Patient-based real-time quality control for quantitative hepatitis B virus DNA test using moving rate of positive and negative patient results
-
Tingting Li
,
Jiamin Li
Abstract
Objectives
Patient-based real-time quality control (PBRTQC) has gained increasing attention in the field of laboratory quality management in recent years. However, PBRTQC has not been reported for use in molecular diagnostics. This study introduces PBRTQC to quantitative hepatitis B virus (HBV) DNA test using moving rate (MR) of positive and negative patient results.
Methods
In contrast to the MR protocols described in other literature, MR protocol for HBV-DNA test has an additional logarithmic transformation and binary conversion steps before using a common statistical process control algorithm, such as the MR. We used all patient test results of HBV-DNA assay from August 2018 to August 2021 at the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, for parameters setting, optimization, and performance validation. The false rejection rate, error detection curves and validation charts were used to assess the MR protocols.
Results
The false rejection rates of two MR protocols were both <0.7%. The optimal block sizes for positive and negative errors in each cut-off value were not the same, so we first proposed a combined protocol that used different block size to detect negative and positive errors. It turned out that the combined protocols outperformed the simple protocols for each cut-off value, especially detecting positive errors.
Conclusions
The performances of MR protocols using positive or negative patient results to detect constant errors of HBV-DNA test could meet laboratory requirements. Therefore, we have provided an effective alternative tool for internal quality control in the field of molecular diagnostics.
Funding source: Guangzhou Basic and Applied Basic Research project
Award Identifier / Grant number: 202102020101
Funding source: Scientific research project of Traditional Chinese Medicine Bureau of Guangdong Province
Award Identifier / Grant number: 20202067
-
Research funding: This work was supported by Scientific research project of Traditional Chinese Medicine Bureau of Guangdong Province (20202067) and Guangzhou Basic and Applied Basic Research project (202102020101).
-
Author contributions: TL designed the study and wrote the manuscript; JL analyzed data. SC, YW and HW collected data; CZ reviewed the manuscript. PK proposed the concept of MR of positive patient results as a QC tool. XH supervised the study and reviewed the manuscript. All the authors have accepted responsibility for the entire content of this submitted manuscript and have approved the submission.
-
Competing interests: Authors state no conflict of interest.
-
Informed consent: Not applicable.
-
Ethical approval: Not applicable.
References
1. WHO. Global hepatitis report 2017. Geneva, Switzerland: World Health Organization; 2017.Search in Google Scholar
2. EASL. EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection. J Hepatol 2017;67:370–98. https://doi.org/10.1016/j.jhep.2017.03.021.Search in Google Scholar PubMed
3. Badrick, T, Bietenbeck, A, Cervinski, MA, Katayev, A, van Rossum, HH, Loh, TP. 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 PubMed
4. Loh, TP, Cervinski, MA, Katayev, A, Bietenbeck, A, van Rossum, H, Badrick, T. Recommendations for laboratory informatics specifications needed for the application of patient-based real time quality control. Clin Chim Acta 2019;495:625–9. https://doi.org/10.1016/j.cca.2019.06.009.Search in Google Scholar PubMed
5. Bietenbeck, A, Cervinski, MA, Katayev, A, Loh, TP, van Rossum, HH, Badrick, T. Understanding patient-based real-time quality control using simulation modeling. Clin Chem 2020;66:1072–83. https://doi.org/10.1093/clinchem/hvaa094.Search in Google Scholar PubMed
6. Loh, TP, Bietenbeck, A, Cervinski, MA, van Rossum, HH, Katayev, A, Badrick, T. Recommendation for performance verification of patient-based real-time quality control. Clin Chem Lab Med 2020;58:1205–13. https://doi.org/10.1515/cclm-2019-1024.Search in Google Scholar PubMed
7. Duan, X, Wang, B, Zhu, J, Shao, W, Wang, H, Shen, J, et al.. Assessment of patient-based real-time quality control algorithm performance on different types of analytical error. Clin Chim Acta 2020;511:329–35. https://doi.org/10.1016/j.cca.2020.10.006.Search in Google Scholar PubMed
8. van Rossum, HH, Kemperman, H. A method for optimization and validation of moving average as continuous analytical quality control instrument demonstrated for creatinine. Clin Chim Acta 2016;457:1–7. https://doi.org/10.1016/j.cca.2016.03.008.Search in Google Scholar PubMed
9. van Rossum, HH, Kemperman, H. Optimization and validation of moving average quality control procedures using bias detection curves and moving average validation charts. Clin Chem Lab Med 2017;55:218–24. https://doi.org/10.1515/cclm-2016-0270.Search in Google Scholar PubMed
10. 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 PubMed
11. Rossum, H, Kemperman, H. Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays. Clin Chem Lab Med 2017;55:1142–51. https://doi.org/10.1515/cclm-2016-0696.Search in Google Scholar PubMed
12. Liu, J, Tan, CH, Badrick, T, Loh, TP. Moving standard deviation and moving sum of outliers as quality tools for monitoring analytical precision. Clin Biochem 2018;52:112–6. https://doi.org/10.1016/j.clinbiochem.2017.10.009.Search in Google Scholar PubMed
13. van Rossum, HH, van den Broek, D. Design and implementation of quality control plans that integrate moving average and internal quality control: incorporating the best of both worlds. Clin Chem Lab Med 2019;57:1329–38. https://doi.org/10.1515/cclm-2019-0027.Search in Google Scholar PubMed
14. Smith, JD, Badrick, T, Bowling, F. A direct comparison of patient-based real-time quality control techniques: the importance of the analyte distribution. Ann Clin Biochem 2020;57:206–14. https://doi.org/10.1177/0004563220902174.Search in Google Scholar PubMed
15. Badrick, T, Bietenbeck, A, Katayev, A, van Rossum, HH, Loh, TP, Cervinski, MA, et al.. Implementation of patient-based real-time quality control. Crit Rev Clin Lab Sci 2020;57:532–47. https://doi.org/10.1080/10408363.2020.1765731.Search in Google Scholar PubMed
16. Li, T, Cao, S, Wang, Y, Xiong, Y, He, Y, Ke, P, et al.. Moving rate of positive patient results as a quality control tool for High-Sensitivity cardiac troponin t assays. Ann Lab Med 2021;41:51–9. https://doi.org/10.3343/alm.2021.41.1.51.Search in Google Scholar PubMed PubMed Central
17. Duan, X, Wang, B, Zhu, J, Zhang, C, Jiang, W, Zhou, J, et al.. Regression-adjusted real-time quality control. Clin Chem 2021;67:1342–50. https://doi.org/10.1093/clinchem/hvab115.Search in Google Scholar PubMed
18. CNAS-CL02-A009. Guidance on the application of accreditation criteria for the medical laboratory quality and competence in the field of molecular diagnostics. CNAS; 2018.Search in Google Scholar
19. van Rossum, HH. Moving average quality control: principles, practical application and future perspectives. Clin Chem Lab Med 2019;57:773–82. https://doi.org/10.1515/cclm-2018-0795.Search in Google Scholar PubMed
20. Yee Lim, C, Badrick, T, Ping Loh, T. Patient-based quality control for glucometers using the moving sum of positive patient results and moving average. Biochem Medica 2020;30:296–306. https://doi.org/10.11613/bm.2020.020709.Search in Google Scholar
21. Westgard, QC. “Westgard rules” and multirule quality control. Available from: https://www.westgard.com/mltirule.htm [Accessed 4 July 2022].Search in Google Scholar
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0338).
© 2022 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- The relevance of establishing method-dependent decision thresholds of serum folate in pregnancy and lactation: when the laboratory stewardship meets the health-care needs
- Reviews
- Strategies to minimise the current disadvantages experienced by women in faecal immunochemical test-based colorectal cancer screening
- What is the impact of circulating histones in COVID-19: a systematic review
- Mini Review
- Diagnostic utility of pleural cell-free nucleic acids in undiagnosed pleural effusions
- Guidelines and Recommendations
- Evaluation of the cardiovascular risk in patients undergoing major non-cardiac surgery: role of cardiac-specific biomarkers
- Genetics and Molecular Diagnostics
- Detection of DNA copy number alterations by matrix-assisted laser desorption/ionization time-of-flight mass spectrometric analysis of single nucleotide polymorphisms
- General Clinical Chemistry and Laboratory Medicine
- Fifty years of newborn screening for congenital hypothyroidism: current status in Australasia and the case for harmonisation
- Commutability assessment of reference materials for homocysteine
- External quality assessment for detection of methylated Syndecan 2 (SDC2) in China
- Patient-based real-time quality control for quantitative hepatitis B virus DNA test using moving rate of positive and negative patient results
- Performance of HDL-C measurements assessed by a 4-year trueness-based EQA/PT program in China
- Two-site evaluation of the Roche Elecsys Vitamin D total III assay
- A novel point-of-care device accurately measures thyrotropin in whole blood, capillary blood and serum
- IgA rheumatoid factor in rheumatoid arthritis
- Reference Values and Biological Variations
- Reference intervals of 14 biochemical markers for children and adolescence in China: the PRINCE study
- Chinese normotensive and essential hypertensive reference intervals for plasma aldosterone and renin activity by liquid chromatography-tandem mass spectrometry
- Biological variation estimates obtained from Chinese subjects for 32 biochemical measurands in serum
- Cancer Diagnostics
- Testosterone analysis in castrated prostate cancer patients: suitability of the castration cut-off and analytical accuracy of the present-day clinical immunoassays
- Cardiovascular Diseases
- Point-of-care high-sensitivity troponin-I analysis in capillary blood for acute coronary syndrome diagnostics
- Platelet count and clinical outcomes among ischemic stroke patients with endovascular thrombectomy in DIRECT-MT
- Infectious Diseases
- Measurement of anti SARS-CoV-2 RBD IgG in saliva: validation of a highly sensitive assay and effects of the sampling collection method and correction by protein
- Letters to the Editors
- The simple reproducibility of a measurement result does not equal its overall measurement uncertainty
- Complexity of serological assays and misunderstandings of WHO International Units
- Ct values of different SARS CoV2 variants: a single center observational study from Innsbruck, Austria
- Alignment of the new generation of Abbott Alinity γ-glutamyltransferase assay to the IFCC reference measurement system should be improved
- Thermal and chronological stability of monocyte distribution width (MDW), the new biomarker for sepsis
- Two comments for the current commutability assessment
- Plasma neurofilament light chain in Chinese children with later-onset spinal muscular atrophy
Articles in the same Issue
- Frontmatter
- Editorial
- The relevance of establishing method-dependent decision thresholds of serum folate in pregnancy and lactation: when the laboratory stewardship meets the health-care needs
- Reviews
- Strategies to minimise the current disadvantages experienced by women in faecal immunochemical test-based colorectal cancer screening
- What is the impact of circulating histones in COVID-19: a systematic review
- Mini Review
- Diagnostic utility of pleural cell-free nucleic acids in undiagnosed pleural effusions
- Guidelines and Recommendations
- Evaluation of the cardiovascular risk in patients undergoing major non-cardiac surgery: role of cardiac-specific biomarkers
- Genetics and Molecular Diagnostics
- Detection of DNA copy number alterations by matrix-assisted laser desorption/ionization time-of-flight mass spectrometric analysis of single nucleotide polymorphisms
- General Clinical Chemistry and Laboratory Medicine
- Fifty years of newborn screening for congenital hypothyroidism: current status in Australasia and the case for harmonisation
- Commutability assessment of reference materials for homocysteine
- External quality assessment for detection of methylated Syndecan 2 (SDC2) in China
- Patient-based real-time quality control for quantitative hepatitis B virus DNA test using moving rate of positive and negative patient results
- Performance of HDL-C measurements assessed by a 4-year trueness-based EQA/PT program in China
- Two-site evaluation of the Roche Elecsys Vitamin D total III assay
- A novel point-of-care device accurately measures thyrotropin in whole blood, capillary blood and serum
- IgA rheumatoid factor in rheumatoid arthritis
- Reference Values and Biological Variations
- Reference intervals of 14 biochemical markers for children and adolescence in China: the PRINCE study
- Chinese normotensive and essential hypertensive reference intervals for plasma aldosterone and renin activity by liquid chromatography-tandem mass spectrometry
- Biological variation estimates obtained from Chinese subjects for 32 biochemical measurands in serum
- Cancer Diagnostics
- Testosterone analysis in castrated prostate cancer patients: suitability of the castration cut-off and analytical accuracy of the present-day clinical immunoassays
- Cardiovascular Diseases
- Point-of-care high-sensitivity troponin-I analysis in capillary blood for acute coronary syndrome diagnostics
- Platelet count and clinical outcomes among ischemic stroke patients with endovascular thrombectomy in DIRECT-MT
- Infectious Diseases
- Measurement of anti SARS-CoV-2 RBD IgG in saliva: validation of a highly sensitive assay and effects of the sampling collection method and correction by protein
- Letters to the Editors
- The simple reproducibility of a measurement result does not equal its overall measurement uncertainty
- Complexity of serological assays and misunderstandings of WHO International Units
- Ct values of different SARS CoV2 variants: a single center observational study from Innsbruck, Austria
- Alignment of the new generation of Abbott Alinity γ-glutamyltransferase assay to the IFCC reference measurement system should be improved
- Thermal and chronological stability of monocyte distribution width (MDW), the new biomarker for sepsis
- Two comments for the current commutability assessment
- Plasma neurofilament light chain in Chinese children with later-onset spinal muscular atrophy
