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Study Information

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 Information
Total Variables: 320
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_educationWhat is the highest level of education you have achieved outside or in the United States?
nih_zipWhat is your zip code?
nih_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_disabilityDo you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities?
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_vape_freqVaping Frequency: Do you now use electronic cigarettes every day, some days, rarely, or not at all?
nih_cig_smoke_freqNicotine Frequency: Do you now smoke cigarettes?
nih_smoking_ynDo you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)?
nih_alcohol_yrsHow often did you have a drink containing alcohol in the past year?
nih_asthmaAsthma
nih_cancerCancer
nih_cancer_active_treatmentCancer (including leukemia or lymphoma) undergoing active treatment?
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_kidney_diseaseChronic kidney disease
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_mental_health_disorderMental health disorder
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
nih_immunocompromisedImmunocompromised condition
nih_chronic_lungOther chronic lung disease
nih_depressionDepression
nih_alc_sub_abuseAlcohol or substance use disorder
nih_iv_drug_useIntravenous drug use
nih_othermhOther mental health disorder
nih_heart_attackA heart attack (myocardial infarction)?
nih_chfCongestive Heart failure (CHF, Heart Failure)?
nih_strokeStroke or TIA (Transient Ischemic Attack or Mini-Stroke)?
nih_immunodeficiencyImmunodeficiency (NOT including HIV)?
nih_hivChronic HIV infection?
nih_anemiaAnemia or other blood disorder (do not include leukemia or lymphoma)?
nih_premature_birthHistory of premature birth (being born before 37 weeks of pregnancy)
nih_chdChronic Heart Disease
nih_cfCystic Fibrosis
nih_cld_bpdCLD BPD (Chronic Lung Disease Bronchopulmonary Dysplasia)
nih_copd_plusChronic obstructive pulmonary disease (COPD) including emphysema, chronic bronchitis, obstructive pulmonary disease?
nih_no_chronic_conditionNo chronic 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_throat_congestion_noseSore throat, congestion or runny nose
nih_red_eyesRed or painful eyes
nih_high_tempA temperature greater than 100.4 °F
nih_other_sympOther
nih_no_symptNone of the above
nih_heightWhat is your height in inches?
nih_weightWhat is your weight in pounds?
nih_height_categoryApproximately what is your height?
nih_weight_categoryApproximately what is your weight?
race_asianAsian
race_blackBlack
race_dkDon't know
race_whiteWhite
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-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs003026_Participant Questionnaires_v2_07APR2021.pdf827.07 KB
Study Documentationphs003026_Protocol_15SEP2021.pdf610.42 KB
Data Files
Total Files: 5
Data Files: 3
Metadata Files: 0
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
phs003026_transformcopy_2024-04-09.csvTabular Data - Harmonizedcsv200

phs003026_origincopy_2024-04-09.csvTabular Data - Non-harmonizedcsv200

phs003026_tier2_3_2023-03-30.csvTabular Data - Non-harmonizedcsv1759