In the JournalsPerspective

‘Simple’ urine test diagnoses preeclampsia faster than gold standard

Kara Rood
Kara Rood

The “simple, non-invasive” Congo Red Dot Paper Test detected preeclampsia in 3 minutes, significantly faster than the current gold standard, according to findings recently published in EClinical Medicine.

“[Preeclampsia] has a large spectrum of medical signs and symptoms resulting in a range of clinical phenotypes and outcomes, making a diagnosis on available clinical and laboratory parameters challenging,” Kara Rood, MD, of the department of obstetrics and gynecology, The Ohio State University College of Medicine, and colleagues wrote.

“It is not uncommon when confronted with clinical ambiguity, particularly close to term, for physicians to indicate delivery even in the absence of a true diagnosis,” they added.

Previously published research suggests the current gold standard for preeclampsia, a time-consuming test for hypertension and 300 mg or more of protein in the urine, is error-prone. Liver and chronic kidney diseases also hinder the current test’s effectiveness.

Rood and colleagues conducted a Congo Red Dot Paper test on fresh urine samples from 346 consecutive pregnant women evaluated for preeclampsia at a single medical center. The mean age of patients in the study was 29 years

Researchers found that during the first triage visit, 32% of women received a clinical diagnosis of preeclampsia, and the Congo Red Dye Paper Test was positive in 25% of the cases. Adjudication confirmed preeclampsia in 28% of all cases, and the Congo Red Dye Paper Test outperformed measured serum and urine markers (80.2% sensitivity, 89.2% specificity, 92.1% negative predictive value, 86.7% accuracy). Among women who were discharged without delivering, 38% had at least one additional triage visit and 12 days (interquartile range, 5-34 days) elapsed between the last negative and first positive paper test.

“Our analysis shows that [Congo Red Dye Paper Test] is not only inexpensive, easy to use, highly accepted by the nursing staff, [it also] identifies women with preeclampsia within 3 minutes. ... [A] negative Congo Red Dye Paper Test could improve wait times in obstetrical triage areas, avoid unnecessary admissions and lower the associated health care expenses,” researchers wrote.

“Our findings have potential to improve accurate timing of patients' transfers to higher-acuity hospitals, and more targeted steroids and magnesium sulfate treatment in patients at risk of indicated preterm delivery from preeclampsia,” they added.

Rood explained other ways the Congo Red Dye Paper Test could change clinical findings in an interview with Healio Primary Care Today.

“This test will help rule diagnosis of preeclampsia in or out in women presenting with vague symptoms and/or an unclear diagnosis in timely fashion without the need for invasive blood work. It will also decrease wait times in obstetrical triages and avoid unnecessary antenatal admissions,” she said.

Rood added that the Congo Red Dye Paper Test is now part of a multicenter trial, and an FDA decision on the test should occur within the next 2 years. – by Janel Miller

Reference: Duhig K, et al. F1000Res. 2018;doi:10.12688/f1000research.12249.1

Disclosures: Rood reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

 

Kara Rood
Kara Rood

The “simple, non-invasive” Congo Red Dot Paper Test detected preeclampsia in 3 minutes, significantly faster than the current gold standard, according to findings recently published in EClinical Medicine.

“[Preeclampsia] has a large spectrum of medical signs and symptoms resulting in a range of clinical phenotypes and outcomes, making a diagnosis on available clinical and laboratory parameters challenging,” Kara Rood, MD, of the department of obstetrics and gynecology, The Ohio State University College of Medicine, and colleagues wrote.

“It is not uncommon when confronted with clinical ambiguity, particularly close to term, for physicians to indicate delivery even in the absence of a true diagnosis,” they added.

Previously published research suggests the current gold standard for preeclampsia, a time-consuming test for hypertension and 300 mg or more of protein in the urine, is error-prone. Liver and chronic kidney diseases also hinder the current test’s effectiveness.

Rood and colleagues conducted a Congo Red Dot Paper test on fresh urine samples from 346 consecutive pregnant women evaluated for preeclampsia at a single medical center. The mean age of patients in the study was 29 years

Researchers found that during the first triage visit, 32% of women received a clinical diagnosis of preeclampsia, and the Congo Red Dye Paper Test was positive in 25% of the cases. Adjudication confirmed preeclampsia in 28% of all cases, and the Congo Red Dye Paper Test outperformed measured serum and urine markers (80.2% sensitivity, 89.2% specificity, 92.1% negative predictive value, 86.7% accuracy). Among women who were discharged without delivering, 38% had at least one additional triage visit and 12 days (interquartile range, 5-34 days) elapsed between the last negative and first positive paper test.

“Our analysis shows that [Congo Red Dye Paper Test] is not only inexpensive, easy to use, highly accepted by the nursing staff, [it also] identifies women with preeclampsia within 3 minutes. ... [A] negative Congo Red Dye Paper Test could improve wait times in obstetrical triage areas, avoid unnecessary admissions and lower the associated health care expenses,” researchers wrote.

“Our findings have potential to improve accurate timing of patients' transfers to higher-acuity hospitals, and more targeted steroids and magnesium sulfate treatment in patients at risk of indicated preterm delivery from preeclampsia,” they added.

Rood explained other ways the Congo Red Dye Paper Test could change clinical findings in an interview with Healio Primary Care Today.

“This test will help rule diagnosis of preeclampsia in or out in women presenting with vague symptoms and/or an unclear diagnosis in timely fashion without the need for invasive blood work. It will also decrease wait times in obstetrical triages and avoid unnecessary antenatal admissions,” she said.

Rood added that the Congo Red Dye Paper Test is now part of a multicenter trial, and an FDA decision on the test should occur within the next 2 years. – by Janel Miller

Reference: Duhig K, et al. F1000Res. 2018;doi:10.12688/f1000research.12249.1

Disclosures: Rood reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

 

    Perspective
    Christine Greves

    Christine Greves

    This is an encouraging, well-designed study. By being published in a journal affiliated with The Lancet, the study also carries a lot of significance.

    Rood and colleagues’ Congo Red Dot Paper Test took only 3 minutes, making it so much faster than traditional testing methods that often require the patient to spend at least a day in the hospital. The Red Dot Paper Test also utilizes fresh urine, which means shipping such specimens off to the lab to check for protein in the urine is not always a “must-do” anymore as part of the preeclampsia diagnosis process.

    However, it is important to note that this test is still undergoing clinical trial, so we are still using our standard methods of diagnosis at this time.

    With about 15% of pregnant women experiencing hypertensive disorders, it is important we have tests like the one Rood et al developed to help us identify and diagnose women with preeclampsia, especially in areas where it is difficult to have lab evaluation. I look forward to hearing more about this test as it goes through further tests and if it becomes available commercially.  

    • Christine Greves, MD
    • OB/GYN, Orlando Health Winnie Palmer Hospital for Women & Babies

    Disclosures: Greves reports no relevant financial disclosures on this topic.