Does a change in quality control results influence the sensitivity of an anti-HCV test?
-
Wayne J. Dimech
,
Giuseppe A. Vincini
Abstract
Background
Laboratories use quality control (QC) testing to monitor the extent of normal variation. Assay lot number changes contribute the greatest amount of variation in infectious disease serology testing. An unexpected change in six lots of an anti-HCV assay allowed the determination of the effect these lot changes made to the assay’s clinical sensitivity.
Methods
Two sets of seroconversion samples comprising of 44 individual samples and 9 external quality assessment scheme (EQAS) samples, all positive to anti-HCV, were tested in affected and unaffected assay lots, and the difference in the quantitative and qualitative results of the samples was analyzed.
Results
Of 44 low-positive seroconversion samples tested in affected and unaffected assay lots, only three samples had results reported below the assay cutoff when tested on two of the six affected assay lot. A further sample had results below the cutoff for only one affected lot. None of the EQAS samples reported false-negative results. Samples having a signal to cutoff value of less than 6.0 generally had lower results in the affected lots compared with the unaffected lots.
Conclusions
Unexpected changes in QC reactivity related to variation, in particular assay lot changes, may affect patient results. This study demonstrated that QConnect Limits facilitated the detection of an unexpectedly large variation in QC test results, allowed for the identification of the root cause of the change, and showed that the risk associated with the change was low but credible. The use of evidence-based QC program is essential to detect changes in test systems.
Acknowledgments
NRL would like to acknowledge Abbott Diagnostics for the collaboration in this study by testing seroconversion panel two and for sharing information that helped better understand the sources of variation. Also, NRL acknowledges DiaMex for performing the testing of some of the samples and contributing seroconversion samples.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. Dimech W, Karakaltsas M, Vincini GA. Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing. Clin Chem Lab Med 2018;56:1970–8.10.1515/cclm-2018-0351Search in Google Scholar
2. Kruk T, Ratnam S, Preiksaitis J, Lau A, Hatchette T, Horsman G, et al. Results of continuous monitoring of the performance of rubella virus IgG and hepatitis B virus surface antibody assays using trueness controls in a multicenter trial. Clin Vaccine Immunol 2012;19:1624–32.10.1128/CVI.00294-12Search in Google Scholar
3. Dimech W, Walker S, Read S, Smeh K, Karakaltsas M, Dent B, et al. Comprehensive quality control programme for serology and nucleic acid testing using an internet-based application. Acc Qual Ass 2004;9:148–51.10.1007/s00769-003-0734-5Search in Google Scholar
4. Kim J, Swantee C, Lee B, Gunning H, Chow A, Sidaway F, et al. Identification of performance problems in a commercial humanimmunodeficiency virus type 1 enzyme immunoassay by multiuser external quality control monitoring and real-time data analysis. J Clin Microbiol 2009;47:3114–20.10.1128/JCM.00892-09Search in Google Scholar
5. Dimech W, Vincini G, Karakaltsas M. Determination of quality control limits for serological infectious disease testing using historical data. Clin Chem Lab Med 2015;53:329–36.10.1515/cclm-2014-0546Search in Google Scholar
6. CLSI. Laboratory Quality Control Based on Risk Management; Approved Guideline. Vol. EP23-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2011.Search in Google Scholar
7. CLSI. Statistical quality control for quantitative measurement procedures: principles and definitions. Vol. CLSI Guideline C24. 4th ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2016.Search in Google Scholar
8. German Medical Association. Revision of the “Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations – Rili-Baek” (unauthorized translation). J Lab Med 2015;39:26–69.10.1515/labmed-2014-0046Search in Google Scholar
9. Public Health England. Quality assurance in the diagnostic virology and serology laboratory. In: Standards Unit Microbiology Services. Colindale, UK: Public Health England, 2015.Search in Google Scholar
10. Australian Standards. Medical laboratories – requirements for quality and competence. Vol. AS ISO 15189-2013. Sydney: Standards Australia, 2013.Search in Google Scholar
11. Badrick T. The quality control system. Clin Biochem Rev 2008;29(Suppl 1):S67–70.Search in Google Scholar
12. Kallner A. International standards in laboratory medicine. Clin Chim Acta 2001;307:181–6.10.1016/S0009-8981(01)00425-9Search in Google Scholar
13. Kinns H, Pitkin S, Housley D, Freedman DB. Internal quality control: best practice. J Clin Pathol 2013;66:1027–32.10.1136/jclinpath-2013-201661Search in Google Scholar PubMed
14. Warkad SD, Song KS, Pal D, Nimse SB. Developments in the HCV screening technologies based on the detection of antigens and antibodies. Sensors (Basel) 2019;19.10.3390/s19194257Search in Google Scholar PubMed PubMed Central
15. Dimech W, Freame R, Smeh K, Wand H. A review of the relationship between quality control and donor sample results obtained from serological assays used for screening blood donations for anti-HIV and hepatitis B surface antigen. Acc Qual Ass 2013;18:11–8.10.1007/s00769-012-0950-ySearch in Google Scholar
16. Aitken CK, Agius PA, Higgs PG, Stoove MA, Bowden DS, Dietze PM. The effects of needle-sharing and opioid substitution therapy on incidence of hepatitis C virus infection and reinfection in people who inject drugs. Epidemiol Infect 2017;145:796–801.10.1017/S0950268816002892Search in Google Scholar PubMed
17. Micallef JM, Macdonald V, Jauncey M, Amin J, Rawlinson W, van Beek I, et al. High incidence of hepatitis C virus reinfection within a cohort of injecting drug users. J Viral Hepat 2007;14:413–8.10.1111/j.1365-2893.2006.00812.xSearch in Google Scholar PubMed
18. European Parliament and the European Council of the European Union. Directive 98/79/EC of the European Parliament and the council on in vitro diagnostic medical devices. Official Journal of the European Communities 1998; Directive 98/79/EC.Search in Google Scholar
19. European Parliament and the European Council of the European Union. Regulation EU 2017/746 of the European Parliament and the council. Regulation (EU) 2017/746 Official Journal of the European Communities, 2017.Search in Google Scholar
20. U.S. Food and Drugs Administration. Code of federal regulations. In: Department of Health and Human Services, Title 21, Volume 7. U.S. Food and Drugs Administration, 2019.Search in Google Scholar
21. NRL Australia. QC investigations. https://www.nrlquality.org.au/qc-investigations. Accessed 24 November 2019.Search in Google Scholar
©2020 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- Quality controls for serology: an unfinished agenda
- A modern and pragmatic definition of Laboratory Medicine
- Reviews
- Blood biochemical characteristics of patients with coronavirus disease 2019 (COVID-19): a systemic review and meta-analysis
- ISO/TS 20914:2019 – a critical commentary
- Mini Review
- Reporting of D-dimer data in COVID-19: some confusion and potential for misinformation
- Opinion Paper
- Implementation of metrological traceability in laboratory medicine: where we are and what is missing
- IFCC Recommendation
- Recommendation for performance verification of patient-based real-time quality control
- Genetics and Molecular Diagnostics
- Comparison of BCR-ABL1 quantification in peripheral blood and bone marrow using an International Scale-standardized assay for assessment of deep molecular response in chronic myeloid leukemia
- General Clinical Chemistry and Laboratory Medicine
- Risk assessment of the total testing process based on quality indicators with the Sigma metrics
- Determination of hemolysis cut-offs for biochemical and immunochemical analytes according to their value
- A computer model for professional competence assessment according to ISO 15189
- Traceability validation of six enzyme measurements on the Abbott Alinity c analytical system
- Evaluating the need for free glycerol blanking for serum triglyceride measurements at Charlotte Maxeke Johannesburg Academic Hospital
- Challenges of LC-MS/MS ethyl glucuronide analysis in abstinence monitoring of liver transplant candidates
- Changes in the result of antinuclear antibody immunofluorescence assay on HEp-2 cells reflect disease activity status in systemic lupus erythematosus
- Reference Values and Biological Variations
- Long-term biological variation estimates of 13 hematological parameters in healthy Chinese subjects
- Age-specific reference values improve the diagnostic performance of AMH in polycystic ovary syndrome
- Establishment of reference intervals for immunoassay analytes of adult population in Saudi Arabia
- Hematology and Coagulation
- Total haemoglobin – a reference measuring system for improvement of standardisation
- Laboratory testing for activated protein C resistance: rivaroxaban induced interference and a comparative evaluation of andexanet alfa and DOAC Stop to neutralise interference
- Cancer Diagnostics
- Identification of a four-gene methylation biomarker panel in high-grade serous ovarian carcinoma
- Performance comparison of two next-generation sequencing panels to detect actionable mutations in cell-free DNA in cancer patients
- Diabetes
- Availability and analytical quality of hemoglobin A1c point-of-care testing in general practitioners’ offices are associated with better glycemic control in type 2 diabetes
- Infectious Diseases
- Validation of a chemiluminescent assay for specific SARS-CoV-2 antibody
- Dynamic profile and clinical implications of hematological parameters in hospitalized patients with coronavirus disease 2019
- Does a change in quality control results influence the sensitivity of an anti-HCV test?
- Letters to the Editor
- Variability between testing methods for SARS-CoV-2 nucleic acid detection 16 days post-discharge: a case report
- L-index, more than a screening tool for hypertriglyceridemia
- Neutralization of biotin interference: preliminary evaluation of the VeraTest Biotin™, VeraPrep Biotin™ and BioT-Filter®
- Counting and reporting band count is unreliable practice due to the high inter-observer variability
- Cigarette smoking prior to blood sampling acutely affects serum levels of the chronic obstructive pulmonary disease biomarker surfactant protein D
- How reliable is the detection of anti-mitochondrial antibodies on murine triple-tissue?
- Further advices on measuring lipoprotein(a) for reducing the residual cardiovascular risk on statin therapy
Articles in the same Issue
- Frontmatter
- Editorial
- Quality controls for serology: an unfinished agenda
- A modern and pragmatic definition of Laboratory Medicine
- Reviews
- Blood biochemical characteristics of patients with coronavirus disease 2019 (COVID-19): a systemic review and meta-analysis
- ISO/TS 20914:2019 – a critical commentary
- Mini Review
- Reporting of D-dimer data in COVID-19: some confusion and potential for misinformation
- Opinion Paper
- Implementation of metrological traceability in laboratory medicine: where we are and what is missing
- IFCC Recommendation
- Recommendation for performance verification of patient-based real-time quality control
- Genetics and Molecular Diagnostics
- Comparison of BCR-ABL1 quantification in peripheral blood and bone marrow using an International Scale-standardized assay for assessment of deep molecular response in chronic myeloid leukemia
- General Clinical Chemistry and Laboratory Medicine
- Risk assessment of the total testing process based on quality indicators with the Sigma metrics
- Determination of hemolysis cut-offs for biochemical and immunochemical analytes according to their value
- A computer model for professional competence assessment according to ISO 15189
- Traceability validation of six enzyme measurements on the Abbott Alinity c analytical system
- Evaluating the need for free glycerol blanking for serum triglyceride measurements at Charlotte Maxeke Johannesburg Academic Hospital
- Challenges of LC-MS/MS ethyl glucuronide analysis in abstinence monitoring of liver transplant candidates
- Changes in the result of antinuclear antibody immunofluorescence assay on HEp-2 cells reflect disease activity status in systemic lupus erythematosus
- Reference Values and Biological Variations
- Long-term biological variation estimates of 13 hematological parameters in healthy Chinese subjects
- Age-specific reference values improve the diagnostic performance of AMH in polycystic ovary syndrome
- Establishment of reference intervals for immunoassay analytes of adult population in Saudi Arabia
- Hematology and Coagulation
- Total haemoglobin – a reference measuring system for improvement of standardisation
- Laboratory testing for activated protein C resistance: rivaroxaban induced interference and a comparative evaluation of andexanet alfa and DOAC Stop to neutralise interference
- Cancer Diagnostics
- Identification of a four-gene methylation biomarker panel in high-grade serous ovarian carcinoma
- Performance comparison of two next-generation sequencing panels to detect actionable mutations in cell-free DNA in cancer patients
- Diabetes
- Availability and analytical quality of hemoglobin A1c point-of-care testing in general practitioners’ offices are associated with better glycemic control in type 2 diabetes
- Infectious Diseases
- Validation of a chemiluminescent assay for specific SARS-CoV-2 antibody
- Dynamic profile and clinical implications of hematological parameters in hospitalized patients with coronavirus disease 2019
- Does a change in quality control results influence the sensitivity of an anti-HCV test?
- Letters to the Editor
- Variability between testing methods for SARS-CoV-2 nucleic acid detection 16 days post-discharge: a case report
- L-index, more than a screening tool for hypertriglyceridemia
- Neutralization of biotin interference: preliminary evaluation of the VeraTest Biotin™, VeraPrep Biotin™ and BioT-Filter®
- Counting and reporting band count is unreliable practice due to the high inter-observer variability
- Cigarette smoking prior to blood sampling acutely affects serum levels of the chronic obstructive pulmonary disease biomarker surfactant protein D
- How reliable is the detection of anti-mitochondrial antibodies on murine triple-tissue?
- Further advices on measuring lipoprotein(a) for reducing the residual cardiovascular risk on statin therapy
