From Bench to Workflow: A Two-Year Real-World Implementation of CINtec PLUS Cytology in a Thai Regional Hospital Laboratory
Keywords:
CINtec PLUS, implementation, clinical pathology laboratory, cervical cancer screening, regional hospitalAbstract
Objective: To evaluate the two-year real-world implementation experience of CINtec PLUS cytology in the clinical pathology laboratory of Uttaradit Hospital, focusing on workflow changes, case volume and indications, positive rate, turnaround time, and practical issues encountered.
Methods: A retrospective descriptive study was conducted, collecting data from all cervical cytology specimens examined by CINtec PLUS cytology at Uttaradit Hospital between 2024 and 2025. Data were analyzed using descriptive statistics, with trend assessment by simple linear regression.
Results: A total of 231 specimens were analyzed. Case volume increased from 98 in year one to 133 in year two. The predominant indication was HPV triage (59.3%). The overall positive rate was 34.6% (95% CI: 28.2–41.4), with the HPV triage group showing the highest positive rate at 40.8%. Median turnaround time decreased from 8.0 to 6.0 working days, and the proportion achieving the target TAT improved from 79.6% to 93.2%. The incidence of practical issues declined from 48.0% to 15.8%.
Conclusion: Implementation of CINtec PLUS cytology in a regional hospital laboratory is feasible and demonstrates measurable improvement across all performance indicators over two years, providing valuable evidence for similar settings in Thailand and Southeast Asia. Further studies systematically evaluating the impact on colposcopy referral and hospital cost are needed to confirm the economic value of this technique in this context.
Keywords: CINtec PLUS, implementation, clinical pathology laboratory, cervical cancer screening, regional hospital
References
Dovnik A, Repše Fokter A. The role of p16/Ki67 dual staining in cervical cancer screening. Curr Issues Mol Biol. 2023;45(10):8476-91. Doi:10.3390/cimb45100534.
Wright TC Jr, Stoler MH, Ranger-Moore J, Fang Q, Volkir P, Safaeian M, et al. Clinical validation of p16/Ki-67 dual-stained cytology for triage of HPV-positive women: Results from the IMPACT trial. Int J Cancer. 2022;150(3):461–71. Doi:10.1002/ijc.33812.
Harper DM, Anderson RJ, Baker E, Yu TM. Cost-effectiveness of p16/Ki-67 dual-stained cytology reflex following co-testing with hrHPV genotyping for cervical cancer screening. Cancer Prev Res. 2023;16(7):393–404. Doi:10.1158/1940-6207.CAPR-22-0455.
Gilbert L, Ratnam S, Jang D, Alaghehbandan R, Schell M, Needle R, et al. Comparison of CINtec PLUS cytology and cobas HPV test for triaging Canadian patients with LSIL cytology referred to colposcopy: A two-year prospective study. Cancer Biomark. 2022;34(3):347–358. Doi:10.3233/CBM-210366.
Aromseree S, Wongjumpa W, Ekalaksananan T, Temtanakitpaisan A, Kleebkaow P, Srisathaporn S, et al. p16/Ki-67 dual staining in positive human papillomavirus DNA testing for predictive diagnosis of abnormal cervical lesions in northeastern Thai women. Asian Pac J Cancer Prev. 2022;23(10):3405–11. Doi:10.31557/APJCP.2022.23.10.3405.
Srisuttayasathien M, Kantathavorn N, Luasiripanthu T, Petchjorm S, Samrarn J, Ittiamornlert P, et al. Correlation between P16/Ki67 in cervical cytology and diagnosis of cervical intraepithelial neoplasia 2-3 in Thai women infected with high-risk types of human papillomavirus. Taiwan J Obstet Gynecol. 2024;63(2):192-8. Doi:10.1016/j.tjog.2024.01.014.
Clarke MA, Wentzensen N, Perkins RB, Garcia F, Arrindell D, Chelmow D, et al. Recommendations for use of p16/Ki67 dual stain for management of individuals testing positive for human papillomavirus. J Low Genit Tract Dis. 2024;28(2):124–30. Doi:10.1097/LGT.0000000000000802.
Øvestad IT, Dalen I, Andersland MS, Vintermyr OK, Moltu P, Berland JM, et al. Triaging HPV-Positive Cervical Samples with p16 and Ki-67 Dual Stained Cytology within an Organized Screening Program-A Prospective Observational Study from Western Norway. Int J Mol Sci. 2023;24(8):7158. Doi:10.3390/ijms24087158
Sepodes B, Rebelo T, Santos F, Oliveira D, Catalão C, Águas F, et al. Optimization of HPV-positive women triage with p16/Ki67 dual staining cytology in an organized cervical cancer screening program in the center region of Portugal. Eur J Obstet Gynecol Reprod Biol. 2024;302:111-5. Doi:10.1016/j.ejogrb.2024.09.003
Ouh YT, Kim HY, Yi KW, Lee NW, Kim HJ, Min KJ. Enhancing Cervical Cancer Screening: Review of p16/Ki-67 Dual Staining as a Promising Triage Strategy. Diagnostics. 2024;14(4):451. Doi:10.3390/diagnostics14040451.
Trzeszcz M, Mazurec M, Jach R, Mazurec K, Kotkowska-Szeps I, Kania M, et al. p16/Ki67 dual stain triage versus cytology in primary human papillomavirus-based cervical cancer screening with limited genotyping. J Med Virol. 2023;95(11):e29271. Doi:10.1002/jmv.29271.
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