Imprecision Investigation and Analysis for Neonatal Screening in China - Phenylalanine and Thyroid Stimulating Hormone.
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.
Xiaoyan
X
Zhang
Shishi
S
Zhang
Wei
W
Wang
Falin
F
He
Kun
K
Zhong
Shuai
S
Yuan
Zhiguo
Z
Wang
D015415:Biomarkers / Q000097:blood; D001774:Blood Chemical Analysis; D002681:China; D006801:Humans; D007231:Infant, Newborn; D059021:Laboratory Proficiency Testing; D015997:Neonatal Screening / Q000379:methods*; D015588:Observer Variation; D010649:Phenylalanine / Q000097:blood*; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D013972:Thyrotropin / Q000097:blood*
D015415:Biomarkers; D010649:Phenylalanine; D013972:Thyrotropin