First trimester Down’s screening for improved maternal and fetal health

“Roche has over 20 years’ experience in assay development, working with key opinion leaders in maternal and fetal health throughout the development of the Elecsys PAPP-A and free ßhCG assays,” said Peter Bialk, head of programme management: immunochemistry, Roche Global. Our assays utilise state-of-the-art electrochemiluminescence (ECL) technology to ensure reliable results and excellent precision, with maximum total variance values that fall well within Fetal Medicine Foundation (FMF) accreditation targets. Fetal Medicine Foundation accreditation of the assays means they have undergone rigorous and detailed evaluation and perform well within the required standards, providing the confidence to support further investigations. Used in conjunction with NT data from FMF-certified centres, detection rates of up to 90% for trisomy 21 can be achieved.1–3 This minimises the need for further invasive investigations and so helps to ensure safer pregnancies.

Instantly improved workflow
Consolidation of these assays on Roche platforms will enhance efficiency by improving turnaround times, reducing hands-on time and allowing automatic test ordering/reporting of results. Users will experience the associated cost and workflow improvements, without compromising assay performance.
The clinical chemistry department at the Royal Devon and Exeter NHS Foundation Trust has been evaluating the assays. Laboratory manager Adrian Cudmore, said: “Consolidation of biochemical Down’s syndrome screening onto our Roche platform will reduce staff training requirements, maintenance procedures and costs. It will also free valuable bench space as we will not need a separate instrument for these first trimester screening tests. In addition, the Roche platform is available 24/7, which will increase our flexibility and capacity to provide this vital service.”

Flexible solution for antenatal screening
The broad cobas platform portfolio meets the needs of every laboratory, with standardised reagents across the platforms to ensure comparability of results. Offering over 200 parameters, the assay portfolio covers a comprehensive range of innovative maternal, fetal and neonatal health monitoring markers, including anaemia, diabetes, endocrinology, fertility, infectious disease, inflammation, pre-eclampsia, thyroid function and others, to ensure a streamlined laboratory workflow.