Recommendations for proficiency testing criteria for hemoglobin A1c based on the Shanghai Center for Clinical Laboratory’s study
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Yi Ju
,
Qing Li
Abstract
Objectives
The US Centers for Medicare & Medicaid Services proposed in 2019 that glycated hemoglobin A1c (HbA1c) be a CLIA′88 regulated analyte. People who commented expressed concerns that the proposed acceptance limit (AL, HbA1c in NGSP unit) ±10% for proficiency testing (PT) would be unable to maintain already improved analytical performance and guarantee the clinical utility of HbA1c testing. Assessing impact of various ALs on PT performance is needed to provide scientific evidence for adopting an appropriate AL.
Methods
Ten patient EDTA-whole blood specimens were distributed to 318 and 336 laboratories in the 2018 and 2019 PT events organized by Shanghai Center for Clinical Laboratory (SCCL). HbA1c concentrations were measured by participants using various methodologies commonly used in the USA and China. Targets were determined using secondary reference measurement procedures (SRM) at SCCL. “Failed Results” were those outside the SRM-defined target ± AL (5% through 10%). Laboratories with Failed Results ≥2 out of five samples per PT event obtained Event Unsatisfactory Status.
Results
HbA1c target values ranged 33.3 mmol/mol (5.2 NGSP%) −102.2 mmol/mol (11.5 NGSP%) for 2018 event, and 33.3 mmol/mol (5.2 NGSP%) −84.7 mmol/mol (9.9 NGSP%) for 2019 event. Overall Laboratory Event Unsatisfactory Rates were 11.3–12.2%, 4.8–5.3%, 0.9–3.1%, 0.6–2.2%, 0.6–1.4% and 0.6–1.4%, at AL of ±5, ±6, ±7, ±8, ±9 and ±10%, respectively.
Conclusions
The AL (in NGSP unit) of ±6% or ±7% for PT evaluation of HbA1c results would be appropriate, with satisfactory event scores for about 95% of participant laboratories in a PT event.
Funding source: Shanghai Natural Science Foundation
Award Identifier / Grant number: (19ZR1445600)
Funding source: National Key Research and Development Program of China
Award Identifier / Grant number: (2019YFF0216500)
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Research funding: Yi Ju is supported by Shanghai Natural Science Foundation (19ZR1445600) and National Key Research and Development Program of China (2019YFF0216500).
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Author contributions: Y.J. contributed inception of the study, analysis of the data and preparation of the manuscript. Z.C. contributed to the design of the study, interpretation of data, literature search, preparation and revision of the manuscript. Q.L. performed data analysis. L. T. implemented PT activities. Y.O. collected and processed data of PT participant laboratories. X.Y. prepared PT materials and samples. W.L. performed IFCC SRM analysis. 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.
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Disclaimer: Use of trade names and commercial sources is for identification only and does not constitute endorsement by the Wadsworth Center of the New York State Department of Health, and the Upstate Medical University.
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- Frontmatter
- Editorial
- Ageing, ACE2 deficiency and bad outcome in COVID-19
- Review
- Harmonization status of procalcitonin measurements: what do comparison studies and EQA schemes tell us?
- Opinion Papers
- Role of ACE2 polymorphism in COVID-19: impact of age
- The importance of correct stratifications when comparing directly and indirectly estimated reference intervals
- General Clinical Chemistry and Laboratory Medicine
- The clinical laboratory: a decision maker hub
- Simultaneous measurement of 13 circulating vitamin D3 and D2 mono and dihydroxy metabolites using liquid chromatography mass spectrometry
- Cerebrospinal fluid hemoglobin levels as markers of blood contamination: relevance for α-synuclein measurement
- Novel severe traumatic brain injury blood outcome biomarkers identified with proximity extension assay
- Hemoglobin Yamagata [β132(H10)Lys→Asn; (HBB: c.399A>T)]: a mosaic to be put together
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- Pediatric reference interval verification for endocrine and fertility hormone assays on the Abbott Alinity system
- Hematology and Coagulation
- Neonatal lymphocyte subpopulations analysis and maternal preterm premature rupture of membranes: a pilot study
- Pro-coagulant imbalance in patients with community acquired pneumonia assessed on admission and one month after hospital discharge
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- Cardiovascular Diseases
- Exercise-induced changes in miRNA expression in coronary artery disease
- Diabetes
- Recommendations for proficiency testing criteria for hemoglobin A1c based on the Shanghai Center for Clinical Laboratory’s study
- Infectious Diseases
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- Hb Johnstown is detected on Mindray BC 6800 Plus analyzer
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- Development of chronic myeloid leukemia in a patient previously diagnosed with a JAK2-positive myeloproliferative neoplasm
- Acquired Pelger-Huet anomaly in two patients with chronic lymphocytic leukemia treated with venetoclax
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