COVID-19 Point-of-Care Testing

Full update June 2021

This chart reviews pertinent information about point-of-care (POC) and home COVID-19 tests available in the U.S. Information within the chart is from the device product labeling unless otherwise noted. At the end of the chart, find information about personal protective equipment, obtaining specimens, patient follow up, and billing for COVID-19 POC tests. See our chart, COVID-19 Testing FAQs, for who should be tested and interpreting test results. Our chart, Point-of-Care Testing in Pharmacies, includes other available POC tests (e.g., flu, strep, etc) and tips to start a POC testing service in your pharmacy.

POC Test/Timing for Results

Kit Storage/Operational Temperature

Specimen Collection

Comments

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:

  • 59°F to 86°F (15°C to 30°C)

nasal swab

  • self-collection (adults)
  • adult-assisted collection (children ≥2 years old)

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:

  • 59°F to 86°F (15°C to 30°C)

nasal swab

  • self-collection (≥14 years old)
  • adult-assisted collection (children 2 to 13 years old)

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:

  • 59°F to 86°F (15°C to 30°C)

Operation:

  • 41°F to 113°F (5°C to 45°C) with 5% to 95% humidity

nasal swab

  • self-collection (≥14 years old)

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:

  • 59°F to 86°F (15°C to 30°C)

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:

  • 59°F to 86°F (15°C to 30°C)

Operation:

  • 59°F to 86°F (15°C to 30°C)
  • Has not been tested at higher or lower temperatures or in high humidity.

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

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:

  • 59°F to 86°F (15°C to 30°C)

Operation:

  • 41°F to 113°F (5°C to 45°C) with 5% to 95% humidity

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:

  • 36°F to 86°F (2°C to 30°C)

Operation:

  • 66°F to 82°F (19°C to 28°C) with 30% to 80% humidity

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:

  • at room temp for up to 45 minutes.
  • refrigerated for up to 24 hours.

Xpert Omni SARS-CoV-239

Results: Not available at time of publication

Storage:

  • 36°F to 82°F (2°C to 28°C)

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

  • recommended: 59°F to 86°F (15°C to 30°C) with 20% to 80% relative humidity
  • allowable: 59°F to 104°F (15°C to 40°C) with 16% to 90% relative humidity

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:

  • at room temp for up to eight hours.
  • refrigerated for up to seven days.

Xpert Xpress SARS-CoV-27

Results:8 ~45 minutes

Storage:

  • 36°F to 82°F (2°C to 28°C)

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:

  • at room temp for up to eight hours.
  • refrigerated for up to seven days.

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:

  • 59°F to 77°F (15°C to 25°C)

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:

  • at room temp for up to four hours.
  • refrigerated for up to three days. Bring refrigerated specimens to room temp before testing.

Cobas SARS-CoV-2 & Influenza A/B15

Results: ~20 minutes

Storage:

  • 36°F to 46°F (2°C to 8°C)

Operation (bring to room temp for use):

  • 59°F to 86°F (15°C to 30°C)

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:

  • at room temp for up to four hours.
  • refrigerated for up to 72 hours.

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:

  • 36°F to 82°F (2°C to 28°C)

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

  • 59°F to 86°F (15°C to 30°C) with 20% to 80% relative humidity

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

nasal swab

  • self-collection (≥15 years old)
  • Adult-assisted collection (children 4 to 14 years old)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

nasal swab

  • self-collection (≥15 years old)
  • Adult-assisted collection (children 2 to 14 years old)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

nasal swab

  • self-collection (≥15 years old)
  • Adult-assisted collection (children 2 to 14 years old)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 77°F (15°C to 25°C)

mid-turbinate swab

  • self-collection (≥16 years old)
  • Adult-assisted collection (children 2 to 15 years old)

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:

  • 59°F to 86°F (15°C to 30°C)

nasal swab

  • self-collection (≥14 years old)
  • Adult-assisted collection (children 2 to 13 years old)

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:

  • 59°F to 86°F (15°C to 30°C)

nasal swab

  • self-collection (≥14 years old)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

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:

  • 34°F to 86°F (1°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

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:

  • 59°F to 86°F (15°C to 30°C)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C) and relative humidity of 10% to 90%.

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:

  • 59°F to 86°F (15°C to 30°C)

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:

  • at room temp for up to four hours.
  • refrigerated for up to four days.

Sofia SARS Antigen FIA12

Results: ~15 minutes

Storage and Operation:

  • 59°F to 86°F (15°C to 30°C)

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 specimens can 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:

  • 59°F to 86°F (15°C to 30°C)

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 specimens can be stored:

  • at room temp or refrigerated for up to 120 hours. Bring refrigerated samples to room temp before testing.

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

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 specimens can be stored:

  • at room temp or refrigerated up to 48 hours. Bring refrigerated samples to room temp before testing.

Not recommended for use with viral transport media.

Status COVID-19/Flu43

Results: ~15 minutes

Storage:

  • 36°F to 86°F (2°C to 30°C)

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

  • 64°F to 86°F (18°C to 30°C)

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 specimens can be stored:

  • at room temp for up to four hours.
  • refrigerated for up to eight hours. Bring refrigerated samples to room temp before testing.

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

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:

  • 39°F to 86°F (4°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

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:

  • 39°F to 77°F (4°C to 25°C)

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

  • 59°F to 86°F (15°C to 30°C)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 68°F to 77°F (20°C to 25°C)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

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:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

fingerstick

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

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

 

Continue for “Tips for COVID-19 POC Testing”

Tips for COVID-19 POC Testing

  • Molecular and antigen tests detect active COVID-19 infection. Serology (antibody) tests detect an immune response to a previous exposure to SARS-CoV-2.1
  • In the U.S., pharmacies can use the following CPT code for POC COVID-19 testing: U0002.2 Prescriber offices can refer to the American Medical Association’s most current guidance on COVID-19 coding and guidance at https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance. For locations looking to obtain a CLIA wavier, the Centers for Medicare & Medicaid (CMS) released a quick start guide to streamline the CLIA-waiver certification process for labs conducting testing for COVID-19.21 The quick start guide can be found at https://www.cms.gov/files/document/laboratory-quick-start-guide-cms-clia-certification.pdf.
  • Use proper PPE. Ensure access, necessary training, fit testing (if using N95 respirators), and adherence to guidance (e.g., CDC [https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html]) for PPE.
  • Know how to obtain specimensfor POC testing.
  • Use an appropriate space to collect specimens. For example, use an isolated space outside of the pharmacy to collect specimens (e.g., the parking lot [drive thru windows may not ensure proper protection, especially if not using supervised self-collection methods]).3
  • Follow policies and procedures for reporting positive and negative test results to patients, and local and state health departments.
  • For all patients with symptoms, regardless of test results, discuss symptom management (e.g., fluids, antipyretic for fever).
  • Patients with positive COVID-19 test should be given instructions on isolation procedures (https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/steps-when-sick.html) and if tested in a pharmacy, referred to their prescriber for further evaluation and management.
  • Have a system to follow-up with patients to ensure referrals are complete, check that symptoms are improving, or assess med tolerability.

References

  1. FDA. Coronavirus disease 2019 (COVID-19) emergency use authorizations for medical devices: in vitro diagnostics EUAs. May 24, 2021. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas. (Accessed May 24, 2021).
  2. Centers for Medicare & Medicaid Services. COVID-19 frequently asked questions (FAQs) on medicare fee-for service (FFS) billing. May 6, 2021. https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf?fbclid=IwAR1SpoehFNlNfLt5axjN4j9ExET2Gp-ekRlatQwPvcRQgnJXcw2jdeksmjc. (Accessed May 6, 2021).
  3. American College of Clinical Pharmacy. Response to HHS statements on authorizing licensed pharmacists to order and administer COVID-19 tests. April 16, 2020. https://www.accp.com/docs/HHS_COVID-19_TESTSAFETY.pdf?utm_source=accp&utm_medium=email&utm_campaign=ACCP%20Test&_zs=hgiPa&_zl=T8G42. (Accessed May 6, 2021).
  4. Product information for Cue COVID-19. Cue Health. San Diego, CA 92121. March 2021.
  5. Product information for ID Now COVID-19. Abbott. Scarborough, ME 04074. September 2020.
  6. Product information for Accula SARS-CoV-2. Mesa Biotech. San Diego, CA 92121 January 2021.
  7. Product information for Xpert Xpress SARSCoV-2. Cepheid. Sunnyvale, CA 94089. January 2021.
  8. Loeffelholz MJ, Alland D, Butler-Wu SM, et al. Multicenter evaluation of the Cepheid Xpert Xpress SARS-CoV-2 test. J Clin Microbiol 2020;58:e00926-20.
  9. Cephid. Quick reference instructions for Xpert Xpress SARS-CoV-2 and GeneXpert Xpress system (tablet configuration). January 2021. https://www.fda.gov/media/136315/download. (Accessed May 6, 2021).
  10. Product information for BinaxNOW COVID-19 Ag Card. Abbott Diagnostics. Scarborough, Maine 04074. December 2020.
  11. Product information for BD Veritor system for rapid detection of SARS-CoV-2. Becton, Dickinson and Company. Sparks, MD 21152. March 2021.
  12. Product information for Sofia SARS Antigen FIA. Quidel. San Diego, CA 92121. December 2020.
  13. Product information for Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette. Salofa Oy. Salo, Finland. December 2020.
  14. Product information for LumiraDx SARS-CoV-2 Ag Test. LumiraDx. Waltham, MA 02453. April 2021.
  15. Product information for Cobas SARS-CoV-2 & Influenza A/B. Roche Molecular Systems. Branchburg, NJ 08876. December 2020.
  16. Product information for Assure COVID-19 IgG/IgM Rapid Test Device. Azure Biotech. Houston, TX 77081. September 2020.
  17. Product information for BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ). BioFire Diagnostics. Salt Lake City, UT 84108. April 2021.
  18. Product information for Xpert Xpress SARS-CoV-2/Flu/RSV. Cepheid. Sunnyvale, CA 94089. January 2021.
  19. Cepheid. Xpert Xpress SARS-CoV-2/Flu/RSV*. https://www.cepheid.com/en_US/tests/Critical-Infectious-Diseases/Xpert-Xpress-SARS-CoV-2-Flu-RSV. (Accessed May 6, 2021).
  20. Product information for RapCov Rapid COVID-19 Test. Advaite. Malvern, PA 19355. April 2021.
  21. Centers for Medicare & Medicaid Services. CMS releases new tools to streamline certification for labs testing for COVID-19. September 25, 2020. https://www.cms.gov/newsroom/press-releases/cms-releases-new-tools-streamline-certification-labs-testing-covid-19. (Accessed May 20, 2021).
  22. Product information for CareStart COVID-19 Antigen. Access Bio. Somerset, NJ 08873. April 2021.
  23. Product information for COVID-19 All-in-One Test Kit. Lucira Health. Emeryville, CA 94608. November 2020.
  24. Product information for Sofia2 Flu + SARS Antigen FIA. Quidel. San Diego, CA 92121. October 2020.
  25. Crouch M. New at-home COVID-19 tests promise results in minutes. April 2, 2021. https://www.aarp.org/health/conditions-treatments/info-2021/at-home-covid-tests.html. (Accessed May 5, 2021).
  26. Product information for QuickVue SARS Antigen Test. Quidel. San Diego, CA 92121. December 2020.
  27. Product information for BinaxNow COVID-19 Antigen Self Test. Abbott. Scarborough, ME 04074. March 2021.
  28. Product information for Ellume COVID-19 Home Test. East Brisbane Qld 4169, Australia. December 2020.
  29. Product information for Clip COVID Rapid Antigen Test. Luminostics. Milpitas, CA 95035. December 2020.
  30. Ellume Health. Ellume COVID-19 home test. https://www.ellumehealth.com/products/consumer-products/covid-home-test. (Accessed May 5, 2021).
  31. Product information for MidaSpot COVID-19 Antibody Combo Detection Kit. Palo Alto, CA 94303. March 2021.
  32. Product information for RightSign COVID-19 IgG/IgM Rapid Test. Hangzhou Biotest Biotech. Hangzhou, P.R. China. January 2021.
  33. Product information for Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit. Exton, PA 19341. April 2021.
  34. Product information for SGTi-flex COVID-19 IgG. Sugentech. Chungcheongbuk-do, 28161, Republic of Korea. January 2021.
  35. Product information for Visby COVID-19 Point of Care. San Jose, CA 95134. February 2021.
  36. Product information for Lucira Check It COVID-19 Test Kit. Quidel. San Diego, CA 92121. (Rev. 4).
  37. Lucira Health. Lucira Check It COVID-19 Test Kit. https://checkit.lucirahealth.com/. (Accessed May 5, 2021).
  38. Product information for Cue COVID-19 Test for Home and Over The Counter (OTC) Use. Cue. Sand Diego, CA 92121. March 2021.
  39. Product information for Xpert Omni SARS-CoV-2. Cepheid. Sunnyvale, CA 94089. April 2021.
  40. Product information for QuickVue At-Home OTC COVID-19 Test. Quidel. San Diego, CA 92121. March 2021.
  41. Product information for Celltrion DiaTrust COVID-19 Ag Rapid Test. Celltrion USA. Jersey City, NJ 07302. March 2021.
  42. Product information for BD Veritor System for Rapid Detection of SARS-CoV-2 & Flue A + B. Becton, Dickinson and Company. Sparks, MD 21152. March 2021.
  43. Product information for Status COVID-19/Flu. Princeton BioMeditech. Monmouth Jct, NJ 08852. March 2021.
  44. California Dental Association. At-home COVID-19 rapid tests now commercially available at local pharmacies. May 3, 2021. https://www.cda.org/Home/News-and-Events/Newsroom/Article-Details/at-home-covid-19-rapid-tests-now-commercially-available-at-local-pharmacies. (Accessed May 6, 2021).
  45. Cue Health. What is cue? https://www.cuehealth.com/what-is-cue/. (Accessed May 6, 2021).
  46. Simply Medical. Introducing the QuickVue At-Home OTC COVID-19 Test. https://www.simplymedical.com/quidel-rapid-test-kit-at-home-covid-19-antigen-test-nasal-swab/1190065pa. (Accessed May 7, 2021).
  47. Quidel. QuickVue At Home. https://quickvueathome.com/. (Accessed May 7, 2021).
  48. CVS. Ellume COVID-19 Home Test. https://www.cvs.com/shop/ellume-covid-19-home-test-prodid-431742. (Accessed May 7, 2021).
  49. Abbott. BinaxNow COVID-29 Ag Card and NAVICA mobile app. https://www.globalpointofcare.abbott/en/product-details/navica-binaxnow-covid-19-us.html. (Accessed May 10, 2021).
  50. Product information for SCoV-2 Ag Detect Rapid Test. InBios International. Seattle, WA 98109. May 2021.
  51. Product information for BinaxNow COVID-19 Ag Card Home Test. Abbott. Scarborough, ME 04074. March 2021.
  52. Product information for BinaxNow COVID-19 Ag Card 2 Home Test. Abbott. Scarborough, ME 04074. March 2021.
  53. Product information for BinaxNow COVID-19 Ag Card 2. Abbott. Scarborough, ME 04074. December 2020.
  54. Product information for QuickVue At-Home COVID-19 Test. Quidel. San Diego, CA 92121. March 2021.

Cite this document as follows: Clinical Resource, COVID-19 Point-of-Care Testing. Pharmacist’s Letter/Prescriber’s Letter. June 2021[370603]

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