Zheng Yulan, Chen Yao, Qiu Xiaolong, Chen Weifen, Lin Qingying, Zeng Yinglin, Zhao Hong, Zhu Wenbin
Department of Pharmacy.
Neonatal Screening Center, Fujian Provincial Maternity and Children's Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.
Medicine (Baltimore). 2019 May;98(19):e15500. doi: 10.1097/MD.0000000000015500.
It is required that the clinical screening of metabolic disorders in newborns meet International Organization for Standardization 15189-2012 approval. The new tandem mass spectrometry (MS/MS) based screening system and its companion reagent should be independently authenticated before their implementation in clinical diagnosis laboratories.Linearity, stability, accuracy, and precision evaluations were carried out to verify the performance of the Waters ACQUITY TQD MS/MS system with the NeoBase non-derivatized MS/MS PerkinElmer kit for detecting amino acids and acylcarnitine in newborns with metabolic disorders.Statistically, the correlation coefficient (R) of 0.9982 to 0.9999 indicates good linearity. The measurements at the beginning and end of the reagent storage procedure were taken for stability verification. No significant difference was detected between the 2 periods. The amino acid exhibited a degree of bias in the range of 0% to 14.17%, with acylcarnitine's being was in the range of 0% to 14.84%; they consequently passed the quality assessment requirements for clinical laboratories of the China National Centre. The amino acids' within-run, between-run, and day-to-day run precision were 1.19% to 7.68%, 1.63% to 5.01%, and 4.77% to 12.48%, respectively, while the total imprecision was 5.55% to 13.33%. Acylcarnitine's within-run, between-run, and day-to-day run precision was 1.2% to 8.43%, 0.19% to 9.60%, and 2.33% to 10.74%, respectively, while it's total imprecision was 6.57% to 13.99%. The manufacturer declared that the total imprecision of the tests, using Multiple Reaction Monitoring, should be less than or equal to 25% of the coefficient of variation for the kit's high and low-quality control levels.The performance of the non-derivatized MS/MS screening system in detecting the amino acids and acylcarnitines passed the test's requirements. It was maintained in accordance with the routine clinical chemical detection system.
要求新生儿代谢紊乱的临床筛查需符合国际标准化组织15189 - 2012认可标准。新的基于串联质谱（MS/MS）的筛查系统及其配套试剂在临床诊断实验室实施前应进行独立验证。进行了线性、稳定性、准确性和精密度评估，以验证沃特世ACQUITY TQD MS/MS系统与珀金埃尔默NeoBase非衍生化MS/MS试剂盒用于检测患有代谢紊乱新生儿的氨基酸和酰基肉碱的性能。从统计学角度看，相关系数（R）在0.9982至0.9999之间表明线性良好。在试剂储存过程开始和结束时进行测量以验证稳定性。两个时期之间未检测到显著差异。氨基酸的偏差程度在0%至14.17%之间，酰基肉碱的偏差程度在0%至14.84%之间；因此它们通过了中国国家中心临床实验室的质量评估要求。氨基酸的批内、批间和日间精密度分别为1.19%至7.68%、1.63%至5.01%和4.77%至12.48%，而总不精密度为5.55%至13.33%。酰基肉碱的批内、批间和日间精密度分别为1.2%至8.43%、0.19%至9.60%和2.33%至10.74%，而其总不精密度为6.57%至13.99%。制造商宣称，使用多反应监测进行测试的总不精密度应小于或等于试剂盒高、低质量控制水平变异系数的25%。非衍生化MS/MS筛查系统在检测氨基酸和酰基肉碱方面的性能通过了测试要求。它按照常规临床化学检测系统进行维护。
