RADx Tech and RADx-ATP Vendors

RADx Tech and RADx-ATP Vendors

The RADx-UP Coordination and Data Collection Center works to support the structures necessary to establish productive collaboration among the RADx programs (RADx-UP, RADx Tech, and RADx-ATP). In support of this, below is a list of RADx-Tech and RADx-ATP vendors that projects can work with to support their COVID-19 testing needs. If you are a part of the RADx-UP network and have questions or concerns about testing, reach out to your Engagement Impact Team (EIT).

RADx TECH and RADx-ATP - Home Collect Options

Organization EUA Status Sample Type Test Information TAT Supervised? Indication Collection Site Key Attributes IFU EUA
Becton, Dickinson and Co. Approved Anterior nasal swabs Test at-home, antigen 15 minutes Unsupervised Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 with: Self-collected anterior nasal swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. Adult collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. Self-collected anterior nasal swab samples from individuals aged 14 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test results are interpreted by the Scanwell Health App and displayed on a compatible smartphone Home collect Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Download here Download here
Boson Biotech Co Approved Anterior nasal swabs Test at-home, antigen 15 minutes Unsupervised Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19, using: Self-collected anterior nasal (nares) swabs from individuals aged 14 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. Adult-collected anterior nasal (nares) swab specimens from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests Home collect Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Single Target Download here Download here
Detect Approved Anterior Nasal Swab Molecular in vitro diagnostic test, Qualitative detection of nucleic acid 60 minutes Unsupervised/app assisted “Non-prescription home use for the qualitative detection of nucleic acid from the novel coronavirus SARS-CoV-2 that causes COVID19 with: Self-collected anterior nasal (nasal) swab samples from individuals aged 14 years or older suspected of COVID-19. Adult-collected anterior nasal swab samples from individuals aged 2 years or older suspected of COVID-19 Self-collected anterior nasal swab samples from individuals aged 14 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.” Home collect RT, LAMP, Lateral Flow Strips, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Download here Download here
Ellume Approved Nasal Swab: Mid-turbinate Test at home, antigen 15 minutes Unsupervised/app assisted Non-prescription home use for the qualitative detection of SARSCoV-2 nucleocapsid antigens from: Self-collected direct mid-turbinate nasal swab specimens from individuals aged 16 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. Adult-collected direct mid-turbinate nasal swab specimens from individuals aged 2 years of age or older with symptoms of COVID-19 within the first 7 days of symptom onset. Self-collected mid-turbinate nasal swab specimens from individuals aged 16 years or older, or adult-collected mid-turbinate nasal swab specimens from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two to three days with at least 24 hours (and no more than 48 hours) between tests Home collect Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Download here Download here 
Maxim Biomedical, Inc. Authorized Anterior nasal swab Test at-home, antigen 15 minutes Unsupervised/adult assisted “Self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first five days of symptom onset. Adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first five days of symptom onset. Self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests” Home Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Download here Download here
Osang Healthcare Approved Anterior nasal swab Test at home, antigen 15 minutes Unsupervised Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 7 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19, using: Self-collected anterior nasal (nares) swabs from individuals aged 14 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. Adult-collected anterior nasal (nares) swab specimens from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. Home collect Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Single Target Download here Download here 
Quidel Corporation Approved Nasal Swab: Anterior nares Test at home, antigen 10 minutes Unsupervised Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 with: Self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first six days of symptom onset. Adult-collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first six days of symptom onset. Self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. Home collect Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Download here Download here 
Roche / SD Biosensor Approved Nasal Swab: Anterior nares Test at home, antigen 20 minutes Unsupervised Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 with: Self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 6 days of symptom onset. Adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 6 days of symptom onset. Self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. Home collect Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target Download here Download here 
Siemens Healthineers Approved Nasal Swab: Anterior nares Test at-home, antigen 15 minutes Unsupervised Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 with: Self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. Adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. Self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests Home collect Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Single Target Download here Download here

RADx Tech and RADx-ATP – High Throughput Labs

PathogenDxAuthorizedNasopharyngeal Swabs, Oropharyngeal Swabs, Mid-Turbinate Nasal Swabs, Anterior Nasal Swabs, Nasal Aspirates, Nasopharyngeal Wash/Aspirates, and Bronchoalveolar Lavage SpecimensRT-PCR + PCR-DNA microarray hybridization, Qualitative detection of RNA4 hours 15 minutesSupervised"Individuals suspected of COVID-19 by their healthcare provider"CLIA Lab that meets the requirements to perform high complexity testsRT-PCR, DNA Microarray Hybridization

Organization & EUA Link EUA Status Sample Type Test Information TAT Supervised? Indication Collection Site Key Attributes
Aegis Sciences Authorized NPS, Mid or Anterior Nasal Swab, OPS and Saliva Nucleic acid, RT-PCR 16-24 hours Supervised Suspected of Covid-19 Sample will be collected by client and sent to Aegis for analysis National reach through various lab locations and Walgreens Pharmacies.
Broad Institute Authorized Nasal Swab Nucleic acid, RT-PCR 24 hours Observed or Unobserved Self-collection Symptomatic (EUA) Institutional (congregate care, schools, employers,  hospital and mobile site collections)/self-collection (EUA -October 2020) Mission driven non profit  with high throughput
Ceres Nanosciences Authorized Nasal Swab, Oral swab, Saliva Other 30 mins NA NA NA Reduce the processing time in wastewater testing by at least 20-fold; Is compatible with high-complexity, point-of-care, or over-the-counter assays.
Helix OpCo Authorized Nasal swab, Oral swab Nucleic acid, next generation sequencing <24 hours Supervised or unsupervised on site collection Symptomatic & Asymptomatic Central Lab
Mammoth Biosciences, Inc. Authorized Nasopharyngeal swabs, oropharyngeal (throat) swabs, mid-turbinate nasal swabs, anterior nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate CRISPR-based, reverse transcription and loop-mediated amplification (RT-LAMP) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens 1.5 hours Supervised Individuals suspected of COVID-19 by their healthcare provider CLIA Lab that meets the requirements to perform high complexity tests RT-LAMP, CRISPR, Single Target
Meridian Bioscience, Inc. Authorized Nasopharyngeal Swabs, Oropharyngeal Swabs, Mid-Turbinate Nasal Swabs, and Anterior Nasal Swabs Real-time RT-PCR test, Qualitative detection of RNA 47 - 85 minutes Supervised "Individuals suspected of COVID-19 by their healthcare provider" CLIA Lab that meets the requirements to perform high or moderate complexity tests Real time RT-PCR
Path Group Authorized Nasal swab, Oral swab, Saliva, Other Nucleic acid, RT-PCR 24 hours Supervised Suspected of Covid-19 CLIA lab
PathogenDx Authorized Nasopharyngeal Swabs, Oropharyngeal Swabs, Mid-Turbinate Nasal Swabs, Anterior Nasal Swabs, Nasal Aspirates, Nasopharyngeal Wash/Aspirates, and Bronchoalveolar Lavage Specimens RT-PCR + PCR-DNA microarray hybridization, Qualitative detection of RNA 4 hours 15 minutes Supervised "Individuals suspected of COVID-19 by their healthcare provider" CLIA Lab that meets the requirements to perform high complexity tests RT-PCR, DNA Microarray Hybridization
Sonic Healthcare Authorized Nasal swab, Oral swab, Sputum, Other Nucleic acid, RT-PCR 24 hours Supervised Symptomatic/Pre-symptomatic CLIA lab Sonic HealthCare geographic locations: Austin TX; Memphis TN; Hicksville NY; Honolulu HI; Los Angeles CA; Las Vegas NV; Jacksonville FL; Toledo OH; Greensboro NC; Providence RI. (Any awardees in these areas could initiate a collaboration with Sonic)
University of California, Los Angeles (UCLA) Authorized Nasopharyngeal swabs, oropharyngeal swab, midturbinate nasal swabs, and anterior nasal swabs Next-Generation Sequencing (NGS) in vitro diagnostic test, Qualitative detection of SARS-CoV-2 RNA 24-48 hours Supervised/Unsupervised "Individuals suspected of COVID-19 by their healthcare provider" Limited to UCLA Clinical Microbiology Laboratory located at Brentwood Annex, 11633 San Vicente Blvd Los Angeles, CA 90049 and UCLA SwabSeq COVID-19 Testing Laboratory located at 650 Charles E Young Dr South, CHS Building, South Tower, 87-300 Los Angeles CA, 90095 RT-PCR and Sequencing, Ideal for large organizations interested in large scale testing

 

RADx Tech-ATP Projects – Point of Care (PoC) Technologies

Talis Biomedical CorporationAuthorizedNasal mid-turbinate swabQualitative in vitro real-time Nucleic Acid Amplification Test (NAAT) System for the automated detection of nucleic acid from SARS-CoV-230 minutesSupervisedIndividuals suspected of COVID-19 by their healthcare providerCLIA-waived/POCRT, Isothermal amplification, Multiple Targets

Organization EUA Status Sample Type Test Information TAT Supervised? Indication Collection Site Key Attributes
ANP Technologies, Inc. Authorized Mid-Turbinate Nasal Swabs Lateral flow immunoassay, Qualitative detection of nucleocapsid protein antigen 15 minutes Supervised "Individuals who are suspected of having COVID-19 by their healthcare provider within the first seven (7) days of symptom onset" OR "Individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests" CLIA Waiver/Point of Care Lateral Flow, Visual Read, Serial Screening
Ellume Authorized Nasal swab Antigen 15 minutes Unsupervised (training through app) Symptomatic & Asymptomatic In-home & institutions Read here
GenBody, Inc. Authorized Nasopharyngeal Swabs, Anterior Nasal Swabs Immunochromatographic rapid diagnostic test, Qualitative detection of nucleocapsid protein antigen 15 - 20 minutes Supervised "Individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset" OR "From individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests" CLIA Waiver/Point of Care Lateral Flow, Visual Read, Serial Screening
Luminostics Authorized Nasal swab Antigen <30 minutes Supervised Symptomatic CLIA-waived/POC Read here
MicroGEM U.S., Inc. Authorized Saliva Qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens; First FDA authorized Point of Care Saliva PCR Test 30 minutes Supervised Individuals suspected of COVID-19 by a healthcare provider CLIA Waiver/Point of Care Real-time RT-PCR, Saliva, Multiple Targets
Minute Molecular Diagnostics, Inc. Authorized Anterior nasal swab Real-time RT-PCR assay intended for the qualitative detection of RNA from SARS-CoV-2 15 minutes Supervised Individuals suspected of COVID-19 by a healthcare provider CLIA Waiver/Point of Care Real-time RT-PCR, Multiple Targets
Qorvo Biotechnologies, LLC Authorized Anterior Nasal Swab Automated bulk acoustic wave biosensor-based test, Qualitative detection of nucleocapsid viral antigens 20 minutes Supervised "Individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset" CLIA Lab that meets the requirements to perform moderate or high complexity tests (CLIA waive claim in clinical study) Bulk Acoustic Wave (BAW) Biosensor, Instrument Read
Quidel  Authorized Nasal swab, Other Antigen, lateral flow assay (LFA) 15 minutes Supervised Suspected of COVID-19; symptoms within 5 days CLIA-waived/POC Read here
Talis Biomedical Corporation Authorized Anterior nasal swab Nasal mid-turbinate swab 30 minutes Supervised Individuals suspected of COVID-19 by their healthcare provider CLIA-waived/POC RT, Isothermal amplification, Multiple Targets
Thermo Fisher Authorized Nasal swab Nucleic acid, RT-PCR 30 minutes Supervised Suspected of COVID-19 Health Care Setting Performance, scalability and mission to serve all populations. Read here.
Uh-Oh Labs, Inc. Authorized Anterior nasal swab Qualitative detection of nucleic acid from SARS-CoV-2 40 minutes Supervised Individuals suspected of COVID-19 by a healthcare provider; Emergency use of this test is limited to authorized laboratories CLIA waiver/POC RT-LAMP, Single Target
Visby Medical Authorized Nasal swab Nucleic acid, RT-PCR 30 minutes Supervised Symptomatic In-home & institutions Read here
Xtrava Health Authorized Anterior Nasal Swabs Lateral flow immunoassay, Qualitative detection of nucleocapsid protein antigen 15 minutes Supervised "Individuals suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset" CLIA Waiver/Point of Care Lateral Flow, Visual Read