Pooling Systems With EUAs

Newest ones at the bottom. If you know of one that’s not on this list, let me know ASAP.

NB: Most of these EUAs say that the tests are only supposed to be used on people suspected of having COVID-19. However, the FDA clearly knows that they’re going to be used off-label to screen asymptomatic folks.

UCSD Health

• Received EUA July 31, 2020
• Up to 5 samples in a pool
• Requires nasopharyngeal or nasal swab or other upper-respiratory sample, collected under supervision of healthcare provider
• Test has to be done at UCSD Health’s own lab (can’t be licensed out)

Poplar Healthcare

• Received EUA August 3, 2020
• Up to 7 samples in a pool
• Requires “clinician-instructed, self-collected” nasal swab or “clinician-collected” nasal, nasopharyngeal, or oropharyngeal swab
• Test has to be done at Poplar’s own lab (can’t be licensed out)

Quest Diagnostics

• Received EUA August 7, 2020
• Up to 4 samples in a pool
• Requires upper respiratory swab (including anterior nasal); not clear if has to be done by healthcare provider
• Tests can be done at any CLIA lab certified for high-complexity tests that Quest designates

BayCare Laboratories

• Received EUA August 31, 2020
• Two samples in a pool
• Requires nasopharyngeal swab
• Test has to be done at BayCare’s own lab (can’t be licensed out)

Verily Life Sciences

• Received EUA September 8, 2020
• Up to 12 samples in a pool
• Updated EUA March 31, 2021 allows adults to do self-collected nasal swab with Verily’s nasal swab kit
• Test has to be done at Verily’s own lab (can’t be licensed out)

LabCorp

• Received EUA September 18, 2020
• Up to 5 samples in a pool; matrix pooling strategy
• Can use nasal swab collected at home
• Test can be licensed to CLIA labs authorized to perform high-complexity tests that are designated by LabCorp
• Has explicit authorization to be used on patients without symptoms

Viracor Eurofins Clinical Diagnostics

• Received EUA October 15, 2020
• Up to 5 samples in a pool
• Requires nasopharyngeal swab
• Has to be done at Eurofins lab (can’t be licensed out)

Roche Molecular Systems

• Received EUA October 15, 2020
• Up to 6 samples in a pool
• Can use clinician-instructed, self-collected nasal swab
• Test can be licensed to CLIA labs authorized to perform high-complexity tests

Centers for Disease Control

• Received EUA December 1, 2020
• Up to 4 samples in a pool
• Requires nasopharyngeal or oropharyngeal swab or other invasively obtained sample procured by healthcare provider
• Test can be licensed to CLIA labs authorized to perform high-complexity tests

BioFire Defense

• Received EUA December 4, 2020
• Up to 8 samples in a pool
• Requires nasopharyngeal swab procured by healthcare provider
• Testing of pooled specimens is limited to Department of Defense labs that can perform high-complexity tests

BioCode

• Received EUA December 7, 2020
• Up to 5 samples in a pool
• Requires nasopharyngeal or nasal swab procured by healthcare provider
• Test can be licensed to CLIA labs authorized to perform high-complexity tests

Alinity m SARS-CoV-2 Assay, by Abbott

• Received EUA December 23, 2020
• Up to 5 samples in a pool
• Requires nasopharyngeal, nasal, or oropharyngeal swab procured by healthcare provider
• Test can be licensed to CLIA labs authorized to perform high-complexity tests

Xpert Xpress SARS-CoV-2 DoD, from Cepheid

• Received EUA December 23, 2020
• Up to 8 samples in a pool
• Requires nasopharyngeal, nasal, oropharyngeal, or mid-turbinate swab procured by healthcare provider
• Limited to US Department of Defense designated CLIA labs authorized to perform high-complexity tests

AMPIPROBE SARS-CoV-2 Test System,
from Enzo Life Sciences

• Received EUA December 30, 2020
• Up to 5 samples in a pool
• Can use pretty much any upper-respiratory swab procured by healthcare provider
• Test can be licensed to CLIA labs authorized to perform high-complexity tests

PerkinElmer New Coronavirus Nucleic Acid Detection Kit

• Received EUA January 12 2021
• Up to 5 samples in a pool
• Can use anterior nasal swab collected “under observation of” a healthcare provider
• Specifically licensed for individuals without symptoms as well as those who are symptomatic
• Test can be licensed to CLIA labs authorized to perform high-complexity tests

Ezplex SARS-CoV-2 G Kit, from SML Genetree

• Received EUA January 13, 2021
• Up to 5 samples in a pool
• Requires nasopharyngeal or oropharyngeal swab procured by healthcare provider
• Test can be licensed to CLIA labs authorized to perform high-complexity tests

Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2

• Received EUA March 25, 2021
• Up to 5 samples in a pool
• Can be used for screening (testing people w/o symptoms)
• Requires self-collected nasal swab from individuals age 18 and older, using the Amazon COVID-19 Test Collection Kit
• Test can be licensed to CLIA labs authorized to perform high-complexity tests

OPTI Medical Systems

• Received EUA April 20, 2021
• Up to 5 samples in a pool
• Can be used for screening (testing people w/o symptoms)
• Requires nasal swab collected by healthcare provider
• Test can be licensed to CLIA labs authorized to perform high-complexity tests

TaqPath Pooling Kit, from ThermoFisher

• Received EUA May 25, 2021
• Up to 5 samples in a pool
• Can be used for screening (testing people w/o symptoms)
• Requires nasal swab collected by healthcare provider
• Test can be licensed to CLIA labs authorized to perform high-complexity tests

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