Analytical performance specifications based on the state-of-the-art for the newborn screening

التفاصيل البيبلوغرافية
العنوان: Analytical performance specifications based on the state-of-the-art for the newborn screening
المؤلفون: José Luis Marín, Leonor Guiñón, Angel Molina, Judit García-Villoria, Anna Soler, L. Álvarez, R.M. López, Ángeles Sahuquillo
المصدر: Clinica Chimica Acta. 510:117-120
بيانات النشر: Elsevier BV, 2020.
سنة النشر: 2020
مصطلحات موضوعية: 0301 basic medicine, Free carnitine, Newborn screening, Percentile, Chromatography, medicine.diagnostic_test, Biochemistry (medical), Clinical Biochemistry, Infant, Newborn, Butyrylcarnitine, General Medicine, Laboratory Only, Glutarylcarnitine, Biochemistry, Total error, 03 medical and health sciences, Neonatal Screening, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, medicine, Humans, Immunoreactive trypsinogen, Laboratories, Mathematics
الوصف: Introduction For the measurands of the newborn screening (NBS), there are no analytical performance specifications (APS) available based on the Milan consensus Models. The objective is to provide total error (TE) APS based on the state-of-the-art (SOTA) for the NBS. Material and Methods 23,662 results were collected from the Spanish NBS EQA scheme between May 2015 and September 2018. Measurands included: thyroid-stimulating hormone (TSH), immunoreactive trypsinogen (IRT), phenylalanine (Phe), tyrosine (Tyr), free carnitine (C0), acetylcarnitine (C2), propionylcarnitine (C3), butyrylcarnitine (C4), isovalerylcarnitine (C5), glutarylcarnitine (C5DC), hexanoylcarnitine (C6), octanoylcarnitine (C8), decanoylcarnitine (C10), myristoylcarnitine (C14), palmitoylcarnitine (C16), stearoylcarnitine (C18). TE APS were calculated as the 90th percentile of the measurement errors, considering 75% of the best results from each laboratory only. It was also studied whether the analytical performance was concentration-dependent. Results When TE APS were calculated including all methods, TSH, IRT, C16 and C18 showed the best analytical performance and Phe, C5DC and C10 showed the worst. Generally, TE APS decreased when considering only majority methods and higher TE APS were obtained for lower concentrations. Discussion Due to the lack of APS based on superior models, the proposed TE APS based on the SOTA can help NBS laboratories to set quality specifications.
تدمد: 0009-8981
DOI: 10.1016/j.cca.2020.07.006
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a6479d991a01dfde8f6b11a1ce62ebf2
https://doi.org/10.1016/j.cca.2020.07.006
Rights: CLOSED
رقم الانضمام: edsair.doi.dedup.....a6479d991a01dfde8f6b11a1ce62ebf2
قاعدة البيانات: OpenAIRE
الوصف
تدمد:00098981
DOI:10.1016/j.cca.2020.07.006