The move may push rural and regional doctors, who must err on the side of caution, to transfer more women to larger hospitals, increasing burden on the system, women and families.
Rapid fetal fibronectin (fFN) tests – used to assess whether a woman is in early labour – are being discontinued, leaving rural and regional doctors in the lurch.
The fFN tests detect traces of fibronectin in vaginal swabs and provide a quantitative indication of the likelihood of preterm labour.
While other tests for preterm labour are available – Partosure and Actim Partus – these tests only provide qualitative results.
US-based med-tech company Hologic, the manufacturer of Rapid fFN 10Q cassettes and Perilynx analysers, announced last month that they would discontinue the products.
“After considerable review and extensive actions over the past two years, we have made the difficult decision to discontinue the sale of Rapid fFN® 10Q quantitative tests,” the company wrote in a media release.
“This decision was made based on a variety of factors, including supply chain variabilities, and the ability to consistently deliver the highest quality products for physicians and their patients.
“We understand that this may present challenges, and we are communicating directly with physicians and healthcare facilities to support them as they transition to other available options.”
The tests are regularly used in rural and remote areas to help decide whether women with early contractions should be sent to a major hospital with facilities to support the preterm baby.
Speaking to The Medical Republic, RDAA president Dr Raymond Lewandowski III said transfer was a “big ask” from a resource perspective, but importantly from a personal perspective as well.
“We tend to talk a lot [about the system] because it’s measurable, there’s a dollar sign … but my experience is that the ask on the woman and the family is, if not bigger, at least as big as the ask on the system,” he told TMR.
Dr Lewandowski said that while the tests weren’t perfect, they were great confirmation that women weren’t going into preterm labour.
The issue with the alternative, Actim Partus, was that the threshold it used was lower than Hologic’s test, meaning less women could be excluded from the need to be transferred.
It was also not validated in very early pregnancies, i.e. in the second trimester, said Dr Lewandowski.
As of yet, the RDAA hadn’t begun advocating for Hologic to reverse its decision.
“It was a business decision, and I can’t tell them that it’s financially viable for them,” said Dr Lewandowski.
“We certainly would like it to be or to have an alternative, but I don’t even know where to push for an alternative.”
He said that if the issue was financial viability, “they could probably raise the price” and it would still be worth it to buy.
Even for doctors like Dr Lewandowski, who see early contractions all the time and get strong “gut feelings” about early labour, “we’re not perfect, and we need something to help support our decision making”.
Dr Lewandowski added that he had recently struggled to procure Actim Partus as an alternative.
Rural Doctors Association of Victoria president Dr Louise Manning said the news was “pretty distressing”, after issues with shortages over recent years.
Dr Manning said she regularly used the tests, as she practices over an hour away from a major regional centre and over three hours from a tertiary centre.
According to Dr Manning, larger regional centres were generally able to manage babies from 32 weeks, but any concern about labour prior to that would require transfer to a larger tertiary centre.
Dr Manning added that the quantitative nature of the fFN test provided more clarity over the timeliness of the transfer.
“The loss of the quantitative test will be a really big problem within my practice and even more remote practices around the country,” she said.
“We’re going to err on the side of caution and probably transfer more women out than probably need to, and that has significant flow-on effects.”
Dr Manning said RDAV and RDAA more broadly would be advocating strongly for the state and federal governments to stop the discontinuation but was unconvinced of their success.
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ACRRM president Dan Halliday told TMR that while it had not yet been formally advised about the discontinuation, he was aware of the issue through local networks.
“It is on our radar,” he said.
“It could result in in our rural women being transferred inadvertently and unnecessarily without appropriate advice.”
Dr Halliday said this was a setback in terms of increasing opportunities for birthing on country and birthing close to home for First Nations communities.
“It’s an area that ACRRM will be monitoring very closely and engaging with the relevant departmental officials as to how we’re going to progress this incident further.”
According to RANZCHOG, quantitative tests similar to the rapid fetal fibronectin tests are in commercial development but are not yet available.
This article was updated 11am 28 August 2024 to include quotes from a media statement from Hologic.
