QuidelOrtho secures Health Canada approval for Triage PLGF test

2024-03-07
诊断试剂临床研究
Triage PLGF is a fluorescence immunoassay intended for use with the Triage MeterPro Instrument to determine placental growth factor (PLGF) in maternal plasma specimens, to detect the presence of angiogenic imbalance Triage PLGF test is a fluorescence immunoassay. (Credit: Louis Reed on Unsplash) US-based in-vitro diagnostic technologies provider QuidelOrtho has secured Health Canada approval for its Triage PLGF test for laboratory use in Canada. Triage PLGF is a fluorescence immunoassay intended for use with the Triage MeterPro Instrument to determine placental growth factor (PLGF) in maternal plasma specimens. The test detects the presence of angiogenic imbalance, a consequence of abnormal placentation and poor blood flow in the placenta. Angiogenic imbalance can lead to maternal and foetal complications of pregnancy, including serious high blood pressure (hypertension) disorder pre-eclampsia. The Triage PLGF test, together with other clinical information, helps diagnosis of preterm pre-eclampsia and the prognosis of short-term delivery in pregnant women. It is used in pregnant women presenting with signs and symptoms of pre-eclampsia after 20 weeks through 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. “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.” Angiogenic imbalance plays a key role in the pathophysiology of preterm pre-eclampsia. It also poses the risk for maternal complications, such as HELLP syndrome and eclampsia, and foetal complications, including prematurity and stillbirth. QuidelOrtho said that its Triage PLGF test will enable clinicians to better detect angiogenic imbalance and evaluate the risk for potential complications. The test delivers results within 15 minutes and provides superior accuracy to support the clinical diagnosis of pre-eclampsia needing delivery within 14 days. When integrated into a clinical management guideline, the test can facilitate quicker diagnosis and a 20% reduction in maternal adverse outcomes. QuidelOrtho said that, unlike other tests which measure two biomarkers on a larger laboratory analyser, the Triage PLGF test measures a single biomarker on the Triage MeterPro instrument.
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