CTRI/2020/07/026759
Completed
未知
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 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ortho Clinical Diagnostics
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed using VITROS® CoV2T assay in VITROS® 3600 or 5600 systems.
- •Asymptomatic health care professionals, will be tested using VITROS® Anti SARS CoV2 Total assay on the VITROS® 3600 Immunodiagnostics or VITROS® 5600 Integrated System.
- •Samples from normal healthy adult asymptomatic individuals (collected before Nov., 2019\) will be tested using VITROS® Anti SARS CoV2 Total assay on the VITROS® 3600 Immunodiagnostics or VITROS® 5600 Integrated System.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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