COVID-19 Point-of-Care Testing (2023)

Molecular tests for rapid detection of COVID-19 authorized for HOME use
Instruct patients to follow test instructions, share ALL test results with their prescriber, and dispose of the testing materials per instructions.

Cue COVID-19 Test for Home and Over The Counter (OTC) Use³⁸

Results:⁴⁵ ~20 minutes

Cost: Approved but not available at time of publication

Storage and Operation:

nasal swab

Authorized OTC for use in people ≥2 years old with or without COVID-19 symptoms.

Smartphone, Cue Health mobile app, and Cue Health Monitoring System (sold separately) required PRIOR to use.

Lucira CHECK IT COVID-19 Test Kit (OTC)³⁶

Results: ~30 minutes

Cost:³⁷ ~$55

Storage and Operation:

nasal swab

For use in people ≥2 years old with or without COVID-19 symptoms.

Instruct patients to use the LUCI portal to have verified test results sent to their phone and transmitted to public health agencies. To start this process patients, need to text “LUCI” to 44544.

For detailed instructions visit https://checkit.lucirahealth.com/.

Lucira COVID-19 All-in-One Test Kit (Rx)²³

Results: ~30 minutes

Storage:

Operation:

nasal swab

Authorized for HOME testing (WITH a prescription) for people ≥14 years old who are suspected to have COVID-19 by their prescriber.

For detailed instructions visit https://shop.lucirahealth.com/.

Molecular tests for rapid detection of COVID-19 authorized for POC use

Accula SARS-CoV-2⁶

Results: ~30 minutes

Storage and Operation:

nasal swab

mid-turbinate swab

Do NOT open pouch >30 minutes before beginning a test.

Swab both nostrils with the same swab.

Add buffer to sample immediately after collection.

• If test is not run immediately after collection (and adding buffer), specimens can be stored:
• at room temp for up to two hours.
• refrigerated for up to 24 hours.

Avoid use of transport media solution if storing specimens before testing due to risk of invalidating test results.

Cue COVID-19⁴

Results: ~20 minutes

Storage:

Operation:

nasal swab

Do NOT open pouch >30 minutes before beginning a test.

Swab both nostrils with the same swab.

Must insert swab into testing cartridge within five minutes of sample collection.

Alternatively, swabs can be used to test previously collected, properly stored nasal specimens in viral transport medium. See product information for these instructions.

ID Now COVID-19⁵

Results: ~15 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

nasopharyngeal swab

nasal swab

throat swab

Do NOT open pouch until just before use.

Swab both nostrils with the same swab.

If test is not run immediately after collection, specimens can be stored at room temp for ≤1 hour.

Avoid use of transport media solution if storing specimens before testing due to risk of false-negative results.

Lucira COVID-19 All-in-One Test Kit²³

Results: ~30 minutes

Storage:

Operation:

nasal swab

Approved for POC testing without age restrictions.

Do NOT open pouch until just before use.

Swab both nostrils with the same swab.

Run test immediately after collection.

Visby Medical COVID-19 Point of Care Test³⁵

Results: ~30 minutes

Storage:

Operation:

nasopharyngeal swab

nasal swab

mid-turbinate swab

Do NOT open pouch until just before use.

When collecting nasal or mid-turbinate swab specimens, swab both nostrils with the same swab. (Only one nostril for nasopharyngeal specimens.)

Add buffer to sample immediately after collection.

If test is not run immediately after collection (and adding buffer), specimens can be stored:

Xpert Omni SARS-CoV-2³⁹

Results: Not available at time of publication

Storage:

Operation (if refrigerated, bring to room temp for use):

nasopharyngeal swab

nasal swab

mid-turbinate swab

Do NOT open cartridge lid until just before use.

When collecting nasal swab specimens, swab both nostrils with the same swab. (Only one nostril for mid-turbinate and nasopharyngeal specimens.)

Run test within 30 minutes of adding the sample to the cartridge.

If test is not run immediately after collection, specimens in transport medium, saline, or eNAT transport medium can be stored:

Xpert Xpress SARS-CoV-2⁷

Results:⁸ ~45 minutes

Storage:

Operation (if refrigerated, bring to room temp for use): 59°F to 86°F (15°C to 30°C) with 20% to 80% relative humidity⁹

nasopharyngeal swab

nasal swab

mid-turbinate swab

oropharyngeal

If test is not run immediately after collection, specimens in viral transport medium or saline can be stored:

Run test within 30 minutes of adding the sample to the cartridge.

Performance has only been established with nasopharyngeal swabs, but nasal, mid-turbinate, and oropharyngeal swabs are considered acceptable specimens.

Molecular tests for rapid detection of COVID-19 and Influenza A/B authorized for POC use

BioFire Respiratory Panel 2.1-EZ

(RP2.1-EZ)¹⁷

Results: ~45 minutes

Storage and Operation:

nasopharyngeal swab

Do NOT open pouch >30 minutes before beginning a test.

If test is not run immediately after collection, specimens in up to 3 mL of transport medium or saline can be stored:

Cobas SARS-CoV-2 & Influenza A/B¹⁵

Results: ~20 minutes

Storage:

Operation (bring to room temp for use):

nasopharyngeal swab

nasal swab

Swab both nostrils with the same swab.

If test is not run immediately after collection, specimens in viral transport medium or normal saline can be stored:

Once specimens have been transferred to the assay tube, they may be stored at room temp for up to four hours.

Xpert Xpress SARS-CoV-2/Flu/RSV¹⁸

Results: ~30 minutes¹⁹

Storage:

Operation (if refrigerated, bring to room temp for use):

nasopharyngeal swab

nasal swab

When collecting nasal swab specimens, swab both nostrils with the same swab. (Only one nostril for nasopharyngeal specimens.)

If test is not run immediately after collection, specimens in 3 mL of viral transport medium or saline can be stored:

• at room temp for up to 24 hours (in viral transport medium) or 48 hours (in saline).
• refrigerated for up to seven days (in viral transport medium or saline). Bring refrigerated specimens to room temp before testing.

Antigen tests for rapid detection of COVID-19 authorized for HOME use
(Negative results do NOT rule out COVID-19, especially in patients with symptoms. If necessary, confirm with a molecular test.)
Instruct patients to follow test instructions, share ALL test results with their prescriber, and dispose of the testing materials per instructions.

BinaxNow COVID-19 Ag Card Home Test (Rx)⁵¹

Results: ~15 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

nasal swab

For people ≥4 years old within seven days of COVID-19 symptom onset.

Performed with certified guides to supervise testing during a video call. Results can be sent to the patient through the NAVICA app. Prescribers report results to public health authorities.

For detailed instructions visit https://www.globalpointofcare.abbott/en/product-details/binaxnow-covid-19-home-test-us.html.

BinaxNow Ag Card 2 Home Test (OTC)^52,*

Results: ~15 minutes

*Authorized, but not available at time of publication

Storage:

Operation (if refrigerated, bring to room temp for use):

nasal swab

For people ≥2 years old with or without symptoms indicated for serial testing twice within three days, ensuring at least 36 hours between tests.

Only to be performed with a telehealth proctor. Results are sent to the patient through email and the NAVICA app.

Patients are to report their results to their prescriber in order to have results sent to the public health authorities.

BinaxNow COVID-19 Antigen Self Test (OTC)²⁷

Results: ~15 minutes

Cost:⁴⁴ ~$24 (includes two tests)

Storage:

Operation (if refrigerated, bring to room temp for use):

nasal swab

For people ≥2 years old with or without symptoms indicated for serial testing twice within three days, ensuring at least 36 hours between tests.

Each kit contains two tests and is indicated for serial self-testing twice within three days, ensuring at least 36 hours between tests.

Patients are to report their results to their prescriber in order to have results sent to the public health authorities.

For detailed instructions visit https://www.globalpointofcare.abbott/en/product-details/binaxnow-covid-19-antigen-self-test-us.html.

Ellume COVID-19 Home Test (OTC)²⁸

Results: ~15 minutes

Cost:⁴⁸ ~$40

Storage:

Operation (if refrigerated, bring to room temp for use):

mid-turbinate swab

For people ≥2 years with or without symptoms.^25,28,30 Includes an adapter to shorten swab for use in children between 2 and 12 years.

Smartphone and smartphone app required PRIOR to use.

Results are automatically sent to smartphone app and public health authorities via secure, HIPAA-compliant cloud connection. Results can also be emailed.^25,28

Test should not be used in people prone to nosebleeds or with a history of facial or head injury or surgery in the last six months.

For detailed instructions visit https://www.ellumecovidtest.com/.

QuickVue At-Home OTC COVID-19 Test⁴⁰

Results:⁴⁷ ~10 minutes

Cost:⁴⁶ ~$30 (includes two tests)

Storage and Operation:

nasal swab

For people ≥2 years old with or without symptoms.

Each kit contains two tests and is indicated for serial self-testing twice within three days, ensuring 24 to 36 hours between tests.

Patients are to report their results to their prescriber in order to have results sent to the public health authorities.

For detailed instructions visit https://quickvueathome.com/.

QuickVue At-Home COVID-19 Test (Rx)⁵⁴

Results: ~10 minutes

Storage and Operation:

nasal swab

Adult-assisted collection (children 8 to 13 years old)

For people ≥8 years old within six days of COVID-19 symptom onset.

Patients are to report their results to their prescriber in order to have results sent to the public health authorities.

For detailed instructions visit https://www.fda.gov/media/146313/download.

Antigen tests for rapid detection of COVID-19 authorized for POC use
(Negative results do NOT rule out COVID-19, especially in patients with symptoms. If necessary, confirm with a molecular test.)

BD Veritor System for Rapid Detection of SARS-CoV-2¹¹

Results: ~15 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

nasal swab

Do NOT open the pouch until just before use.

Swab both nostrils with the same swab.

After processing the swab in the extraction reagent, tests must be run within 30 minutes.

Interpret results between 15 and 20 minutes after starting the test.

Avoid storing specimens in viral transport media.

BinaxNow COVID-19 Ag Card¹⁰ and BinaxNow COVID-19 Ag Card 2⁵³

Results:^10,53 ~15 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

nasal swab

BinaxNow COVID-19 Ag Card is indicated for use in symptomatic patients within 7 days of symptom onset.⁴⁹

BinaxNow COVID-19 Ag Card 2 is indicated for serial testing twice over three days with at least 36 hours between tests in patient with or without symptoms.⁴⁹

Do NOT open the pouch until just before use.^10,53

Swab both nostrils with the same swab.^10,53

Run test within one hour of specimen collection.^10,53

Interpret results between 15 and 30 minutes after starting the test.^10,53

Avoid storing specimens in viral transport media.^10,53

Results of both tests can be captured with the NAVICA app.⁴⁹

Celltrion DiaTrust COVID-19 Ag Rapid Test⁴¹

Results: ~15 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

nasopharyngeal swab

Do NOT open the pouch more than one hour before use.

When collecting the specimens, swab one or both nostrils. If both nostrils are swabbed, use the same swab.

Interpret results between 15 and 20 minutes after starting the test.

If test is not run immediately after collection, specimens can be stored in extraction buffer at room temp for up to four hours.

CareStart COVID-19 Antigen²²

Results: ~10 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

nasopharyngeal swab

nasal swab

Do NOT open the pouch until just before use.

When collecting nasal swab specimens, swab both nostrils with the same swab. (Only one nostril for nasopharyngeal specimens.)

Interpret results between 10 and 15 minutes after starting the test.

If test is not run immediately after collection, specimens can be stored in extraction buffer at room temp for ≤4 hours.

Clip COVID Rapid Antigen Test²⁹

Results: ~30 minutes

Storage and Operation:

nasal swab

Do NOT open pouch until just before use.

Swab both nostrils with the same swab.

Run test within 30 minutes of specimen collection.

Interpret results between 15 and 20 minutes after starting the test.

Avoid storing specimens in viral transport media.

LumiraDx SARS-CoV-2 Ag Test¹⁴

Results: ~12 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

nasopharyngeal swab

nasal swab

Do NOT open pouch until just before use.

Swab both nostrils with the same swab (nasal swab specimens). One or both nostrils can be swabbed for nasopharyngeal specimens.

If test is not run immediately after collection, specimens can be stored at room temp for up to five hours.

SCoV-2 Ag Detect Rapid Test⁵⁰

Results: ~25 minutes

Storage and Operation:

nasal swab

For use in patients with suspected COVID-19 within five days of symptom onset.

Can be used with serial testing, twice within three days ensuring 24 to 48 hours between tests in people without symptoms.

Do NOT open pouch until just before use.

Swab both nostrils with the same swab.

Interpret results between 20 and 25 minutes after starting the test.

If test is not run immediately after collection, specimens can be stored:

Sofia SARS Antigen FIA¹²

Results: ~15 minutes

Storage and Operation:

nasal swab

Do NOT open pouch until just before use.

Use one nostril (the one with the most secretion) to collect sample.

If test is not run immediately after collection, unprepared specimenscan be stored at room temp or refrigerated for up to 48 hours.

Prepared specimens can be stored out of direct sunlight, at room temp, for up to one hour before testing.

Not recommended for use with viral transport media as this may decrease sensitivity (increase the chance for a false negative).

QuickVue SARS Antigen Test²⁶

Results: ~10 minutes

Storage and Operation:

nasal swab

Do NOT open the pouch more than one hour before use.

Swab both nostrils with the same swab.

Interpret results between 10 and 15 minutes after starting the test.

If test is not run immediately after collection, unprepared specimenscan be stored:

Not recommended for use with viral transport media.

Antigen tests for rapid detection of COVID-19 and Influenza A/B for POC use
(Negative results do NOT rule out COVID-19, especially in patients with symptoms. If necessary, confirm with a molecular test.)

BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B⁴²

Results: ~15 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

nasal swab

Do NOT open the pouch more than five minutes before use.

Run test within 30 minutes of specimen collection.

Interpret results between 15 and 20 minutes after starting the test.

Not recommended for use with viral transport media.

Sofia 2 Flu + SARS Antigen FIA²⁴

Results: ~15 minutes

Storage and Operation:

59°F to 86°F (15°C to 30°C)

nasopharyngeal swab

nasal swab

Do NOT open the pouch until just before use.

Use one nostril (the one with the most secretion) to collect sample.

Interpret results between 15 and 30 minutes after starting the test.

If test is not run immediately after collection, unprepared specimenscan be stored:

Not recommended for use with viral transport media.

Status COVID-19/Flu⁴³

Results: ~15 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

nasopharyngeal swab

Do NOT open the pouch until just before use.

Interpret results between 15 and 20 minutes after starting the test.

If test is not run immediately after collection, unprepared specimenscan be stored:

Not recommended for use with viral transport media.

Serology (antibody) tests for rapid detection of an immune response to a recent exposure to SARS-CoV-2
(Should generally NOT be used to diagnose COVID-19. Positive results do not mean patients are immune or protected from reinfection.)
Available POC serology tests provide qualitative (yes/no); not quantitative (number of antibodies) results.
When using fingerstick POC samples for antibody testing, tests should be run immediately after sample collection.

Assure COVID-19 IgG/IgM Rapid Test¹⁶

Results: ~15 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

fingerstick

Do NOT open the pouch until just before use.

Interpret results between 15 and 30 minutes after starting the test.

Confirm positive results with a different IgG or IgM assay, due to the risk of false positive results from cross-reactivity with other antibodies.

Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit³³

Results: ~15 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

fingerstick

Do NOT open the pouch until just before use.

Interpret results between 15 and 20 minutes after starting the test.

MidaSpot COVID-19 Antibody Combo Detection Kit³¹

Results: ~20 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

fingerstick

Do NOT open the pouch more than 15 minutes before use.

Interpret results between 18 and 25 minutes after starting the test.

RapCov Rapid COVID-19 Test²⁰

Results: ~15 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

fingerstick

Do NOT use if onset of symptoms was <15 days ago.

Do NOT open the pouch until just before use.

Interpret results between 15 and 20 minutes after starting the test.

RightSign COVID-19 IgG/IgM Rapid Test Cassette³²

Results: ~10 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

fingerstick

Do NOT open the pouch more than one hour before use.

Interpret results between 15 and 20 minutes after starting the test.

Test may be less accurate if used in patients whose onset of symptoms was <15 days ago.

SGTi-flex COVID-19 IgG³⁴

Results: ~10 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

fingerstick

Do NOT open the pouch until just before use.

Interpret results between 10 and 30 minutes after starting the test.

Test may be less accurate if used in patients whose onset of symptoms was <15 days ago.

Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test¹³

Results: ~10 minutes

Storage:

Operation (if refrigerated, bring to room temp for use):

fingerstick

Do NOT open the pouch more than one hour before use.

Interpret results between 10 and 20 minutes after starting the test.