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Abstract

Imprecision Investigation and Analysis for Neonatal Screening in China - Phenylalanine and Thyroid Stimulating Hormone by Xiaoyan Zhang, Shishi Zhang, Wei Wang, Falin He, Kun Zhong, Shuai Yuan, Zhiguo Wang

Background: To investigate the current status of IQC practice of neonatal screening in China.
Methods: The IQC data of Phe and TSH testing were collected. Coefficient of variations (CVs) and cumulative CVs of every month in 2014 were compared with the 1/3 and 1/4 TEa.
Results: Of the 219 laboratories, the return rates ranged from 71.23% to 89.95% of 12 months in 2014. The rates of CVs for 2 lots less than 1/3 TEa were 60.27% and 68.78% (Phe), 67.05% and 65.68% (TSH); less than 1/4 TEa were 32.10% and 35.99% (Phe), 32.35% and 27.55% (TSH); rates of cumulative CVs less than 1/3 TEa were 57.89% and 65.98% (Phe), 61.21% and 60.93% (TSH); less than 1/4 TEa were 29.61% and 30.74% (Phe), 27.48% and 22.41% (TSH).
Conclusions: The testing capabilities and performances of neonatal screening laboratories can be objectively evaluated by the quality specifications of acceptable imprecision.

DOI: 10.7754/Clin.Lab.2016.160416