Rapid Tests With EUAs

Newest ones at the bottom. All of these tests can be used at a school –
other rapid tests are out there, but they have to be done at a lab.

NB #1: The EUAs for many of these tests state that they are supposed to be used only by CLIA labs or point-of-care settings that have a CLIA waiver or the like. However, the FDA has stated that “a laboratory [may] extend its existing CLIA Certificate to operate a COVID-19 temporary testing site in an off-site overflow location, which may include schools”.

NB #2: Many EUAs also say that the tests are only supposed to be used on people suspected of having COVID-19. However, the HHS document linked above also notes that if somebody were to use these tests on people with no symptoms, the US government wouldn’t come after them.

Sofia 2, from Quidel

• Received EUA May 8, 2020
• Updated EUA April 1, 2021 allows screening (testing w/o symptoms) if used “twice over two or three days with at least 24 hours and no more than 36 hours between tests”
• 80% sensitivity, 100% specificity (company claims higher, but that hasn’t borne out in the field). A big meta-analysis found 77.4% sensitivity, 99.1% specificity.
• Technically for use in CLIA labs or at point-of-care in facilities with CLIA waiver
• Requires nasal swab
• Not clear whether swab has to be performed by provider

BD Veritor, from Becton, Dickinson and Co.

• Received EUA July 2, 2020
• A version that can detect both SARS-CoV-2 and influenza A and B
  received EUA March 24, 2021
• Updated EUA March 31, 2021 allows screening (testing w/o symptoms) if used “twice over two or three days with at least 24 hours and no more than 48 hours between tests”
• 84% sensitivity, 100% specificity (A big meta-analysis says 63.5% sensitivity, 99.5% specificity)
• For use in CLIA labs or at point-of-care in facilities with CLIA waiver
• Requires nasal swab
• Not clear whether swab has to be performed by provider
• Intended for individuals “suspected of COVID-19 by their healthcare provider within the first 5 days of the onset of symptoms.”

LumiraDx

• Received EUA August 18, 2020
• Company claims 98% sensitivity, 100% specificity; a big meta-analysis says 88.2% sensitivity, 98.6% specificity
• For use in CLIA labs or at point-of-care in facilities with CLIA waiver
• Requires nasal swab
• Not clear whether swab has to be performed by provider
• Intended for individuals “suspected of COVID-19 by their healthcare provider within the first 12 days of the onset of symptoms.”

From Abbott

Except for the criteria above,
these two Abbott tests are exactly the same.

• Can be used with Abbott’s NAVICA app
• 99 – 100% specificity
• The sensitivity of this test is hotly debated. What’s not in dispute: It’s less sensitive than PCR
• It’s less sensitive in asymptomatic people than it is in people with symptoms
• It’s less sensitive in children than it is in adults (here’s more evidence, this time based on research on Panbio, the British version of the BinaxNOW)
• The higher the amount of virus in your nose, the more likely you are to show up positive on this test

The questions is, how much does that matter? Answer: It depends.

• “Antigen tests might be particularly useful when real-time RT-PCR tests are not readily available or have prolonged turnaround times. ” Getting results quickly is critical. Knowing someone is infected five days later, after they’ve had a chance to infect a bunch of people, doesn’t help. And this test is definitely better than no test at all.
• “Serial antigen testing can improve detection.” If you’re testing every other day, you have a better chance of diagnosing an infectious person than if you’re only testing once. This is why the home test requires two tests in a row.
• Since this test does pick up people with more virus in their systems, maybe the people it doesn’t pick up aren’t as infectious.

CareStart, from AccessBio
aka KarmaCare COVID-19 Antigen Test

• Received EUA October 8, 2020
• 88% sensitivity, 100% specificity
• For use in CLIA labs or at point-of-care in facilities with CLIA waiver
• Requires anterior nasal swab
• Intended for individuals “suspected of COVID-19 by their healthcare provider within the first 5 days of symptom onset,” and as of April 12, for folks w/o symptoms “when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.”

CareStart COVID-19 Antigen Home Test

• Received EUA August 2, 2021
• The at-home, non-prescription version of the test above.
• You can swab yourself if you’re 14 years old or older, an adult has to do the swabbing if you’re age 2 – 13.

Sampinute, from Celltrion

• Received EUA October 23, 2020
• Company claims 94% sensitivity, 100% specificity
• For use in CLIA labs or at point-of-care in facilities with CLIA waiver
• Requires nasopharyngeal swab
• Intended for individuals “suspected of COVID-19 by their healthcare provider within the first 5 days of symptom onset.”

Lucira COVID-19 All-In-One Test Kit

• Received EUA November 17, 2020
• Not an antigen test – a molecular amplification (LAMP) test
• Company claims 94% positive predictive agreement (similar to sensitivity) and 98% predictive percent agreement (similar to specificity)
• For use at point-of-care in facilities with CLIA waiver or at home with Rx
• Requires self-collected nasal swab for individuals aged 14 and older; nasal swab by clinician for kids
• Intended for individuals “suspected of COVID-19 by their healthcare provider.”

Clip COVID Rapid Antigen Test, from Luminostics

• Received EUA December 7, 2020
• Company claims 96% sensitivity
• For use in CLIA labs that can perform high, moderate or waived complexity tests, or at point-of-care in facilities with CLIA waiver
• Requires anterior nasal swab
• Intended for individuals “suspected of COVID-19 by their healthcare provider within the first 5 days of symptom onset.”

Ellume COVID-19 Home Test

• Received EUA December 15, 2020
• For people with symptoms: Sensitivity 96%, specificity 100%
• For people without symptoms: Sensitivity 91%, specificity 96%
• Over the counter; results delivered via a smartphone app
• Requires mid-turbinate nasal swab “self-collected by an individual age 16 years or older, or . . . collected by an adult from an individual 2 years of age and older.”
• Authorized for individuals ages 2 years and older, with or without symptoms
• Does not require a prescription

From Abbott

From Quidel

QuickVUE At-Home OTC COVID-19 Test

• Received EUA March 31, 2021
• Can be used for screening (no symptoms)
• Authorized for folks age 2 and up
• Requires self-collected nasal swab from folks age 14 and up, or adult-collected nasal swab from folks age 2 and up
• Must be used “twice over two or three days with at least 24 hours and no more than 36 hours between tests”
• Individuals should report results (whether + or -) to their health-care provider
• Sensitivity 83.5%, specificity 99.2% (click here for definitions)

• None of these three tests distinguishes between SARS-CoV and SARS-CoV-2 (the virus that causes COVID-19)
• All require anterior nasal swab
• Unlike the Quidel’s Sofia test, they don’t require a special piece of equipment – you read them like pregnancy tests.

Status COVID-19/Flu, from Princeton BioMeditech

• Received EUA February 4, 2021
• Company claims 93.9% sensitivity
• Doesn’t distinguish between SARS-CoV and SARS-CoV-2 (the virus that causes COVID-19); hasn’t been validated against all existing variants
• For use in CLIA labs that can perform high, moderate or waived complexity tests, or at point-of-care in facilities with CLIA waiver
• Requires nasopharyngeal swab
• Intended for individuals “suspected of respiratory viral infection by their healthcare provider within the first 5 days of the onset of symptoms.”

Cue COVID-19 Test for Home and Over The Counter (OTC) Use

• Received EUA March 5, 2021
• It’s a molecular test, not an antigen test
• Company claims 97.4% positive predictive agreement with PCR, 99.1% negative predictive agreement with PCR
• Authorized for nonprescription home use; requires a smartphone app
• Requires anterior nasal swab; adults can self-swab, kids >/= 2 yrs and up can be swabbed by an adult
• Can be used by people with or without symptoms

DiaTrust, from Celltrion

• Received EUA April 16, 2021
• Company claims 94.3% sensitivity
• Requires nasopharyngeal swab
• Intended for individuals “suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset” or for people without symptoms “when used twice over two or three days with at least 24 hours and no more than 48 hours between tests.”
• Can be used at point of care with a CLIA waiver

Sienna-Clarity COVID-19 Antigen Rapid Test Cassette

• Received EUA May 20, 2021
• Company claims 87.5% sensitivity
• Requires nasopharyngeal swab
• Intended for individuals “suspected of COVID-19 by their healthcare provider within the first 6 days of symptom onset.”
• Can be used at point of care with a CLIA waiver

InteliSwab COVID-19 Rapid Test, from OraSure

• Received EUA June 4, 2021
• Can be used for screening (no symptoms) when used “twice over two or three days with at least 24 hours and no more than 36 hours between tests.”
• Authorized for folks age 15 and up
• Requires self-collected nasal swab from folks age 18 and up, or adult-collected nasal swab from folks age 15 – 18
• Individuals should report results (whether + or -) to their health-care provider
• Can be used at point of care with a CLIA waiver, Certificate of Compliance, or Certificate of Accreditation.
• Sensitivity and specificity data not publicly available

INDICAID COVID-19 Rapid Antigen Test, from Phase

• Received EUA July 28, 2021
• Intended for individuals “suspected of COVID-19 by their healthcare provider within the first 5 days of symptom onset.”
• Requires nasal swab collected by health-care practitioner or self-collected from folks age 18 and up under the supervision of a health-care practitioner.
• In symptomatic people, company’s study showed 85.3% positive predictive agreement (similar to sensitivity) and 94.9% negative predictive agreement (similar to specificity)
• In asymptomatic people, the same study showed 84.2% positive predictive agreement and 99.9% negative predictive agreement.
• Can be used at point of care with a CLIA waiver, Certificate of Compliance, or Certificate of Accreditation.

GenBody COVID-19 Ag test

• Received EUA July 13, 2021
• Intended for individuals “suspected of COVID-19 by their healthcare provider within the first 6 days of symptom onset.”
• Requires nasopharyngeal swab
• In symptomatic people, company’s study showed 90% sensitivity and 98% specificity
• In asymptomatic people, the same study showed 94% sensitivity and 100% specificity.
• Can be used at point of care with a CLIA waiver, Certificate of Compliance, or Certificate of Accreditation.

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