Data from the recently completed randomized controlled trial has been presented at the ISSHP European Congress this September in Berlin, Germany. This interventional study evaluated the real life performance and clinical utility of the Roche Elecsys sFlt-1/PlGF ratio test in the guidance of admission of patients with suspicion of pre-eclampsia (PE) – a life threatening condition for pregnant women. The authors of the INSPIRE study found that its use in combination with current clinical guidelines allows the safe discharge of patients who will not develop PE while increasing the proportion of PE patients who are admitted.
Observational clinical studies published in 2016, have documented the benefits that the use of the sFlt-1/PlGF blood test ratio could offer to patients, clinicians, and the NHS. The studies show that the ratio test can provide clinically useful information on the risk of impending danger to mother and fetus.
An economic assessment published by Dr. Vatish in Ultrasound in Obstetrics & Gynecology 2016 found that widespread adoption could produce savings equivalent to £344 per case and further savings are realized from freeing up beds and clinicians’ time.
Hypertensive disorders, such as PE, currently affect approximately 13.5 per cent of pregnancies in the UK and it is estimated that as many as 80,000 pregnant women are investigated for suspected PE. Before the test was made available, treatment guidelines recommended that all women presenting with hypertension and proteinuria should be considered for admission to hospital for monitoring, although most would not go on to develop the condition. This unnecessary hospitalization of women caused undue stress and anxiety for mothers, as well as significant costs to hospitals and the NHS.
The ratio test, offered by Roche Diagnostics, was recommended by NICE in May 2016 to rule out women at risk. The test allows healthcare professionals to conduct a simple blood test and determine whether an individual patient will develop PE over the next week, with 99.3 per cent accuracy (95% confidence interval [CI], 97.9-99.9). Women deemed not at risk could safely return to community care.
The INSPIRE study recruited 369 patients, of whom 185 were assigned to the reveal group (where the sFlt/PlGF ratio was known) and 184 to non-reveal (where the test result was not released by the laboratory). Analysis showed that within admitted patients, there was a reduction of 34% in those deemed to be low risk (ratio ≤38), by using the test. Importantly, no discharged patients in either group with a ratio ≤38 developed PE within 7 days (256 patients in total). Furthermore, there was also an increased admission of patients who developed PE within 1 week in the reveal group and thus use of the test enriched the PE population of patients in hospital, without increasing the overall admission rate. This ultimately ensured that those who needed a high level of care received it, while others were able to safely return home.
The study showed that the sFlt-1/PlGF ratio test has a performance in real life, which confirms previous findings from observational studies, particularly in its high negative predictive value. Its use in combination with current clinical guidelines for hypertension enables the safe discharge of patients who will not develop pre-eclampsia while increasing the proportion of pre-eclampsia patients who are admitted.
Paul Skingley, Director of Centralized Solutions, Roche Diagnostics, said:
It’s hugely encouraging to see a bank of evidence for the ever-growing benefits of the Roche Diagnostics Elecsys test. Following its inclusion in the NICE guidance last year, we have been communicating the advantages that the test can offer to clinicians, and it is clear that the test can offer a great deal in contributing to cost savings and increasing efficiencies in the NHS, as well as providing a superior care pathway for pregnant women that presented with suspected pre-eclampsia.