Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Ortho Clinical Diagnostics
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate the positive percent agreement (PPA) of the serological assay in comparison with the currently in use RT PCR assay To evaluate the PPA of the serological assay in symptomatic patients of Covid-19 (SARS CoV2 RT PCR Positive), when the sample was collected post 8 days from the onset of symptoms. Timepoint: Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed | — |
Countries
India
Contacts
Public ContactDr Smita Sarma
Medanta- The Medicity
Outcome results
None listed