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Study Information

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

Estimated Cohort Size: 100

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 Information
Total Variables: 86
Study Variables Information Table
Variable Name
Label
nih_record_idUser ID
nih_ageWhat is your age?
nih_sexWhat is your biological sex assigned at birth?
nih_coughCough
nih_fever_chillsFever or Chills
nih_diff_breathShortness of breath or difficulty breathing
nih_headacheHeadache
nih_muscle_acheMuscle ache
nih_olfactoryNew loss of taste or smell
nih_fatigueExcessive fatigue
nih_nausea_vomiting_diarrheaNausea, vomiting, or diarrhea
nih_abdom_painAbdominal pain
nih_skin_rashSkin rash
nih_heightWhat is your height in inches?
nih_weightWhat is your weight in pounds?
abdominal_painAbdominal pain
ageWhat is your age? (Age in years. For babies less than 1 year old, write 0 as the age)
chillsChills
coughCough
diarrheaDiarrhea
excessive_fatigueExcessive fatigue
feverFever
headacheHeadache
height_feetHeight Feet
height_inchesHeight Inches
muscle_acheMuscle ache
nausea_vomitingNausea/vomiting
new_loss_of_taste_or_smellNew loss of taste or smell
sexWhat is your biological sex assigned at birth?
shortness_of_breath_or_difShortness of breath or difficulty breathing
skin_rashSkin rash
weight_lbsWhat 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-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002709_Data Collection Technologies.pdf31.34 KB
Study Documentationphs002709_Manual of Operations.pdf1.08 MB
Data Files
Total Files: 18
Data Files: 6
Metadata Files: 6
Dictionary Files: 6
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
rad_018_807-01_LoD_DATA_origcopy.csvTabular Data - Non-harmonizedcsv26
rad_018_807-01_Clinical_samples_DATA_transformcopy.csvTabular Data - Harmonizedcsv99
rad_018_807-01_Technology_DATA_origcopy.csvTabular Data - Non-harmonizedcsv3
rad_018_807-01_Spikes_samples_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2
rad_018_807-01_sample_stability_DATA_origcopy.csvTabular Data - Non-harmonizedcsv66
rad_018_807-01_Clinical_samples_DATA_origcopy.csvTabular Data - Non-harmonizedcsv99