Performance Assessment of Internal Quality Control (IQC) Products in Blood Transfusion Compatibility Testing in China

PLoS One. 2015 Oct 21;10(10):e0141145. doi: 10.1371/journal.pone.0141145. eCollection 2015.

Abstract

Internal quality control (IQC) is a critical component of laboratory quality management, and IQC products can determine the reliability of testing results. In China, given the fact that most blood transfusion compatibility laboratories do not employ IQC products or do so minimally, there is a lack of uniform and standardized IQC methods. To explore the reliability of IQC products and methods, we studied 697 results from IQC samples in our laboratory from 2012 to 2014. The results showed that the sensitivity and specificity of the IQCs in anti-B testing were 100% and 99.7%, respectively. The sensitivity and specificity of the IQCs in forward blood typing, anti-A testing, irregular antibody screening, and cross-matching were all 100%. The reliability analysis indicated that 97% of anti-B testing results were at a 99% confidence level, and 99.9% of forward blood typing, anti-A testing, irregular antibody screening, and cross-matching results were at a 99% confidence level. Therefore, our IQC products and methods are highly sensitive, specific, and reliable. Our study paves the way for the establishment of a uniform and standardized IQC method for pre-transfusion compatibility testing in China and other parts of the world.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Blood Cells / cytology
  • Blood Transfusion / standards*
  • China
  • Hematologic Tests / trends*
  • Humans
  • Laboratories / standards*
  • Quality Control
  • Reproducibility of Results
  • Sensitivity and Specificity

Grants and funding

This work was supported by the National Natural Science Foundation of China (81101318), the Science and Technology Project of Chongqing Municipal Education Commission (KJ1400202). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.