Study Information
dbGaP Study Accession: phs002738
NIH Institute/Center: NHLBI
RADx Data Program: RADx Tech
Release Date: 08/12/2022
DOI: 10.60773/5ff3-nc70
Study Description: The 5534 prospective clinical study sought to examine the performance of the 5534 device, for the detection of SARS-CoV-2 nucleocapsid protein antigen compared to the Roche 6800 Cobas PCR for SARS-CoV-2 assay. The goal of the 5534 study was for EUA approval for the device to use among symptomatic persons by trained healthcare personnel collected nasal, saliva, and dried bloodspot specimens. Note: no device performance data were included in the dataset.
Updated Date: 04/17/2024
Principal Investigator: Gibson, Laura
Has Data Files: Yes
Study Domain: Diagnostic Testing; Medical Device or Tool Development; Virological Testing
Data Collection Method: Antigen Testing Device; Smartphone; Survey
Keywords: Near Patient Testing; Symptomatic Population
Study Design: Device Verification
Multi-Center Study: No
Study Sites: Emory University
Data Types: Clinical; Questionnaire or Survey
Study Start Date: 11/03/2020
Study End Date: 01/12/2021
Species: Human
Sample Size: 187
Study Population Focus: Adults; Children; 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 Emory 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 phs002738.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
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_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_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_vaping_yn | Vaping use (Yes or No) |
| 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_yn | Alcohol use (Yes or No) |
| nih_lifetime_use_alcohol | In 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_yrs | How often did you have a drink containing alcohol in the past year? |
| nih_alcohol_frequency | How often did you have a drink containing alcohol ? |
| nih_asthma | Asthma |
| nih_cancer | Cancer |
| nih_cancer_active_treatment | Cancer (including leukemia or lymphoma) undergoing active treatment? |
| nih_cancer_past_yr | Cancer diagnosis and/or treatment within the past 12 months |
| 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_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_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_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_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? |
| age_at_registration | Age |
| alcohol | How often did you have a drink containing alcohol in the past year? |
| anemia | Anemia or other blood disorder (do not include leukemia or lymphoma)? |
| asthma | Asthma, to the point that you use inhalers daily or have been to the hospital for your asthma? |
| cancer | Cancer (including leukemia or lymphoma) undergoing active treatment? |
| cf | CF |
| chd | CHD |
| chf | Congestive Heart failure (CHF, Heart Failure)? |
| ckd | Decreased kidney (renal) function or kidney (renal) failure? |
| cld_bpd | CLD BPD |
| cond_prev_activity | Do you have any serious physical or mental condition(s) that limit your ability to perform daily activities? |
| copd | COPD (emphysema, chronic bronchitis, obstructive pulmonary disease)? |
| coronary_artery_disease | Coronary artery disease (blockages in your heart vessels) or angina (chest pain)? |
| cough | A cough (worse than usual) |
| diabetes | Diabetes? Do not include pre-diabetes. |
| doctor_shopping | Because 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_bathing | Do you have difficulty dressing or bathing? (5 years or older) |
| ethnicity | Are you of Hispanic or Latino origin? |
| fever_chills | Symptoms of fever or chills |
| hbp | High blood pressure or hypertension (except that occurred during pregnancy and did not last after pregnancy)? |
| hearing | Are you deaf or do you have serious difficulty hearing? |
| heart_attack | A heart attack (myocardial infarction)? |
| high_temp | A temperature greater than 100.4 °F |
| hiv | Chronic HIV infection? |
| immunodeficiency | Immunodeficiency (NOT including HIV)? |
| memory | Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? (5 years or older) |
| mental_illness | Have 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_aches | Muscle aches (worse than usual) |
| nausea_vomiting_diarrhea | Nausea, vomiting or diarrhea |
| no_symptoms | None of the above |
| premature | History of premature birth (being born before 37 weeks of pregnancy) |
| race_amind | American Indian |
| race_asian | Asian |
| race_black | Black |
| race_dk | Don't know |
| race_other | Other |
| race_pacisl | Pacific Islander |
| race_white | White |
| red_eyes | Red or painful eyes |
| sc_anemia | Have you ever been told by a physician or healthcare provider that you have sickle cell anemia? |
| sex | Gender |
| shortness_of_breath | Shortness of breath |
| smoking | Do you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)? |
| stroke | Stroke or TIA (Transient Ischemic Attack or Mini-Stroke)? |
| unable_to_taste_or_smell | Unable to taste or smell |
| user_id | User ID |
| vision | Are you blind or do you have serious difficulty seeing, even when wearing glasses? |
| walk_stairs | Do you have serious difficulty walking or climbing stairs? (5 years or older) |
| working | We would like to know about what you do-are you working now, looking for work, retired, keeping house, a student, or what? |
| zip | Zipcode |
| 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
Data Files
Total Files: 5
Data Files: 3
Metadata Files: 0
Dictionary Files: 2