Detection of Antibodies to COVID-19

Not Applicable

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/07/026759
• Lead Sponsor: Ortho Clinical Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identifying individuals with an adaptive immune response to SARS-CoV-2 infection.Timepoint: Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed. Titres at 8th day will be considered as baseline data

Secondary Outcome Measures

Name	Time	Method
To evaluate the positive percent agreement (PPA) of the serological assay in comparison with the <br/ ><br>currently in use RT PCR assay <br/ ><br>To evaluate the PPA of the serological assay in symptomatic patients of Covid-19 (SARS CoV2 <br/ ><br> RT PCR Positive), when the sample was collected post 8 days from the onset of symptoms. <br/ ><br>Timepoint: Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed