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目的 探讨新生儿筛查滤纸干血样法检测过程中 ,可能影响促甲状腺素 (TSH)及苯丙氨酸 (phe)测定结果的因素 ,以建立有效的改进措施。方法 观察采血时间等因素对酶免疫标记法(BA ELISA)和细菌抑制法结果的影响 ,观察其变化规律。结果 新生儿筛查试验影响因素众多 ,TSH测定 :72h后采血结果稳定 ,季节间TSH水平有差异 ,应选择不同的适宜的筛查临界值 ;滤纸血样自然干燥易于洗脱 ;于干血样 1/ 4处取样结果近于靶值 ;BA ELISA洗脱 4～ 5h效果较好。phe测定 :72h后采血可减少假阳性 ;制板温度以 5 5～ 6 0℃为宜 ,加血样间距不宜过密。结论 采血时间、临界值、血片处理等因素影响筛查结果 ,选择最佳实验条件 ,能较好保证新生儿筛查试验质量
Objective To explore the factors that may affect the determination of thyroid-stimulating hormone (TSH) and phenylalanine (phe) in the process of testing newborn screening filter paper dry blood samples, in order to establish effective measures for improvement. Methods The effects of blood sampling time and other factors on the results of enzyme-linked immunosorbent assay (BA ELISA) and bacterial inhibition were observed. Results There were many influencing factors in neonatal screening test. TSH assay showed stable blood sampling after 72h, different TSH levels in different seasons, different suitable screening thresholds should be selected, filter paper blood samples were easy to elute in natural drying, 4 samples near the target value; BA ELISA elution 4 ~ 5h better. Phe determination: 72h after blood can reduce false positive; plate temperature to 5 5 ~ 6 0 ℃ is appropriate, plus blood samples should not be too close spacing. Conclusion The time of blood collection, the critical value and the blood chip treatment affect the screening results. Selecting the best experimental conditions can better ensure the quality of neonatal screening test