Human Pharma Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
HP Country Pharmacovigilance, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Curr Med Res Opin. 2021 Jun;37(6):939-947. doi: 10.1080/03007995.2021.1914943. Epub 2021 Apr 29.
To safeguard key workers involved in development and production of medicines and ensure business continuity, we developed an occupational healthcare program, performed by our company's occupational healthcare services, to assess the infection and immune status for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This pilot program, conducted at our company facilities, evaluated the suitability of diagnostic tools in our setting for program upscaling.
We used different marketed diagnostics (including tests for antibodies against spike protein subunits S1 and S2 and nucleocapsid [N] protein) combined with medical history, symptoms and likelihood of infection. We evaluated the testing strategy over four visits in 141 employees (known positive COVID-19 history, = 20; unknown status, = 121) between April and June 2020 at four company locations in Germany. Digital self-monitoring over the pilot program duration was also included.
No incident infections were detected. Based on immune status, medical history and likelihood of infection, 10 participants (8.3%) with previously unknown history of COVID-19 were identified to have been infected before entering the program. These participants, who recalled no or mild symptoms in the preceding months, were primarily identified using an assay that detected both S1 and S2 immunoglobulin (Ig) G. The frequency of positive lateral flow assay (LFA) results (IgM or IgG directed against the N-protein) in this cohort was lower compared with participants with a known history of COVID-19 (0‒10.8% vs. 33.8‒75.7%, respectively).
Data from this pilot program suggest that LFA for antibodies may not always reliably detect current, recent or past infections; consequently, these have not been included in our upscaled occupational healthcare program. Regular testing strategies for viral RNA and antibodies directed against different SARS-CoV-2 proteins, combined with hygiene rules and a comprehensive baseline assessment, are recommended to ensure avoidance of infections at workplace as reliably as possible.
为了保护参与药品研发和生产的关键人员，确保业务连续性，我们制定了一项职业健康计划，由公司的职业健康服务部门实施，以评估严重急性呼吸综合征冠状病毒 2 （SARS-CoV-2）的感染和免疫状况。该试点计划在公司设施中进行，评估了我们设定中诊断工具的适用性，以实现计划扩大。
我们使用了不同的市售诊断方法（包括针对刺突蛋白亚单位 S1 和 S2 以及核衣壳 [N] 蛋白的抗体检测），并结合病史、症状和感染可能性。我们在 2020 年 4 月至 6 月期间，在德国的四个公司地点对 141 名员工（已知 COVID-19 阳性史，=20；未知情况，=121）进行了四次访问，评估了该检测策略。试点计划期间还包括数字自我监测。
未发现感染事件。根据免疫状况、病史和感染可能性，在进入该计划之前，有 10 名（8.3%）先前未知 COVID-19 史的参与者被确定已感染。这些参与者在过去几个月中回忆起无或轻度症状，主要是通过检测针对 S1 和 S2 免疫球蛋白（Ig）G 的检测方法来识别。与具有已知 COVID-19 史的参与者相比（分别为 0-10.8%和 33.8-75.7%），该队列中侧向流动测定（LFA）结果（针对 N 蛋白的 IgM 或 IgG）阳性的频率较低。
该试点计划的数据表明，LFA 检测抗体可能并不总是可靠地检测当前、近期或过去的感染；因此，这些方法并未包含在我们扩大的职业健康计划中。建议采用定期检测病毒 RNA 和针对不同 SARS-CoV-2 蛋白的抗体的策略，结合卫生规则和全面的基线评估，以尽可能可靠地确保在工作场所避免感染。
