Simple test offers quick diagnosis of potentially deadly prenatal condition

The Congo Red Dot Test, which researchers say can be used to test pregnant women for preeclampsia. (Dan Smith)

By Nicole Kwan-February 04, 2016

Researchers have discovered a simple test used for Alzheimer’s diagnosis is effective at detecting one of the world’s deadliest pregnancy-related conditions, which experts say could have a major impact on worldwide health.

In research presented Thursday at the Society for Maternal-Fetal Medicine’s annual pregnancy meeting, the non-invasive Congo Red Dot (CRD) diagnostic test was shown to have an 86 percent accuracy rate in diagnosing preeclampsiain a collaborative study between The Ohio State Wexner Medical Center and Nationwide Children’s Hospital.

Historically, preeclampsia had been diagnosed after 20 weeks of pregnancy, but researchers said their test could be used across all gestational ages and has been tested with twins as well.

Preeclampsia affects 5 to 8 percent of pregnancies worldwide. While 75 percent of cases are mild, the condition can escalate quickly, especially without treatment. At the most serious, it can develop into eclampsia, affecting brain function, or causing seizures or coma.

For the developing fetus, there is the risk of separation of the placenta from the uterus, pregnancy loss, and poor or premature birth. Babies who are delivered preterm run the risk of long-term health issues such as learning disorders, cerebral palsy, deafness and blindness.

The condition is responsible for about 18 percent of maternal deaths in the United States, and it is, along with other hypertensive disorders, the leading cause of maternal and infant illness and death. According to the Preeclampsia Foundation, by conservative estimates, these disorders are globally responsible for 76,000 maternal and 500,000 infant deaths annually.

While preeclampsia is characterized by high blood pressure and protein in the urine, these measurable symptoms are also found in other diseases such as hypertension and kidney disease, making it difficult to discern a patient’s diagnosis. Plus, even if a woman had high blood pressure before pregnancy, she’s still at risk for preeclampsia, which could worsen her condition, said first author Dr. Kara Rood, a fellow in the division of maternal-fetal medicine in the department of obstetrics and gynecology at Ohio State’s Wexner Medical Center.

The only cure for a pregnant woman is early delivery, after which preeclampsia resolves in the postpartum period. However, the baby is left with all the risks of prematurity.

The CRD test works by mixing a patient’s urine with the red dye and placing it on special paper. If no abnormal proteins are present, the dye sticks to the paper. When abnormalities are present, they attach to the dye and disperse along the paper.

Other diagnostic tests exist, but none are as accurate as the CRD test, Rood said, and many require the mother to give blood, are labor-intensive, have a longer turnaround time, and need more technology to process.

“Ours is really non-invasive since it uses urine, can be done bedside, and takes three minutes to have results read by a nurse,” she told FoxNews.com.

The test’s simple execution, which requires no additional equipment, could have a major impact on global health, especially in remote areas.

“Our hope is that it can be available to all women worldwide to help aid in diagnosing— to not only help decrease maternal mortality, but also infant mortality due to premature delivery,” Rood said.

Rood’s team has been working on the test for the last decade. Initially, Dr. Irina A. Buhimschi, director of the Center for Perinatal Research in The Research Institute at Nationwide Children’s, identified abnormally or misfolded proteins in the urine of women with preeclampsia. Looking into other diseases with these abnormalities, they discovered it was similar to Alzheimer’s disease. The Congo Red Dot (CRD) test is used at autopsy to identify the abnormal proteins, which led researchers to testing it with preeclampsia. 

Researchers, who partnered with the United States Agency for International Development (USAID) and Saving Lives at Birth, said the exact cost of the test has yet to be determined, but their main goal is to make it as inexpensive as possible. They’re currently working with the Food and Drug Administration (FDA) and hoping to make it available soon, but were unable to provide an estimate. Researchers are also in the process of studying who can administer the test, be it a clinician, a nurse or potentially even the patient herself. 

Researchers said the bench-to-bedside study is especially gratifying, as they seldom see their work applied to patients.

“This is an exciting moment,” Dr. Catalin S. Buhimschi, director of maternal-fetal medicine and vice chair in the department of obstetrics and gynecology at Wexner, told FoxNews.com. “It’s a typical example of a bench-to-bedside study.”