Point-of-Care Testing
A How-To Guide for the Non-Laboratorian
Point-of-care testing (POCT), or near-patient testing, is diagnostic testing conducted close to the patient, often by clinical personnel outside of the laboratory. POCT can enhance patient care by expanding the opportunities for healthcare services at different patient and population levels.
This “how-to” guide is intended for non-laboratorians who are engaged in setting up a process or physical space designed to provide testing at or near where patient care is provided. This guide provides an overview of POCT, including a discussion of the cost-benefit analysis of implementing POCT and the use of POCT in various healthcare settings. It presents the challenges to consider when selecting and implementing POCT. It also offers tools to address and manage those challenges and offers solutions to overcome barriers faced in various settings to ensure quality test results that are reliable for patient care.
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Point-of-care testing (POCT), or near-patient testing, is diagnostic testing conducted close to the patient, often by clinical personnel outside of the laboratory. POCT is regularly performed by personnel without a laboratory science degree or credentialing in laboratory medicine. POCT provides faster turnaround of test results that can expedite patient care decisions, in part because a sample does not need to be transported to a laboratory and requires little to no sample processing. The potential of POCT to streamline patient management and elevate the patient experience, as well as improve patient satisfaction and care outcomes, is increasing the popularity of this delivery option for diagnostic testing. A wide range of tests, testing products, and devices are currently available on the market. Manufacturers are continuously developing new or improved instrumentation that is simpler, is easier to use and maintain, and can provide laboratory-comparable test results. However, implementing POCT can present many challenges. In the US, all laboratory testing is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law, regardless of where the test is conducted or what type of facility provides testing (1). POCT is subject to CLIA regulations, which vary depending on the complexity of the test. Minimal requirements exist for simple tests, like urine pregnancy and whole blood glucose, to which CLIA refers as waived complexity. More complex testing, such as blood gases, requires a variety of documentation to meet the CLIA requirements. Method verification, written policies and procedures, timely operator training and competency, manufacturer’s directed maintenance, quality control, management of reagent supply and storage, proper disposal of hazardous waste, and adequate environmental management practices for operator and patient safety are all required for more complex POCT. Worldwide, laboratory regulations vary by country, and local regulations may be more or less stringent than the US CLIA regulations.
This guidance document is intended for non-laboratorians who are involved in setting up a process or physical space designed to provide testing at or near where patient care is provided. This guide presents the challenges to consider when selecting and implementing diagnostic testing. It also offers tools to address and manage those challenges and offers solutions to overcome barriers faced in various settings, to ensure quality test results that are reliable for patient care. Employees who are charged with addressing these POCT challenges vary by job title and role. This guide is not meant to be an all-inclusive ‘how to’ set up a POCT laboratory. It is to be used as supportive instruction and education to implement good laboratory practices. The guide is most helpful when used in conjunction with all information provided by the test manufacturer, including the Manufacturer’s Instructions for Use (MIFU) for testing materials, products, and devices that one has selected to provide laboratory testing services to patients.
POCT is performed at or near the patient. This means that testing can be performed quickly at the site where the results will be used with no need to transport specimens. There are many benefits to performing testing at the point of care, including
POCT can be more expensive to perform than central laboratory testing, but savings in other areas of care can justify the cost. If a test can be performed on-site, when a patient is with the provider, then the advantage of immediate treatment and consultation can be invaluable. Patient satisfaction is increased when results can be shared during the physician appointment and the care plan can be immediately outlined. POCT can also be useful for management of antibiotic resistance, allowing providers to explain why an antibiotic is not necessary based on the POCT results. For an urgent care center, having laboratory results available on-site enhances the ability to treat patients in real time and potentially decreases the patient wait time. However, a cost-benefit analysis ought to be performed to ensure that added cost of POCT will improve patient outcomes and/or patient satisfaction.
POCT in inpatient hospital settings is useful in situations where immediate results are needed to diagnose or treat a patient, usually to avoid escalation of their condition or decide on immediate treatment. In some cases, a POC test can ensure that valuable operating room/surgery or procedure rooms do not experience delays due to patients not having pre-procedure testing completed before arrival. In other cases, where delay in treatment (e.g., tPA for stroke victims) can lead to poorer outcomes, POCT is invaluable.
In outpatient settings, performing testing at the time of the patient visit means the patient can receive treatment during the visit, obviating a need to travel to a collection site for specimen collection. The clinician can address the test results immediately and advise the patient on their care. Keeping a close watch on patient results—for example, hemoglobin A1c—can lead to better disease management.
Because of the SARS-CoV-2 pandemic, infectious disease testing has become ever more decentralized. To contain the pandemic, many sites where large numbers of individuals are gathered are requiring negative tests and are offering testing at the venue. Cruise ships and other locations that are far from healthcare sites often use POCT to care for their customers. Due to the rise of telehealth, convenient ‘off-site’ testing is becoming more necessary. Mobile health needs portable, easy-to-use devices to bring healthcare to the population and make healthcare more accessible to all.
One approach to start or expand a POCT service is to consider the goals of the facility and the needs of the patient population to be served by adding POCT. Those planning the service should summarize their goals, ensure that the solution under consideration will accomplish those goals, and align the testing plan with the facility’s mission and strategic objectives.
[See PDF for Table 1.]
In broad terms, it is common that a ‘point of care (POC) testing device’ is either small and of a weight easily considered to be ‘handheld,’ or is at least portable from one physical location to another (toted by hand or via a wheeled cart, aka ‘mobile lab’ or ‘lab on a cart’). Typically, a POC testing device is designed to be used with or without connectivity (a means of interfacing to the electronic medical record). Another design inclusion is the ability to ‘lock out’ operators unless they meet required compliance qualifications and to ‘lock out’ testing being performed if quality control requirements have not been met. Specimen integrity checks—detections for insufficient quantity or inadequate, poor-quality specimens—are helpful features that manufacturers incorporate into POC devices. POC device manufacturers also include features to track or document cleaning and/or maintenance, including filter changes and optical standard checks.
The use of hematology analyzers in POC or near-patient settings for complete blood count (CBC) analysis requires careful consideration of the specific clinical diagnostic needs of the target patient population. The choice of the analyzer may be driven by the prevalence of specific diseases or, for pediatric patients, by age. A CLIA-waived instrument may be considered in some settings but not in others. For example, CLIA-waived CBC analyzers like the Sysmex XW-100 are not intended for use in hematology-oncology patients and children under two years of age. Recently FDA-approved analyzers are not intended for use in children under the age of two years or three months (PixCell Hemoscreen™ and SightOLO ® , respectively). In addition to considering the target patient population, it is important to note that some hematology instruments can perform a 3-part differential while others offer a 5-part differential. A 3-part differential may not be sufficient for a clinic that sees patients with diseases leading to eosinophilia or basophilia. The reportable ranges of the parameters offered by specific instruments should match the values expected in the specific patient population, to minimize the number of repeated draws or of specimen referred to the central lab.
Several methodologies and instruments are available for monitoring coagulation in POC settings. Testing for Prothrombin Time/International Normalized Ratio (PT/INR) in monitoring of chronic anticoagulation therapy and for platelet responsiveness to therapy can be useful in specific settings, such as anticoagulation clinics, catheterization labs, interventional radiology in hospital settings, etc. More complex testing methods are available that provide a comprehensive assessment of the coagulation process in more complex patients. In recent years, thromboelastography has emerged as a valuable methodology to determine the coagulation status of patients undergoing major surgery, in intensive care settings, or for hemophilia patients with inhibitors. The use of these instruments in the POC setting is driven by clinical needs, and concerns about sample stability, requiring immediate processing in near-patient settings, can be determined by lab management on a case-by-case basis.
Rapid diagnostic tests (RDT) have been used for many years in the quest to diagnose infectious diseases at the point of care. There are lateral-flow, immunochromatographic tests readily available to be performed as waived complexity tests while a patient waits for their results. Currently available and new to POCT are nucleic acid amplification tests (such as PCR or RT-PCR). These assays are performed using bench-top equipment.
POC tests have tremendous potential for improving cardiovascular disease (CVD) care. With the ability to offer high-quality biomarker measures in a variety of clinical settings, including acute care, outpatient clinics, clinical research centers, personal households, rural areas, and developing countries, POC testing can ensure that more people have access to CVD testing. In the operating room/surgery, intensive care unit, cardiac catheterization unit, and emergency department, real-time feedback is critical to maximize care and customize therapies in rapidly changing health scenarios. Quantitative CVD risk assessment and clinician-patient risk discussions are important components for optimal CVD prevention, according to current CVD prevention guidance geared toward individualized therapy recommendations based on unique benefit-harm assessments for a given patient (2). Pre-visit POC testing is a novel technique for providing tailored, guideline-recommended primary preventive treatment. Commonly used POC tests in cardiac care measure cardiac troponin (cTn) T and I. POC high-sensitivity cTn (hs-cTn) tests may become available soon; however, evidence is required to ensure that new POC hs-cTn tests meet analytical and clinical guidelines. In addition to measuring cardiac troponin, several POC devices are available for measuring thrombosis serum biomarkers, such as D-dimer, and for markers of coagulation and platelet function.
There are many POCT options for additional diseases and clinical applications. These include, but are not limited to, tests for pregnancy, some cancers, diabetes, and renal disease, and for critical care.
[See PDF for Table 2.]
Immunoassay options for point of care will involve either individual tests (lateral flow, etc.) or an instrument platform. These antibody-focused assays are ideal and common for many targets, such as protein detection, drug testing, or even infectious disease. An instrument platform will typically take some amount of space in an office or laboratory and require training for the user. While a laboratory can include multiple platforms, each addition will require more space and training. Thus, it is important to choose an option that may cover multiple (or all) needs for immunoassay POC testing for your facility. It will also be critical to consider the associated workflow with the platform and ensure it is meeting the requirements that are justifying a POC platform. For tests that are individual and do not require any dedicated equipment, a facility can more easily have several distinct types of testing kits from various manufacturers to achieve their desired menu offering. However, there is still value in familiarity for your facility staff. It will be critical to analyze the workflow and turnaround time and ensure that the overall needs are being met by the solution.
Molecular POC tests are becoming more readily available as their speed and cost becomes more conducive to POC needs. They can be excellent solutions for detecting infectious disease or other molecular markers, but they cannot detect antibodies, proteins, or chemicals. Some platforms will provide only a qualitative answer, while others will provide a quantitative answer for how much of the molecular target is present. Typically, a molecular assay has the potential to be more specific and sensitive than an immunoassay, but that is not always true or beneficial. For example, a molecular flu test may have the ability to identify a specific strain of influenza. However, it might only identify flu A or B, which can also be achieved with an immunoassay. Additionally, higher sensitivity may not always be a beneficial feature. Some studies show that a small amount of Clostridium difficile can sometimes be found in a perfectly healthy individual. Since a molecular test may detect that small/normal amount when it is not the cause of a symptom, treatment may be initiated when it is not necessary or appropriate. As seen in the example of C. difficile, evaluating the clinical utility of each test is necessary to prevent unhelpful diagnoses or treatment.
POC chemistry analyzers provide wide test menus, including electrolytes and metabolic and lipid panels, and may include immunoassay methods as well. POC chemistry analyzers may specifically target urine or blood analytes, or a disease condition that requires specific biomarkers, such as diabetes (glucose, or HbA1c, or microalbumin/creatinine ratio), myocardial biomarkers (troponin I, cardiac myoglobin, NT-proBNP), Alzheimer’s disease (Amyloid beta-42), and others. While some POC analyzers use technologies similar to larger lab-based analyzers, others use specific technologies like microfluidics (e.g., lab-on-a-chip) or centrifugal microfluidics, and specific sensor methodologies like optical sensors, electrochemical transducers, and others (4). Novel technologies geared toward use in resource-limited settings include paper-based analytical devices and electrospun fiber-based biosensors (5). Microfluidic devices may allow storage of reagents in liquid or lyophilized forms and their release and manipulation when the assay is performed.
All US locations performing any laboratory testing must obtain a certificate to perform testing from The Centers for Medicare & Medicaid Services (CMS)/CLIA. All testing that involves a sample taken from a patient and that has results used in diagnosis, treatment, or monitoring of that patient must be performed at a site with a CLIA certificate. The available certificates are:
The application form for a CLIA certificate is found on the CMS/ CLIA website and must be filled out completely and sent to CMS/CLIA, which will send an invoice for payment (6). Upon receipt of payment, the certificate will be issued. The certificate must be displayed at the testing site.
The FDA determines test complexity. Only waived testing can be performed by a site with a Certificate of Waiver. CMS defines waived testing as simple tests with a low risk for an incorrect result. They include certain tests listed in the CLIA regulations, as well as tests cleared by the FDA for home use. Moderate complexity testing can be performed in a laboratory or near-patient setting with either a Certificate of Compliance or Certificate of Accreditation. Waived testing can also be performed under these certificates. High complexity testing is normally not performed in a POC environment and will not be discussed in this document. A searchable CLIA database is available to help determine the complexity of a test (7).
Regulations for the facility performing waived testing under a certificate of waiver are minimal. Besides obtaining the appropriate CLIA certificate, the MIFU must be followed. Any deviation from the MIFU would make the test high complexity, so following all applicable instructions is essential. Instructions for performing testing must be available to testing personnel. Anyone who has been trained can perform waived testing, and the requirements for CLIA Laboratory Director do not require laboratory background. Quality control must be performed per MIFU. State or local accreditation requirements may need to be considered and implemented.
Regulations for moderate complexity training are more stringent. There are specific requirements for CLIA Laboratory Director, technical consultant, clinical consultant, and testing personnel. Competency assessment, training, quality control, verification and validation of devices and test kits, and quality management are all specified in the regulations, and will be discussed individually in this document. All sites with either Certificate of Compliance or Certificate of Accreditation can also perform waived testing.
The FDA may also grant Emergency Use Authorization (EUA) when necessary, as for the SARS-CoV-2 pandemic. Newly developed tests will be provided temporary approval from the FDA to be used as stated in the EUA letters. If the letter states that the test can be used in POC situations, then it can be treated as a waived device/kit. If the letter states that it can be used in a laboratory only, then it must be managed as a moderate complexity test.
It is imperative to comply with all regulations for POCT. Ensure that the laboratory addresses the following questions:
Additional considerations to review beyond which kit or device to purchase include the laboratory equipment needed and facility requirements (Table 3).
[See PDF for Table 3.]
Laboratory environments are dictated by the testing that is performed and what the manufacturer dictates in their package inserts. Laboratories must ensure that they have met proper temperature control, lighting, humidity, air quality, water quality, and altitude expectations. Some instruments are equipped with internal detectors that will alert the user, while others rely on manual documentation to verify. All testing will require some element of personal protective equipment (PPE). The type and level of PPE will be defined by what testing is being performed. Laboratory waste management should be considered for biohazard disposal of regulated waste. Management of waste can be contracted out or maintained at the laboratory, depending on your laboratory’s need. Ensuring occupational health and security of staff is important. Laboratories should have a route for health assessments of laboratory staff and for the safety/security of the laboratory itself (reference CLSI for specifics) (8). Factors to be defined:
The “facility” is the physical space (e.g., environment) that encompasses the POC laboratory. If the lab is a shared activity space, involve all stakeholders of each activity conducted in the lab design. Stakeholders may include the owners, lab managers, lab users, faculty and staff, patient representatives, and facilities and maintenance personnel. Next, consider practical environmental limitations starting with the physical size of the space and identify how much counter/ bench top space will be required for each activity, equipment storage requirements (e.g., coordinate lab furniture capacity with the height and weight of the lab equipment), and the number and type of users that will be working within the space. Using diagrams and workflow plans, consider how the lab/POCT users will coordinate effective and efficient use of the space. Doing so will define which counter space will be dedicated to “clean” vs ‘‘soiled” spaces to minimize contamination of patient samples and the environment and will improve workflow processes. Consult Environmental, Health, and Safety (EH&S) experts to ensure that the lab/POC facility minimizes safety hazards and includes all required components. Based on the types of tests being performed, a handwashing sink or eyewash station may be required. Plan for chemical storage and containment in the facility. Cleaning and disinfecting supplies for the POC device or instrument must comply with the MIFU; the product used to clean and disinfect the countertop surface is in line with the countertop materials (not necessarily the same as the instrument product required). Coordinate changes to the HVAC, electrical, plumbing, or other mechanical systems with building and maintenance engineers. In addition to mapping out the spatial use of the lab, determine the power and backup power requirements for any lab equipment. If the testing facility or counter space can be accessible by patients or non-laboratory personnel, introduce measures to maintain security of the testing equipment, electronics, and protected/personal health information (PHI).
[See PDF for subsequent detailed operational sections and addenda templates.]
Many POCT devices are available on the market, and there has been a rapid increase of options in the past few years. This is largely due to medical care trending towards patient-centered care, which has been accelerated by the SARS-CoV-2 pandemic. POCT appears to be capable of creating a balance between rapid diagnostic testing used on-site in the acute care setting with system-centered care using large main laboratory or reference laboratory testing. The appeal of POCT is the potential for quicker clinical decision-making that allows for convenient real-time diagnosis and treatment within one patient care event. Outcomes for immediate patient care and future long-term care have steadily improved with the ability to obtain testing results without the delays that may be associated with traditional reference laboratory testing. The future of POCT will likely bring new testing for a wide variety of uses, such as the following (32):
With emerging technologies, it is imperative that stakeholders collectively identify what testing is needed and which method or platform best meets the needs for patient-centered care. A team of people should be involved in these discussions: clinical laboratorians, physicians, compliance personnel, and end user representatives. The success of future POCT relies on partnering for investigation, implementation, and monitoring quality over time.
Gyorgy Abel, MD, PhD, DABCC, FAACC
Carlo Brugnara, MD
Saswati Das, MD, PGDHHM, FAACC
Kathleen David, MT(ASCP)
Erika B. Deaton-Mohney MT(ASCP), CPP
Kerstin Halverson, BA, MS
Peggy A. Mann, MS, MT(ASCP), CPP
David Moore, MBA
James H. Nichols, PhD, DABCC, FAACC
Caitlin R. Ondracek, PhD
Nichole Korpi-Steiner, PhD, DABCC, FAACC
Authors listed in alphabetical order
All authors confirmed they have contributed to the intellectual content of this paper and have met the following four requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; (c) final approval of the published article; and (d) agreement to be accountable for all aspects of the article thus ensuring that questions related to the accuracy or integrity of any part of the article are appropriately investigated and resolved.
Upon manuscript completion, all authors completed the author disclosure form. Disclosures and/or potential conflicts of interest: Employment or Leadership: J.H. Nichols, The Journal of Applied Laboratory Medicine, AACC; G.A., Lahey Hospital & Medical Center, Burlington, MA; K.D., Tricore Reference Laboratories; E.B.D.M., Bronson Health System, AACC CLS Council Chair Elect; K.H., Werfen, AACC CPOCT Division Nominating Committee Member, AACC CLS Nominating Committee Member; P.A.M., Clinical Laboratory Standards Institute POC Expert Panel Chair; D.M., ProciseDx Inc, Lucira Health; C.R.O., AACC; N.K.S., Board of Director, ComACC. Consultant or Advisory Role: C.B., Sysmex Diagnostics; K.D., Werfen Advisory Board; P.A.M., Werfen POCT Advisory Board; N.K.S., Werfen Acute Care Diagnostics POC Advisory Council. Stock Ownership: D.M., ProciseDx Inc, Lucira Health. Honoraria: K.D., AACC CLS Forum; P.A.M., Werfen POCT Advisory Board; K.H., AACC CPOCT Regional Bootcamp and Annual Meeting Research Funding: S.D, Department of Science and Technology, Government of India. Expert Testimony: None declared. Patents: None declared.
Sight Diagnostics (Sight) provided commercial support for this publication. Sight agreed that the content of this publication will be unbiased and educational in nature and not promotional. AACC is dedicated to ensuring balance, independence, objectivity, and scientific rigor in all educational activities. AACC received feedback from Sight during the development of this document and reviewed the content for scientific accuracy. AACC made final decisions on the subject matter expert writing group members and scientific content contained within this guide.
The writing group thanks the AACC Board of Directors, AACC Academy Council, AACC Science & Practice Core Committee, and Sight leadership for their careful review of this document. Special thanks to Kristen Hauck for proofreading.
[See PDF for full References list.]
[See PDF for full Glossary list.]
This guide includes addenda, including glossaries, templates, and forms, to serve as tools in the implementation of POCT. These are for reference use only; individual POCT laboratories may have unique needs.
All the addenda are included in the full guide. You can also download individual addenda here:
Please contact Beth Oates at [email protected], if you have comments and for copyright and translation information.
This document was sponsored by Sight Diagnostics. The content was written by AACC member subject matter experts and reviewed by the AACC Board of Directors, AACC Academy Council, AACC Science & Practice Core Committee, and Sight Diagnostics.