Evaluation of blood lead measurements by the 6-year external quality assessment program in China

Background: Blood lead is an important clinical indicator. A typical tool for promoting standardisation or harmonisation is external quality assessment (EQA). Therefore, the National Centre for Clinical Laboratories (NCCL) in China launched the EQA Program for blood lead measurement in 2006 to assess its standardisation process. Methods: Blood lead EQA samples tested for homogeneity and stability were sent to participating laboratories. The return data were grouped according to the detection method. The robust mean value, robust coefficient of variation (CV) and standard uncertainty were calculated according to ISO 13528. The evaluation criteria were determined based on a thorough analysis of the previous pass rate and the current detection level. Overall trends in the blood lead EQA program over 6 years were investigated by calculating the pass rates of participating laboratories. We compared the pass rates and current issues of different detection methods and analysed the target values, bias and CV results of mainstream detection methods. Results: A total of 4,283 laboratories participated in EQA programs from 2017 to 2022. The pass rates were generally increasing while the inter-laboratory mean CVs were decreasing. For samples with varying concentrations, the higher the concentration, the smaller the CV. According to the evaluation criteria, the most used measurement methods, Graphite Furnace Atomic Absorption Spectrometry (GFAAS) and Tungsten Ship Atomic Absorption Spectrometry (TSAAS) demonstrated better performances than Differential Potentiometric Stripping (DPS), Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Flame Atomic Absorption Spectrometry (FAAS). Furthermore, DPS, ICP-MS and FAAS outperformed Anodic Stripping Voltammetry (ASV).Conclusion: Our study provides reliable information on the standardisation of blood lead measurement procedures for manufacturers and clinical laboratories. Further improvements for standardisation are still required to make laboratories more patient-centred.

Automated summary

The National Centre for Clinical Laboratories (NCCL) in China launched the EQA Program for blood lead measurement in 2006 to assess its standardisation process. The results showed that the pass rates of participating laboratories gradually increased over six years, while the inter-laboratory mean CVs decreased. Graphite Furnace Atomic Absorption Spectrometry (GFAAS) and Tungsten Ship Atomic Absorption Spectrometry (TSAAS) demonstrated better performances compared to other detection methods.