dbGaP Study Accession: phs003237
NIH Institute/Center: NIBIB
RADx Data Program: RADx Tech
Release Date: 04/13/2023
DOI: 10.60773/0va3-6933
Study Description: Objective: To evaluate performance of Ag-RDT for detection of SARS-CoV-2 in relation to onset of infection for symptomatic and asymptomatic participants. Design, Setting, and Participants: Prospective cohort study conducted from October 2021 to February 2022 among participants > 2 years-old from across the US who enrolled using a smartphone app. During each testing encounter, participants self-collected one nasal swab and performed Ag-RDT at home; at-least fifteen minutes later, a second nasal swab was self-collected and shipped for SARS-CoV-2 RT-PCR at a central lab. Both nasal swabs were collected 7 times at 48-hour intervals (over approximately 14 days) followed by an extra nasal swab collection with home Ag-RDT test 48-hours after their last PCR sample. Each participant was assigned to one of the three emergency use authorized (EUA) Ag-RDT tests used in this study. This analysis was limited to participants who were asymptomatic and tested negative by antigen and molecular tests on their first day of study participation.
Updated Date: 04/17/2024
Principal Investigator: Soni, Apurv
Has Data Files: Yes
Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Rapid Diagnostic Test (RDT)
Data Collection Method: Antigen Testing Device; Molecular Nucleic Acid or PCR Testing Device; Survey
Keywords: Asymptomatic Population; Symptomatic Population; Testing Effectiveness
Study Design: Longitudinal Cohort
Multi-Center Study: No
Data Types: Behavioral; Questionnaire or Survey
Study Start Date: 10/18/2021
Study End Date: 03/31/2022
Species: Human
Estimated Cohort Size: 7361
Study Population Focus: Adults; Children; Older Adults or Elderly
Acknowledgement Statement: This study was supported through funding, 3U54HL143541-05S1, for the National Heart Lung and Blood Institute (NHLBI) as part of the RADx Tech program. Operations support and data management occurred primarily through the UMass Chan Medical School’s Center for Clinical and Translational Science, Clinical Studies Core, and the Department of Population and Quantitative Health Sciences. Data collection occurred through the MyDataHelps Platform managed by the CareEvolution team. Quest Diagnostics ran the standard comparators (Roche 6800 Cobas PCR for SARS-CoV-2 assays). Approved users should acknowledge the provision of data access by dbGaP for accession phs003237.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: PA-20-272
NIH Grant or Contract Number(s): 3U54HL143541-05S1
Consent/Data Use Limitations: General Research Use
Variable Name | Label |
---|---|
nih_record_id | User ID |
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 | What is the highest level of education you have achieved outside or in the United States? |
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_disability | Do you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities? |
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_vape_freq | Vaping Frequency: Do you now use electronic cigarettes every day, some days, rarely, or not at all? |
nih_cig_smoke_freq | Nicotine Frequency: Do you now smoke cigarettes? |
nih_smoking_yn | Do you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)? |
nih_alcohol_yrs | How often did you have a drink containing alcohol in the past year? |
nih_asthma | Asthma |
nih_cancer | Cancer |
nih_cancer_active_treatment | Cancer (including leukemia or lymphoma) undergoing active treatment? |
nih_cardiovascular_disease | Cardiovascular disease |
nih_chronic_kidney_disease | Chronic kidney disease |
nih_diabetes | Diabetes |
nih_hypertension | Hypertension |
nih_mental_health_disorder | Mental health disorder |
nih_sickle_cell_disease | Sickle cell disease |
nih_pregnancy | Pregnancy status |
nih_immunocompromised | Immunocompromised condition |
nih_chronic_lung | Other chronic lung disease |
nih_depression | Depression |
nih_alc_sub_abuse | Alcohol or substance use disorder |
nih_iv_drug_use | Intravenous drug use |
nih_othermh | Other mental health disorder |
nih_heart_attack | A heart attack (myocardial infarction)? |
nih_chf | Congestive Heart failure (CHF, Heart Failure)? |
nih_stroke | Stroke or TIA (Transient Ischemic Attack or Mini-Stroke)? |
nih_immunodeficiency | Immunodeficiency (NOT including HIV)? |
nih_hiv | Chronic HIV infection? |
nih_anemia | Anemia or other blood disorder (do not include leukemia or lymphoma)? |
nih_premature_birth | History of premature birth (being born before 37 weeks of pregnancy) |
nih_chd | Chronic Heart Disease |
nih_cf | Cystic Fibrosis |
nih_cld_bpd | CLD BPD (Chronic Lung Disease Bronchopulmonary Dysplasia) |
nih_copd_plus | Chronic obstructive pulmonary disease (COPD) including emphysema, chronic bronchitis, obstructive pulmonary disease? |
nih_no_chronic_condition | No chronic condition |
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_throat_congestion_nose | Sore throat, congestion or runny nose |
nih_red_eyes | Red or painful eyes |
nih_high_temp | A temperature greater than 100.4 °F |
nih_other_symp | Other |
nih_no_sympt | None of the above |
nih_height | What is your height in inches? |
nih_weight | What is your weight in pounds? |
nih_height_category | Approximately what is your height? |
nih_weight_category | Approximately what is your weight? |
race_amind | American Indian |
race_asian | Asian |
race_black | Black |
race_dk | Don't know |
race_pacisl | Pacific Islander |
race_white | White |
zip | Zipcode |
age | - |
AlcoholUse | - |
ChildIntro_Test | - |
cigarrettesperday | - |
closecontact_b | - |
closecontactduration | - |
closecontactduration_b | - |
closecontacthousehold | - |
closecontacthousehold_b | - |
closecontactwhen | - |
closecontactwhen_b | - |
colorblind | - |
cond_alcohol_subs | - |
cond_asthma | - |
cond_cancer | - |
cond_chronic_lung_disease | - |
cond_ckd | - |
cond_copd | - |
cond_cvd | - |
cond_depression | - |
cond_diabetes | - |
cond_hypertension | - |
cond_immun_compromised | - |
cond_iv_drug | - |
cond_mental_health | - |
cond_none | - |
cond_other | - |
cond_seriousmentalillness | - |
cond_sicklecell | - |
cond_SickleCell | - |
contactduration | - |
contactduration_b | - |
ct_ldt1 | - |
ct_ldt2 | - |
currentconditionsother | - |
Deaf | - |
devicenum | - |
DifficultyBathing | - |
difficultydecisionmaking | - |
DifficultyErrands | - |
DifficultyWalking | - |
EcigUse | - |
educationgrade | - |
EducationLevel | - |
egene | - |
EmploymentStatus | - |
employmentstatusother | - |
employmentstatusstudent | - |
EnrollmentDt | - |
expertreadresult | - |
gender_man | - |
gender_noans | - |
gender_nonbin | - |
gender_none | - |
gender_trans | - |
gender_woman | - |
HealthInsurance | - |
HearAbout | - |
height_cm | - |
HispanicOrigin | - |
houseid | - |
housing | - |
housingcategorization | - |
housingother | - |
ldt_result | - |
LimitDailyActivity | - |
NicotineUse | - |
nih_chronic_kidney_disease_treat | - |
nih_coronary_artery_disease_angi | - |
nih_studyday | - |
orf_gene | - |
otc_result | - |
overallhealth | - |
pacisl_nathaw | - |
pacisl_samoan | - |
participantidentifier | - |
ParticipantIdentifier | - |
position | - |
ppl_per_hh | - |
Pregnant | - |
priorinfection | - |
priorinfectiontimeframe | - |
priorinfectionwhen | - |
race_asian_asian | - |
race_asian_chinese | - |
race_asian_filipino | - |
race_asian_indian | - |
race_asian_japanese | - |
race_asian_korean | - |
race_asian_noans | - |
race_asian_other | - |
race_asian_vietnamese | - |
race_noans | - |
race_oth | - |
recentpositivetest | - |
recentpositivetestlocation | - |
roche_result | - |
SetParticipantType | - |
Sex | - |
smp_abd_pain | - |
smp_body_aches | - |
smp_cough | - |
smp_fatigue | - |
smp_fever | - |
smp_headache | - |
smp_loss_smell | - |
smp_nausea | - |
smp_none | - |
smp_other | - |
smp_rash | - |
smp_runny_nose | - |
smp_sob | - |
target1_result_orf | - |
target2_result_egene | - |
testnumber | - |
tiebreaker | - |
Useful_Alerts | - |
Useful_AppInstructions | - |
Useful_PhoneCalls | - |
Useful_SignUp | - |
Useful_Support | - |
Useful_TestShipment | - |
Useful_TextMessages | - |
vaccinated | - |
VaccineIntent_elig | - |
vaccinerecordcompany | - |
VaccineRecordDose1Company_elig | - |
VaccineRecordDose1Date | - |
VaccineRecordDose2Company_elig | - |
VaccineRecordDose2Date | - |
VaccineRecordDose3Company_elig | - |
VaccineRecordDose3Date | - |
VaccineRecordDose4Company_elig | - |
VaccineRecordDose4Date | - |
VaccineRecordDoses_elig | - |
VaccineRecord_elig | - |
VisionDifficulty | - |
weight_kg | - |