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 Name | Label |
---|---|
nih_race | What is your race? |
nih_ethnicity | Are you of Hispanic or Latino origin? May include Spanish origin. |
nih_age | What is your age? |
nih_sex | What is your biological sex assigned at birth? |
nih_education_yrs | How many years of education have you completed? |
nih_zip | What is your zip code? |
nih_employment | Please specify your employment status. |
nih_insurance | What kind of health insurance do you have? |
nih_deaf | Are you deaf or do you have serious difficulty hearing? |
nih_blind | Are you blind or do you have serious difficulty seeing, even when wearing glasses? |
nih_memory | Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? |
nih_walk_climb | Do you have serious difficulty walking or climbing stairs? |
nih_dress_bathe | Do you have difficulty dressing or bathing? |
nih_errand | Because 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_yn | Vaping use (Yes or No) |
nih_nicotine_yn | Nicotine use (Yes or No) |
nih_alcohol_yn | Alcohol use (Yes or No) |
nih_asthma | Asthma |
nih_cancer | Cancer |
nih_cardiovascular_disease | Cardiovascular disease |
nih_chronic_kidney_disease | Chronic kidney disease |
nih_chronic_lung_disease | Chronic lung disease |
nih_diabetes | Diabetes |
nih_hypertension | Hypertension |
nih_immunosuppressive_condition | Immunosuppressive condition |
nih_serious_mental_illness | Serious mental illness |
nih_sickle_cell_disease | Sickle cell disease |
nih_pregnancy | Pregnancy status |
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_conjunctivitis | Conjunctivitis |
nih_health_status | Would you say that (your) health in general is excellent, very good, good, fair, or poor? |
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) |
alcohol_use | Alcohol Use |
asthma | Asthma |
blind | Are you blind or do you have serious difficulty seeing, even when wearing glasses? |
cancer | Cancer |
cardiovascular_disease | Cardiovascular disease |
chills | Chills |
chronic_kidney_disease | Chronic kidney disease |
chronic_lung_disease | Chronic lung disease |
conjunctivitis | Conjunctivitis |
cough | Cough |
deaf | Are you deaf or do you have serious difficulty hearing? |
diabetes | Diabetes |
diarrhea | Diarrhea |
dress_bathe_dis | Do you have difficulty dressing or bathing? |
education | How many years of education have you completed? (Years of education from 0 - 20+) |
employment | Are you employed? |
errand_dis | Because of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping? |
ethnicity | Are you of Hispanic or Latino origin? |
excessive_fatigue | Excessive fatigue |
fever | Fever |
headache | Headache |
health_status | Would you say that (your) health in general is excellent, very good, good, fair or poor? |
height_feet | Height Feet |
height_inches | Height Inches |
hypertension | Hypertension |
immunosuppressive_conditio | Immunosuppressive condition |
insurance | What kind of health insurance do you have? |
memory_dis | Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? |
muscle_ache | Muscle ache |
nausea_vomiting | Nausea/vomiting |
new_loss_of_taste_or_smell | New loss of taste or smell |
nicotine | Nicotine Use |
pregnancy_status | Pregnancy status |
race | What is your race? Mark one or more boxes. |
serious_mental_illness | Serious mental illness |
sex | What is your biological sex assigned at birth? |
shortness_of_breath_or_dif | Shortness of breath or difficulty breathing |
sickle_cell_disease | Sickle cell disease |
skin_rash | Skin rash |
vaping | Vaping Use |
walking_climbing_dis | Do you have serious difficulty walking or climbing stairs? |
weight_lbs | What is your weight? (Weight in pounds) |
zip | Zip 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 | - |