Author(s)

Zhang Lei ¹, Yang Feng ², Zhu Junzhe ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Zhang Lei

ABSTRACT

The iGFBP-1 Rapid Test Cassette (Vaginal Secretion) is a visually interpreted, qualitative immunochromatographic assay designed for the detection of insulin-like growth factor-binding protein 1 (iGFBP-1) in vaginal secretions of pregnant women. As a major protein marker of amniotic fluid, iGFBP-1 serves as an indicator for the diagnosis of rupture of fetal membranes (ROM). This study aims to do clinical studies of iGFBP-1 Rapid Test Cassette (Vaginal secretion) with the iGFBP-1 positive specimens and negative specimens which confirmed with other Rapid Test. A total of 230 vaginal swab specimens (100 iGFBP-1 positive and 130 iGFBP-1 negative, confirmed by another commercial iGFBP-1 rapid test) were analyzed. The results demonstrated high relative sensitivity (98.0%, 95%CI: 93.0%-99.8%), relative specificity (97.7%, 95%CI: 93.4%-99.5%) and overall accuracy (97.8%, 95%CI: 95.0%-99.3%). Intra-assay and inter-assay precision were excellent, with >99% correct identification of specimens across three lots. No cross-reactivity was observed with common vaginal microorganisms and no interference was detected from substances such as globulin, hemoglobin or bilirubin at clinically relevant concentrations. These findings indicate that the iGFBP-1 Rapid Test Cassette is a reliable, rapid, and practical tool for the qualitative detection of iGFBP-1 in vaginal secretions, aiding in the timely diagnosis of ROM and supporting clinical decision-making in obstetric care.

KEYWORDS

iGFBP-1; Rapid Test Cassette; Vaginal Secretion; Rupture of Fetal Membranes (ROM); Immunochromatographic Assay; Prenatal Diagnosis

CITE THIS PAPER

Zhang Lei, Yang Feng, Zhu Junzhe, iGFBP-1 Rapid Test Cassette (Vaginal Secretion): Performance Characteristics and Clinical Application in Detecting Rupture of Fetal Membranes. MEDS Clinical Medicine (2025) Vol. 6: 128-132. DOI: http://dx.doi.org/10.23977/medsc.2025.060419.

REFERENCES

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[9] Hangzhou AllTest Biotech Co., Ltd. iGFBP-1 Rapid Test Cassette (Vaginal Secretion) Package Insert. REF: FIG-502. Revision Date: 2024-11-26.
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