MetaMedical™ Solutions Inc

Health Canada approves QuidelOrtho’s diagnostic test

Diagnostic healthcare solutions provider QuidelOrtho has announced that its Triage placental growth factor (PₗGF) test has received Health Canada approval for in-lab use.

The Triage PₗGF test is a fluorescence immunoassay and is intended to be used with the small-footprint Triage MeterPro Instrument.

It is used for the quantitative determination of PₗGF in maternal plasma specimens.

The test can detect the presence of angiogenic imbalance, due to abnormal placentation and poor blood flow in the placenta that can lead to maternal and fetal complications of pregnancy, including pre-eclampsia.

Together with other clinical information, the Triage PₗGF test aids in diagnosing preterm pre-eclampsia. It can also help in assessing the risk of imminent delivery in symptomatic women between 20 and 35 weeks of gestation.

QuidelOrtho Canada country director Bernard Michaud said: “When signs or symptoms of pre-eclampsia are present, it is critical to the health and safety of the mother and her unborn baby that clinicians have the information necessary to determine the optimal course of action to achieve the best possible outcome for the pregnancy.

Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free

Your download email will arrive shortly

We are confident about the
quality of our Company Profiles. However, we want you to make the most
decision for your business, so we offer a free sample that you can download by
submitting the below form

By GlobalData

“The Triage PₗGF test is intended to help clinicians diagnose pre-eclampsia sooner and may provide them with information on whether the pregnancy is likely to deteriorate within the next 14 days, allowing for a better patient care management plan.”

The test enables clinicians to better detect angiogenic imbalance and evaluate the risk of maternal and fetal complications.

Capable of providing results within approximately 15 minutes, the test is said to provide high accuracy to support the clinical diagnosis of pre-eclampsia requiring delivery within 14 days.

It is also expected to contribute to a 20% reduction in maternal adverse outcomes when incorporated into clinical guidelines.

Last year, QuidelOrtho obtained De Novo authorisation from the US Food and Drug Administration (FDA) for its Sofia 2 SARS Antigen+ FIA test.

Source link