Validation of urinary Congo Red preeclampsia detection point-of-care devise

Area of Science:

• Obstetrics and Gynecology
• Clinical Diagnostics
• Maternal-Fetal Medicine

Background:

• Preeclampsia is a significant cause of maternal morbidity and mortality worldwide.
• Early and accurate diagnosis of preeclampsia is crucial for timely intervention and improved outcomes.
• Current diagnostic methods can be invasive or time-consuming, necessitating simpler screening tools.

Purpose of the Study:

• To evaluate the diagnostic performance of a commercial Congo Red urine test for assessing preeclampsia risk.
• To determine the test's ability to detect preeclampsia and its predictive values.
• To assess the utility of the test in ruling in or ruling out preeclampsia within specific timeframes.

Main Methods:

• Prospective non-intervention study involving women with suspected preeclampsia.
• Congo Red urine test administered at enrollment and 1-3 subsequent occasions.
• Analysis of test results against confirmed preeclampsia diagnosis, calculating detection rates, false-positive rates, and predictive values.

Main Results:

• The study included 538 women with available follow-up data; 95 were diagnosed with preeclampsia.
• At enrollment, the detection rate was 18% and the false-positive rate was 3.2%.
• The negative predictive value was 85%, and the test ruled out preeclampsia within 7 days in 98% of cases.

Conclusions:

• The Congo Red urine test demonstrates screening potential for preeclampsia.
• Its ability to rule out preeclampsia within 7 days offers a significant management advantage.
• The test can aid in patient triage and selection for peripheral center management.