Truscreen Detection of Cervical Tissues for High-Risk Human Papillomavirus-Infected Women During the COVID-19 Pandemic

Abstract

Objectives: To evaluate the efficacy of TruScreen (TS01) for high-risk human papillomavirus (HR-HPV) women compared with other methods in reducing colposcopy referral rates in hospitals. Methods: A single-center, prospective, case–control study was conducted from December 2019 to June 2020. Results: Among 139 (46.2%) HR-HPV positive patients, 58 were CIN1, 52 were CIN2-3 and 29 had cervical cancer (n = 29). The sensitivity and specificity of detecting CIN2+ by TS01, colposcopy and HPV16/18 testing were 96.3% and 46.4%, 85.2% and 40.5% and 59.3% and 74.1%, respectively. The highest sensitivity was 96.3% at HPV16/18 and TS01 (each positive results), and the highest specificity was 83.6% at HPV16/18 and TS01 (both positive) for CIN2+ compared with the other methods. Conclusion: TS01 is a noninvasive screening method and can be used to diagnose cervical lesions quickly. It is especially suitable as triage tool for HR-HPV-positive women facing SARS-Cov-2 exposure and infection risks in hospital.

Significant specificity of TruScreen in cervical cytology of ASC and LSIL women with incomplete cervical transformation zone type during COVID-19 post-pandemic in China: a prospective study

“…A recent study about TS applied in hrHPV infected women reported TS combined with HPV 16/18 had the highest specificity (83.6%) comparing with TS alone or HPV 16/18 alone [18]. Our study reported similar specificities of TS combined with hrHPV of significancy (82.8% for CIN1+, 73.3% for CIN2+) and significantly higher PPV of CIN1+ comparing with hrHPV alone.…”

“…We used Hologic Aptima HPV test for testing 14 types hrHPV E6/E7 mRNA (types 16,18,31,33,35,39,45,51,52,56,58,59,66,68) and Hybribio Rapid GenoArray to determine the 21 specific HPV types including 13 high-risk types (types 16,18,31,33,35,39,45,51,52,56,58,59, and 68), 6 low-risk types (types 6,11,42,43,44,and CP8304 [81]) and 2 probable high-risk types (types 53 and 66). The tests were carried out and reported according to manufacturer's instructions.…”

“…Briefly, it detects and analyzes cervical tissues through optoelectronic signals emitted from the tip of the device. Up to date, TS has been studied in several studies in different population worldwide [13][14][15][16][17][18][19]. According to a meta-analysis, the pooled sensitivity, specificity and area under curve (AUC) of TS were 76%, 69%, 0.7859 respectively, the author thus concluded that TS had a moderately good diagnostic accuracy [20].…”

Patient care and access to clinical trials in gynaecological oncology: Global Implications of the Early Phase of the COVID-19 pandemic

“…Currently, a shift to minimally invasive surgery (laparoscopy or robotic surgery) when possible is recommended 6,16,27,28 , as it is associated with shortened recovery and hospitalization periods and thus minimizing the risk for a perioperative COVID-19 infection. Alternatives to the standard cytology screening 29 , new fractionation systematics 30 and the question of novel care and multidisciplinary communicative models have also been risen during this pandemic 7,18,20 . During the pandemic, decrease in minimally invasive surgery were reported by less-experienced gynaecologic oncologists 31 .…”

Patient care and access to clinical trials in gynaecological oncology: global implications of the early phase of the COVID-19 pandemic

“…Currently, a shift to minimally invasive surgery (laparoscopy or robotic surgery) when possible is recommended [ 6 , 16 , 27 , 28 ], as it is associated with shortened recovery and hospitalisation periods and thus minimising the risk for a perioperative COVID-19 infection. Alternatives to the standard cytology screening [ 29 ], new fractionation systematics [ 30 ] and the question of novel care and multidisciplinary communicative models have also been risen during this pandemic [ 7 , 18 , 20 ]. During the pandemic, decrease in minimally invasive surgery was reported by less-experienced gynaecologic oncologists [ 31 ].…”