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Study Information

dbGaP Study Accession: phs002544

NIH Institute/Center: NCATS

RADx Data Program: RADx-rad

Release Date: 01/26/2022

DOI: 10.60773/w5vb-c640

Study Description: This project was in response to the NIH's RADx-rad Emergency Responses to the COVID-pandemic for new or non-traditional technologies developed for single extracellular vesicle, exosome and extracellular RNA (exRNA) isolation and analysis and reposition them for detection of SARS-CoV-2. The project's group was a grantee in the NIH Common Fund Extracellular RNA Communication (ERC) Program advancing a new and emerging technology of Acoustofluidic Separation (AFS) for label-free, high yield and purity exosomes from biofluids which is coupled to extracellular RNA characterization using Surface Enhanced Raman Spectroscopy (SERS) for single EV identification. This project was to reposition the AFS EV technology and SERS for the non-invasive earliest detection of SARS-CoV-2 in saliva of infected patients. Host immunity to SARS-CoV-2 was also assessed in the saliva samples, permitting the earliest detection of SARS-CoV-2 infection and host immunity non-invasively in a saliva sample.

Updated Date: 09/27/2023

Principal Investigator: Wong, David T

Has Data Files: Yes

Study Domain: Medical Device or Tool Development; Virological Testing

Data Collection Method: Molecular Nucleic Acid or PCR Testing Device

Keywords: Early Detection; Electric Field–Induced Release and Measurement (EFIRM); Exosome based; Host Immunity; Surface Enhanced Raman Spectroscopy (SERS)

Study Design: Device Validation

Multi-Center Study: No

Data Types: Clinical; Immunological

Study Start Date: 12/21/2020

Study End Date: 11/30/2022

Species: Human

Estimated Cohort Size: 90

Study Population Focus: N/A

Acknowledgement Statement: This study was supported through funding, 4U18TR003778-02, for the National Center for Advancing Translational Sciences (NCATS) as part of the RADx-rad program. Approved users should acknowledge the provision of data access by dbGaP for accession phs002544.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): 4U18TR003778-02

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 299
Study Variables Information Table
Variable Name
Label
nih_record_idUser ID
nih_raceWhat is your race?
nih_ethnicityAre you of Hispanic or Latino origin? May include Spanish origin.
nih_ageWhat is your age?
nih_sexWhat is your biological sex assigned at birth?
nih_nicotine_ynNicotine use (Yes or No)
nih_tobaccoTobacco Use
nih_alcohol_ynAlcohol use (Yes or No)
nih_asthmaAsthma
nih_cancerCancer
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_kidney_diseaseChronic kidney disease
nih_chronic_lung_diseaseChronic lung disease
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_immunosuppressive_conditionImmunosuppressive condition
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)
alcohol_useAlcohol Use
asthmaAsthma
cancerCancer
cardiovascular_diseaseCardiovascular disease
chillsChills
chronic_kidney_diseaseChronic kidney disease
chronic_lung_diseaseChronic lung disease
coughCough
diabetesDiabetes
diarrheaDiarrhea
ethnicityAre you of Hispanic or Latino origin?
excessive_fatigueExcessive fatigue
feverFever
headacheHeadache
height_feetHeight Feet
height_inchesHeight Inches
hypertensionHypertension
immunosuppressive_conditioImmunosuppressive condition
muscle_acheMuscle ache
nausea_vomitingNausea/vomiting
new_loss_of_taste_or_smellNew loss of taste or smell
nicotineNicotine Use
raceWhat is your race? Mark one or more boxes.
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)
acquisition_time-
acquisition_time_unit-
analyte_type-
analytical_cutoff_description-
analytical_cutoff_min-
antigen_id-
antigen_name-
antigen_region-
antigen_region_end-
antigen_region_start-
area_under_the_roc_curve-
assay_readout-
assay_readout_description-
assay_readout_unit-
assay_result-
backward_inner_primer_sequence-
backward_inner_primer_source-
backward_inner_primer_source_url-
backward_loop_primer_sequence-
backward_loop_primer_source-
backward_loop_primer_source_url-
backward_outer_primer_sequence-
backward_outer_primer_source-
backward_outer_primer_source_url-
biorecognition_type-
capture_antibody_clonality-
capture_antibody_host_organism_name-
capture_antibody_host_organism_taxonomy_id-
capture_antibody_ig_type-
capture_antibody_source-
capture_antibody_source_id-
capture_antibody_source_url-
capture_antibody_target_organism_name-
capture_antibody_target_organism_taxonomy_id-
capture_antibody_target_protein_id-
capture_antibody_target_protein_name-
capture_antigen_expression_system-
capture_antigen_id-
capture_antigen_modification-
capture_antigen_region-
capture_antigen_region_end-
capture_antigen_region_start-
capture_antigen_source-
capture_antigen_source_id-
capture_antigen_source_url-
capture_antigen_target_organism_name-
capture_antigen_target_organism_taxonomy_id-
capture_olignucleotide_source-
capture_olignucleotide_source_url-
capture_oligonucleotide_sequence-
capture_receptor_formulation-
capture_receptor_id-
capture_receptor_modification-
capture_receptor_name-
capture_receptor_purification_method-
capture_receptor_purity-
capture_receptor_region_end-
capture_receptor_region_start-
capture_receptor_source-
capture_receptor_source_id-
capture_receptor_source_name-
capture_receptor_source_url-
clinical_cutoff_description-
clinical_cutoff_min-
clinical_cutoff_min_unit-
clinical_sensitivity-
clinical_sensitivity_ci_max-
clinical_sensitivity_ci_min-
clinical_sensitivity_ci_percent-
clinical_specificity-
clinical_specificity_ci_max-
clinical_specificity_ci_min-
clinical_specificity_ci_percent-
cohort_id-
cohort_size-
copies_of_non_sars_cov_2_particles-
copies_of_sars_cov_2_particles-
copies_of_total_particles-
covid_diagnosis-
covid_test_ct_value-
covid_test_result-
covid_test_result_raw-
covid_test_specimen_collector-
covid_test_specimen_type-
covid_test_specimen_type_other-
covid_test_target_disease_status-
covid_test_type-
covid_test_type_other-
covid_vaccine-
covid_vaccine_doses-
covid_vaccine_type-
days_since_first_vaccine-
days_since_second_vaccine-
detector_antibody_clonality-
detector_antibody_clone-
detector_antibody_id-
detector_antibody_modification-
detector_antibody_modification_role-
detector_antibody_name-
detector_antibody_source-
detector_antibody_source_url-
detector_nucleotide_modification_3prime-
detector_olignucleotide_source_url-
detector_oligonucleotide_modification_3prime_role-
detector_oligonucleotide_sequence-
detector_oligonucleotide_source-
dynamic_range_max-
dynamic_range_max_unit-
dynamic_range_min-
dynamic_range_min_unit-
false_negatives-
false_positives-
forward_inner_primer_sequence-
forward_inner_primer_source-
forward_inner_primer_source_url-
forward_loop_primer_sequence-
forward_loop_primer_source-
forward_loop_primer_source_url-
forward_outer_primer_sequence-
forward_outer_primer_source-
forward_outer_primer_source_url-
gisaid_clade-
gisaid_id-
immobilization_reagent_id-
immobilization_reagent_inchi_key-
immobilization_reagent_name-
immobilization_reagent_source-
immobilization_reagent_source_id-
immobilization_reagent_source_url-
isolate_name-
laser_power_max-
laser_power_min-
laser_power_unit-
laser_wavelength-
laser_wavelength_unit-
limit_of_blank-
limit_of_detection-
limit_of_detection_unit-
map_height-
map_size_unit-
map_step_size-
map_width-
negative_predictive_value-
negative_predictive_value_ci_max-
negative_predictive_value_ci_min-
negative_predictive_value_ci_percent-
non_clinical_cutoff_min-
non_clinical_cutoff_min_unit-
non_clinical_sensitivity-
non_clinical_sensitivity_ci_max-
non_clinical_sensitivity_ci_min-
non_clinical_sensitivity_ci_percent-
non_clinical_specificity-
non_clinical_specificity_ci_max-
non_clinical_specificity_ci_min-
non_clinical_specificity_ci_percent-
nucleotide_db_id-
pango_lineage-
positive_predictive_value-
positive_predictive_value_ci_max-
positive_predictive_value_ci_min-
positive_predictive_value_ci_percent-
protocol_id-
raman_shift_max-
raman_shift_min-
raman_shift_unit-
reporter_conjugation-
reporter_formulation-
reporter_id-
reporter_modification-
reporter_mutations-
reporter_name-
reporter_organism_name-
reporter_organism_taxonomy_id-
reporter_region-
reporter_region_end-
reporter_region_start-
reporter_source-
reporter_source_id-
reporter_source_name-
reporter_source_url-
sample_concentration-
sample_concentration_unit-
sample_group-
sample_id-
sample_media-
sample_media_id-
sample_media_source-
sample_media_source_name-
sample_media_source_url-
sample_size-
secondary_detector_antibody_id-
secondary_detector_antibody_modification-
secondary_detector_antibody_modification_role-
secondary_detector_antibody_name-
secondary_detector_antibody_source-
signal_detection-
specimen_dilution_factor-
specimen_type-
standard_antibody_clonality-
standard_antibody_clone-
standard_antibody_id-
standard_antibody_isotype-
standard_antibody_name-
standard_antibody_source-
standard_antibody_source_url-
study_id-
study_population-
substrate_id-
substrate_inchi_key-
substrate_name-
substrate_source-
substrate_source_id-
substrate_source_url-
surface-
symptom_onset_days-
target_analyte_id-
target_analyte_name-
target_analyte_type-
target_organism_name-
target_organism_taxonomy_id-
technology_description-
technology_platform-
technology_reference-
true_label-
true_negatives-
true_positives-
virus_batch_number-
virus_preinactivation_tcid50-
virus_preinactivation_tcid50_unit-
virus_sample_concentration-
virus_sample_concentration_reference_gene-
virus_sample_formulation-
virus_sample_genome_equivalents-
virus_sample_genome_equivalents_reference_gene-
virus_sample_genome_equivalents_unit-
virus_sample_grow_cell_line-
virus_sample_inactivation_method-
virus_sample_source-
virus_sample_source_url-
virus_sample_type-
virus_source-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002544_COVID-19 Course Survey_26FEB2021.pdf1.09 MB
Study Documentationphs002544_HOS REDCap Survey_15APR2020.pdf560.47 KB
Study Documentationphs002544_Protocol.pdf223.66 KB
Data Files
Total Files: 126
Data Files: 42
Metadata Files: 42
Dictionary Files: 42
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
rad_018_778-01_Ab_EFIRM_CLINICALSAMPLE_DATA_transformcopy.csvTabular Data - Harmonizedcsv163
rad_018_778-01_EFIRMCLINICALSAMPLE_Antigen_DATA_transformcopy.csvTabular Data - Harmonizedcsv20
rad_018_778-01_EFIRMCLINICALSAMPLE_EFIRM_RNA_DATA_transformcopy.csvTabular Data - Harmonizedcsv20
rad_018_778-01_NAB_CLINICALSAMPLE_DATA_transformcopy.csvTabular Data - Harmonizedcsv154
rad_018_778-01_SERS_CLINICALSAMPLES_DATA_origcopy.csvTabular Data - Non-harmonizedcsv80
rad_018_778-01_EFIRMCLINICALPERFORMANCEMETRICS_Antigen_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2
rad_018_778-01_EFIRMSPIKEDSAMPLE_EFIRM_RNA_DATA_origcopy.csvTabular Data - Non-harmonizedcsv7
rad_018_778-01_EFIRMSPIKEDSAMPLERESULTS_EFIRM_RNA_DATA_origcopy.csvTabular Data - Non-harmonizedcsv7
rad_018_778-01_NAB_ANALYTICALPERFORMANCEMETRICS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1
rad_018_778-01_NAB_SPIKEDSAMPLERESULTS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv8
rad_018_778-01_SERS_SPIKEDSAMPLESRESULTS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv20
rad_018_778-01_Ab_EFIRM_ANALYTICALPERFORMANCEMETRIC_DATA_origcopy.csvTabular Data - Non-harmonizedcsv4
rad_018_778-01_EFIRMSPIKEDSAMPLERESULTS_Antigen_DATA_origcopy.csvTabular Data - Non-harmonizedcsv8
rad_018_778-01_VQA_Antigen_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1
rad_018_778-01_EFIRMCLINICALPERFORMANCEMETRICS_EFIRM_RNA_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2
rad_018_778-01_EFIRMCLINICALSAMPLE_EFIRM_RNA_DATA_origcopy.csvTabular Data - Non-harmonizedcsv20
rad_018_778-01_EFIRMSPIKEDSAMPLE_Antigen_DATA_origcopy.csvTabular Data - Non-harmonizedcsv8
rad_018_778-01_Ab_EFIRM_SPIKEDSAMPLE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv54
rad_018_778-01_Ab_EFIRM_CLINICALSAMPLE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv163
rad_018_778-01_NAB_CLINICALSAMPLERESULTS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv186
rad_018_778-01_EFIRMCLINICALSAMPLE_Antigen_DATA_origcopy.csvTabular Data - Non-harmonizedcsv20
rad_018_778-01_SERS_ANALYTICALPERFORMANCEMETRICS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1
rad_018_778-01_Ab_EFIRM_SPIKEDSAMPLERESULTS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv54
rad_018_778-01_SERS_SPIKEDSAMPLE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv20
rad_018_778-01_EFIRMCLINICALSAMPLERESULTS_Antigen_DATA_origcopy.csvTabular Data - Non-harmonizedcsv40
rad_018_778-01_EFIRMTECHNOLOGYDESCRIPTION_Antigen_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2
rad_018_778-01_Ab_EFIRM_CLINICALPERFORMANCEMETRICS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv9
rad_018_778-01_EFIRMTECHNOLOGYDESCRIPTION_EFIRM_RNA_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2
rad_018_778-01_NAB_CLINICALSAMPLE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv154
rad_018_778-01_VQA_SERS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1
rad_018_778-01_SERS_CLINICALPERFORMANCEMETRICS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1
rad_018_778-01_NAB_TECHNOLOGYDESCRIPTION_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1
rad_018_778-01_NAB_SPIKEDSAMPLE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv8
rad_018_778-01_VQA_EFIRM_RNA_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1
rad_018_778-01_Ab_EFIRM_TECHNOLOGYDESCRIPTION_DATA_origcopy.csvTabular Data - Non-harmonizedcsv6
rad_018_778-01_Ab_EFIRM_CLINICALSAMPLERESULTS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv732
rad_018_778-01_EFIRMANALYTICALPERFORMANCEMETRIC_EFIRM_RNA_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2
rad_018_778-01_SERS_TECHNOLOGYDESCRIPTION_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2
rad_018_778-01_NAB_CLINICALPERFORMANCEMETRICS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv3
rad_018_778-01_EFIRMCLINICALSAMPLERESULTS_EFIRM_RNA_DATA_origcopy.csvTabular Data - Non-harmonizedcsv40
rad_018_778-01_SERS_CLINICALSAMPLERESULTS_DATA_origcopy.csvTabular Data - Non-harmonizedcsv80
rad_018_778-01_EFIRMANALYTICALPERFORMANCEMETRIC_Antigen_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2