Prenatal Screening for Trisomy 21 - Recent Advances and ：21三体综合征的最新进展及产前筛查.pptVIP

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Prenatal Screening for Trisomy 21 - Recent Advances and ：21三体综合征的最新进展及产前筛查.ppt

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Prenatal Screening for Trisomy 21 - Recent Advances and ：21三体综合征的最新进展及产前筛查

Epidemiological monitoring is a subjective process that uses objective criteria as a guide. One must consider test volume to determine the appropriate monitoring interval. We have had the problem of sonographers that perform so few scans that it is impossible to monitor their data for very long periods of time. Is this acceptable? Another difficulty has been trying to predict or explain sudden shifts in median data in order to react appropriately. For example, with a serum marker reagent lot change we know to look carefully for median stability. When dealing with NT measurement, sonographers work outside of the lab, may not be easy to reach, and may change affiliation or add new personnel without notifying the lab. Communication with sonography centers and staff members is a critical component to successful quality control of NT and something new to screening laboratories. 1st trim. marker Median MoM NT 2.17 PAPP-A 0.20 Free b-hCG 0.25 Trisomy 18: Marker Levels GE Palomaki 2011, analysis of published literature 2nd trim. marker Median MoM AFP 0.66 uE3 0.36 hCG 0.39 inhA 0.88 PAPP-A 0.10 Modeled Performance Test DR for 0.1% FPR DR for 0.5% FPR 2nd trim. triple 72 82 1st trim. combined 80 90 Serum integrated 80 89 Full integrated 90 95 Trisomy 18: Screening Performance GE Palomaki 2011, unpublished Actual Performance Based on clinical trial data, the observed screen positive rate in practice will be higher than the modeling suggests. Trisomy 13 2nd trimester markers are not informative. 1st trimester markers are informative. Their pattern is similar to that found in trisomy 18. But, published data on trisomy 13 marker levels are biased and too small to estimate their levels with accuracy. It is reasonable to assume that the majority of trisomy 13 cases will be identified as part of current trisomy 18 screening protocols that include 1st trimester markers. Laboratory Issues in Prenatal Screening Serum marker assays Free b-hCG or total b-hCG in the