Department of Medical Research and Education, Taipei Veterans General Hospital, No. 201, Sec 2, Shih-Pai Rd, Taipei 112, Taiwan.
Ann Acad Med Singap. 2008 Dec;37(12 Suppl):84-4.
The nationwide neonatal screening for glucose-6-phosphate dehydrogenase (G6PD) deficiency in Taiwan was started on 1 July 1987. A network of G6PD referral hospitals distributed all around Taiwan was organised for follow-up, confirmatory testing, medical care and genetic counselling. To assess the reliability of confirmatory and screening tests, an external quality assurance (QA) programme for G6PD assay was developed.
Lyophilised quality control (QC) materials and dried blood spots were prepared from erythrocytes and whole blood for confirmatory and screening tests, respectively. The external QA surveys were carried out every 1 to 2 months. The QA results were evaluated and compared to the consensus result and reference value. The test results were submitted through internet by participating laboratories and the summary reports were published on a webpage (http:// www.g6pd.tw) within 2 weeks.
Twenty-one referral laboratories in Taiwan and 16 screening laboratories in Germany, Lebanon, Mainland China, Philippines, Thailand, Taiwan, Turkey, and Vietnam have been participating in the QA programme. From 1988 to 2007, 144 QA surveys for confirmatory testing were sent to referral laboratories. Among the 2,622 reports received, 292 (11.1%) were found to be abnormal. Interlaboratory coefficient of variation (CV) for the confirmatory test has reached below 10% in recent years. The significant improvement in interlaboratory CV was found to be correlated with the preventive site visits to the referral laboratories since November 2004. From 1999 to 2007, 52 external QA surveys for the screening test were performed. Among 504 reports received, 97 (19.2%) were found to be abnormal. From the 5040 blood spots tested by the screening laboratories, 95 false negative (1.9%) and 187 false positive (3.7%) results were reported.
The external QA programme has been useful for monitoring the performance of the referral hospitals and screening laboratories and helpful for the participating laboratories to improve their test quality.
台湾于 1987 年 7 月 1 日开始对葡萄糖-6-磷酸脱氢酶（G6PD）缺乏症进行全国性新生儿筛查。在台湾各地组织了 G6PD 转诊医院网络，以进行随访、确认检测、医疗保健和遗传咨询。为了评估确认和筛查试验的可靠性，开发了 G6PD 测定的外部质量保证（QA）计划。
为确认和筛查试验分别从红细胞和全血制备冻干质控（QC）材料和干血斑。每 1 至 2 个月进行一次外部 QA 调查。评估 QA 结果并与共识结果和参考值进行比较。参与实验室通过互联网提交测试结果，在两周内将汇总报告发布在网页上（http://www.g6pd.tw）。
台湾的 21 家转诊实验室和德国、黎巴嫩、中国大陆、菲律宾、泰国、台湾、土耳其和越南的 16 家筛查实验室参加了 QA 计划。从 1988 年到 2007 年，向转诊实验室发送了 144 次确认检测 QA 调查。在收到的 2622 份报告中，发现 292 份（11.1%）异常。近年来，确认试验的实验室间变异系数（CV）达到 10%以下。自 2004 年 11 月以来，对转诊实验室进行预防性现场访问后，发现实验室间 CV 的显著改善与这一发现相关。从 1999 年到 2007 年，进行了 52 次筛查试验的外部 QA 调查。在收到的 504 份报告中，发现 97 份（19.2%）异常。在筛查实验室检测的 5040 个血斑中，报告了 95 个假阴性（1.9%）和 187 个假阳性（3.7%）结果。
外部 QA 计划有助于监测转诊医院和筛查实验室的表现，并有助于参与实验室提高测试质量。
