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 |