Application of genetic screening processor in screening neonatal glucose-6-phosphate dehydrogenase deficiency
| Autor: | Yu Zhang, Haixia Miao, Rulai Yang, Dingwen Wu, Rongqing Chen, Ting Zhang, Kexin Fang, Yezhen Shi, Xinwen Huang |
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| Rok vydání: | 2021 |
| Předmět: |
Male
Spectrum analyzer Percentile Accuracy and precision Coefficient of variation Population Glucosephosphate Dehydrogenase Neonatal Screening stomatognathic system Predictive Value of Tests medicine Humans Genetic Testing education education.field_of_study Chromatography business.industry Infant Newborn Relative bias General Medicine medicine.disease Glucosephosphate Dehydrogenase Deficiency Female False positive rate business Research Article Glucose-6-phosphate dehydrogenase deficiency |
| Zdroj: | Zhejiang Da Xue Xue Bao Yi Xue Ban |
| ISSN: | 1008-9292 |
| DOI: | 10.3724/zdxbyxb-2021-0275 |
| Popis: | OBJECTIVE: To evaluate the performance of genetic screening processor (GSP analyzer) in neonatal screening for glucose-6-phosphate dehydrogenase (G6PD)deficiency. METHODS: The accuracy and precision of GSP analyzer was evaluated with the control materials from National Center for Clinical Laboratories and the low and high quality G6PD control kit (fluorescence analysis). GSP analyzer and semi-automatic fluorescence immunoanalyzer (1420 analyzer) were simultaneously used to detect 2622 neonatal screening samples and 41 confirmed samples to analyze the correlation and consistency of the test results; 78 floating samples and 78 non-floating samples were detected to compare the result. A total of 1 100 384 neonatal screening samples from January 2017 to December 2018 and 855 856 neonatal screening samples from January 2019 to December 2020 were detected with 1420 analyzer and GSP analyzer, respectively. Referring to the percentile method and the expert consensus, the new cut-off value of GSP analyzer for G6PD deficiency in screening was established. RESULTS: The relative bias of GSP analyzer in detecting G6PD was 0.71%–4.23%; the intra assay precision was 4.34%–4.91%, the inter assay precision was 0.85%–2.12%, and the total coefficient of variation was 5.44%–5.72%. There was a significant positive correlation between G6PD activity detected by GSP analyzer and 1420 analyzer ( r=0.740, P0.05). The sensitivities of GSP analyzer and 1420 analyzer in screening G6PD deficiency were both 100.00%, and the specificities were both more than 99.80%. Compared with 1420 analyzer, the positive predictive value, positive rate and prevalence of G6PD deficiency detected by GSP analyzer were increased, and the false positive rate was decreased (all P |
| Databáze: | OpenAIRE |
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