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Study Information

dbGaP Study Accession: phs002682

NIH Institute/Center: NIBIB

RADx Data Program: RADx Tech

Release Date: 08/12/2022

DOI: 10.60773/54ae-xy13

Study Description: There are two device studies under the 2183 banner. The 2183b study used an enhanced visual display compared to the original study (2183a), so it has been renamed. These prospective clinical studies sought to examine the performance of the 2183 device (a and b), a lateral flow immunoassay for the point-of-care (POC) detection of SARS-CoV-2 nucleocapsid protein antigen, compared to the Roche 6800 Cobas PCR for SARS-CoV-2 assay. The goal of the 2183b study was for EUA approval for the device to be used among symptomatic persons by trained healthcare personnel collected mid-turbinate specimens. Note: no device performance data will be included in the data files.

Updated Date: 04/09/2024

Principal Investigator: Gibson, Laura

Has Data Files: Yes

Study Domain: Medical Device or Tool Development; Point-of-Care (POC) Testing; Rapid Diagnostic Test (RDT)

Data Collection Method: Antigen Testing Device; Survey

Keywords: Near Patient Testing

Study Design: Device Validation

Multi-Center Study: Yes

Study Sites: UMass Chan Medical School and Northwestern University

Data Types: Clinical; Questionnaire or Survey

Study Start Date: 10/16/2020

Study End Date: 11/06/2020

Species: Human

Estimated Cohort Size: 488

Study Population Focus: N/A

Acknowledgement Statement: This study was supported through funding, 75N92020C00020-P00001-9999-1, for the National Institute of Biomedical Imaging and Bioengineering (NIBIB) 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. Data collection occurred through the Eureka Platform managed by the UCSF 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 phs002682.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.

NIH Grant or Contract Number(s): 75N92020C00020-P00001-9999-1

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 301
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_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_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_vaping_ynVaping use (Yes or No)
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_ynAlcohol use (Yes or No)
nih_lifetime_use_alcoholIn your entire life, have you had at least 1 drink of any kind of alcohol, not counting small tastes or sips? (Yes or No)
nih_alcohol_yrsHow often did you have a drink containing alcohol in the past year?
nih_alcohol_frequencyHow often did you have a drink containing alcohol ?
nih_asthmaAsthma
nih_cancerCancer
nih_cancer_active_treatmentCancer (including leukemia or lymphoma) undergoing active treatment?
nih_cancer_past_yrCancer diagnosis and/or treatment within the past 12 months
nih_chronic_kidney_diseaseChronic kidney disease
nih_chronic_kidney_disease_treatmentChronic kidney disease treatment
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_mental_health_disorderMental health disorder
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
nih_coronary_artery_disease_anginaCoronary artery disease (blockages in your heart vessels) or angina (chest pain)?
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_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_throat_congestion_noseSore throat, congestion or runny nose
nih_red_eyesRed or painful eyes
nih_high_tempA temperature greater than 100.4 °F
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?
age_at_registrationAge
alcoholHow often did you have a drink containing alcohol in the past year?
anemiaAnemia or other blood disorder (do not include leukemia or lymphoma)?
asthmaAsthma, to the point that you use inhalers daily or have been to the hospital for your asthma?
cancerCancer (including leukemia or lymphoma) undergoing active treatment?
cfCF
chdCHD
chfCongestive Heart failure (CHF, Heart Failure)?
ckdDecreased kidney (renal) function or kidney (renal) failure?
cld_bpdCLD BPD
cond_prev_activityDo you have any serious physical or mental condition(s) that limit your ability to perform daily activities?
copdCOPD (emphysema, chronic bronchitis, obstructive pulmonary disease)?
coronary_artery_diseaseCoronary artery disease (blockages in your heart vessels) or angina (chest pain)?
coughA cough (worse than usual)
diabetesDiabetes? Do not include pre-diabetes.
doctor_shoppingBecause of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping? (15 years old or older)
dressing_bathingDo you have difficulty dressing or bathing? (5 years or older)
ethnicityAre you of Hispanic or Latino origin?
fever_chillsSymptoms of fever or chills
hbpHigh blood pressure or hypertension (except that occurred during pregnancy and did not last after pregnancy)?
hearingAre you deaf or do you have serious difficulty hearing?
heart_attackA heart attack (myocardial infarction)?
high_tempA temperature greater than 100.4 °F
hivChronic HIV infection?
immunodeficiencyImmunodeficiency (NOT including HIV)?
memoryBecause of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? (5 years or older)
mental_illnessHave you ever been told by a physician, psychologist, or healthcare provider that you have any mental illness (for example depression, anxiety, bipolar, schizophrenia, or other)?
muscle_achesMuscle aches (worse than usual)
nausea_vomiting_diarrheaNausea, vomiting or diarrhea
no_symptomsNone of the above
prematureHistory of premature birth (being born before 37 weeks of pregnancy)
race_amindAmerican Indian
race_asianAsian
race_blackBlack
race_dkDon't know
race_otherOther
race_pacislPacific Islander
race_whiteWhite
red_eyesRed or painful eyes
sc_anemiaHave you ever been told by a physician or healthcare provider that you have sickle cell anemia?
sexGender
shortness_of_breathShortness of breath
smokingDo you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)?
strokeStroke or TIA (Transient Ischemic Attack or Mini-Stroke)?
unable_to_taste_or_smellUnable to taste or smell
user_idUser ID
visionAre you blind or do you have serious difficulty seeing, even when wearing glasses?
walk_stairsDo you have serious difficulty walking or climbing stairs? (5 years or older)
workingWe would like to know about what you do-are you working now, looking for work, retired, keeping house, a student, or what?
zipZipcode
abc_concern-
abc_location-
abc_performed-
abc_time-
action_taken_1-
action_taken_2-
action_taken_3-
action_taken_4-
adverse_what_1-
adverse_what_2-
adverse_what_3-
adverse_what_4-
alcohol_how_many-
alcohol_often-
alcohol_six_or_more-
an_concern-
an_location-
an_medium-
an_performed-
an_time-
ASSAY-
attribution_1-
attribution_2-
attribution_3-
attribution_4-
complex-
confident-
congestion-
covid_tx_curr-
covid_tx_prev-
covid_vax-
covid_vax_co-
covid_vax_co2-
covid_vax_co3-
covid_vax_date_dose1-
covid_vax_date_dose2-
covid_vax_date_dose3-
covid_vax_doses-
cumbersome-
date_end_1-
date_end_2-
date_end_3-
date_end_4-
date_start_1-
date_start_2-
date_start_3-
date_start_4-
days_since_symptom_start-
dbs_concern-
dbs_location-
dbs_performed-
dbs_sample_success-
dbs_time-
dev_date_noted_1-
dev_date_noted_2-
dev_date_noted_3-
dev_date_noted_4-
dev_date_occured_1-
dev_date_occured_2-
dev_date_occured_3-
dev_date_occured_4-
dev_risk_1-
dev_risk_2-
dev_risk_3-
dev_risk_4-
difficult_breathing-
easy-
education-
education_additional-
expected_1-
expected_2-
expected_3-
expected_4-
fatigue-
frequent-
gender_additional-
headache-
height_ft-
height_in-
household_sx_past_48_hrs-
inconsistency-
indian_health-
insurance_any-
insurance_direct-
insurance_not_covered-
insurance_work-
int_cont_result-
integrated-
internal_cont_res-
internal_flags-
internal_flags_desc-
known_exposure-
known_exposure_days-
learn-
medicaid-
medicare-
mt_concern-
mt_location-
mt_medium-
mt_medium_oth-
mt_performed-
mt_sample_success-
mt_time-
muscle_body_aches-
nih_chronic_kidney_disease_trt-
nih_coronary_artery_dis_angina-
np_concern-
np_location-
np_medium-
np_medium_oth-
np_performed-
np_sample_success-
np_time-
outcome_1-
outcome_2-
outcome_3-
outcome_4-
performed_lab-
pregnancy-
promoter-
quick-
research_datetime-
research_test-
runny_nose-
sal_concern-
sal_performed-
sal_sample_success-
sal_time-
scratchy_throat-
serious_1-
serious_2-
serious_3-
serious_4-
severity_1-
severity_2-
severity_3-
severity_4-
site-
smoking_amount-
smoking_ecig-
sore_throat-
sore_throat_2-
stand_adverse_attrib-
stand_adverse_event-
stand_adverse_what__1-
stand_adverse_what__2-
stand_adverse_what__3-
stand_adverse_what__4-
stand_adverse_what__5-
stand_adverse_what__99-
standard_datetime-
standard_form_dt-
standard_result-
standard_test-
stand_concerns-
stand_cycle_time-
stand_cycle_time_1-
stand_cycle_time_2-
stand_cycle_time_ind-
stand_cycle_time_tar-
stand_d_result-
stand_location-
stand_method-
stand_performed-
stand_qs_result-
stand_result_time-
stand_tar1-
stand_tar2-
sus_score-
technical-
tricare-
vb_concern-
vb_count_tube_gold-
vb_count_tube_green-
vb_count_tube_oth-
vb_count_tube_red-
vb_location-
vb_sample_success-
vb_time-
vb_type_tube_gold-
vb_type_tube_green-
vb_type_tube_oth-
vb_type_tube_oth_specify-
vb_type_tube_red-
vb_volume-
weight-
why_dbs_samp_not_collec-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002682_MASTER Baseline Survey_Adult_03MAY2021.pdf935.91 KB
Study Documentationphs002682_MASTER Baseline Survey_Pediatric_17SEP2021.pdf963.10 KB
Study Documentationphs002682_MASTER Pediatric-Specific Research Center Staff Survey_17SEP2021.pdf809.89 KB
Study Documentationphs002682_MASTER POCT Usability Questionnaire_Adult_03MAY2021.pdf577.33 KB
Study Documentationphs002682_MASTER POCT Usability Questionnaire_Pediatric_17SEP2021.pdf606.79 KB
Study Documentationphs002682_Protocol_02DEC2020.pdf734.24 KB
Data Files
Total Files: 7
Data Files: 5
Metadata Files: 0
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
phs002682_2022-08-10_DATA_transformcopy.csvTabular Data - Harmonizedcsv488

phs002682_2022-08-10_DATA_origcopy.csvTabular Data - Non-harmonizedcsv488

phs002682_transformcopy_2024-04-09.csvTabular Data - Harmonizedcsv488

phs002682_tier2_3_2024-04-09.csvTabular Data - Non-harmonizedcsv488

phs002682_origincopy_2024-04-09.csvTabular Data - Non-harmonizedcsv488