Point-of-Care Testing in Pharmacies

Point-of-care (POC) testing is a growing practice within pharmacies, and another way for pharmacies to expand patient care opportunities. POC tests are available for acute and chronic conditions. Examples of POC tests used to screen for and manage chronic conditions include A1C, cholesterol, and antibodies to hepatitis C and human immunodeficiency viruses. In addition, POC tests are also used to identify acute infections (e.g., influenza, group A strep pharyngitis [strep throat], COVID-19). The first chart below answers common questions about POC testing. The second chart below reviews important information about some POC tests used within pharmacies including samples used, time required for testing, who to screen, and steps to take based on results. Share our resources for technicians, Point-of-Care Testing: Technician Checklist and technician tutorial: Optimizing Pharmacy Workflow, with your techs to help them get involved in POC testing.

Abbreviations: CLIA = clinical laboratory improvement amendments; POC = point-of-care.

Common Questions About Point-of-Care Testing

**Continue to the next chart for information about some available POC tests**

Topic/Questions

Answer/Pertinent Information

Who regulates point-of-care testing in pharmacies?

In the U.S., pharmacies must obtain a CLIA waiver to conduct POC tests, using FDA-cleared tests.1

In Canada, POC testing is limited to tests approved by Health Canada and is regulated at the provincial level.3,4

What are some of the potential benefits of point-of-care testing in pharmacies?

Benefits of POC testing in pharmacies may include:1,2

  • improved patient outcomes with early detection and early intervention or facilitating care
  • enhanced appropriate medication use
  • reduced costs to the healthcare system by reducing emergency room visits and hospitalizations
  • increased pharmacy revenue
  • expanded scope of pharmacist and pharmacy technician roles
  • improved satisfaction due to convenience, accessibility, etc
  • patient convenience and an increased capacity of the healthcare system

What are some of the challenges of point-of-care testing in pharmacies?

Challenges of implementing POC testing in pharmacies may involve:1,2

  • logistics with existing workflow (e.g., walk-in vs scheduled appointments, space concerns)
  • time and costs associated with training and competency (e.g., how to run POC tests, disease state management)
  • time and costs to adhere to regulations for pharmacist prescribing or secure collaborative practice agreements
    • Develop prescriber-specific plans ahead of time (i.e. collaboration) if prescriptions will be needed based on test results, as some prescribers may be resistant to writing for meds for patients without seeing them.
  • limited reimbursement of services by payers requiring patients to pay out of pocket
  • a lack of awareness by patients and prescribers of the services offered
    • Work as a team to market services (e.g., place flyers in bags at check out, hang fliers, talk with customers and prescribers).

Who can conduct point-of-care testing in pharmacies?

State and provincial laws and regulations will specify who can conduct POC tests. Some may not permit POC testing in pharmacies, some may limit testing to pharmacists, while others may allow technicians to conduct some POC tests.

Check laws and regulations in your area to understand what is permitted.

U.S. subscribers can access the National Community Pharmacists Association (NCPA) website on POC testing for helpful information on available CLIA-waived tests and opportunities for pharmacist involvement in POC testing at https://www.ncpanet.org/innovation-center/diversified-revenue-opportunities/point-of-care-(poc)-testing.

Depending on the laws, regulations and policies, certification may be needed to offer point-of-care testing. For example, in the U.S., National Association of Chain Drug Stores (NACDS) offers a certification program (http://nacds.learnercommunity.com/Point-of-Care-Testing-Certificate).

What is the general process for conducting point-of-care tests in pharmacies?

Obtain a CLIA waiver.

Make your pharmacy-specific plan for testing.

  • Identify the location where testing will occur
  • Determine which tests you will offer
  • Ensure pharmacists and pharmacy technicians receive proper training
  • Plan for changes in workflow
  • Develop a plan for how to identify patients for testing
  • Create marketing materials (handouts, fliers, “pitches” [what will be said when talking with patients or prescribers])

Secure testing supplies (e.g., including test kits, cleaning supplies, disposal containers, refrigerator for storage).

 

**Continue for information about certain POC tests**

Examples of Available Point-of-Care Tests

The chart below reviews some commonly used POC tests (list is NOT all-inclusive) including proper storage, testing samples, who to screen, and next steps based on results. Insurance may not always cover testing, but CPT codes (U.S. subscribers) are provided for billing purposes. Follow laws, regulations, policies, and procedures for required training or certifications, using tests in your practice, and what to do with results (e.g., collaborative practice agreements, state protocols, medication therapy management [MTM] programs, referral to prescriber). Review sensitivity and specificity of POC tests. Tests are not always 100% accurate. See our CE, Health Screenings in the Pharmacy, for how to set up health screening and POC testing services in your pharmacy.

Abbreviations: A1C = hemoglobin A1C; CV = cardiovascular; HDL = high-density lipoprotein, HCV = hepatitis C virus; HIV = human immunodeficiency virus; LDL = low-density lipoprotein; MTM = medication therapy management; POC = point-of-care; TC = total cholesterol.

Example POC Tests

Product Specific Notes

Who to Screen

Next Steps Based on Results

Hyperlipidemia: High cholesterol levels increase a patients’ risk for CV disease and stroke. POC fingerstick blood tests are available to check patient’s cholesterol levels to screen for hyperlipidemia and to monitor cholesterol levels in patients receiving treatment. Most tests measure TC, HDL, triglycerides, and glucose. In addition, many provide values for LDL, TC/HDL ratio, and non-HDL cholesterol. In the U.S., use the following CPT codes for POC cholesterol testing: lipid panel (80061QW), TC (82465QW), HDL (83718QW), triglycerides (84478QW), and glucose (82947QW).7

  • CardioChek
  • Cholestech (U.S. only)

*Fasting is not always required for all cholesterol tests. Some prescribers ask patients to fast for nine to 12 hours prior to checking cholesterol levels.27

Uses a fingerstick blood sample for testing.9,10

Results: ~90 seconds (CardioChek)9 or 5 minutes (Cholestech)10

Requires blood sample volume of about 40 microliters.8,10

Cholestech testing cassettes should be stored in the refrigerator (36°F to 46°F [2°C to 8°C]). Cassettes can be kept at room temperature (48°F to 86°F [9°C to 30°C]) for ≤30 days.10

CardioChek test strips can be stored at room temperature (68°F to 86°F [20°C to 30°C]) or in the refrigerator (35°F to 46°F [2°C to 8°C]).

If refrigerated, bring CardioChek test strips and Cholestech cassettes to room temperature (68°F to 86°F [20°C to 30°C]) prior to use.8,10

Use our charts to identify who to screen:

Use our charts for treatment recommendations:

U.S. subscribers can use our dyslipidemia conversation starter to help guide patient discussions about cardiovascular risk, healthy lifestyle choices, and benefits and possible side effects with statins.

If available, consider enrolling patients into MTM services or cholesterol education classes.

Have a system to follow-up with patients to ensure referrals are complete or assess med tolerability.

Diabetes: Having diabetes increases a patient’s risk for CV disease, stroke, and other complications. POC fingerstick blood tests are available to check patient’s A1C to screen for diabetes and to monitor glucose control over time. In the U.S., use the following CPT codes for POC A1C testing: 83036QW or 83037QW.7

A1CNow

Uses a fingerstick blood sample for testing.11

Results: ~5 minutes11

Requires a blood sample volume of
5 microliters (one large drop).11

A1CNow analyzers, test cartridges, and shaker kits can be used until their expiration date if stored in the refrigerator (36°F to 46°F [2°C to 8°C]). Analyzers, cartridges, and shake kits can be stored at room temperature (64°F to 82°F [18°C to 28°C]) for up to four months. If not used within four months, these should be discarded, regardless of expiration date. Bring test kits to room temperature (64°F to 82°F [18°C to 28°C]) prior to use.11

 

Recommendations vary on who to screen for diabetes. To keep things simple, you can consider screening all patients at least:

Guidance varies on when and in whom to start therapy. One option is to consider the following:

  • A1C between 5.7% and 6.4%
    (6% to 6.4% [Canada])
    (i.e., prediabetes): encourage lifestyle changes and treat or refer patients to prescribers if they have additional risk factors for CV disease.5,12
  • A1C ≥6.5% (diabetes): treat or refer patients to prescribers.5,12

Use our resources:

U.S. subscribers can use our diabetes conversation starter to guide patient discussions.

If available, consider enrolling patients with high A1Cs into MTM services or diabetes classes.

Have a system to follow-up with patients to ensure referrals are complete or assess med tolerability.

Hepatitis C: Hepatitis C is a common and contagious viral liver disease with many available treatment options. Screening for hepatitis C can help identify patients who may benefit from antiviral therapy. In the U.S., use the following CPT codes for POC HCV testing: 86803QW.7

OraQuick HCV Rapid Antibody Test

Use a fingerstick blood sample for testing.13

Results: ~20 to 40 minutes13

Requires a blood sample volume sufficient to fill the entire collection loop.13

Test kits can be stored at room temperature or in the refrigerator. If stored in the refrigerator, bring test kits to operating temperatures (59°F to 99°F [15°C to 37°C]) before opening the package.13

Follow the latest screening and treatment recommendations:

Patients with positive screening HCV test results should be referred to their prescriber for confirmatory testing, further evaluation, and management.

See our chart, Hepatitis C Treatment Overview, for treatment options in treatment-naive adults.

See our CE, Navigating Hepatitis C, for more on screening, medications, and monitoring.

Have a system to follow-up with patients to ensure referrals are complete or assess med tolerability.

HIV: HIV is a serious infection affecting millions. Advances in antiretroviral therapy have improved both the tolerability and effectiveness of therapy. Screening for HIV can help identify patients who may benefit from antiretroviral therapy. In the U.S., use the following CPT codes for POC HIV testing: 86701QW and G0433QW.7

INSTi HIV-1/
HIV-2 Rapid Antibody Test

Uses a fingerstick blood sample for testing.14,15

Results: ~60 seconds14,15

Requires a blood sample volume of about 50 microliters.14

Test kits can be stored at room temperature (59°F to 86°F [15°C to 30°C]). Kits should not be opened until ready to use.14

All adolescents and adults should get tested for HIV at least once as a routine part of medical care. In addition, more frequent testing (at least annually) is recommended for men who have sex with men (MSM), persons who inject drugs, and other persons at high risk for HIV infection (e.g., unprotected sex with multiple partners, history of other sexually transmitted diseases).17,18

For patients unsure about getting tested, see the CDC handout, HIV Testing 101 (https://www.cdc.gov/hiv/pdf/library/factsheets/hiv-testing-101-info-sheet.pdf).

Patients with positive screening HIV test results should be referred to their prescriber for confirmatory testing, further evaluation, and management.

See our CE courses, HIV/AIDS Prevention and Management and Drug Therapy Review for HIV/AIDS, for more on treatment and other resources for HIV information.

Have a system to follow-up with patients to ensure referrals are complete or assess med tolerability.

OraQuick ADVANCE Rapid HIV-1/2 Antibody Test (U.S. only)

Uses an oral fluid or fingerstick blood sample for testing.16

Results: ~20 minutes16

Test kits can be stored at room temperature or in the refrigerator. If stored in the refrigerator, bring test kits to operating temperatures (59°F to 99°F [15°C to 37°C]) before opening the package.16

When using the fingerstick method, requires a blood sample volume sufficient to fill the entire collection loop.16

When using the oral fluid method, ensure patients have not had anything to eat or drink for at least 15 minutes and have not used any oral care products for at least 30 minutes prior to collecting oral fluid samples.16

All adolescents and adults should get tested for HIV at least once as a routine part of medical care. In addition, more frequent testing (at least annually) is recommended for men who have sex with men (MSM), persons who inject drugs, and other persons at high risk for HIV infection (e.g., unprotected sex with multiple partners, history of other sexually transmitted diseases).17,18

For patients unsure about getting tested, see the CDC handout, HIV Testing 101 (https://www.cdc.gov/hiv/pdf/library/factsheets/hiv-testing-101-info-sheet.pdf).

Patients with positive screening HIV test results should be referred to their prescriber for confirmatory testing, further evaluation, and management.

See our CE courses, HIV/AIDS Prevention and Management and Drug Therapy Review for HIV/AIDS, for more on treatment and other resources for HIV information.

Have a system to follow-up with patients to ensure referrals are complete or assess med tolerability.

Influenza: Influenza is a contagious respiratory infection, usually seen during late fall or winter. Patients may present to the pharmacy to purchase over-the-counter medicines to treat flu symptoms. POC testing is available for influenza. In the U.S., use the following CPT code for POC influenza testing: 87502QW.7

BD Veritor for rapid detection of flu A+B

Cobas influenza A/B (U.S. only)

Uses a nasal swab sample for testing.19,22

Results: ~10 minutes (BD Veritor) or 20 minutes (Cobas)19,22

BD Veritor test kits can be stored at room temperature or in the refrigerator
(36°F to 86°F [2°C to 30°C]). If stored in the refrigerator, bring test kits to room temperature (59°F to 86°F [15°C to 30°C]) prior to use.19

Store Cobas test kits in the refrigerator
(36°F to 46°F [2°C to 8°C]).22

 

Can consider testing patients with flu-like symptoms, especially if symptoms came on suddenly. Flu-like symptoms often include:23

  • fever or feeling feverish/chills
  • cough
  • sore throat
  • runny or stuffy nose
  • muscle or body aches
  • headaches
  • fatigue

For all patients with flu-like symptoms, regardless of test results, discuss supportive care (e.g., fluids, acetaminophen or ibuprofen for aches and fever, humidifiers, etc).

For patients with positive flu tests presenting within 48 hours of symptom onset:

For patients with negative flu tests, consider referring patients with significant symptoms to their prescriber for further evaluation, especially adults. Rapid flu tests seem better at detecting the flu in children than in adults.21

Have a system to follow-up with patients to ensure referrals are complete, symptoms are improving, or assess med tolerability.

Strep A: Strep A pharyngitis (strep throat) is a contagious respiratory infection, that primarily impacts children. Patients or their caregivers may present to the pharmacy to purchase over-the-counter medicines to treat fever or sore throat. POC testing is available for strep A. In the U.S., use the following CPT code for POC strep A testing: 87651QW.7

BD Veritor for rapid detection of group A strep

Uses a throat swab sample for testing.20

Results: ~5 minutes20

Test kits can be stored at room temperature or in the refrigerator
(36°F to 86°F [2°C to 30°C]). If stored in the refrigerator, bring test kits to room temperature (59°F to 86°F [15°C to 30°C]) prior to use.20

Can consider testing patients with symptoms of strep throat. Strep throat symptoms often include:24

  • sudden onset sore throat
  • fever
  • odynophagia (painful swallowing)

For all patients with symptoms, regardless of test results, discuss symptom management (e.g., fluids, acetaminophen or ibuprofen for pain and fever, gargling salt water).

o Some prescribers may require a confirmatory test or throat culture regardless of results to ensure accurate results and the most appropriate use of antibiotics.25

For patients with a positive strep A test:

For patients with symptoms suggestive of strep throat and a negative strep A test:

  • Guidelines recommend a throat culture in children and adolescents to rule out strep.26

Have a system to follow-up with patients to ensure referrals are complete, symptoms are improving, or assess med tolerability.

Coronavirus (COVID-19): COVID-19 is a very contagious respiratory infection. Patients may present to the pharmacy to purchase over-the-counter medicines to treat fever or cough or simply to be tested for COVID-19. Molecular and antigen tests detect active COVID-19 infection.31 At the time of publication there are NOT any COVID-19 antibody tests approved for POC use. In the U.S., use the following CPT code for POC COVID-19 testing: U0002.40 Some pharmacies or pharmacists may wait for further guidance before testing patients.35 Follow these tips to maximize safety and adherence to guidelines for testing:35 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], Health Canada [https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/health-professionals.html) for PPE. Know how to obtain samples for POC testing. For symptomatic patients, nasal swabs using the front of the nose rather than the depth of the nasal cavity (nasopharyngeal) can be used, including supervised self-collection of specimens at collection sites (samples should only be collected at testing site).33,34 See product information for how to collect samples. Here is a video demonstrating nasopharyngeal sample collection: https://www.nejm.org/doi/full/10.1056/NEJMvcm2010260?query=RP. Use an appropriate space to collect samples. Use an isolated space outside of the pharmacy to collect samples (e.g., the parking lot [drive thru windows may not ensure proper protection, especially if not using supervised self-collection methods]).35

Molecular test for rapid detection of COVID-19:

  • Cue COVID-19 (U.S. only)
  • ID Now COVID-19 (U.S. only)
  • Accula SARS-CoV-2 Test (U.S. only)
  • Xpert Xpress SARS-CoV-2 test (U.S. only)

 

 

 

 

 

 

  • Uses a nasopharyngeal or nasal swab (nasal swab [Accula SARS-CoV-2 and Cue COVID-19]) for testing.28,30,36,41
  • Results:28,30,37,41
    • Cue COVID-19: ~25 minutes
    • ID Now COVID-19: ~15 minutes
    • Accula SARS-CoV-2: ~30 minutes
    • Xpert Xpress SARS-CoV-2: ~45 minutes
  • Kits can be stored at room temp (59°F to 86°F [15°C to 30°C], 59°F to 82°F [15°C to 28°C] for Xpert Xpress SARS-CoV-2]).28,30,36,41 ID Now COVID-19 and Xpert Xpress SARS-CoV-2 can be refrigerated (36°F to 46°F [2°C to 8°C]). If refrigerated, bring kits to room temp (59°F to 86°F [15°C to 30°C]) prior to use.28,36
  • If not tested immediately, some specimens can be stored at room temp (59°F to 86°F [15° to 30°C]) for ≤2 hours [8 hours for Xpert Xpress SARS-CoV-2] or refrigerated (36°F to 46°F [2°C to 8°C]) ≤24 hours [7 days for Xpert Xpress SARS-CoV-2] prior to testing.28,30,36 Avoid use of transport media solution if storing samples before testing with ID Now COVID-19 due to false-negative risk.38
  • Can consider testing patients with symptoms of COVID-19. COVID-19 symptoms often include:29
    • fever
    • cough
    • shortness of breath or difficulty breathing
    • chills or repeated shaking with chills
    • muscle pain
    • headache
    • sore throat
    • new loss of taste or smell
  • Follow policies and procedures for reporting positive and negative test results to patients, prescribers, 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 referred to their prescriber for further evaluation and management.
  • Have a system to follow-up with patients to ensure referrals are complete, symptoms are improving, or assess med tolerability.

Antigen tests for rapid detection of COVID-19:

  • Sofia 2 SARS Antigen FIA
  • Uses a nasopharyngeal or nasal swab for testing.39
  • Results:39 ~15 minutes
  • Store test kits at room temperature (59°F to 86°F [15°C to 30°C].39
  • If not tested immediately, 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]) ≤24 hours (Note this recommendation is based on data from influenza virus, nasal or nasopharyngeal swabs).39
  • If transport of samples is required, minimally dilute samples with transport medium (1 mL or less), as dilution may result in decreased test sensitivity and increase the number of false negative results.39
  • Can consider testing patients with symptoms of COVID-19. COVID-19 symptoms often include:29
    • fever
    • cough
    • shortness of breath or difficulty breathing
    • chills or repeated shaking with chills
    • muscle pain
    • headache
    • sore throat
    • new loss of taste or smell
  • Follow policies and procedures for reporting positive and negative test results to patients, prescribers, 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 referred to their prescriber for further evaluation and management.
  • Negative results do not rule out COVID-19 infection. If necessary, confirm with a follow-up molecular test (see row above).39
  • Have a system to follow-up with patients to ensure referrals are complete, symptoms are improving, or assess med tolerability.

 

Project Leader in preparation of this clinical resource (351205): Beth Bryant, Pharm.D., BCPS, Assistant Editor, last updated June 16, 2020

References

  1. Adams AJ, Klepser ME. Quick read: do point-of-care tests add value? APhA annual meeting, 2016. March 4-7. Baltimore, MD. https://aphameeting.pharmacist.com/sites/default/files/slides/Quick%20Read%20Point%20of%20Care_handout.pdf. (Accessed October 30, 2019).
  2. Alberta College of Pharmacy. The point-of-care testing (POCT) environment: considerations in developing a framework for POCT in pharmacy practice. May 2016. https://abpharmacy.ca/sites/default/files/Point%20of%20Care%20Testing%20Whitepaper.pdf?redirect. (Accessed October 30, 2019).
  3. Nova Scotia College of Pharmacists. Standards of practice: testing. September 2015. http://www.nspharmacists.ca/wp-content/uploads/2015/10/PharmacistTestingStandardsOfPractice.pdf. (Accessed October 30, 2019).
  4. Advisory Committee on Laboratory Medicine. College of Physicians & Surgeons of Alberta. Performance of point-of-care testing in unaccredited settings: a guideline for non-laboratorians. Revised June 2017. http://cpsa.ca/wp-content/uploads/2015/03/Point-of-Care_Testing_-_Guidelines_for_Physicians.pdf. (Accessed October 30, 2019).
  5. American Diabetes Association. 2. Classification and diagnosis of diabetes: standards of medical care in diabetes–2019. Diabetes Care 2019 Jan;42(Suppl 1):S13-28.
  6. Diabetes Canada Clinical Practice Guideline Expert Committee, Ekoe JM, Goldenberg R, Katz P. Screening for diabetes in adults. Can J Diabetes 2018;42(Suppl 1):S16-S19.
  7. Centers for Medicare & Medicaid Services. Tests granted waived status under CLIA. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/waivetbl.pdf. (Accessed October 31, 2019).
  8. Product information for pts panels lipid panel test strips. Polymer Technology Systems. Indianapolis, IN 46268. June 2016.
  9. CardioChek PA test system user guide. Polymer Technology Systems. Indianapolis, IN 46268. January 2018.
  10. Cholestech LDX user manual. Alere San Diego. San Diego, CA 92121. June 2013.
  11. A1CNow professional procedure guide. Polymer Technology Systems. Indianapolis, IN 46268. March 2017.
  12. Diabetes Canada Clinical Practice Guideline Expert Committee, Punthakee Z, Goldenberg R, Katz P. Definition, classification and diagnosis of diabetes, prediabetes, and metabolic syndrome. Can J Diabetes 2018;42(Suppl 1):S10-S15.
  13. Product information for OraQuick HCV rapid antibody test. OraSure Technologies. Bethlehem, PA 18015. June 2012.
  14. Product monograph for INSTi HIV-1/HIV-2 antibody test kit. BioLytical Laboratories. Richmond, BC V6V 2X7. 2014.
  15. BioLytical Laboratories. INSTi HIV-1/HIV-2 rapid antibody test. https://biolytical.com/products/insti-hiv-1hiv-2/. (Accessed October 31, 2019).
  16. Product information for OraQuick advance rapid HIV-1/2 antibody test. OraSure Technologies. Bethlehem, PA 18015. March 2016.
  17. CDC. Implementing HIV testing in nonclinical settings: a guide for HIV testing providers. https://www.cdc.gov/hiv/pdf/testing/CDC_HIV_Implementing_HIV_Testing_in_Nonclinical_Settings.pdf. (Accessed October 31, 2019).
  18. Government of Canada. Human immunodeficiency virus – HIV screening and testing guide. August 2014. https://www.canada.ca/en/public-health/services/hiv-aids/hiv-screening-testing-guide.html#c1. (Accessed October 31, 2019).
  19. Product information for BD Veritor for rapid detection of flu A+B. Becton, Dickinson and Company. Sparks, MD 21152. July 2018.
  20. Product information for BD Veritor for rapid detection of group A strep. Becton, Dickinson and Company. Sparks, MD 21152. January 2019.
  21. CDC. Influenza (flu). Diagnosing flu: questions & answers. February 2018. https://www.cdc.gov/flu/symptoms/testing.htm. (Accessed November 1, 2019).
  22. Product information for Cobas influenza A/B. Roche Diagnostics. Indianapolis, IN 46250. 2017.
  23. CDC. Influenza (flu). Flu symptoms and complications. September 18, 2019. https://www.cdc.gov/flu/symptoms/symptoms.htm. (Accessed November 1, 2019).
  24. CDC. Group A streptococcal (GAS) disease. November 1, 2018. https://www.cdc.gov/groupastrep/diseases-hcp/strep-throat.html. (Accessed November 1, 2019).
  25. University of Washington. Study: Confirm negative rapid strep throat results with lab culture. May 2014. https://newsroom.uw.edu/story/study-confirm-negative-rapid-strep-throat-results-lab-culture. (Accessed November 4, 2019).
  26. Shulman ST, Bisno AL, Clegg HW, et al. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America. Clin Infect Dis 2012;55:1279-82. [Erratum Clin Infect Dis 2014;58:1496].
  27. Lab tests online. Lipid panel. September 2019. https://labtestsonline.org/tests/lipid-panel. (Accessed November 5, 2019).
  28. Product information for ID Now COVID-19. Abbott. Scarborough, ME 04074. April 2020.
  29. CDC. Coronavirus disease 2019 (COVID-19): frequently asked questions. Updated April 23, 2020. https://www.cdc.gov/coronavirus/2019-ncov/faq.html. (Accessed April 27, 2020).
  30. Product information for Accula Sars-CoV-2 Test. Mesabiotech. San Diego, CA 92121. March 2020.
  31. American Pharmacists Association. COVID-19: demystifying testing for the SARS-CoV-2 virus. April 9, 2020. https://media.pharmacist.com/COVID19/APhACOVID-19Demystifying0420_Revised_web.pdf. (Accessed April 15, 2020).
  32. CDC. Division of laboratory systems (DLS): 04/09/2020: lab update: FDA clarifies CLIA-waived status for point-of-care SARS-CoV-2 tests under emergency use authorizations. https://www.cdc.gov/csels/dls/locs/2020/fda_clarifies_clia-waived_status.html. (Accessed April 17, 2020).
  33. FDA. FDA news release: Coronavirus (COVID-19_ update: daily roundup. March 23, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup. (Accessed April 17, 2020).
  34. FDA. FAQs on diagnostic testing for SARS-CoV-2. Updated April 24, 2020. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2. (Accessed April 27, 2020).
  35. 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 April 20, 2020).
  36. Product information for Xpert Xpress SARS-CoV-2. Cepheid. Sunnyvale, CA 94089. April 2020.
  37. Cepheid. Xpert Xpress SARS-CoV-2 test. https://www.cepheid.com/coronavirus. (Accessed April 20, 2020).
  38. Abbott. ID Now COVID-19 technical brief April 2020. https://www.alere.com/en/home/product-details/id-now-covid-19.html. (Accessed April 27, 2020).
  39. Product information for Sofia 2 SARS Antigen FIA. Quidel. San Diego, CA 92121. April 2020.
  40. APhA. Addressing the COVID-19 crisis: an open forum webinar series for pharmacists. May 28, 2020. https://www.pharmacist.com/sites/default/files/audience/Week10PresentationCOVID-19WebinarSeries.pdf. (Accessed June 12, 2020).
  41. Cue COVID-19 test instructions for use. Cue Health. San Diego, CA 92121. June 2020.

Cite this document as follows: Clinical Resource, Point-of-Care Testing in Pharmacies. Pharmacist’s Letter/Prescriber’s Letter. December 2019.

Related Articles