COVID-19 Point-of-Care Testing

(Updated December 21, 2020)

The chart below reviews pertinent information about available point-of-care (POC) and home COVID-19 tests available in the U.S. Information in each row of the chart is from the device product labeling unless otherwise specified. Proceed to the end of the chart for 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 more on who should be tested and interpreting and reporting test results. Our chart, Point-of-Care Testing in Pharmacies, includes a listing of other available POC tests (e.g., flu, strep, etc) and guidance on how 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

Cue COVID-194

Results: ~25 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 high temperatures or in humidity

nasal swab

Avoid opening foil pouch more than 30 minutes before beginning a test.

Swab both nostrils with the same swab.

Must insert swab into testing cartridge within 5 minutes of sample collection.

ID Now COVID-195

Results: ~15 minutes

Storage:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F [15°C to 30°C]

nasopharyngeal swab

nasal swab

throat swab

Avoid opening foil 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 (59°F to 86°F [15°C to 30°C]) for ≤2 hours.
  • in the refrigerator (36°F to 46°F [2°C to 8°C]) for ≤24 hours. Bring samples to room temperature before testing.

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

Accula SARS-CoV-26

Results: ~30 minutes

Storage and Operation:

  • 59°F to 86°F (15°C to 30°C)

nasal swab

Avoid opening foil pouch more than 30 minutes before beginning a test.

Swab both nostrils with the same swab.

If test is not run immediately after collection:

  • unprepared specimens can be stored:
    • at room temp (59°F to 86°F [15°C to 30°C]) for ≤2 hours.
    • in the refrigerator (36°F to 46°F [2°C to 8°C]) for ≤24 hours.
  • prepared specimens (after adding buffer) can be stored:a
    • at room temperature for ≤24 hours.
    • refrigerated for ≤72 hours.
    • frozen at -4°F (-20°C) for ≤1 week.

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

Xpert Xpress
SARS-CoV-2
7

Results:8 ~45 minutes

Storage:

  • 36°F to 82°F (2°C to 28°C)

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

  • 59°F to 86°F (15°C to 30°C) with 20% to 80% relative humidity9

nasopharyngeal swab

nasal swab

mid-turbinate swab

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

  • at room temp (59°F to 86°F [15°C to 30°C]) for ≤8 hours.
  • refrigerated (36°F to 46°F [2°C to 8°C]) for ≤7 days.

COVID-19 All-in-One Test Kit23

Results: ~30 minutes

Storage:

  • 59°F to 82°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 and home testing (WITH a prescription) using self-collection for people 14 years and older.

Avoid opening foil pouch until just before use.

Swab both nostrils with the same swab.

Run test immediately after collection.

In addition to the above information, when used at home instruct patients to follow all testing instructions and:

  • share ALL test results with the prescriber.
  • dispose of all test kit materials in the plastic disposal bag that comes with the test.

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

Cobas SARS-CoV-2 & Influenza A/B15

Results: ~20 minutes

Storage:

  • 36°F to 46°F (2°C to 8°C)

Operation (bring kit to room temp prior to 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 can be stored:

  • at room temp (59°F to 86°F [15°C to 30°C]) ≤4 hours.
  • refrigerated (36°F to 46°F [2°C to 8°C]) ≤72 hours.

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

Avoid opening pouch until just before use.

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

  • at room temp 59°F to 77°F (15°C to 25°C) for ≤4 hours
  • refrigerated (36°F to 46°F [2°C to 8°C]) for ≤3 days. Bring refrigerated specimens to room temperature before testing.

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 kit to room temp prior to 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 is used for nasopharyngeal specimen collection.)

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

  • at room temp 59°F to 86°F (15°C to 30°C) for ≤24 hours
  • refrigerated (36°F to 46°F [2°C to 8°C]) for ≤7 days. Bring refrigerated specimens to room temperature before testing.

Antigen tests for rapid detection of COVID-19
(Negative results do NOT rule out COVID-19. If necessary, confirm with a molecular test.)

BinaxNow COVID-19 Ag Card10

Results ~15 minutes

Storage:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

nasal swab

Avoid opening foil pouch until just before use.

Swab both nostrils with the same swab.

Conduct test within one hour of specimen collection. False negative results may occur if specimens are tested past one hour of collection.

Avoid storing specimens in viral transport media.

BinaxNow COVID-19 Ag Card Home Test27

Results ~15 minutes

Storage:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)


nasal swab


Home test WITH a prescription for people 4 years or older within seven days of symptoms onset.

  • Self-collection for people 15 years or older
  • Adult-assisted collection for children between 4 and 15 years.

Test should be done only with supervision though a telehealth visit.

Counsel patients or caregivers to avoid touching the swab tip, other than inside the nostril when collecting the sample and to avoid opening the foil pouch until just before use.

Kit can be disposed of in household trash.


Clip COVID Rapid Antigen Test29

Results: ~30 minutes

Storage and Operation:

59°F to 86°F (15°C to 30°C)

nasal swab

Avoid opening foil pouch until just before use.

Swab both nostrils with the same swab.

Conduct the test within 30 minutes of specimen collection.

Avoid storing specimens in viral transport media.


Ellume COVID-19 Home Test28

Results: ~15 minutes

Cost:25 ~$30


Storage and Operation:

  • 59°F to 77°F (15°C to 25°C)

mid-turbinate swab

Self-collection for people 16 years or older.

Adult-assisted collection for children between 2 and 16 years.

Includes adapter to shorten swab for use in children between the ages of 2 and 12 years.


Home test withOUT a prescription for people 2 years or older25

Can be used in patients with or without symptoms.26

Smartphone and smartphone app required PRIOR to use. After downloading the app, patients will:

  • answer a few questions within the app and watch the video.
  • follow the step-by-step instructions to perform the test.

Results are automatically sent to smartphone app and public health authorities via secure, HIPAA compliant cloud connection. Results can also be emailed.25,26

Counsel patients or caregivers to:

  • keep smartphone with the downloaded app within 3 inches of the analyzer until test results are available.
  • avoid touching the swab tip (other than inside the nostril).
  • perform test within one hour of opening foil pouch.
  • contact their healthcare provider to discuss results (positive or negative) and next steps, and to see if further testing is needed.
  • dispose of kit in household trash (battery per to local regulations).

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.


LumiraDx SARS-CoV-2 Ag Test14

Results: ~15 minutes

Storage:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

nasal swab

Avoid opening foil 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 temperature (59°F to 86°F [15°C to 30°C]) for ≤5 hours.
  • frozen (-112°F [-80°C]) ≤5 days. Bring frozen samples to room temperature before testing.

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 kit to room temp prior to use):

  • 59°F to 86°F (15°C to 30°C)

nasal swab

Avoid opening foil 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.

Sofia 2 SARS Antigen FIA12

Results: ~15 minutes

Storage and Operation:

  • 59°F to 86°F (15°C to 30°C)

nasopharyngeal swab

nasal swab

Avoid opening foil pouch until just before use.

Collect sample using one nostril, preferably the nostril with the most secretion.

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

  • at room temperature (59°F to 86°F [15° to 30°C]) or refrigerated (36°F to 46°F [2°C to 8°C]) ≤48 hours. Bring refrigerated samples to room temperature before testing.

Prepared specimens can be stored out of direct sunlight, at room temperature, for ≤6 hours before testing.

Not recommended for use with viral transport media.13

CareStart COVID-19 Antigen22

Results: ~10 minutes

Storage:

  • 34°F to 86°F (1°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

nasopharyngeal swab

Avoid opening foil pouch until just before use.

Collect sample using one nostril.

Avoid reading results <10 minutes or >15 minutes after starting the test.

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

  • at room temperature (59°F to 86°F [15°C to 30°C]) for ≤4 hours.
  • frozen (-112°F [-80°C]) ≤5 days. Bring frozen samples to room temperature before testing.

Antigen tests for rapid detection of COVID-19 and Influenza A/B

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


Avoid opening foil pouch until just before use.

Avoid reading results >30 minutes after starting the test.

Collect sample using one nostril, preferably the nostril with the most secretion.

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

  • at room temperature (59°F to 86°F [15°C to 30°C]) or refrigerated (36°F to 46°F [2°C to 8°C]) ≤48 hours. Bring refrigerated samples to room temperature 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.)

Assure/FaStep COVID-19 IgG/IgM Rapid Test16

Results: ~15 minutes

Storage:

  • 36°F to 86°F (2°C to 30°C)

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

  • 59°F to 86°F (15°C to 30°C)

fingerstick

Qualitative (yes/no), not quantitative (number of antibodies) results.

Avoid opening foil pouch until just before use.

Avoid reading results <15 minutes or >30 minutes after adding the buffer.

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

  • refrigerated (36°to 46°F [2°C to 8°C]) for ≤7 days. Bring refrigerated specimens to room temperature before testing.

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

  1. Based on viability data from testing similar viruses in the Accula SARS-CoV-2 test buffer.

 

--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 specimens for 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.

Prepared by the Editors of Therapeutic Research Center (361002); last modified December 21, 2020.

References

  1. FDA. Coronavirus disease 2019 (COVID-10) emergency use authorizations for medical devices: in vitro diagnostics EUAs. September 15, 2020. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas. (Accessed September 15, 2020).
  2. Centers for Medicare & Medicaid Services. COVID-19 frequently asked questions (FAQs) on medicare fee-for service (FFS) billing. September 11, 2020. https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf?fbclid=IwAR1SpoehFNlNfLt5axjN4j9ExET2Gp-ekRlatQwPvcRQgnJXcw2jdeksmjc. (Accessed September 15, 2020).
  3. American College of Clinical Pharmacy. Response to HHS statements on authorizing 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 September 15, 2020).
  4. Product information for Cue COVID-19. Cue Health. San Diego, CA 92121. August 2020.
  5. Product information for ID Now COVID-19. Abbott. Scarborough, ME 04074. June 2020.
  6. Product information for Accula SARS-CoV-2. Mesa Biotech. San Diego, CA 92121 April 2020.
  7. Product information for Xpert Xpress SARSCoV-2. Cepheid. Sunnyvale, CA 94089. May 2020.
  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 (hub configuration). April 2020. https://www.cepheid.com/Package%20Insert%20Files/Xpress-SARS-CoV-2/QRI%20Xpress%20SARS.COV2%20Hub%20302-3752%20Rev.%20B.pdf. (Accessed September 15, 2020).
  10. Product information for BinaxNOW COVID-19 Ag Card. Abbott Diagnostics. Scarborough, Maine 04074. August 2020.
  11. Product information for BD Veritor system for rapid detection of SARS-CoV-2. Becton, Dickinson and Company. Sparks, MD 21152. August 2020.
  12. Product information for Sofia SARS Antigen FIA. Quidel. San Diego, CA 92121. August 2020.
  13. Quidel. Sofia SARS Antigen: frequently asked questions. July 2020. https://www.quidel.com/sites/default/files/product/documents/FQ2037404EN00.pdf. (Accessed September 15, 2020).
  14. Product information for LumiraDx SARS-CoV-2 Ag Test. LumiraDx Waltham, MA 02453. August 2020.
  15. Product information for Cobas SARS-CoV-2 & Influenza A/B. Roche Molecular Systems. Branchburg, NJ 08876. September 2020.
  16. Product information for FaStep COVID-19 IgG/IgM Rapid Test Device. Assure Tech Co. Gongshu District, Hangzhou, 310011 Zhejiang, China. September 2020.
  17. Product information for BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ). BioFire Diagnostics. Salt Lake City, UT 84108. October 2020.
  18. Product information for Xpert Xpress SARS-CoV-2/Flu/RSV. Cepheid. Sunnyvale, CA 94089. October 2020.
  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 October 6, 2020).
  20. Product information for Sofia-2 Flu + SARS Antigen FIA. Quidel. San Diego, CA 92121. October 2020.
  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 October 8, 2020).
  22. Product information for CareStart COVID-19 Antigen. Access Bio. Somerset, NJ 08873. October 2020.
  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. Stein R. FDA authorizes 1st home coronavirus test that doesn’t require a prescription. December 15, 2020. https://www.npr.org/sections/health-shots/2020/12/15/946692950/fda-authorizes-first-home-coronavirus-test-that-doesnt-require-a-prescription. (Accessed December 16, 2020).
  26. Ellume Health. COVID-19 Home Test. https://www.ellumehealth.com/products/consumer-products/covid-home-test. (Accessed December 16, 2020).
  27. Product information for BinaxNow COVID-19 Ag Card Home Test. Abbott Diagnostics Scarborough. Scarborough, ME 04074. December 2020.
  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.

Cite this document as follows: Clinical Resource, COVID-19 Point-of-Care Testing. Pharmacist’s Letter/Prescriber’s Letter. October 2020.

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