Global Health Medical Device Compendium/Congo Red Dot Test

Device data
Health topic	Maternal mortality
Classification	Preventative Diagnosis
Scope	Clinical trial
Manufacturer location	Connecticut, united States

Preeclampsia is pregnancy-induced hypertension, or high blood pressure, and is associated with high protein levels in the urine. While high blood pressure is the most distinguished sign of the disease, it is also linked to damage in several organs such as the kidneys, liver, and endothelium. There is a critical need in the developing world for low-cost diagnostics for preeclampsia. Preeclampsia occurs in as many as 10% of pregnancies, usually in the second or third trimester, and after the 32nd week. It is particularly difficult to diagnose when preexisting disease such as hypertension is present.

Detailed description of the solution

The Congo Red Dot urine test is based on a common red dye, Congo red, which is attracted to misfolded proteins. Preeclampsia is pregnancy-specific disease that involves misfolded proteins. The test can identify preeclampsia patients and women who need to deliver their babies immediately. Overall, this test will help identify high-risk patients that should be transported from remote settings to facilities where there is access to specialized care for preeclampsia, such as magnesium sulfate therapy.

Designed by

Designed by: Researchers at the Yale School of Medicine. The lead researcher is Irina Buhimschi, MD, an Associate Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at Yale School of Medicine
This device is made: at the Yale School of Medicine in New Haven, Connecticut, U.S.A.

When and where it was tested/implemented

This device was tested in the United States. The clinical trial was presented on February 4th, 2010, at the Society for Maternal-Fetal Medicine's (SMFM) 30th Annual Meeting: The Pregnancy Meeting.

Funding Source

This research was funded by the McKern Award for Perinatal Research. Link available here.

References

Peer-reviewed publication

The link to the following references available here.

Buhimschi, Irina et al. 20: Assessment of global protein misfolding load by urine "Congo Red Dot" test for diagnosis and prediction of outcome in women with preeclampsia (PE). American Journal of Obstetrics and Gynecology 201, No. 6 Supplement 1 (December 2009): S12-13.
Buhimschi, Irina et al. 239: Preeclampsia is a disease characterized by specific supramolecular aggregates of misfolded proteins and congophilia. American Journal of Obstetrics and Gynecology 199, No. 6, Supplement 1 (December 2008): S78.
Buhimschi, Irina et al. Proteomic profiling of urine identifies specific fragments of SERPINA1 and albumin as biomarkers of preeclampsia. American Journal of Obstetrics and Gynecology 199, No. 5 (November 2008): 551.e1-551.e16.
Lachmeijer, Augusta M. A. et al. Searching for preeclampsia genes: the current position. European Journal of Obstetrics & Gynecology and Reproductive Biology 105, No. 2 (November 15, 2002): 94-113.
Saadat, Mandana et al. Maternal and Neonatal Outcomes in Women with Preeclampsia. Taiwanese Journal of Obstetrics and Gynecology 46, No. 3 (September 2007): 255-259.
Sevene, E et al. System and market failures: the unavailability of magnesium sulphate for the treatment of eclampsia and pre-eclampsia in Mozambique and Zimbabwe. BMJ 331, No. 7519 (October 1, 2005): 765-769.

Internally generated reports

Huynh, N. (2010, December 1). Congo red dot test: A groundbreaking method to diagnose preeclampsia. Link available here.

Externally generated reports

Contemporary, OB/GY. (2010, April 1). Society for maternal-fetal medicine: Urine test for preeclampsia.

Danilatos, G. (2010, July 17). Preeclampsia. OB/GYN Notes. Link available here.

Larson, N. F. (2010, February 10). Congo red dot urine test can predict, diagnose preeclampsia.

Melville, NA. (2010, December 1). Urine Test Early in Pregnancy Can Predict Preeclampsia.

Simple test can help predict and diagnose preeclampsia. Science Daily (2010, February 4). Link available here.

IP and copyright

Patented in the United States under Catalin S. Buhimschi, Irina Buhimschi, and Errol Norwitz on June 1, 2010. 07727733 Cl. 435-7.21

Page data
SDG	SDG03 Good health and well-being, SDG09 Industry innovation and infrastructure
Authors	Lonny Grafman, Chris Waterguy, Emilio, Kathleen Sienko, Amir Sabet Sarvestani
License	CC-BY-SA-3.0
Organizations	Appropedia Foundation, University of Michigan
Language	English (en)
Related	0 subpages, 1 pages link here
Redirects	Congo Red Dot Test
Views	195 page views (analytics)
Created	February 8, 2012 by Evashiu
Last edit	September 10, 2026 by Felipe Schenone
Cite as	Evashiu (2012–2026). "Global Health Medical Device Compendium/Congo Red Dot Test". Appropedia. Retrieved September 30, 2026.
API queries	basic, semantic, html, files, more