NEW YORK – The UK National Institute for Health and Care Excellence updated its preeclampsia testing recommendations on Wednesday, adding two PerkinElmer assays to its list of suitable tests, while expanding the use of two other previously recommended tests sold by Roche and Quidel.
The four recommended assays are PerkinElmer's Delfia Xpress PLGF 1-2-3 and Delfia Xpress sFlt-1/PLGF 1-2-3, Roche's Elecsys immunoassay sFlt-1/PLGF ratio, and Quidel's Triage PLGF Test. All should be used together with standard clinical assessment to help rule out or rule in preeclampsia for people suspected of having the condition.
NICE also said that each assay should be used according to the manufacturer's indications for use, and may benefit groups at higher risk of severe adverse pregnancy outcomes, such as people from African, Caribbean, and Asian family backgrounds. They also recommended that tests be used once per episode of suspected preterm eclampsia.
PerkinElmer's assays are new additions to the list of recommended tests. NICE said that they were not previously recommended because there was not enough evidence supporting accuracy.
"High-quality evidence now shows that [the Delfia Xpress PLGF 1-2-3 test], and the Delfia Xpress sFlt-1/PLGF 1-2-3 ratio assay, have good accuracy for preterm preeclampsia," NICE said in the recommendation.
NICE previously recommended Roche's Elecsys immunoassay sFlt-1/PLGF ratio and Quidel's Triage PLGF Test to rule out preeclampsia, but the tests were not recommended to help diagnose it, because the organization was concerned that it could lead to people being offered early births unnecessarily. NICE said data now shows this not to be the case, and said both could be used to diagnose the condition.
PerkinElmer in a separate statement welcomed the new NICE recommendation. "As a result, healthcare providers across the UK will have more options in the solutions they may use to help diagnose and initiate treatment for expectant mothers suspected of this condition," the Waltham, Massachusetts-based company said.
PerkinElmer noted that both assays carry CE-IVD marks, and said that the company's assay is available in two formats which can be processed on its Delfia Xpress random access platform.