IVD PRODUCT | CercaTest®RED

Maternal & Fetal Medicine

CercaTest RED® Preeclampsia Detection

The CercaTest Red kit from Shuwen Biotech is intended to aid in pre-eclampsia diagnosis in women with a gestational age of 20 weeks or greater, by qualitative detection of misfolded proteins in urine. The result of the CercaTest Red Test should be interpreted along with clinical symptoms and other laboratory test results.

This product is intended for pregnant women to home-test by self.

First-in-class: adopting new biomarkers, exclusive products, patent protection
Convenient: Urine sample, non-invasive and safe, self testing at home
Fast: 5 minutes for results
Intuitive: Based on color differences, the results can be visually interpreted
Accuracy: high sensitivity, high specificity, high precision

Instructions for Use

Product Info

Specification：1 test/box, 3 tests/box
NMPA：皖械注准20242400106
CE marked

referrences

Buhimschi IA, et al. Sci Transl Med. 2014;6(245):245ra92.
Zeisler H, et al. N Engl J Med. 2016 Jan 7;374(1):13-22.
Xuemin Liu, et al. Current Medical Research and Opinion, DOI: 10.1080/03007995.2024.2314245.
美国妇产科医师协会（ACOG）, 妊娠期高血压和子痫前期指南2020版. Obstet Gynecol, 2020, 135:e237–60.
国际妊娠期高血压疾病研究学会（ISSHP）, 妊娠期高血压疾病临床指南2021版. Pregnancy Hypertension, 2021, 27:148-169.
高龄产妇妊娠期并发症防治策略研究项目组. 子痫前期防治的集束化管理建议. 中国实用妇科与产科杂志, 2022, 38(5):534-537.
中华医学会妇产科学分会妊娠期高血压疾病学组. 妊娠期高血压疾病诊治指南（2020）. 中华妇产科杂志, 2020, 55(4):227-38.
中华医学会妇产科学分会妊娠期高血压疾病学组. 子痫前期的预测及预防指南（2025）. 中华妇产科杂志， 2025,60(5):329-342.