SACCOMANNO PAP SMEAR COLLECTION SYSTEM A New Device for Conventional Pap Smear and Liquid-Based Cervical Cytology Smear Sanolife srl: manufacturer Operational headquarters: Via Alfonso Gatto 2/A 20089 Rozzano (MI) Tel: +39 02 90751922 Fax:+39 02 45701729 E-mail: info@sanolife.it Registered office: Via della Resistenza, 56 20090 Buccinasco (Milan) - Italy SACCOMANNO PAP SMEAR COLLECTION SYSTEM Exact Touch Benefits ® • Increased “monolayering” enhances Cytological examination. • Decreases need for repeat pap smears. • Requires only one 360° rotation, thus saving time and patient discomfort. • Laboratory preparation time is minimized due to custom form fit of glass slide (no adhesives). • Has no moving parts. This eliminates potential problems encountered with two-piece collection systems. • The flexible bristle design is anatomically correct, providing optimal cell sampling. • Exact Touch is a useful device since it removes more endocervical and metaplastic squamous cells and requires less time than a method utilizing two collection system (Prof. De Palo et al.). • The lateral arms of the Exact Touch device are self-limiting for consistent access to the squamo-columnar junction. (An adequate and representative cellular sampling of the squamocolumnar junction and the endocervical canal is mandatory to avoid false-negative sampling errors of PapTest). • No sharp wires that may cause Erythema and Erosion. • Cellular clumping and debris are negligible. • Cervical specimen is applied in two paintbrushlike strokes eliminating the time-consuming and costly VCE technique. • Cell preservation is enhanced when the paintbrush-like application to the glass slide and CentaFix spray are applied, minimizing airdrying. • Spatula may be used to obtain vaginal specimen. ENDOCERVICAL CELLS ECTOCERVICAL CELLS SPATULA SACCOMANNO PAP SMEAR COLLECTION SYSTEM A brief history Saccomanno G. with other people, such as Koss L.G., has guided the development of the cytopathology, a new science introduced only recently in the 1900s. Saccomanno also developed a blending method for urine cytology, but he is famous for a concentration technique of the respiratory tract specimens (sputum, bronchial washings, bronchoalveolar lavage samples and tracheal aspirates). Infact, many laboratories of cytopathology in the world use the Saccomanno method, a procedure to homogenise the samples of the respiratory tract before spreading the material onto a glass slide. These specimens are usually prefixed with the Saccomanno's fixative. In 1989, Saccomanno invented the Exact-Touch, a new single sampler for the uterine cervix and a fixative called Centrafix for processing conventional smears. Sanolife Srl is the manufacturer of the Exact-Touch® Saccomanno Pap Smear Collection System, considered by the several Studies the optimal method for the Pap Smear Collection. The first article that described this new technique to collect ectocervical cells and endocervical cells and its advantages was the following: Cenci M., Midulla, De Iorio P., Vecchione A. "Exact Touch®: A new single sampler for the uterine cervix". Acta Cytologica 1999, 43 (Nov.-Dec.) Technology So Advanced It's Patented Exact Touch® is a plastic device for ecto-endocervical sampling at the same time. It consists of two arms, one endocervical and one ectocervical, with soft plastic bristles, and at the other end there is a plastic spatula. The ectocervical arm is semilunar and 2.0 cm long, and the length of the bristles is 0.3 cm. The ectocervical arm originates perpendicularly from the centre of the ectocervical arm. It is 1.5 cm long, and the length of the bristles is 0.3 cm near to the ectocervical arm and degrading to 0.15 cm near the top. The total length of the Exact Touch® is 20 cm. The Exact Touch® Pap Smear Collection System is highly accurate integrated approach for the early detection of cervical cancer. One piece, anatomically correct medical device used for simultaneous collection of endocervical and ectocervical cells for pap procedures. SACCOMANNO PAP SMEAR COLLECTION SYSTEM DIRECTION FOR USE EVERY KIT CONTAINS STEP 1 Complete patient identification labeling. 1.Exact-Touch® Saccomanno Pap Smear Collection System. 2.Slide 3.Slide holder, a separate cardboard box for each sample. 4.Centra Fix, Saccomanno spray fixative - for 50kits. STEP 2 Write patient name on frosted end of slide. STEP 3 After exposing the uterine cervix A. Gently insert the endocervical collection arm of the Exact-Touch® into the cervical os. B. Continue to advance Exact-Touch® until the lateral collection arm bristles contact the ectocervix. C. Rotate Exact-Touch® 360º while maintaining gentle pressure against the cervical face. REFERENCES M.Cenci, C.Midulla, P.De Iorio, A.Vecchione Universtià “La Sapienza” - Rome, Italy Exact-Touch®: a new single sampler for the uterine cervix. Acta Cytologica 199; 43:000-000 STEP 4 Transfer the sample to the slide by sweeping the bristles horizzontally across the glass slide surface while maintaining moderate pressure. (The Exact-Touch® handle should be held at 45° angle to the slide while the transfer is being performed). Lift the bristles from the slide, rotate 180° and repeat transfer process. G.De Palo, B. Stefanon, L.Alasio, S.Pilotti Istituto Nazionale per lo Studio e la Cura dei Tumori Milan, Italy Exact-Touch®: a new devide for cervical cytology. Comparison with Ayre spatula plus Cytobrush submitted to Cytopathology. STEP 5 Immediately spray fixative over the entire surface of the slide. For best effect, spray bottle should be held 5 to 6 inches from slide. Allow slide to dry. D.Minucci, et al. - University of Padua, Italy The quality of cervical smears collected with different devices. Cytohistological and cytocolposcopical correlations in CIN. STEP 6 If Exact-Touch® kit is used, close and fasten slide holder. Sanolife srl: manufacturer Operational headquarters: Via Alfonso Gatto 2/A 20089 Rozzano (MI) Tel: +39 02 90751922 Fax:+39 02 45701729 E-mail: info@sanolife.it Registered office: Via della Resistenza, 56 20090 Buccinasco (Milan) - Italy G.Putignano, C. Carriero - Università di Bari, Italy “Exact-Touch®” per lo Screening Colpocitologico G.Mojana, A.Frigerio - Università degli studi di Milano Italy - Screening Citologico Cervicale G.Gale, B.C.Bedney - Comparison of Pap Smear Procedures