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POCT Detection of Urinary Misfolded Proteins Provides Sensitive and Specific Diagnosis of Preeclampsia

25 Pages Posted: 25 Oct 2018

See all articles by Xing-min Li

Xing-min Li

Shuwen Biotech Co. Ltd.

Xue-Min Liu

China Medical University - Department of Obstetrics and Gynecology

Ying Dong

Shuwen Biotech Co. Ltd.

Jun Xu

Shuwen Biotech Co. Ltd.

Xiao-Ying Yuan

Shuwen Biotech Co. Ltd.

Xiao-Bin Tang

Shuwen Biotech Co. Ltd.

Jay Zhang

Shuwen Biotech Co. Ltd.

Juan Du

China Medical University - Department of Obstetrics and Gynecology

More...

Abstract

Background:  Aggregates of misfolded proteins, which previously were shown to be related to preeclampsia, may be used as diagnostic marker by testing patients' urine. We developed an easy-to-perform POCT (point of care test) method for detecting urinary misfolded proteins we termed "Misfolded Protein Test", and validated its diagnostic utility in a large clinically relevant cohort.  

Methods: 1,539 women hospitalized at Shengjing Hospital were eligible for the study. Urine samples were tested by Misfolded Protein Test. Consistency analysis were conducted using The American College of Obstetricians and Gynecologists (ACOG, 2013) guidelines as golden standard.  

Findings:  Participants were randomized into training (773) and validation set (766). According to the criterion that identified in the training set, our POCT test was demonstrated in validation set having sensitivity 86.11%, specificity 96.52%, positive predictive value (PPV) 88.57%, and negative predictive value (NPV) 95.69% for diagnosis of early onset preeclampsia, and corresponding value of 75.76%, 96.89%, 69.44%, and 97.22% for all preeclampsia. In addition, patients with preeclampsia history, in-vitro fertilization (IVF), or multifetal pregnancy were demonstrated more susceptible to preeclampsia (all P values below 0.001). Primary hypertension or nephrosis (P < 0.001) were also risk factors to preeclampsia.  

Interpretation:  Our simple and non-invasive Misfolded Protein Test for detecting misfolded proteins is highly sensitive and specific for diagnosis of preeclampsia, especially for early-onset preeclampsia. Furthermore, we confirmed in a large non-selective in-patient population that factors including preeclampsia history, abortion history, IVF, multifetal pregnancy, primary hypertension or nephrosis are each independently significant risk factors of preeclampsia.  

Clinical Trial Number: registered at chictr.org, number ChiCTR1800017692.

Funding Statement:  The authors state: "This study received no external funding."

Declaration of Interests: The authors declare no competing interests.

Ethics Approval Statement: This research was approved by Medical Ethics Committee of Shengjing Hospital. Written informed consent was waived due to the usage of remaining samples of Urine Routine test.

Suggested Citation

Li, Xing-min and Liu, Xue-Min and Dong, Ying and Xu, Jun and Yuan, Xiao-Ying and Tang, Xiao-Bin and Zhang, Jay and Du, Juan, POCT Detection of Urinary Misfolded Proteins Provides Sensitive and Specific Diagnosis of Preeclampsia (October 17, 2018). Available at SSRN: https://ssrn.com/abstract=3269602 or http://dx.doi.org/10.2139/ssrn.3269602

Xing-min Li (Contact Author)

Shuwen Biotech Co. Ltd. ( email )

Deqing, Zhejiang 313200
China

Xue-Min Liu

China Medical University - Department of Obstetrics and Gynecology

Shenyang, Liaoning 110004
China

Ying Dong

Shuwen Biotech Co. Ltd.

Deqing, Zhejiang 313200
China

Jun Xu

Shuwen Biotech Co. Ltd.

Deqing, Zhejiang 313200
China

Xiao-Ying Yuan

Shuwen Biotech Co. Ltd.

Deqing, Zhejiang 313200
China

Xiao-Bin Tang

Shuwen Biotech Co. Ltd.

Deqing, Zhejiang 313200
China

Jay Zhang

Shuwen Biotech Co. Ltd.

Deqing, Zhejiang 313200
China

Juan Du

China Medical University - Department of Obstetrics and Gynecology ( email )

Shenyang, Liaoning 110004
China

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