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Study Information

dbGaP Study Accession: phs002588

NIH Institute/Center: NCATS

RADx Data Program: RADx-rad

Release Date: 11/11/2022

DOI: 10.60773/cfem-qh07

Study Description: COVID-19 presented a public health emergency: There was a critical need for rapid, not reagent-intensive, non-invasive testing technologies. This program led to the production of a prototype system to diagnose COVID-19 infection using the body odor signature of the disease. The goal of this program was to maximize societal impact by creating a validated prototype that can be used in a community or workplace setting by minimally trained personnel for low-cost, on-the-spot diagnosis within minutes. The system was developed in a manner that puts it on a pathway for rapid FDA approval. The Research Aims were: Aim 1. Optimization, assembly, and integration of a prototype system with the ability to examine odor signature of COVID-19 in samples of body odor. The system was simple to use, posed essentially zero risk to the operator and the test subject, and reported a result within minutes. The production cost at scale was approximately $9,000 for the complete measurement system, with a per test cost of approximately $0.50. The design and construction of the prototype was conducted by Novo Engineering, a leading firm with extensive experience in medical device development. Aim 2. Software development. Software for the system from VOC sampling to final diagnostic result was developed to ensure error-free operation of the device. Preliminary results suggested that simple linear discriminant analysis (LDA) does an excellent job of classifying VOCs from human body odor as COVID-19 positive or negative (92% sensitivity and 87% specificity). Optimization of the sensor array (Aim 1) and use of richer feature sets in the classifier models led to further performance improvements in the prototype system. Aim 3. System Benchmarking and Validation. The full prototype system was benchmarked against a number of VOC mixtures, with and without in vitro skin models. The system went through extensive testing against body odor samples from individuals with pathological conditions other than COVID-19 and other sources of potentially confounding VOCs. The prototype was validated against 400 samples drawn from the COVID-SAFE program at Penn. The screening included all members of the Penn community, and represented incredible racial and ethnic diversity as well as a wide variance in age, sex, and gender. Aim 4. Regulatory Approval Plan. The plan was developed under the direction of Sr/Key personnel John Fuson, JD, an attorney at Crowell & Moring LLP and a former Associate Chief Counsel at FDA. Novo Engineering had extensive experience in guiding prototype design in alignment with the requirements for FDA approval. The proposed COVID-19 VOC-based testing device was regulated by the FDA, likely as a Class I or II medical device. Because there is no clear predicate device to reference in this case, a direct de novo petition was submitted to FDA asking the agency to categorize and clear the proposed COVID-19 testing device as Class I or Class II without reference to any predicate.

Updated Date: 01/18/2024

Principal Investigator: Johnson, Alan T

Has Data Files: Yes

Study Domain: Medical Device or Tool Development; Novel Biosensing or VOC; Rapid Diagnostic Test (RDT); Virological Testing

Data Collection Method: Unspecified COVID Testing Device

Keywords: Bioengineering; Body Odor; Individuals with Pathological Conditions Other than COVID-19; Infectious Diseases; Networking and Information Technology Research and Development (NITRD)

Study Design: Longitudinal Cohort

Multi-Center Study: Yes

Study Sites: University of Pennsylvania; Florida International University

Data Types: Chemosensor; Electronic Medical Records; Individual Phenotype

Study Start Date: 12/21/2020

Study End Date: 05/31/2022

Species: Human

Estimated Cohort Size: 400

Study Population Focus: N/A

Acknowledgement Statement: This study was supported through funding, 4U18TR003775-02, for the National Center for Advancing Translational Sciences (NCATS) as part of the RADx-rad program. Sample collection done in partnership with VOC Health (CEO Richard Postrell). Approved users should acknowledge the provision of data access by dbGaP for accession phs002588.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-20-017

NIH Grant or Contract Number(s): 4U18TR003775-02

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 194
Study Variables Information Table
Variable Name
Label
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_education_yrsHow many years of education have you completed?
nih_zipWhat is your zip code?
nih_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_deafAre you deaf or do you have serious difficulty hearing?
nih_blindAre you blind or do you have serious difficulty seeing, even when wearing glasses?
nih_memoryBecause of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions?
nih_walk_climbDo you have serious difficulty walking or climbing stairs?
nih_dress_batheDo you have difficulty dressing or bathing?
nih_errandBecause of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping?
nih_vaping_ynVaping use (Yes or No)
nih_nicotine_ynNicotine use (Yes or No)
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_serious_mental_illnessSerious mental illness
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
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_conjunctivitisConjunctivitis
nih_health_statusWould you say that (your) health in general is excellent, very good, good, fair, or poor?
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
blindAre you blind or do you have serious difficulty seeing, even when wearing glasses?
cancerCancer
cardiovascular_diseaseCardiovascular disease
chillsChills
chronic_kidney_diseaseChronic kidney disease
chronic_lung_diseaseChronic lung disease
conjunctivitisConjunctivitis
coughCough
deafAre you deaf or do you have serious difficulty hearing?
diabetesDiabetes
diarrheaDiarrhea
dress_bathe_disDo you have difficulty dressing or bathing?
educationHow many years of education have you completed? (Years of education from 0 - 20+)
employmentAre you employed?
errand_disBecause of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping?
ethnicityAre you of Hispanic or Latino origin?
excessive_fatigueExcessive fatigue
feverFever
headacheHeadache
health_statusWould you say that (your) health in general is excellent, very good, good, fair or poor?
height_feetHeight Feet
height_inchesHeight Inches
hypertensionHypertension
immunosuppressive_conditioImmunosuppressive condition
insuranceWhat kind of health insurance do you have?
memory_disBecause of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions?
muscle_acheMuscle ache
nausea_vomitingNausea/vomiting
new_loss_of_taste_or_smellNew loss of taste or smell
nicotineNicotine Use
pregnancy_statusPregnancy status
raceWhat is your race? Mark one or more boxes.
serious_mental_illnessSerious mental illness
sexWhat is your biological sex assigned at birth?
shortness_of_breath_or_difShortness of breath or difficulty breathing
sickle_cell_diseaseSickle cell disease
skin_rashSkin rash
vapingVaping Use
walking_climbing_disDo you have serious difficulty walking or climbing stairs?
weight_lbsWhat is your weight? (Weight in pounds)
zipZip or Postal Code: (De-Identified zip code)
analyte_type-
assay_result-
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-
covid_test_name-
covid_test_result-
covid_test_specimen_collector-
covid_test_specimen_type-
covid_test_type-
desorption_temperature-
desorption_temperature_unit-
desorption_time-
desorption_time_unit-
extraction_time-
extraction_time_unit-
false_negatives-
false_positives-
gc_carrier_gas-
gc_column-
gc_column_film_thickness-
gc_column_film_thickness_unit-
gc_column_flow-
gc_column_flow_unit-
gc_column_inner_diameter-
gc_column_inner_diameter_unit-
gc_column_length-
gc_column_length_unit-
gc_column_source-
gc_column_source_url-
gc_injection_method-
gcms_total_runtime-
gcms_total_runtime_unit-
gc_oven_first_temperature_ramp-
gc_oven_first_temperature_ramp_unit-
gc_oven_second_temperature_ramp-
gc_oven_second_temperature_ramp_unit-
gc_oven_start_temperature-
gc_oven_start_temperature_hold_time-
gc_oven_start_temperature_hold_time_unit-
gc_oven_start_temperature_unit-
gc_oven_temperature_end_first_ramp-
gc_oven_temperature_end_first_ramp_unit-
gc_oven_temperature_end_second_ramp-
gc_oven_temperature_end_second_ramp_unit-
measurement_type-
ml_method-
ml_method_description-
ms_interface_temperature-
ms_interface_temperature_unit-
ms_ionization_temperature-
ms_ionization_temperature_unit-
ms_ionization_type-
ms_ionization_voltage-
ms_ionization_voltage_unit-
ms_quad_temperature-
ms_quad_temperature_unit-
ms_scan_range_max-
ms_scan_range_min-
ms_scan_range_unit-
negative_predictive_value-
negative_predictive_value_ci_max-
negative_predictive_value_ci_min-
negative_predictive_value_ci_percent-
negative_samples-
negative_samples_in_calculation-
nih_record_id-
peak_id-
positive_predictive_value-
positive_predictive_value_ci_max-
positive_predictive_value_ci_min-
positive_predictive_value_ci_percent-
positive_samples-
positive_samples_in_calculation-
protocol_id-
sample_equilibration_time-
sample_equilibration_time_unit-
sample_extraction_temperature-
sample_extraction_temperature_unit-
sampling_technology_color_code-
sampling_technology_source-
sampling_technology_source_url-
signal_detection-
specimen_type-
study_id-
study_id-
study_population-
technology_description-
technology_platform-
technology_reference-
true_negatives-
true_positives-
validation_test-
validation_test_permutations-
voc_compound_formula-
voc_compound_inchikey-
voc_compound_name-
voc_compound_retention_time-
voc_compound_retention_time_unit-
voc_relative_abundance-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002588_Participant Demographics_18MAY2022.xlsx13.11 KB
Study Documentationphs002588_Protocol.pdf59.86 KB
Study Documentationphs002588_SOP_Wave Capture_18FEB2022.pdf144.65 KB
Study Documentationphs002588_VOC Subject Questionnaire_21FEB2022.pdf13.55 KB
Data Files
Total Files: 15
Data Files: 5
Metadata Files: 5
Dictionary Files: 5
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
rad_017_775-01_FIUCOVIDVO_Clinical_Samples_DATA_transformcopy.csvTabular Data - Harmonizedcsv102
rad_017_775-01_FIUCOVIDVOC_Performance_Metrics_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1
rad_017_775-01_FIUCOVIDVO_Clinical_Samples_DATA_origcopy.csvTabular Data - Non-harmonizedcsv102
rad_017_775-01_FIUCOVIDVOC_Test_Results_DATA_origcopy.csvTabular Data - Non-harmonizedcsv4080
rad_017_775-01_FIUCOVIDVOC_Technology_Description_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1