National Program for External Quality Assessment of Chinese Newborn Screening Laboratories

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

doi:10.3390/ijns6020038

Cited by 3 publications

(3 citation statements)

References 8 publications

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“…There are several recent reports related to expanded NBS with MS/MS: an evaluation of MS/MS implementation in Suqian city (North) [ 447 ]; analyses of the cost effectiveness of ENBS in Shenzhen (South) [ 448 ] and Zhejiang province (East) [ 449 ]; and studies to determine the disease spectrum and genetic characteristics of IEMs detected by ENBS in Xi’an city (Northwest) [ 450 ] and Changsha (Central) [ 451 ]. A robust system-wide quality management system exists including both laboratories (National Center for Clinical Laboratories) [ 452 ] and non-laboratory components [ 453 ], sometimes augmented by regional quality improvement activities [ 454 ]. A large study was reported in 2021 that determined normal ranges for 35 MS/MS conditions in the Chinese newborn population [ 455 ].…”

Section: Resultsmentioning

confidence: 99%

Current Status of Newborn Bloodspot Screening Worldwide 2024: A Comprehensive Review of Recent Activities (2020–2023)

Therrell,

Padilla,

Borrajo

et al. 2024

IJNS

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Newborn bloodspot screening (NBS) began in the early 1960s based on the work of Dr. Robert “Bob” Guthrie in Buffalo, NY, USA. His development of a screening test for phenylketonuria on blood absorbed onto a special filter paper and transported to a remote testing laboratory began it all. Expansion of NBS to large numbers of asymptomatic congenital conditions flourishes in many settings while it has not yet been realized in others. The need for NBS as an efficient and effective public health prevention strategy that contributes to lowered morbidity and mortality wherever it is sustained is well known in the medical field but not necessarily by political policy makers. Acknowledging the value of national NBS reports published in 2007, the authors collaborated to create a worldwide NBS update in 2015. In a continuing attempt to review the progress of NBS globally, and to move towards a more harmonized and equitable screening system, we have updated our 2015 report with information available at the beginning of 2024. Reports on sub-Saharan Africa and the Caribbean, missing in 2015, have been included. Tables popular in the previous report have been updated with an eye towards harmonized comparisons. To emphasize areas needing attention globally, we have used regional tables containing similar listings of conditions screened, numbers of screening laboratories, and time at which specimen collection is recommended. Discussions are limited to bloodspot screening.

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Section: Resultsmentioning

confidence: 99%

Current Status of Newborn Bloodspot Screening Worldwide 2024: A Comprehensive Review of Recent Activities (2020–2023)

Therrell,

Padilla,

Borrajo

et al. 2024

IJNS

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“…To ensure the quality of screening, the National Center of Clinical Laboratory (NCCL) of China requires all NBS laboratories to participate in the Newborn Screening Quality Assurance Program (NSQAP). 4,5 By providing plans for internal quality control (IQC) and external quality assessment (EQA), the NSQAP ensures testing accuracy in all screening laboratories. NBS is a complex system comprising more than only laboratory testing.…”

Section: Introductionmentioning

confidence: 99%

Improving quality management of newborn screening in southwest China

Wan

et al. 2021

J Int Med Res

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Objective Newborn screening (NBS) programs benefit tens of millions of infants worldwide each year. However, the extremely large screening populations and number of laboratories involved pose great challenges to maintaining high screening quality. To achieve continuous quality improvement, we established a comprehensive quality management system (CQMS) in southwest China. Methods External quality assessment (EQA) and internal quality control were carried out for basic quality management. We used 16 quality indicators (QIs) to monitor the entire screening process, with external supervision from the China National Accreditation Service for Conformity Assessment. All retrospective data for quality assessment were collected consecutively from laboratory management and patient follow-up systems. Results From 2015 to 2019, satisfactory EQA performance was achieved, with an average score greater than 97 for each screening item. QI monitoring showed that NBS quality improved continuously. The rate of health education provision increased from 90.9% to 100% and the recall rate after a positive primary screening increased from 85.4% to 99.2%. The unsatisfactory specimen rate and rate of newborns lost to follow-up decreased to 0.38% and 0.08%, respectively. Conclusions Implementing a CQMS and monitoring the whole screening process using QIs may yield continuous quality improvement of NBS.

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“…However, in mainland China, there are still disputes on the utilization cut-off value for the PKU screening, as different cut-off values are used in various regions. [10][11][12] In this study, we aimed to optimize the cut-off value in Xinjiang Uygur Autonomous Region based on the Phe screening results. Our study contributed to the PKU screening based on the Phe concentration.…”

mentioning

confidence: 99%

Optimization of Phenylalanine Cut-Off Value in Newborn Screening Based on Blood Sampling Time

Liu

Jin

et al. 2022

Am J Perinatol

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Objective The aim of this study was to optimize the cut-off value of phenylalanine (Phe) for phenylketonuria (PKU) screening in Xinjiang Uygur Autonomous Region based on the time of blood sampling. Study Design In this study, 110,806 neonates born in 91 obstetrics and gynecology hospitals of Xinjiang Uygur Autonomous Region between June 2017 and December 2019 were divided into two groups (i.e., groups 1 and 2) based on the sampling time. The concentration of Phe was determined using fluorimetric method. The optimization of the Phe cut-off value was conducted using the receiver operating characteristic curve from the treating set involving 80,354 neonates. Then, the diagnostic values of the optimized Phe cut-off value were evaluated using validation set involving 30,452 neonates, based on the comparison of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) obtained from conventional cut-off value. Results A range of cut-off values was used for preliminary Phe concentrations in the two groups to analyze the sensitivity, specificity, PPV, and NPV. The optimized cut-off value of Phe in group 1 was 2.0, while that in the group 2 was 2.21. A comparison was given to PPV, NPV, sensitivity, and specificity generated by the optimized cut-off value and the conventional cut-off value, which yielded similar sensitivity, specificity, and PPV, and less recalled number of samples. Conclusion The optimization of cut-off value of Phe based on sampling time is feasible for PKU screening in Xinjiang Uygur Autonomous Region. In addition, the false positive rate was significantly reduced, which may save more efforts in sample recalling process. Key Points

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National Program for External Quality Assessment of Chinese Newborn Screening Laboratories

Cited by 3 publications

References 8 publications

Current Status of Newborn Bloodspot Screening Worldwide 2024: A Comprehensive Review of Recent Activities (2020–2023)

Current Status of Newborn Bloodspot Screening Worldwide 2024: A Comprehensive Review of Recent Activities (2020–2023)

Improving quality management of newborn screening in southwest China

Optimization of Phenylalanine Cut-Off Value in Newborn Screening Based on Blood Sampling Time

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