National Program for External Quality Assessment of Chinese Newborn Screening Laboratories

Yuxuan Du; Wei Wang; Jiali Liu; Zhixin Zhang; Zhen Zhao; Falin He; Shuai Yuan; Zhiguo Wang

doi:10.3390/ijns6020038

National Program for External Quality Assessment of Chinese Newborn Screening Laboratories

Int J Neonatal Screen. 2020 May 9;6(2):38. doi: 10.3390/ijns6020038. eCollection 2020 Jun.

Authors

Yuxuan Du^{1

2

3}, Wei Wang^{1

2

3}, Jiali Liu^{1

2

3}, Zhixin Zhang^{1

2

3}, Zhen Zhao^{1

2

3}, Falin He^{1

2

3}, Shuai Yuan^{1

2

3}, Zhiguo Wang^{1

2

3}

Affiliations

¹ National Center for Clinical Laboratories, Beijing Hospital, Beijing 100730, China; [email protected] (Y.D.); [email protected] (W.W.); [email protected] (J.L.); [email protected] (Z.Z.); [email protected] (Z.Z.); [email protected] (F.H.); [email protected] (S.Y.).
² National Center of Gerontology, Beijing Hospital, Beijing 100730, China.
³ Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China.

Abstract

Objectives: To analyze the coefficient of variation (CV) of external quality assessment (EQA) in Chinese newborn screening (NBS) laboratories.

Method: EQA's robust CV was analyzed by the Clinet-EQA evaluation system.

Results: Participating laboratories of the EQA program increased annually. There was more than a 11-fold increase in phenylalanine (Phe) and thyroid stimulating hormone (TSH). It has shown a declining robust CV, which has tended to level off in recent years. The interquartile range (IQR) of Phe and TSH's robust CV has decreased from 15.5% to 1.5% and from 22.8% to 1.8%, respectively. Compared to bacterial inhibition assay (BIA), the robust CV of Phe has been shown to be relatively reduced in the fluorescence assay and quantitative enzymatic assay (QEA). The robust CV by ELISA was relatively unstable compared to DELFIA and FEIA. In addition, the robust CVs of glucose-6-phosphate dehydrogenase (G6PD) and 17-alpha-hydroxy progesterone (17-OHP) by Genetic Screening Processor (GSP) were lower than other systems. The median of robust CV by non-derivatized MS/MS (Fenghua) in Phe and free carnitine were around 2.2-4.7% and 2.6-5.2%.

Conclusion: Neonatal screening has developed rapidly in China and the majority of participant laboratories had satisfactory performance for the quantitative results.

Keywords: coefficient of variation; external quality assessment; newborn screening.