Prescribing At-Home COVID-19 Testing Kits for Patients

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Following the issuance of several emergency use authorizations by the FDA that allow at-home sample collection, it is imperative for the pharmacy team to stay abreast of current testing recommendations and limitations.

Along with other health care professionals, pharmacists have been called to aid in the fight against the coronavirus disease 2019 (COVID-19) pandemic. One of our primary roles as health care professionals is to clarify health information and provide reliable, accessible advice to patients.

Recently, our roles have further expanded due to the approval by the Department of Health and Human Services (DHS) to allow pharmacists to administer severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing.1

Furthermore, following the issuance of several emergency use authorizations (EUAs) by the FDA that allow at-home sample collection,2 it is imperative for the pharmacy team to stay abreast of current testing recommendations and limitations when recommending SARS-CoV-2 home tests to patients.

Testing Indication

All current COVID-19 guidelines recommend testing based on a priority stratification algorithm. Symptomatic hospitalized patients, long-term care facility residents, and health care workers are classified as high priority for testing.3-5 Persons exposed to a confirmed or suspected COVID-19 case, whether or not they are symptomatic, are classified as priority.3-5 Asymptomatic persons with no known exposure are not considered a priority.3-5

However, it is reasonable to recommend testing in such persons if they are employed in workplaces located in communities with a moderate-to-high rate of viral transmission.6 Additionally, these workplaces should consist of the following: be composed of essential workers, provide housing to employees, be located in remote settings with limited access to medical care, or be in a setting where physical distancing between coworkers and the public is difficult.6

Accessibility

If cost is an issue, the DHS website includes an online locator listing free testing sites in all 50 states.7 For patients concerned about potential exposure from a testing facility and who have a reliable internet connection, it may be beneficial to recommend an at-home sampling test.

At-home tests may only be obtained via prescription.8 Most can be purchased online and require a completed symptom questionnaire reviewed by health care professionals.

Additionally, testing kits are overnighted to patients who are considered at-risk. All testing kits require samples to be mailed to the corresponding laboratory on the same day of specimen collection.

Sampling Method

Proper sample collection is imperative for testing accuracy and is an important counseling point for pharmacists.8 Patient samples for SARS-CoV-2 tests are typically collected via saliva samples or nasopharyngeal, nasal, or oropharyngeal swabs. In general, nasopharyngeal and nasal swabs are considered more accurate and are the preferred sampling method by many guidelines.4,5

Given the potential difficulty, awkwardness, and discomfort of self-administered specimen collection, some home test kits also require video conferencing with a health care professional for directly observed collection,2 which may alleviate apprehensions a consumer may have about potentially inappropriate collection.

Reliability

Diagnostic tests for SARS-CoV-2 are 1 of 2 types: molecular or antigen-based.4,8 Although antigen tests typically have a rapid turnaround time, false negatives are more likely and require follow-up testing to confirm a negative result.4,7 Therefore, molecular testing is preferred by all current guidelines and is the only currently available method for home test kits.2-5

Many EUA marketed tests fail to disclose information regarding the test’s sensitivity and specificity either on their website or on package labeling. For this reason, it is beneficial to refer patients to those tests which have disclosed sensitivity and specificity above 90% in order to decrease the incidence of false negatives.

There are many tests, including some that promote fraudulent and/or misleading information, advertised to patients, which can make safe and effective product selection more difficult. As one of the most accessible and trusted health care professions, pharmacists are aptly positioned to help patients navigate the many options available for at home testing.

The table below contains a review of the currently available EUA issued home sampling kits that can be prescribed to patients.

Kit

Collection Method

Time to receive results

Accuracy

Cost

Pixel by LabCorp COVID-19 test home collection kit

Nasal swab

2-3 days

N/A

$0 upfront

Quest

Diagnostics Self-Collection Kit for COVID-19

Nasal swab

N/A

N/A

N/A

Vault at-home collection device:

Saliva*

48-72 hours

Specificity: 90%

$150.00

Hims & Hers

Saliva

3-5 days

NS

$150.00

Vitagene COVID-19 Saliva Test Kit

Saliva

72 hours

Specificity: 100%

Sensitivity: 99.99%

$129.00

Assurance SARS-CoV-2 Panel

Nasal swab

1-2 days

NS

$150.00

Picture COVID-19 Home Collection Kit

Nasal swab

3 days

NS

$119.00

Everlywell COVID-19 Test Home Collection Kit

Nasal swab

24-48 hours

NS

$109.00

P23 At-Home COVID-19 Test Collection Kit

Nasal swab

24-48 hours

NS

N/A

LetsGetChecked Coronavirus (COVID-19) Test

Nasal swab

24-27 hours

NS

$119.00

Gravity Diagnostic COVID-19 Assay

Nasal swab

N/A

NS

N/A

Phosphorus COVID-19 RT-qPCR Test

Saliva

74 hours

Sensitivity 97.1%

Specificity 98.2%

$140.00

KPMAS COVID-19 Test Kit

Nasal swab

N/A

N/A

Free to members

Kroger Health COVID-19 Test Home

Collection Kit.

Nasal swab

48 hours

N/A

N/A

Compass Laboratory Services SARS-CoV2 Assay

Nasal swab

N/A

N/A

N/A

Quest

Diagnostics Self-Collection Kit for COVID-19

Nasal swab

N/A

N/A

N/A

NS indicates not stated (general assurance of specificity and/or sensitivity without specific data);

N/A, not available (no mention of specificity and/or sensitivity or pricing)

*Virtually observed

REFERENCES

  • HHS Statements on Authorizing Licensed Pharmacists to Order and Administer COVID-19 Tests. HHS.gov. https://www.hhs.gov/about/news/2020/04/08/hhs-statements-on-authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.html. Published 2020. Accessed August 18, 2020.
  • Emergency Use Authorization. U.S. Food and Drug Administration. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. Published 2020. Accessed July 28, 2020
  • COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed [insert date].
  • Coronavirus Disease 2019 (COVID-19): Overview of Testing for SARS-CoV-2. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/hcp/testingoverview.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Fclinical-criteria.html. Published 2020. Accessed August 6, 2020.
  • Hanson KE, Caliendo AM, Arias CA, et al. Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19 [published online ahead of print, 2020 Jun 16]. Clin Infect Dis. 2020;ciaa760. doi:10.1093/cid/ciaa760
  • SARS-CoV-2 Testing Strategy: Considerations for Non-Healthcare Workpla. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/testing-non-healthcare-workplaces.html#testing-3. Published 2020. Accessed August 20, 2020.
  • Community-Based Testing Sites for COVID-19. HHS.gov. https://www.hhs.gov/coronavirus/community-based-testing-sites/index.html. Published 2020. Accessed August 6, 2020.
  • Coronavirus Testing Basics. U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/coronavirus-testing-basics. Published 2020. Accessed July 28, 2020.
  • Hahn S. Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits. Published 2020. Accessed July 28, 2020.