Two additional assays provide full support for the commonly-used triple test for second trimester risk assessment for Down's syndrome
PerkinElmer has announced the availability of new assays, alpha-fetoprotein (AFP) and unconjugated estriol (uE3), to extend the capabilities of its Delfia Xpress system for maternal health screening.
When used in conjunction with an existing Delfia Xpress assay for the free beta moiety of human chorionic gonadotrophin (free hCG), the two additional assays provide full support for the commonly-used triple test for second trimester risk assessment for Down's syndrome.
Prenatal screening, by the quantitative detection of maternal serum markers, is a cost-effective, safe and non-invasive method of assessing the risk of foetal disorders including chromosomal abnormalities indicating Down's syndrome, and neural tube defects.
In pregnancies where a high risk is observed by screening, doctors can then provide diagnostic testing to determine specific issues, as well as help parents prepare and adapt to the situation.
The detection of chromosomal abnormalities may be performed in either the first or second trimester of pregnancy; in either case, it is usual to measure a combination of markers in order to achieve acceptable levels of sensitivity and specificity.
With the addition of two new assays, PerkinElmer is able to offer Delfia Xpress assays for all of the key first and second trimester markers, and provide full support for clinics and laboratories whatever their chosen screening strategy.
The Delfia Xpress platform is based on a small random access instrument and represents a total solution, including software, reagents and controls.
Assays for all of the key maternal health screening analytes are also supplied for PerkinElmer's established batch automatic system, AutoDelfia, as well as the Delfia semi-automatic system.
"The random access analyser complements the high throughput of the AutoDelfia very well, and therefore has a potential role for 'stat' analysis or for small throughput analytes in the large screening laboratory," said Sue Standing, consultant scientist, Birmingham Women's Health Care Trust.
"Alternatively it could do the whole workload of a small screening centre or be used in the prenatal clinic for real-time risk assessment".
"PerkinElmer is the only company to offer automated systems for both high and low throughput needs in first and second trimester screening," said Ann-Christine Sundell, vice president, general manager genetic screening, PerkinElmer.
"Delfia Xpress includes a full panel of prenatal assays, furthering the company's efforts to ensure that doctors and laboratories can quickly and easily diagnose foetal disorders at various points during pregnancy".
PerkinElmer first trimester prenatal screening assays free hCG and PAPP-A, for the Delfia Xpress, AutoDelfia and Delfia systems have previously been approved by the Fetal Medicine Foundation (FMF), and Health Canada.
Delfia and AutoDelfia second trimester assays are cleared for marketing in Canada, while the corresponding Delfia Xpress assays are currently under review in that country.
PerkinElmer products for prenatal screening are not available in the USA.
