None listed
Conditions
Interventions
None listed
Sponsors
Algorithmic Biologics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects whose Guardians are willing to give written informed consent for study participation Subjects who are ready to comply with the study related procedures
Exclusion criteria
Exclusion criteria: Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of Tapestry: Sensitivity is defined as 1 minus (the number of samples called positive by the standard of care and called negative by tapestry)/(number of samples called positive by the standard of care) and Specificity of Tapestry as compared to Specificity of Standard Modalities: Specificity is defined as 1 minus (number of samples called negative by standard of care but called positive by tapestry)/(number of samples called negative by standard of care)Timepoint: The single time point at which the data will be analysed will be 12 weeks from the start of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recommend how Tapestry can be used to screen neonates for IEMTimepoint: The time point at which the data will be analysed remains common with that mentioned under primary outcomes, i.e. with the overall data analysis, at 12 weeks from the start of the study. | — |
Countries
India
Contacts
Public ContactDr Manoj Gopalkrishnan
Algorithmic Biologics Private Limited
Outcome results
None listed