PerkinElmer Inc., Vanadis Diagnostics, Stockholm, Sweden.
PerkinElmer Inc., Waltham, MA, USA.
Acta Obstet Gynecol Scand. 2021 Aug;100(8):1497-1500. doi: 10.1111/aogs.14125. Epub 2021 Jun 10.
To evaluate the effect of repeating test failures using an automated, non-sequencing based non-invasive prenatal testing test on a general-risk population in Finland.
A total of 545 samples from women who represent the average-risk population in Oulu, Finland were analyzed with Vanadis non-invasive prenatal testing. Repeat testing of test failures was performed using a second sample. Results before and after repeat testing were compared with the reference outcome, as determined by clinical examination of neonates.
There were eight test failures after first-pass analysis, representing 1.5% of samples (95% CI 0.6%-2.9%). Seven out of eight failures could be resolved by analysis of a second sample, thereby reducing the test failure rate from 1.5% to 0.2% (95% CI 0.0%-1.0%).
Repeating test failures with a second plasma sample could significantly reduce the effective failure rate, thereby providing a way to effectively minimize test failures and further improving clinical utility and test performance.
评估在芬兰一般风险人群中使用基于自动化、非测序的无创性产前检测测试重复测试失败的效果。
使用 Vanadis 无创性产前检测对来自芬兰奥卢的代表一般风险人群的 545 个样本进行了分析。对测试失败的重复测试使用了第二个样本。将前后两次测试的结果与新生儿临床检查确定的参考结果进行了比较。
首次分析后有 8 个测试失败，占样本的 1.5%（95%CI 0.6%-2.9%）。8 个失败中有 7 个可以通过分析第二个样本得到解决，从而将测试失败率从 1.5%降低至 0.2%（95%CI 0.0%-1.0%）。
用第二个血浆样本重复测试失败可以显著降低有效失败率，从而提供了一种有效减少测试失败的方法，并进一步提高了临床实用性和测试性能。
