Uni-Medica Secures China’s First Class II Medical Device Certificate for Vaginal Microbiota Immunofluorescence Detection Kit

2025-12-31

     Recently, Uni-Medica has obtained the approval for its Class II Medical Device Certificate for the Vaginal Microbiota Immunofluorescence Detection Kit (Fluorescent Staining Method), with the registration certificate number: Yue Xie Zhu Zhun 20252401709. Following the approval of the national Class III Medical Device Certificate for its HPV E6/E7 mRNA 15-genotype detection kit, this marks another major breakthrough for Uni-Medical in the field of maternal and child health. This kit can be used in conjunction with the Fluorescent Scanning and Image Analysis System (Gis1000, 2000 and 3000 series), providing a more accurate basis for the precise diagnosis and treatment of vaginal inflammations.

   The staining solution of this kit mainly consists of a variety of fluorescent dyes, antibodies, buffers and other components. Clinically, it stains smears of vaginal secretions to identify clue cells, hyphae, spores and Trichomonas vaginalis in vaginal secretions, and is used for the auxiliary diagnosis of bacterial vaginosis, fungal vaginosis, trichomonal vaginosis and other vaginal diseases.

1.More Accurate Test Results

Compared with the Gram staining method, the performance of this kit is as follows: the sensitivity is 99.54% with a 95% confidence interval of 97.48%~99.99%; the specificity is 97.85% with a 95% confidence interval of 92.45%~99.74%; and the accuracy is 99.04% with a 95% confidence interval of 97.22%~99.80%. It not only applies to single infections, but also enables easier differentiation of various mixed infections, delivering more accurate test results for all types of vaginitis.

2. Class II Medical Device with More Stable Staining Performance 

Class II medical devices are subject to rigorous clinical trial verification and a detailed registration and approval process. As China’s first fluorescent staining product for vaginal secretions, this kit has obtained its certificate after undergoing multiple rounds of clinical verification as well as registration and approval procedures. Its stability, specificity and other performance characteristics have been widely recognized in clinical practice, delivering more stable staining results and clearer morphological displays for various microorganisms and exfoliated cells.

3. More Compliant Clinical Application

The intended use of this kit is to perform fluorescent staining on clue cells, hyphae, spores and Trichomonas vaginalis in vaginal secretions, and it can be used for the auxiliary diagnosis of bacterial vaginosis, fungal vaginosis and trichomonal vaginosis. In other words, it is applicable for the fluorescent staining of vaginal inflammations, with a clearer intended use and thus enabling more compliant clinical application. Additionally, the 2023 Guidelines for the Standardization of Clinical Examination and Result Reporting of Vaginal Secretions explicitly states that the fluorescent staining method features high sensitivity and strong anti-interference capability.

4. Complete Supporting Equipment with AI Interpretation Support

This product is compatible with all models of the Fluorescent Scanning and Image Analysis System (Gis1000, Gis2000 and Gis3000 series). It is equipped with a robust AI database and an independently developed fluorescent staining detection model for vaginal secretions based on a deep learning framework. Built on a large volume of clinical sample data, the model delivers objective and accurate results with an overall accuracy rate of over 95%.