Rapid Tests With EUAs

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

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.

The Quidel Sofia instrument.

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)
  • 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 (independent preprint article says overall sensitivity more like 80%, but could be as high as 91% if sample obtained at right time)
  • 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
  • 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.”
Abbott BinaxNOW At Home Test.

From Abbott

BinaxNOW
(Click here for BinaxNOW COVID-19
Ag Card Home Test)
  • Received EUA August 26, 2020
  • Labeled for use in adults within 7 days of symptom onset, but many places also use it to screen asymptomatic people.
  • 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
BinaxNOW
COVID-19 Antigen Self Test
  • Received EUA March 31, 2021
  • Does not require prescription
  • Can be done anywhere
  • Can be used for screening (no symptoms)
  • Labeled for use in folks ages 2 and up
  • Requires self-collected nasal swab from folks age 15 and up or adult-collected swab from folks age 2 and up
  • Test must be used “twice over three days with at least 36 hours between tests”
  • Individuals should report their results (whether + or -) to their health-care provider
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.

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.”
Sampinute box and testing unit.
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 percent agreement (similar to sensitivity) and 98% negative 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
BinaxNOW COVID-19 Ag CARD and phone showing Navica app

From Abbott

BinaxNOW COVID-19 Ag Card
Home Test
  • Received EUA December 16, 2020
  • For use in individuals within 7 days of symptom onset, by prescription only or
  • Company claims 91.7 – 100% sensitivity in those individuals
  • Requires nasal swab obtained under the supervision of a healthcare provider
    • Can be self-collected by individuals 15 years of age and older
    • Collected by an adult from individuals 4 – 14 years of age
  • Requires Abbott’s NAVICA app: You download the app and use it to see if you meet eligibility requirements for the test. If you do, they send the test to you or to a pharmacy where you can pick it up.
  • $25/test
BinaxNOW COVID-19
Ag Card 2 Home Test
  • Received EUA March 31, 2021
  • Can be used for screening (no symptoms)
  • No prescription needed, but requires “supervision of a telehealth proctor”
  • Requires nasal swab obtained under the supervision of a healthcare provider
    • Can be self-collected by individuals
      15 years of age and older
    • Collected by an adult from individuals
      2 – 14 years of age
  • Test must be used “twice over three days with at least 36 hours between tests.”
  • Requires Abbott’s NAVICA app
Several QuickVUE tests for different diseases.
The boxes look kind of pretty together because they picked good colors.


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)
QuickVUE SARS Antigen Test
  • Received EUA December 18, 2020
  • Intended for individuals “suspected of COVID-19 by their healthcare provider within the first 5 days of the onset of symptoms.”
  • For use in CLIA labs that can perform high, moderate or waived complexity tests, or at point-of-care in facilities with CLIA waiver
  • Company claims 96% positive predictive agreement with PCR, 99.3% negative predictive agreement with PCR
QuickVUE At-Home
COVID-19 Test
  • Received EUA March 1, 2021
  • Authorized for prescription home use for individuals “suspected of COVID-19 by their healthcare provider within the first 6 days of the onset of symptoms.”
  • Swabs can be self-collected by individuals age 14 and older; they can be collected by adults for kids ages 8 – 13
  • 84.8% positive predictive agreement with PCR, 99.1% negative predictive agreement with PCR
Princeton BioMeditech Status Flu A&B rapid test.

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.”
Using the Cue test.

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

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