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Evaluation of repeat testing of a non-sequencing based NIPT test on a Finnish general-risk population
Filip Karlsson1, Tarja Ahola1, Jenny Dahlberg1
1PerkinElmer Inc., Vanadis Diagnostics, Stockholm, Sweden.
Introduction:
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.
Material And Methods:
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.
Results:
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%).
Conclusions:
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.
