Abstract
IntroductionThis survey was initiated to obtain knowledge on the current situation of internal quality control (IQC) practice for tumour markers (TMs) in China. Additionally, we tried to acquire the most appropriate quality specifications.Materials and methodsThis survey was a current status survey. The IQC information had been collected via online questionnaires. All of 1821 clinical laboratories which participated in the 2016 TMs external quality assessment (EQA) programme had been enrolled. The imprecision evaluation criteria were the minimal, desirable, and optimal allowable imprecisions based on biological variations, and 1/3 total allowable error (TEa) and 1/4 TEa.ResultsA total of 1628 laboratories answered the questionnaires (89%). The coefficients of variation (CVs) of the IQC of participant laboratories varied greatly from 1% (5th percentile) to 13% (95th percentile). More than 82% (82 - 91%) of participant laboratories two types of CVs met 1/3 TEa except for CA 19-9. The percentiles of current CVs were smaller than cumulative CVs. A number of 1240 laboratories (76%) reported their principles and systems used. The electrochemiluminescence was the most used principle (45%) and had the smallest CVs.ConclusionsThe performance of laboratories for TMs IQC has yet to be improved. On the basis of the obtained results, 1/3 TEa would be realistic and attainable quality specification for TMs IQC for clinical laboratories in China.
Highlights
This survey was initiated to obtain knowledge on the current situation of internal quality control (IQC) practice for tumour markers (TMs) in China
Data, and the CVs are compared with different quality specifications
There are several standards which could be used to evaluate the CVs of IQC, such as the specifications based on biological variations including the minimal, desirable, and optimal allowable imprecisions, and 1/3 total allowable error (TEa) and 1/4 TEa
Summary
This survey was initiated to obtain knowledge on the current situation of internal quality control (IQC) practice for tumour markers (TMs) in China. The diagnosis of cancer is mostly confirmed by biopsy which has been considered as “gold standard” for a long time, tumour markers (TMs) have an important role in staging and treatment of the cancer [1]. Internal quality control (IQC) plays a significant role in the routine practice of clinical laboratories. The central role of IQC is to detect clinically important errors and evaluate repeatability in the analytical process.
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