dbGaP Study Accession: phs003026
NIH Institute/Center: NHLBI
RADx Data Program: RADx Tech
DOI: 10.60773/5061-0a66
Release Date: 09/01/2022
Study Description: This was a sub-study of the COVID-19 Test At Home Study. The objective was to gather data on performance of Quidel QuickVue for detection of SARS-CoV-2. This sub-study was used to provide data to Quidel to supplement their existing EUA application for an at-home test. In this study, asymptomatic participants with known close contact to someone who was positive for SARS-CoV-2 infection within the past seven days was asked to self-administer a Quidel QuickVue test and receive a comparator PCR test at the study site on the first day of the study. Thereafter, participants received a test-kit to perform Quidel QuickVue test daily at home, preferably in the morning, for five consecutive days. Participants were asked to return to the study site on day 2 for a second PCR test and on the final day (study day 6). However, if any of the home-tests from days 3-5 resulted as positive or participants developed symptoms and their PCR test result was negative on days 1-2, they were asked to come to the study-site for a comparator PCR test earlier than day 6. Participants were given two additional days to return to the study site if they were unable to come on day 6 for an exit PCR; for those participants, they performed an additional Quidel QuickVue test at home before the standard test at the study site. This means that if they came in on day 6, then no at home test was performed on days 7 and 8. If they came in on day 7 then they performed a test at home on day 7. If they came in on day 8 then they performed a test at home on days 7 and 8. The primary objective of this sub-study was to evaluate the performance (positive percent agreement and negative percent agreement) of the Quidel QuickVue test when self-administered by participants in an unsupervised setting at the study site in comparison to a comparator PCR test performed the same day by study staff. Secondary objectives of this sub-study were to: 1) evaluate the performance (positive percent agreement and negative percent agreement) of the Quidel QuickVue test when self-administered by participants at home in comparison to a comparator PCR performed at the beginning and end of the study and 2) Compare self-reported interpretation of QuickVue test result with interpretation made by a study staff in-person (on day 1) and digitally (days 2-6).
Updated Date: 04/17/2024
Principal Investigator: Broach, John
Has Data Files: Yes
Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Medical Device or Tool Development
Data Collection Method: Antigen Testing Device; Molecular Nucleic Acid or PCR Testing Device; Smartphone
Keywords: Asymptomatic Population; People with Known COVID Exposure
Study Design: Longitudinal Cohort
Multi-Center Study: Yes
Study Sites: University of Massachusetts Chan Medical School; Northwestern University and John Hopkins University
Data Types: Behavioral; Questionnaire or Survey
Study Start Date: 03/25/2021
Study End Date: 12/30/2021
Species: Human
Estimated Cohort Size: 200
Study Population Focus: Adults; Older Adults or Elderly
Acknowledgement Statement: This study was supported through funding, 5U54HL143541-04, 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. Additional recruitment of participants occurred at Northwestern University and John Hopkins University. 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 phs003026.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: PAR-17-453
NIH Grant or Contract Number(s): 5U54HL143541-04
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_asian | Asian |
race_black | Black |
race_dk | Don't know |
race_white | White |
age | - |
AlcoholUse | - |
CigarrettesPerDay | - |
CloseContact | - |
CloseContactDays | - |
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_other_other | - |
ContactDuration | - |
ContactHousehold | - |
CurrentConditionsOther | - |
CurrentCovid | - |
DataReport | - |
EcigUse | - |
EducationGrade | - |
EducationLevel | - |
Eligibility | - |
EmploymentStatus | - |
EmploymentStatusOther | - |
EmploymentStatusStudent | - |
EnrollmentDt | - |
EUAResultDate | - |
EUAResultDate_1 | - |
EUAResultDate_2 | - |
EUAResultDate_3 | - |
EUAResultDate_4 | - |
EUATestDate | - |
EUATestDate_1 | - |
EUATestDate_2 | - |
EUATestDate_3 | - |
EUATestDate_4 | - |
EUATestResult | - |
EUATestResult_1 | - |
EUATestResult_2 | - |
EUATestResult_3 | - |
EUATestResult_4 | - |
FurtherInfoProvided | - |
gender_man | - |
gender_noans | - |
gender_nonbin | - |
gender_trans | - |
gender_woman | - |
HealthInsurance | - |
height_cm | - |
HispanicOrigin | - |
Housing | - |
HousingOther | - |
InPersonDelivery | - |
is_18 | - |
LimitDailyActivity | - |
LongForm | - |
MasklessContactDuration | - |
NasalSwab1 | - |
NasalSwab2 | - |
NicotineUse | - |
nih_chronic_kidney_disease_trt | - |
nih_coronary_artery_dis_angina | - |
NoFurtherInfoProvidedRation | - |
OverallHealth | - |
ParticipantIdentifier | - |
PCRKnowledge | - |
PictureIntro | - |
Pregnant | - |
PriorInfection | - |
PriorInfectionTimeframe | - |
quest_assay | - |
quest_ct1 | - |
quest_ct2 | - |
quest_ct_orig | - |
quest_dos | - |
quest_result | - |
quest_target1 | - |
quest_target2 | - |
race_asian_asian | - |
race_asian_chinese | - |
race_asian_filipino | - |
race_asian_indian | - |
race_asian_other | - |
race_asian_vietnamese | - |
race_nativeam | - |
race_noans | - |
race_oth | - |
reasonsforcontact_appissues | - |
reasonsforcontact_interpret | - |
reasonsforcontact_other | - |
reasonsforcontact_positivetest | - |
reasonsforcontact_symptom_rep | - |
reasonsforcontact_test_issues | - |
research_test | - |
ResultCommunicationDate | - |
se_attended_school_1 | - |
se_attended_school_2 | - |
se_attended_school_3 | - |
se_attended_sleepover_1 | - |
se_attended_sleepover_2 | - |
se_attended_sleepover_3 | - |
se_bars_1 | - |
se_bars_2 | - |
se_bars_3 | - |
se_buffets_1 | - |
se_buffets_2 | - |
se_buffets_3 | - |
se_casinos_1 | - |
se_casinos_2 | - |
se_casinos_3 | - |
se_christmas_caroling_1 | - |
se_christmas_caroling_2 | - |
se_christmas_caroling_3 | - |
se_church_1 | - |
se_church_2 | - |
se_church_3 | - |
se_curbside_or_takeout_food_1 | - |
se_curbside_or_takeout_food_2 | - |
se_curbside_or_takeout_food_3 | - |
se_date_1 | - |
se_date_2 | - |
se_date_3 | - |
se_dined_at_a_rest_outdoor_1 | - |
se_dined_at_a_rest_outdoor_2 | - |
se_dined_at_a_rest_outdoor_3 | - |
se_doctor_appointment_1 | - |
se_doctor_appointment_2 | - |
se_doctor_appointment_3 | - |
se_driving_through_mult_states_1 | - |
se_driving_through_mult_states_2 | - |
se_driving_through_mult_states_3 | - |
se_engagement_none_1 | - |
se_engagement_none_2 | - |
se_engagement_none_3 | - |
se_family_reunion_1 | - |
se_family_reunion_2 | - |
se_family_reunion_3 | - |
se_grocery_delivery_1 | - |
se_grocery_delivery_2 | - |
se_grocery_delivery_3 | - |
se_hire_a_house_cleaner_1 | - |
se_hire_a_house_cleaner_2 | - |
se_hire_a_house_cleaner_3 | - |
se_home_exercise_1 | - |
se_home_exercise_2 | - |
se_home_exercise_3 | - |
se_ice_skated_indoors_1 | - |
se_ice_skated_indoors_2 | - |
se_ice_skated_indoors_3 | - |
se_ice_skating_outdoors_1 | - |
se_ice_skating_outdoors_2 | - |
se_ice_skating_outdoors_3 | - |
se_indoor_gym_1 | - |
se_indoor_gym_2 | - |
se_indoor_gym_3 | - |
se_indoor_restaurant_1 | - |
se_indoor_restaurant_2 | - |
se_indoor_restaurant_3 | - |
se_instore_getting_groceries_1 | - |
se_instore_getting_groceries_2 | - |
se_instore_getting_groceries_3 | - |
SelfInterpret | - |
se_movie_theaters_1 | - |
se_movie_theaters_2 | - |
se_movie_theaters_3 | - |
se_multihh_celebration_1 | - |
se_multihh_celebration_2 | - |
se_multihh_celebration_3 | - |
se_played_basketball_indoors_1 | - |
se_played_basketball_indoors_2 | - |
se_played_basketball_indoors_3 | - |
se_sat_in_an_airplane_1 | - |
se_sat_in_an_airplane_2 | - |
se_sat_in_an_airplane_3 | - |
se_sledding_1 | - |
se_sledding_2 | - |
se_sledding_3 | - |
se_spending_time_hh_members_1 | - |
se_spending_time_hh_members_2 | - |
se_spending_time_hh_members_3 | - |
se_stayed_in_a_hotel_1 | - |
se_stayed_in_a_hotel_2 | - |
se_stayed_in_a_hotel_3 | - |
se_used_public_restroom_1 | - |
se_used_public_restroom_2 | - |
se_used_public_restroom_3 | - |
se_used_public_transit_1 | - |
se_used_public_transit_2 | - |
se_used_public_transit_3 | - |
se_video_chats_1 | - |
se_video_chats_2 | - |
se_video_chats_3 | - |
se_visited_hair_salon_barber_1 | - |
se_visited_hair_salon_barber_2 | - |
se_visited_hair_salon_barber_3 | - |
se_visited_indoor_malls_1 | - |
se_visited_indoor_malls_2 | - |
se_visited_indoor_malls_3 | - |
se_visited_outlet_malls_1 | - |
se_visited_outlet_malls_2 | - |
se_visited_outlet_malls_3 | - |
se_walks_with_strangers_1 | - |
se_walks_with_strangers_2 | - |
se_walks_with_strangers_3 | - |
se_went_to_an_office_1 | - |
se_went_to_an_office_2 | - |
se_went_to_an_office_3 | - |
se_working_from_home_1 | - |
se_working_from_home_2 | - |
se_working_from_home_3 | - |
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 | - |
startdt | - |
target1_result | - |
target2_result | - |
TestStripImageExpertRead_res | - |
TestStripImagePartRead_res | - |
TravelPCR | - |
Vaccine | - |
VaccineRecord | - |
VaccineRecordCompany | - |
VaccineRecordDose1Date | - |
VaccineRecordDose2Date | - |
VaccineRecordDoses | - |
VisionDifficulty | - |
weight_kg | - |
Withdraw_NoContact | - |
Zip | - |