dbGaP Study Accession: phs002709
NIH Institute/Center: NCATS
RADx Data Program: RADx-rad
Release Date: 07/25/2022
DOI: 10.60773/ws7v-2r18
Study Description: COVID-19, a global pandemic due to its rapid progression, is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). There are different assays for COVID-19 testing, including nucleic acid, serological, antigen, and ancillary tests used in hospitals. In this study, a biochip assay that can simultaneously detect SARS-CoV-2 protein and RNA from biofluids by using surface markers, and simultaneously detect/quantify target proteins and RNA at single virus resolution was developed. Amplification of the signals were achieved by targeting different regions of the viral RNA (e.g., viral nucleocapsid N1, N2), and a tyramide signal amplification (TSA) assay for viral surface proteins. To demonstrate the clinical utility of the technology, it was deployed and tested using different biofluids, including NPS, and saliva from COVID-19 patients.
Updated Date: 12/09/2022
Principal Investigator: Reategui, Eduardo
Has Data Files: Yes
Study Domain: Medical Device or Tool Development
Data Collection Method: Molecular Nucleic Acid or PCR Testing Device
Keywords: Biochip Assay; Biofluid Detection; Clinical Utility; Exosome; Exosome-based; RNA; S-protein
Study Design: Device Validation
Multi-Center Study: No
Data Types: Imaging
Study Start Date: 12/21/2020
Study End Date: 06/30/2023
Species: Human
Sample Size: 99
Study Population Focus: Adults; Older Adults or Elderly
Publication URL: https://pubmed.ncbi.nlm.nih.gov/35579189/; https://pubmed.ncbi.nlm.nih.gov/36934525/
Acknowledgement Statement: This study was supported through funding, 4U18TR003807-02, for the National Center for Advancing Translational Sciences (NCATS) as part of the RADx-rad program. We acknowledge all the patients and healthy volunteers who participated in this study. Approved users should acknowledge the provision of data access by dbGaP for accession phs002709.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.
Funding Opportunity Announcement (FOA) Number: RFA-OD-20-018
NIH Grant or Contract Number(s): 4U18TR003807-02
Consent/Data Use Limitations: General Research Use
Variable Name | Label |
|---|---|
| nih_record_id | User ID |
| nih_age | What is your age? |
| nih_sex | What is your biological sex assigned at birth? |
| nih_cough | Cough |
| nih_fever_chills | Fever or Chills |
| nih_diff_breath | Shortness of breath or difficulty breathing |
| nih_headache | Headache |
| nih_muscle_ache | Muscle ache |
| nih_olfactory | New loss of taste or smell |
| nih_fatigue | Excessive fatigue |
| nih_nausea_vomiting_diarrhea | Nausea, vomiting, or diarrhea |
| nih_abdom_pain | Abdominal pain |
| nih_skin_rash | Skin rash |
| nih_height | What is your height in inches? |
| nih_weight | What is your weight in pounds? |
| abdominal_pain | Abdominal pain |
| age | What is your age? (Age in years. For babies less than 1 year old, write 0 as the age) |
| chills | Chills |
| cough | Cough |
| diarrhea | Diarrhea |
| excessive_fatigue | Excessive fatigue |
| fever | Fever |
| headache | Headache |
| height_feet | Height Feet |
| height_inches | Height Inches |
| muscle_ache | Muscle ache |
| nausea_vomiting | Nausea/vomiting |
| new_loss_of_taste_or_smell | New loss of taste or smell |
| sex | What is your biological sex assigned at birth? |
| shortness_of_breath_or_dif | Shortness of breath or difficulty breathing |
| skin_rash | Skin rash |
| weight_lbs | What is your weight? (Weight in pounds) |
| analyte_type | - |
| antigen_formulation | - |
| antigen_name | - |
| antigen_region | - |
| antigen_source | - |
| antigen_source_url | - |
| assay_readout | - |
| assay_readout_description | - |
| assay_result | - |
| biorecognition_type | - |
| capture_antibody_expression_system | - |
| capture_antibody_formulation | - |
| capture_antibody_host_organism_name | - |
| capture_antibody_modification | - |
| capture_antibody_modification_role | - |
| capture_antibody_name | - |
| capture_antibody_purity | - |
| capture_antibody_source | - |
| capture_antibody_source_url | - |
| capture_antibody_target_organism_name | - |
| capture_antibody_target_organism_taxonomy_id | - |
| capture_antigen_name | - |
| capture_antigen_region | - |
| capture_antigen_source | - |
| capture_antigen_source_url | - |
| detector_antibody_clonality | - |
| detector_antibody_formulation | - |
| detector_antibody_host_organism_name | - |
| detector_antibody_modification | - |
| detector_antibody_modification_role | - |
| detector_antibody_name | - |
| detector_antibody_role | - |
| detector_antibody_source | - |
| detector_antibody_source_url | - |
| detector_antibody_target_organism_name | - |
| detector_antibody_target_organism_subtype | - |
| detector_antibody_target_organism_taxonomy_id | - |
| immobilization_reagent_id | - |
| immobilization_reagent_source | - |
| isolate_name | - |
| protocol_id | - |
| sample_concentration | - |
| sample_concentration_unit | - |
| sample_id | - |
| sample_media | - |
| signal_detection | - |
| study_id | - |
| surface | - |
| target_analyte_type | - |
| target_organism_name | - |
| target_subtype | - |
| target_taxonomy_id | - |
| technology_description | - |
| technology_platform | - |