Pilot Study Evaluating the Feasibility of Digitalised Cytolological Slides for Telecytology, Before Implementation in Cameroon

The study will take place over four months. The consultation where the clinician undertakes the colposcopy and takes the additional cytological sample will be the only visit necessary for the patient in relation to the study.

The investigators will require thirty usable cervical samples from the colposcopy clinic of the Maternity of Geneva. The spatula used to take the smear should be immediately transferred to a 10ml sample pot and the head of the spatula should be snapped off and left inside. The investigators will only accept samples that have followed the aformentioned conditions, and it is expected to recruit more than the 30 participants needed if sampling is insufficient. The samples will be prepared by one of 3 laboratory technicians at the same hospital using the manual Surepath® liquid-based preparation method. This includes cell randomization, pipetting and enrichment of diagnostic cervical cells through centrifugation using a settling chamber to create a cellular slide preparation in a circle of 13 mm diameter. The Pap staining procedure is then applied within the chamber.

All thirty glass slides will be scanned and digitalized with a compact portable scanner (Ocus, ®40 by Grundium, Finland). The same laboratory technician who prepared the cervical sample will scan the slide. Ocus ®40 has a 1-slide capacity and permits the acquisition of a whole-slide image as well as robotic microscopy. The scanner features a 12-megapixel image sensor with a 40x objective (numerical aperture: 0.75) and can be connected to a laptop computer over a Wireless Local Area Network (WLAN) connection. To avoid areas being out of focus, the Z-stack modality of acquisition will be used at three focal plane levels with a 1 µ interval. In Europe, Ocus®40 is IVDR certified for diagnostic use.

The ease of the manual preparation method and scanning of slides will be assessed by asking the laboratory technician to rate the difficulty from very easy to very difficult on a 5-point rating scale (score 1= very difficult, 5=very easy) for each preparation step. The time taken for the manual preparation and scanning of glass slides will also be measured with a stopwatch and recorded by the technician.

Quality characteristics of the thirty digitalized slides will be scored as excellent, good, fair, or poor (based on sharpness and visualization through thick cell clusters) by two cytopathologists reading the slides. The time taken to screen digitized slides will be calculated.