THE CONTRACTOR SHALL DEVELOP AN INFRASTRUCTURE TO INTEGRATE VARIOUS TYPES OF REAL WORLD DATA FROM A VARIETY OF CLINICAL AND NONCLINICAL SOURCES IN ORD

这份合同的目标是开发基础设施，以从各种来源收集各种类型的数据，以便使用一组集成的关联数据来执行关键分析，这些数据代表患者层面的SARS CoV-2核酸扩增测试(NAAT)和抗体测试的商业纵向实验室测试结果，以评估已知的SARS-CoV-2血清阳性对后续再感染率的影响，并使用现实世界数据(RWD)进行队列研究设计。这些数据将被分析，以确定SARS-CoV-2抗体是否对再次感染具有保护作用，如果是，这种保护作用持续多长时间。虽然与疫苗相关的临床试验正在进行中，但结果可能比使用RWD进行潜在分析要慢。队列被定义为所有接受SARS-CoV-2抗体检测的患者，这些患者可以进行纵向跟踪(至少一年)。纵向分析将使用商业实验室测试结果中的数据，这些数据与住院、门诊和药房索赔的数据(从2020年1月到目前的每月下载到政府的业绩期间的数据)、代表住院期间接受的详细服务的医院收费数据、以及来自与医疗保健系统和社区实践相集成的门诊设施的EMR数据相关联。

The objective of this contract is to develop infrastructure to collect data of various types and from various sources in order to perform critical analyses using an integrated set of linked data representing commercial longitudinal laboratory test results at the patient level for SARS CoV-2 Nucleic Acid Amplification Test (NAAT) and antibody testing to assess the impact of known SARS-CoV-2 seropositivity on the rate of subsequent re-infection with a cohort study design using Real World Data (RWD). The data will be analyzed to determine whether antibodies to SARS-CoV-2 are protective against re-infection, and if so, how long that protection last. While vaccine-related clinical trials are underway, results are likely to be slower than potential analyses using RWD. The cohort is defined as all patients tested for SARS-CoV-2 antibodies that can be followed longitudinally (for a minimum of one year). The longitudinal analysis will be conducted using data from commercial lab test results linked to data (beginning with data pulled from January 2020 through present with monthly downloads to the Government for the Period of Performance over four months) from claims for inpatient, outpatient and pharmacy data, hospital chargemaster data representing detailed services received during an inpatient hospital admission, and EMR data from outpatient facilities both integrated with a health care system as well as for community practices.