:12–8. https://doi.org/10.1016/j.cca.2015.03.003.Search in Google Scholar
25. De Grande, LAC, Goossens, K, Van Uytfanghe, K, Das, B, MacKenzie, F, Patru, MM, 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;467:8–14. https://doi.org/10.1016/j.cca.2016.04.032.Search in Google Scholar
© 2022 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- Lot-to-lot variation: no longer a neglected issue
- Review
- Health Technology Assessment to assess value of biomarkers in the decision-making process
- Mini Review
- Diagnostic performance of the fully automated Roche Elecsys SARS-CoV-2 antigen electrochemiluminescence immunoassay: a pooled analysis
- Opinion Papers
- Preanalytical quality improvement – an interdisciplinary journey
- Metrological traceability and clinical traceability of laboratory results – the role of commutability in External Quality Assurance
- Lot-to-lot reagent verification: challenges and possible solutions
- EFLM Paper
- An approach for determining allowable between reagent lot variation
- General Clinical Chemistry and Laboratory Medicine
- Introduction of BD Vacutainer® Barricor™ tubes in clinical biobanking and application of amino acid and cytokine quality indicators to Barricor plasma
- Delays during PBMC isolation have a moderate effect on yield, but severly compromise cell viability
- Investigation of the effects of pneumatic tube transport system on routine biochemistry, hematology, and coagulation tests in Ankara City Hospital
- Comparison of three different protocols for obtaining hemolysis
- Report from the HarmoSter study: impact of calibration on comparability of LC-MS/MS measurement of circulating cortisol, 17OH-progesterone and aldosterone
- Point-of-care testing in primary healthcare: a scoring system to determine the frequency of performing internal quality control
- Hematology and Coagulation
- The flagging features of the Sysmex XN-10 analyser for detecting platelet clumps and the impacts of platelet clumps on complete blood count parameters
- Cancer Diagnostics
- Thyroglobulin and thyroglobulin antibodies: assay-dependent management consequences in patients with differentiated thyroid carcinoma
- Infectious Diseases
- Hyris bCUBE SARS-CoV-2 rapid molecular saliva testing: a POCT innovation on its way
- Ultrasensitive assay for saliva-based SARS-CoV-2 antigen detection
- Identification of contagious SARS-CoV-2 infected individuals by Roche’s Rapid Antigen Test
- Monocyte distribution width (MDW) as a screening tool for early detecting sepsis: a systematic review and meta-analysis
- Perinatal asphyxia partly affects presepsin urine levels in non-infected term infants
- Letters to the Editors
- Spurious results for total and free prostate-specific antigen (PSA); sometimes really “a riddle wrapped in a mystery inside an enigma”
- Reply to: Spurious results for total and free prostate-specific antigen (PSA); sometimes really “a riddle wrapped in a mystery inside an enigma”
- Spike vs. nucleocapsid serum antigens for COVID-19 diagnosis and severity assessment
- A rapid semi-quantitative test for determination of SARS-CoV-2 antibody levels
- Diagnostic potential of leukocyte differential and cell population data in prediction of COVID-19 among related viral and bacterial infections at Emergency Department
- Added value of drug-laboratory test interaction alerts in test result authorisation
- Pre-analytical considerations for the analysis of uracil and 5,6-dihydrouracil in heparin plasma
- Rare unstable and low oxygen affinity haemoglobin variant, Hb Hazebrouck, detected on Sysmex XN-9000
- Multicancer early detection
Articles in the same Issue
- Frontmatter
- Editorial
- Lot-to-lot variation: no longer a neglected issue
- Review
- Health Technology Assessment to assess value of biomarkers in the decision-making process
- Mini Review
- Diagnostic performance of the fully automated Roche Elecsys SARS-CoV-2 antigen electrochemiluminescence immunoassay: a pooled analysis
- Opinion Papers
- Preanalytical quality improvement – an interdisciplinary journey
- Metrological traceability and clinical traceability of laboratory results – the role of commutability in External Quality Assurance
- Lot-to-lot reagent verification: challenges and possible solutions
- EFLM Paper
- An approach for determining allowable between reagent lot variation
- General Clinical Chemistry and Laboratory Medicine
- Introduction of BD Vacutainer® Barricor™ tubes in clinical biobanking and application of amino acid and cytokine quality indicators to Barricor plasma
- Delays during PBMC isolation have a moderate effect on yield, but severly compromise cell viability
- Investigation of the effects of pneumatic tube transport system on routine biochemistry, hematology, and coagulation tests in Ankara City Hospital
- Comparison of three different protocols for obtaining hemolysis
- Report from the HarmoSter study: impact of calibration on comparability of LC-MS/MS measurement of circulating cortisol, 17OH-progesterone and aldosterone
- Point-of-care testing in primary healthcare: a scoring system to determine the frequency of performing internal quality control
- Hematology and Coagulation
- The flagging features of the Sysmex XN-10 analyser for detecting platelet clumps and the impacts of platelet clumps on complete blood count parameters
- Cancer Diagnostics
- Thyroglobulin and thyroglobulin antibodies: assay-dependent management consequences in patients with differentiated thyroid carcinoma
- Infectious Diseases
- Hyris bCUBE SARS-CoV-2 rapid molecular saliva testing: a POCT innovation on its way
- Ultrasensitive assay for saliva-based SARS-CoV-2 antigen detection
- Identification of contagious SARS-CoV-2 infected individuals by Roche’s Rapid Antigen Test
- Monocyte distribution width (MDW) as a screening tool for early detecting sepsis: a systematic review and meta-analysis
- Perinatal asphyxia partly affects presepsin urine levels in non-infected term infants
- Letters to the Editors
- Spurious results for total and free prostate-specific antigen (PSA); sometimes really “a riddle wrapped in a mystery inside an enigma”
- Reply to: Spurious results for total and free prostate-specific antigen (PSA); sometimes really “a riddle wrapped in a mystery inside an enigma”
- Spike vs. nucleocapsid serum antigens for COVID-19 diagnosis and severity assessment
- A rapid semi-quantitative test for determination of SARS-CoV-2 antibody levels
- Diagnostic potential of leukocyte differential and cell population data in prediction of COVID-19 among related viral and bacterial infections at Emergency Department
- Added value of drug-laboratory test interaction alerts in test result authorisation
- Pre-analytical considerations for the analysis of uracil and 5,6-dihydrouracil in heparin plasma
- Rare unstable and low oxygen affinity haemoglobin variant, Hb Hazebrouck, detected on Sysmex XN-9000
- Multicancer early detection
