Kathryn Maurer1, Hongxue Luo2, Zhiyong Shen3, Guixiang Wang2, Hui Du2, Chun Wang2, Xiaobo Liu4, Xiamen Wang5, Xinfeng Qu6, Ruifang Wu2, Jerome Belinson7. 1. Gynecologic Oncology Division, Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address: maurerk@ccf.org. 2. Department of Ob/Gyn, Peking University Shenzhen Hospital, Shenzhen, PR China. 3. Hyde Biomedical Corporation, Wuhu City, Anhui, PR China. 4. Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA. 5. BGI Clinical Laboratories, Shenzhen, PR China. 6. BGI Clinical Laboratories, Shenzhen, PR China; Preventive Oncology International, Cleveland Heights, OH, USA. 7. Gynecologic Oncology Division, Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA; Preventive Oncology International, Cleveland Heights, OH, USA.
Abstract
BACKGROUND: Solid media transport can be used to design adaptable cervical cancer screening programs but currently is limited by one card with published data. OBJECTIVE: To develop and evaluate a solid media transport card for use in high-risk human papillomavirus detection (HR-HPV). STUDY DESIGN: The Preventative Oncology International (POI) card was constructed using PK 226 paper(®) treated with cell-lysing solution and indicating dye. Vaginal samples were applied to the POI card and the indicating FTA (iFTA) elute card. A cervical sample was placed in liquid media. All specimens were tested for HR-HPV. Color change was assessed at sample application and at card processing. Stability of the POI card and iFTA elute card was tested at humidity. RESULTS: 319 women were enrolled. Twelve women had at least one insufficient sample with no difference between media (p=0.36). Compared to liquid samples, there was good agreement for HR-HPV detection with kappa of 0.81 (95% CI 0.74-0.88) and 0.71 (95% CI 0.62-0.79) for the POI and iFTA elute card respectively. Sensitivity for ≥CIN2 was 100% (CI 100-100%), 95.1% (CI 92.7-97.6%), and 93.5% (CI 90.7-96.3%) for the HR-HPV test from the liquid media, POI card, and iFTA elute card respectively. There was no color change of the POI card noted in humidity but the iFTA elute card changed color at 90% humidity. CONCLUSIONS: The POI card is suitable for DNA transport and HR-HPV testing. This card has the potential to make cervical cancer screening programs more affordable worldwide.
BACKGROUND: Solid media transport can be used to design adaptable cervical cancer screening programs but currently is limited by one card with published data. OBJECTIVE: To develop and evaluate a solid media transport card for use in high-risk human papillomavirus detection (HR-HPV). STUDY DESIGN: The Preventative Oncology International (POI) card was constructed using PK 226 paper(®) treated with cell-lysing solution and indicating dye. Vaginal samples were applied to the POI card and the indicating FTA (iFTA) elute card. A cervical sample was placed in liquid media. All specimens were tested for HR-HPV. Color change was assessed at sample application and at card processing. Stability of the POI card and iFTA elute card was tested at humidity. RESULTS: 319 women were enrolled. Twelve women had at least one insufficient sample with no difference between media (p=0.36). Compared to liquid samples, there was good agreement for HR-HPV detection with kappa of 0.81 (95% CI 0.74-0.88) and 0.71 (95% CI 0.62-0.79) for the POI and iFTA elute card respectively. Sensitivity for ≥CIN2 was 100% (CI 100-100%), 95.1% (CI 92.7-97.6%), and 93.5% (CI 90.7-96.3%) for the HR-HPV test from the liquid media, POI card, and iFTA elute card respectively. There was no color change of the POI card noted in humidity but the iFTA elute card changed color at 90% humidity. CONCLUSIONS: The POI card is suitable for DNA transport and HR-HPV testing. This card has the potential to make cervical cancer screening programs more affordable worldwide.