Poljak Mario, Cuschieri Kate, Waheed Dur-E-Nayab, Baay Marc, Vorsters Alex
Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, NHS Lothian Scotland, Edinburgh, United Kingdom.
Acta Dermatovenerol Alp Pannonica Adriat. 2021 Mar;30(1):21-26.
The World Health Organization elimination goal for cervical cancer relies on screening 70% of women at ages 35 and 45, preferentially through molecular HPV testing. The SARS-CoV-2 pandemic has led to an unprecedented demand for molecular tests and platforms. Our objective was to gain insight into the impact of SARS-CoV-2 on the actual or anticipated shortage of tests, equipment, consumables, and staff required to deliver molecular HPV laboratory services and to consider the implications for the sustainability and development of cervical screening programs.
A 19-item online questionnaire was created and made available online between December 2020 and February 2021. Five companies with clinically validated HPV and SARS-CoV-2 tests in their portfolios were invited to provide a statement on the volumes of molecular COVID-19 tests produced, relevant changes to manufacturing capacity, and their current and post-pandemic strategy for HPV tests.
We received responses from 57 laboratories representing 30 countries and six continents. Among these, 74% reported experiencing a supply shortage, 54% reported a shortage of personnel, and 33% reported delays in ordering equipment. Three companies described expansion of manufacturing lines, investment in diagnostic infrastructure, and scale-up of manufacturing capacity. Two companies specifically referred to opportunities for the use of platforms for COVID-19 testing to support HPV testing in time.
The demand for SARS-CoV-2 testing is competing with HPV testing, compounded by a shortage of staff. This represents a challenge for existing laboratory services and for settings keen to implement HPV-based screening. However, supply challenges may be addressed in time, given the significant investment in manufacturing capacity. In addition, innovation around molecular COVID-19 testing systems may result in solutions that address the shortage of rapid low-cost HPV testing systems for low-resource settings. Finally, because the demand for COVID-19 testing is likely to decrease, this may release both workforce and platform capacity for high-throughput HPV testing. The global health community should be alert to the opportunities around innovation and capacity if cervical cancer elimination goals are to be reached.
世界卫生组织消除宫颈癌的目标依赖于对35岁和45岁女性中70%的人群进行筛查,优先通过分子HPV检测来实现。严重急性呼吸综合征冠状病毒2(SARS-CoV-2)大流行导致对分子检测和平台的需求空前增加。我们的目标是深入了解SARS-CoV-2对提供分子HPV实验室服务所需的检测、设备、耗材和人员的实际或预期短缺的影响,并考虑对宫颈癌筛查项目的可持续性和发展的影响。
创建了一份包含19个条目的在线问卷,并于2020年12月至2021年2月期间在网上发布。邀请了五家拥有经临床验证的HPV和SARS-CoV-2检测产品的公司,就所生产的分子新冠病毒检测数量、生产能力的相关变化以及它们当前和疫情后HPV检测的策略发表声明。
我们收到了来自代表30个国家和六大洲的57个实验室的回复。其中,74%报告经历了供应短缺,54%报告人员短缺,33%报告订购设备延迟。三家公司描述了生产线的扩展、对诊断基础设施的投资以及生产能力的扩大。两家公司特别提到了利用新冠病毒检测平台及时支持HPV检测的机会。
对SARS-CoV-2检测的需求与HPV检测相互竞争,人员短缺使情况更加复杂。这对现有实验室服务以及热衷于实施基于HPV的筛查的机构构成了挑战。然而,鉴于在生产能力方面的大量投资,供应挑战可能会及时得到解决。此外,围绕分子新冠病毒检测系统的创新可能会产生解决低资源环境中快速低成本HPV检测系统短缺问题的方案。最后,由于对新冠病毒检测的需求可能会下降,这可能会释放出用于高通量HPV检测的劳动力和平台能力。如果要实现消除宫颈癌的目标,全球卫生界应警惕围绕创新和能力的机遇。