Diagnostic Testing

Types of Specimen Collection

The type of specimen collected is dependent upon the type of test being administered. Upper respiratory specimens are recommended by the CDC for initial diagnostic testing. Lower respiratory specimens (sputum) can be considered in patients who have a productive cough.


CDC Interim Guidelines for Collecting and Handling Clinical Specimens for COVID-19 Testing: 

CDC Specimen Collection Information:

Nasopharyngeal and oropharyngeal:

Sputum cough/suction:

Deep nasal collection: 


What is Observed Self-Collection?

On May 5th, 2020, the CDC updated guidance for COVID-19 testing that included the general procedure for self-administered specimen collection under clinical supervision. Many pharmacies with existing COVID-19 testing sites have transitioned to this observed self-collection model. Under this model, patients are asked to self-administer a nasal swab test while being observed by a trained pharmacist. This collection method can be more comfortable for patients and can provide reliable results with guidance from pharmacy staff. To use this collection method, the CDC requires the swab to be handed to the patient only while wearing clean, protective gloves. After the specimen collection is completed by the patient, the swab must immediately be placed in a sterile transport device and sealed. 

Using this method, the CDC recommends using standard precautions when the provider supervising self collection is maintaining a social distance of 6 feet or more. By using this method and implementing social distancing, PPE can be preserved for other uses. The minimum PPE recommended with this type of collection include gloves and some type of face covering.

Link to standard precaution information and guidelines for specimen collection: 


Potential Lab Partners and Point of Care Platforms

There are a number of potential lab partners that pharmacies could work with to provide COVID-19 testing. Partnering with a lab may simplify the testing process, improve access to testing for patients, and increase the volume of tests that can be performed. The typical role of certified laboratories is to provide the tests being used, interpret results, and handle reporting, while the pharmacy serves as the specimen collection site. Some labs may provide PPE and other equipment to healthcare personnel during testing. If a pharmacy partners with a laboratory to act as a collection site, they operate under the laboratory’s CLIA designation and do not need to obtain their own waiver. This can also simplify the payment process, as the pharmacy collects their fee from their partner laboratory.

Potential lab partners include Mako Laboratories, Quest Diagnostics, LabCorp, and BioReference Laboratories. This list is not comprehensive.

It is recommended that pharmacies check with their existing wholesale partners for any point of care needs. If your wholesaler does not provide something that your pharmacy requires for testing, other wholesale partnerships that may offer point of care supplies include Mutual Drug, Smith Drug, McKesson, and Cardinal Health. This list is not comprehensive.


Recommendations for Supplies, PPE, and Equipment

The CDC recommends that patients with a confirmed or possible COVID-19 infection should wear a facemask when being medically evaluated. Healthcare personnel should adhere to Standard and Transmission-Based Precautions when caring for patients with COVID-19. Additionally, the CDC generally recommends source control and physical distancing for healthcare workers. Up to date recommendations for PPE and infection control can be found using the CDC Infection Control Guidance for Healthcare Professionals about Coronavirus (COVID-19):

Donning PPE:

Doffing PPE:

CDC PPE Burn Rate Calculator:

NCDHHS asks that every effort is made to obtain PPE through regular supply chains. However, if there is trouble obtaining necessary PPE, a request can be submitted through NCDHHS at the following link:

NCDHHS also realizes that in order to keep up with testing requirements, testing supplies are in constant demand. If your facility is in need of testing supplies, visit the following link for more information about how to request: 


Safety Protocol

What to Tell Patients Prior to Testing

To maintain the health of patients and employees during testing at your pharmacy, it is important to have a safety protocol in place. Prior to testing, let patients know what to expect and how to best prepare. Explain what negative and positive diagnostic test results mean.* Lastly, let the patient know where testing will take place at your pharmacy and what they should expect upon arrival.

*see interpreting results section


Where and How Testing Will Be Conducted

Many pharmacies are conducting COVID-19 testing in drive-throughs or in a designated area of the pharmacy parking lot. Testing areas outside of the pharmacy are convenient for patients that are being tested and are safer for patients who need to come to the pharmacy for other purposes. Most specimens can be collected while the patient remains in their car. NCDHHS suggests that all testing sites allow for a walk-up option for patients who may not have transportation. Tests may be performed by trained personnel or by using the observed self-collection model. If the specimen is self-collected by the patient, ensure the patient is instructed on how to properly obtain the specimen.


How to Protect Employees and Other Patients

To protect pharmacy employees and other patients, ensure that current CDC guidelines for healthcare personnel PPPE use are checked frequently and adhered to. Appropriate signage should be utilized to maintain physical distancing when appropriate and to guide patients to the designated testing areas. Employees must wear appropriate PPE and limit contact with patients who have a suspected or confirmed COVID-19 infection. Refer to the specimen collection section for information on safe collection practices. For patients that are suspected to have COVID-19, employees should implement the CDC’s recommendations for infection prevention and control practices. Current CDC guidance can be found here:

NCDHHS provider guidance:


Patient Checklist

When Should Patients Get Tested?

Testing recommendations are dependent upon patient specific factors such as presence of symptoms, potential exposure, and external requirements (work, travel, school, etc.). Up to date recommendations regarding whether to receive COVID-19 testing can be found through either the CDC or NCDHHS: 


Triage Steps

It is recommended to screen patients for symptoms before they are tested for COVID-19. To protect patients and employees, screening may be done over-the-phone to determine if the patient requires COVID-19 testing. Once patients are screened, they can make an appointment to be tested. It is important to note that triage can be completed using different methods based on what is most comfortable, safe, and convenient for individual sites. Preferences for screening and triage should consider current county levels of COVID-19 community transmission.



Testing Steps

Let patients know where testing will take place at your pharmacy. Once a patient is at your pharmacy for testing, they should wear a facemask and remain in their car to reduce the risk of exposure. Instruct patients to follow all signage and directions at the testing site. Discuss a clear plan to report results to each patient. Let them know what current recommendations are regarding quarantine and isolation while awaiting test results and in the event of a positive result. Up to date information on these recommendations from the CDC can be found here:

Example of provider checklists for reference:

Example of pharmacy checklist for triage:


Interpreting Results

If the patient tests positive, ensure they receive guidance and resources on how to care for themselves and prevent the spread of infection. Follow protocols for reporting the positive result to local or state health departments. A positive test indicates that the patient most likely has a current active COVID-19 infection. If the patient tests negative, understand that it only means they are not currently infected with COVID-19. A negative viral test does not indicate whether a patient has been previously infected, whether they will be susceptible to future infection, or if they are in the very early stages of an infection. See quarantine information section for information on quarantine and isolation protocols. 



Reporting Results

In February, NCDHHS added COVID-19 as a condition that clinicians and laboratories are required to report to the state. Based upon this requirement, all positive cases must be reported. In North Carolina, cases are reported using the North Carolina Electronic Disease Surveillance System (NC EDDS). Local health departments, multi county health departments, and laboratories use this system for reporting directly to NCDHHS. Individual sites and laboratories that do not use NC EDDS should report via phone or fax to their respective local health department who will then utilize NC EDDS for reporting to the state health department. Results collected from individual sites should not be reported to federal entities like the CDC. As cases are reported, state health departments will provide case information to the CDC directly through the HHS Protect System.

If a pharmacy is considering serving or preparing to serve as a specimen collection site, they are advised to discuss reporting with the partner laboratory conducting the testing as they will likely handle any necessary reporting. Aside from reporting to health departments, the Statewide Standing Order for COVID-19 Diagnostic Testing also requires COVID-19 test results to be reported to the patient and the patient’s health care provider.

For more information regarding reporting, please see the NCDHHS website:




If your pharmacy is partnering with a lab to conduct COVID-19 diagnostic testing, the lab will likely handle necessary documentation for each patient tested. However, pharmacies may want to consider documenting confirmed positive COVID-19 cases. All information collected from patients must comply with HIPAA standards and regulations. During public health emergencies, the HIPAA Privacy Rule allows patient information to be shared.

It is recommended that protocols for documentation and record-keeping of viral testing can be conducted in the same way that pharmacies currently handle documentation for vaccinations. The following is a non-exhaustive list for things that should be documented and/or the pharmacy should consider documenting: consent form for the test, when the sample is collected, sent, and received by the lab if applicable, the result of the test, when and how the patient is notified, and lastly, how the conversation went with the patient.



Patient Information and Education

What the Test Does

Diagnostic tests can tell if a patient currently has an active COVID-19 infection (i.e. are infected at the time the test is given). These tests will not indicate if a patient was previously infected.


When the Results Might Be Ready

The time it takes to receive test results can vary depending on the test manufacturer. Most of the rapid diagnostic point of care tests authorized by the FDA can provide results in less than an hour.


How to Get Results

Pharmacies administering  COVID-19 tests will be responsible for presenting patients with their results. Provide patients with the contact information for your pharmacy and instruct them to speak with a pharmacist for their results.


Interpreting Results

  • A positive result means, most likely, a patient CURRENTLY has an active COVID-19 infection. This also means they can actively spread the virus to others around them.

  • A negative result means, most likely, a patient DOES NOT currently have an active COVID-19 infection. It does not mean they are less likely to become infected and could also mean that they are in the early stages of an infection.


What Actions to Take After Getting Results

If a patient has been diagnosed with COVID-19 (i.e. received a positive result from a diagnostic test) and does not require hospitalization, they should stay at home unless they require medical care. In the event that they do need to leave their home for medical care, patients should avoid using public transportation and going to non-medical public places, such as grocery stores or gas stations. While at home, patients should self-isolate by staying in a room separate from others who live there. If they must be in a shared living space at any time, proper social distancing and mask wearing should be utilized. Efforts should be made to sanitize all shared areas.  Advise patients to take care of themselves by getting plenty of rest and drinking fluids. Patients should stay in touch with their doctor while monitoring their symptoms. Resources on managing COVID-19 infection for both the patient and the caregiver can be found here:


Quarantine and Isolation Information

Quarantine refers to the strategy of preventing transmission after a known exposure to someone with COVID-19. Isolation refers to the strategy of preventing transmission from someone with known or suspected COVID-19 infection to someone without an infection. Specific up to date recommendations on when, how, and with whom to utilize these strategies can be found on the CDC website: