QuidelOrtho Corp. received approval from Health Canada for its Triage PLGF test for laboratory use in Canada. The Triage PLGF test is a fluorescence immunoassay to be used with the small footprint Triage MeterPro Instrument for the quantitative determination of placental growth factor (“PLGF”) in maternal plasma specimens. 

The test is intended to detect the presence of angiogenic imbalance, a consequence of abnormal placentation and poor blood flow in the placenta, which can lead to maternal and fetal complications of pregnancy, including preeclampsia.(1)

Diagnosing Preeclampsia

Preeclampsia is a serious disorder that affects up to 5 percent of pregnancies in Canada. (2) The Triage PLGF test is used with other clinical information to aid in the diagnosis of preterm preeclampsia and in the prognosis of short-term delivery in women presenting with signs and symptoms of preeclampsia after 20 weeks and prior to 35 weeks of gestation. Diagnosis of preeclampsia indicates delivery within 14 days.(3)

“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,” says Bernard Michaud, country director, Canada at QuidelOrtho. “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 central role in the pathophysiology of preterm preeclampsia and places the pregnancy at risk for maternal complications, like HELLP syndrome and eclampsia, and fetal complications, like prematurity and stillbirth. With the Triage PLGF test, clinicians can be positioned to better detect angiogenic imbalance and assess the risk for these complications. The Society of Obstetricians and Gynecologists of Canada (SOGC) guidelines indicate the measurement of angiogenic markers, such as those detected by the Triage PLGF test, because of strong clinical evidence supporting their use to aid in the diagnosis of preeclampsia and prognosis for adverse pregnancy outcomes.(4)

Further reading: QuidelOrtho Gets FDA Clearance for Multiplex Molecular Platform and Herpes Simplex Virus Assay

The Triage PLGF test delivers results in approximately 15 minutes and provides high accuracy to support the clinical diagnosis of preeclampsia needing delivery within 14 days, the company says. When integrated into a clinical management guideline, the Triage PLGF test can lead to faster diagnosis and a 20% reduction in maternal adverse outcomes.(5) The Triage PLGF test is available to customers in Canada for use with the Triage MeterPro instrument. 

References:

  1. Redman CWG, Sargent IL. Pre-eclampsia, the placenta and the maternal systemic inflammatory response—a review. Placenta. 2003;24 Suppl A:S21-7. doi:10.1053/plac.2002.0930
  2. Ontario Health (Quality). Placental growth factor (PLGF)-based biomarker testing to help diagnose pre-eclampsia in people with suspected pre-eclampsia: A health technology assessment. Ont Health Technol Assess Ser. 2023;23(3):1-146.
  3. Quidel Triage PLGF Pack Insert
  4. Magee LA, Smith GN, Bloch C, et al. Guideline No. 426: Hypertensive disorders of pregnancy: Diagnosis, prediction, prevention, and management. J Obstet Gynaecol Can. 2022;44(5):547-571.e1. doi:10.1016/j.jogc.2022.03.002. PMID: 35577426
  5. Duhig KE, Myers J, Seed PT, et al. Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial. Lancet. 2019;393(10183):1807-18. doi:10.1016/S0140-6736(18)33212-4