News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

UK’s NHS to Distribute New Clinical Laboratory Test for Women Suspected of Having Pre-Eclampsia

Based on clinical trials of the medical laboratory test, pregnant women can expect a reduced risk for experiencing complications associated with the dangerous blood disorder

Clinical pathology laboratories and obstetricians in the UK may soon have a new blood test that can help provide earlier diagnoses of pre-eclampsia, a hypertensive disorder of pregnancy that can cause liver and kidney disfunctions and, if untreated, can lead to eclampsia and deadly seizures.

Following a clinical trial conducted by scientists at King’s College London (King’s College), the National Health Service (NHS) in the United Kingdom (UK) announced it would be making the new test widely available.

The researchers published their findings in The Lancet medical journal. Their paper explains that the clinical trial took place in 11 maternity units in the UK from June 2016 through October 2017. And that 1,023 women were divided into two groups:

  • 576 (56%) were in the “intervention group,” meaning they had PGF test results made available to their maternity teams;
  • 447 (44%) did not have PGF test results made available.

The researchers, the Independent reported, wanted to determine the impact, if any, the new test’s results would have on diagnoses.

Significantly Reduced Time to Diagnosis

Trial results indicated that measuring the placental growth factor (PGF) in women who are suspected of having pre-eclampsia can increase speed to diagnosis. “PGF testing was shown to reduce the average time to pre-eclampsia diagnosis from 4.1 days to 1.9 days, and serious complications before birth (such as eclampsia, stroke, and maternal death) [dropped] from 5% to 4%,” a King’s College press release stated.

“Complications like stroke, seizures and maternal death fell by 20% when doctors had access to PGF testing,” the Independent reported.

The researchers stated in their study, “Our trial has shown that, in women presenting with suspected pre-eclampsia, PGF measurement, incorporated into a management algorithm based on national guidelines, significantly reduces the time taken for treating clinicians to diagnose pre-eclampsia. This improvement was associated with a significant reduction in maternal adverse outcomes, with no detected difference in gestational age at delivery or adverse perinatal outcomes.”

The King’s College press release states, “Pre-eclampsia is suspected in around 10% of UK pregnancies, affecting approximately 80,000 women annually. If untreated, it can progress to cause complications in the woman, including damage to vital organs, fits, and can be fatal for the woman and baby. Globally, 100 women die as a result of the condition every day.”

The release also noted that “doctors were able to diagnose pre-eclampsia on average two days sooner. This was associated with significant improvements in outcomes for women without causing health problems for babies.”

Tony Young, PhD (above), National Clinical Lead for Innovation at NHS, stated in the King’s College press release that “This innovative blood test helps determine the risks of pre-eclampsia in pregnancy, enabling women to be directed to appropriate care or reduce unnecessary worry more quickly.” (Photo copyright: LinkedIn.)

Measuring PGF in Clinical Laboratory Study

PGF is a molecular marker for inflammation associated mostly with the mother’s placenta. The King’s College researchers wanted to find out if a quicker diagnosis of pre-eclampsia was possible. And, if so, could it reduce adverse outcomes in the mother and baby?

“For the last hundred years, we have diagnosed pre-eclampsia through measuring blood pressure and checking for protein in a woman’s urine. These are relatively imprecise and often quite subjective,” said Lucy Chappell, PhD, NIHR Research Professor in Obstetrics at King’s College, and lead author of the study, in the news release.

“We knew that monitoring PGF was an accurate way to help detect the condition, but [we] were unsure whether making this tool available to clinicians would lead to better care for women. Now we know that it does,” she concluded.

Pre-eclampsia can lead to stroke, seizures, and even death of expectant mothers and unborn children. It is usually diagnosed after 20 weeks of gestation through blood pressure tests and urine tests that show hypertension and elevated protein levels.

“We found that the availability of PGF test results substantially reduced the time to clinical confirmation of pre-eclampsia. Where PGF was implemented, we found a lower incidence of maternal adverse outcomes,” the researchers wrote in their study.

Similar Study in the US

In the UK, pre-eclampsia affects about one in 20 pregnancies or 80,000 women each year, New Scientist explained. While in the US, data compiled from the Centers for Disease Control and Prevention (CDC) indicate that pre-eclampsia affects one in 25 pregnancies or about 154,220 women annually.

Researchers in Ohio also recently reported on a test and a piloted clinical study for rapid diagnosis of pre-eclampsia.

Scientists at Ohio State University’s College of Medicine and Wexner Medical Center (OSU), and at Nationwide Children’s Hospital, have developed a non-invasive red-dye-on-paper urine test to identify pre-eclampsia at the point-of-care, a Wexner press release announced.

“This is the first clinical study using the point-of-care, paper-based Congo Red Dot (CRD) diagnostic test, and the mechanism proved superior in establishing or ruling out a diagnosis of pre-eclampsia,” Kara Rood, MD, a maternal-fetal medicine physician at Wexner Medical Center and first author of the study said in the Wexner press release. “Our findings will have a huge impact on the health of women and children.”

The researchers published their findings in EClinicalMedicine, a Lancet Journal.

“Pre-eclampsia is often described as ‘mysterious’ because it’s difficult to diagnose. Our researchers show that there’s an easy, non-invasive test that will help diagnose this condition and maintain the health of pregnant women and their babies,” K. Craig Kent, MD, OSU Dean of the College of Medicine, said in the press release.

Clinical laboratory tests such as these being developed in the US and abroad could help pregnant women worldwide experience happy pregnancies and give birth to healthy babies. Medical laboratory leaders in this country may want to stay abreast of the development of these simple blood and urine tests.

                                                                        —Donna Marie Pocius

Related Information:

Pre-Eclampsia: NHS to Roll Out Breakthrough Test Which Speeds Up Diagnosis and Can Save Lives

Blood Test Helps Accurate, Rapid Diagnosis for Pre-eclampsia

Blood Pressure in Pregnancy

Placental Growth Factor Testing to Assess Women with Suspected Pre-eclampsia: a Multi-Centre, Pragmatic, Stepped-wedge Cluster Randomized Controlled Trial

Pre-Eclampsia Blood Test Could Help Diagnose the Condition Earlier

Research Finds Simple Urine Test Allows for Rapid Diagnosis of Pre-eclampsia

Despite Passage of New Law on CLIA enforcement, Ohio State University Settles with CMS Agrees to Pay $268,000, and Names New Clinical Laboratory Medical Director

Medical laboratory continues to operate, retains its CLIA certificate, and maintains that the PT violations at heart of CMS case were inadvertent

One nationally prominent clinical laboratory organization closed its chapter in the ongoing story of CLIA enforcement of the regulations governing the inadvertent referral of proficiency testing specimens. But this chapter ended with an unexpected twist for the Ohio State University Wexner Medical Center (OSUWMC), which was given severe sanctions by officials of the Centers for Medicare & Medicaid Services (CMS), despite recent enactment of a new federal law on the subject of enforcement of CLIA proficiency testing errors.

The settlement between OSUWMC and CMS was announced on January 16. It calls for OSUWMC to:

  • Appoint a new medical director for the clinical laboratory,
  • Pay $268,000, and
  • Provide additional training to the medical laboratory staff in proficiency testing (PT).

New Medical Director Named at OSUWMC’s Clinical Laboratory

OSU named Daniel Sedmak, M.D., to the position of medical director of the clinical laboratory, as part of this resolution with federal officials who administer the Clinical Laboratory Improvement Amendments (CLIA). Sedmak is currently the Chair of the OSU College of Medicine, Department of Pathology and a professor of pathology.


Last month, Ohio State University Wexner Medical Center issued a press release stating that it had resolved pending sanctions assessed against its clinical laboratory by the Centers for Medicare & Medicaid Services for violations of CLIA requirements, including the inadvertent referral of proficiency testing specimens. (Photo by


TEST Act Signed By President Obama, Provides Regulators Discretion When Clinical Laboratories Mistakenly Violate CLIA PT Requirements

Pathologists will welcome this law, which provides more latitude for federal regulators should a medical laboratory inadvertently refer a proficiency testing specimen

Last Tuesday, the clinical laboratory testing industry gained an important measure of regulatory relief after President Obama signed into law the Taking Essential Steps for Testing (TEST) Act of 2012. This law removes severe penalties for medical laboratories that inadvertently violate proficiency testing (PT)  requirements.

More specifically, the language of the TEST Act provides guidance to federal regulators to resolve an issue concerning the inadvertent referral of PT specimens as defined by the Clinical Laboratory Improvement Amendments (CLIA) statute of 1988. (See The Dark ReportCongress May Respond to Tough CLIA PT Penalties,” August 6, 2012.) (more…)

Bill to Fix CLIA Proficiency Testing Language for Clinical Laboratories Passes in the House, Awaits Senate’s Return in November

New law would lessen penalties for medical laboratories from violations of CLIA regulations if they made inadvertent referrals of  proficiency tests to other clinical labs

Clinical laboratories may have to wait at least another month before the U.S. Senate returns from recess to vote on a bill to remove severe penalties for labs that inadvertently violate certain CLIA proficiency testing (PT) requirements. A similar bill was passed in the House in September.

The bill, S. 3391: Taking Essential Steps for Testing Act, was ready for a Senate vote in mid-October. It was set aside so that senators could return home while the campaign season entered its final weeks. (more…)

CLIA Officials Propose Major Sanctions against Prominent Academic Center Clinical Laboratory Due to Inadvertent Referral of Proficiency Test Referrals

Many clinical laboratory directors are unaware that CLIA officials have proposed heavy sanctions against the medical laboratory of the Ohio State University Wexner Medical Center, located in Columbus, Ohio. The enforcement actions include possible revocation of the lab’s CLIA license because of the inadvertent referral of proficiency testing specimens by the OSUWMC lab.

This is a significant event for the clinical laboratory profession. It will certainly catch the attention of those pathologists who serve as laboratory directors in labs holding Clinical Laboratory Improvement Amendments (CLIA) certification. It is extremely rare for any first-rank medical laboratory organization to face the possibility of having its CLIA license revoked by CLIA officials. (more…)