2011Chinese Journal of Birth Health & HeredityRequires access

Evaluation on the external quality assessment of neonatal screening for 6 years.

He Jian‐Ping

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Abstract

Objective:To evaluate our results of external quality assessment(EQA)program of the newborn screening laboratory for 10 years,and summarize the problems in the screening measurement.Methods:The phenylalanine(Phe)and thyrotropin(TSH)values in dried blood spot specimens on filter paper distributed by national center were measured by fluorometrie method and fluorescence enzyme immunoassay(FEIA)respectively.The results sent by national center were analyzed.Results:In the 90 specimens of 18 batches,the bias range of TSH and Phe measurement was wide(-38.89%~44.44%and-29.63%~86.36%respectively) and their average values were 7.03%and 3.02%respectively;85 quantitative results of TSH and 86 quantitative results of Phe measurement were in the quality control,accounting for 94.44%(85/90)and 95.56%(86/90)respectively.The qualitative analysis of 88 TSH specimens and 87 Phe specimens conformed to the expected results,accounting for 97.8%(88/90)and 96.7%(87/90) respectively.The result of every batch was up to 80%.Conclusion: Our neonatal screening laboratory is in control and it is useful to attend the EQA program of national center to ensure the accuratissime of the detection and the stability of the analytical process in newborn screening.

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Objective:To evaluate our results of external quality assessment(EQA)program of the newborn screening laboratory for 10 years,and summarize the problems in the screening measurement.Methods:The phenylalanine(Phe)and thyrotropin(TSH)values in dried blood spot specimens on filter paper distributed by national center were measured by fluorometrie method and fluorescence enzyme immunoassay(FEIA)respectively.The results sent by national center were analyzed.Results:In the 90 specimens of 18 batches,the bias range of TSH and Phe measurement was wide(-38.89%~44.44%and-29.63%~86.36%respectively) and their average values were 7.03%and 3.02%respectively;85 quantitative results of TSH and 86 quantitative results of Phe measurement were in the quality control,accounting for 94.44%(85/90)and 95.56%(86/90)respectively.The qualitative analysis of 88 TSH specimens and 87 Phe specimens conformed to the expected results,accounting for 97.8%(88/90)and 96.7%(87/90) respectively.The result of every batch was up to 80%.Conclusion: Our neonatal screening laboratory is in control and it is useful to attend the EQA program of national center to ensure the accuratissime of the detection and the stability of the analytical process in newborn screening.

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Available abstract

Objective:To evaluate our results of external quality assessment(EQA)program of the newborn screening laboratory for 10 years,and summarize the problems in the screening measurement.Methods:The phenylalanine(Phe)and thyrotropin(TSH)values in dried blood spot specimens on filter paper distributed by national center were measured by fluorometrie method and fluorescence enzyme immunoassay(FEIA)respectively.The results sent by national center were analyzed.Results:In the 90 specimens of 18 batches,the bias range of TSH and Phe measurement was wide(-38.89%~44.44%and-29.63%~86.36%respectively) and their average values were 7.03%and 3.02%respectively;85 quantitative results of TSH and 86 quantitative results of Phe measurement were in the quality control,accounting for 94.44%(85/90)and 95.56%(86/90)respectively.The qualitative analysis of 88 TSH specimens and 87 Phe specimens conformed to the expected results,accounting for 97.8%(88/90)and 96.7%(87/90) respectively.The result of every batch was up to 80%.Conclusion: Our neonatal screening laboratory is in control and it is useful to attend the EQA program of national center to ensure the accuratissime of the detection and the stability of the analytical process in newborn screening.

Key concepts: External quality assessment, Newborn screening, Medicine, Immunoassay, Quality assessment, Pediatrics, Pathology, Immunology

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