Evaluation on China National External Quality Assessment for Neonatal Screening Laboratory in 2001

Objective To evaluate the compentence of phenylalanine(Phe) and thyrotropin (TSH) measurement in neonatal screening laboratory by use of establishment of national external quality assessment(EQA) in neonatal screening laboratory.Methods National external quality assessment scheme in measurement of phenylalanine (Phe) and thyrotropin (TSH) is established in newbom screening laboratory according to US CDC neonatal screening quality assurance program.Five dry-blood spots are distributed by EQA organizer to participating laboratory each time,and 3 times each year, After performing the requested tests,laboratories return their results to the EQA organizer,and a statistical analysis is performed to determine global and method-specific means and standard deviations of results for each analyse as well as performance assessment of individual laboratories.Results Twenty nine laboratories participate the EQA scheme in neonatal screening in 2001.The methods of TSH:Time-resolved immunofurometric assay (DELIA) (48.1%),average of interlaboratory coefficient of variation( C\-\{Inter\} ) is 12.2%;ELISA (29.6%), CV\-\{Inter\} is 33.5%;fluorometric enzyme immunoassay (22.2%), CV\-\{Inter\} is 35.9%.The methods of Phe:bacteria inhibition assay (58.6%), CV\-\{Inter\} is 23.8%;fluorometric assay (41.4%), CV\-\{Inter\} is 15.4%.Conclusion The recommended external quality assessment is useful to find out the problems in the Phe and TSH measurement and improve the quality of neonatal screening laboratory.