Evaluation and Validation of the clinical performance of VITROS Anti SARS COV2 Total assay in the COVID-19 patient population and commercialization of the Assay on VITROS 3600

Ortho Clinical Diagnostics0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed using VITROSÂ® CoV2T assay in VITROSÂ® 3600 or 5600 systems.
•Asymptomatic health care professionals, will be tested using VITROSÂ® Anti SARS CoV2 Total assay on the VITROSÂ® 3600 Immunodiagnostics or VITROSÂ® 5600 Integrated System.
•Samples from normal healthy adult asymptomatic individuals (collected before Nov., 2019) will be tested using VITROSÂ® Anti SARS CoV2 Total assay on the VITROSÂ® 3600 Immunodiagnostics or VITROSÂ® 5600 Integrated System.

•Exclude samples from patients for whom the time between symptom onset and collection of samples cannot be determined.
•Exclude grossly hemolyzed, icteric or turbid samples, or samples with visible particulates that are not getting removed even after centrifugation.

发起方

Ortho Clinical Diagnostics