244P - Optimization of early diagnostics of cervical intraepitelial neoplasies and cervical cancer

Background

To evaluate the practical significance of the effectiveness of the modified coloring solution “CIN-DIAG” in the diagnosis of pathological changes of the cervix.

Methods

The modified CIN-DIAG coloring solution is a sterile cotton swab on a plastic stick in a plastic tube, and the coloring solution is in the cap of the tube. Appearance of the coloring solution: a clear brown liquid; The volume of the coloring solution is 2 ml ± 5%; the pH of the coloring solution is in the range of 4 to 7 units. Mechanism of action: after applying the staining solution to the epithelial tissue, in the presence of atypical cells, folic acid, via the folate receptors on the surface of these cells, quickly enters the cytoplasm, is oxidized by the active oxygen present in the cell, and the tampon stains at different intensities. Normal cells have a low content of active oxygen, so there is little expression of folic acid receptors on the surface of the cells and the tampon does not stain after the reaction.

Results

The study included 20 (100%) patients, of which: with CIN I - 5 (25%), CIN II - 3 (15%), CIN III - 4 (20%), patients with cervical cancer - 5 (25 %), with cervical erosion - 2 (10%) and 1 (5%) women with a visually unchanged cervix. The age of women ranged from 29 to 64 years, the average age was 40 ± 0.7 years (p>0,5). In case CIN1, the tampon was colored dark green, with CIN2 it was blue-green, with CIN3 it was blue, and with cervical cancer, it was dark gray and black. The results obtained fully met the requirements of the regulatory document, the sensitivity of the coloring solution was 98%, the specificity was 95%.

Conclusions

Thus, the modified CIN-DIAG coloring solution has the advantages of economy, affordability, low technical requirements, safety and non-invasiveness, as a result of which it can be successfully applied in remote regions of the country.

Clinical trial identification

Editorial acknowledgement