Continuing Education Activity

Point-of-care testing is clinical laboratory testing performed at or near the site where patient care is delivered. Unlike traditional laboratory testing, which may involve delays in sample transport and result reporting, point-of-care testing offers rapid turnaround times that support timely clinical decision-making. Advances in technology, including miniaturized electronics and improved instrumentation, have enabled devices to become smaller, more accurate, and more accessible across various healthcare settings. This development allows a broad range of healthcare professionals, and in some cases even patients, to perform testing that informs immediate treatment decisions. The rapid availability of results has the potential to improve both clinical and economic outcomes by streamlining care, preventing delays in therapy, and enhancing patient satisfaction.

Through this activity, participants develop competence in evaluating the methodology, benefits, and limitations of point-of-care testing while enhancing skills in interpreting and applying results to patient care. The activity emphasizes strategies for integrating testing into care workflows, identifying factors that may compromise accuracy, and selecting the most suitable test for the clinical situation. Collaboration among clinicians, pharmacists, and laboratory professionals is crucial to ensure accurate test utilization, prevent misinterpretation, and align treatment decisions with patient safety goals. By strengthening interprofessional communication, participants learn to support effective care coordination, improve diagnostic precision, and reduce the risk of unnecessary delays or adverse outcomes. Ultimately, this activity equips the healthcare team to deliver high-quality, patient-centered care while improving efficiency and overall outcomes.

Objectives:

• Identify the appropriate indications for point-of-care testing based on the patient's presentation and clinical scenario.
• Apply quality control measures and perform regular maintenance and calibration of point-of-care testing equipment to ensure accurate and reliable results.
• Implement point-of-care testing procedures in accordance with established protocols, including proper specimen collection, handling, and storage.
• Collaborate with other healthcare professionals in the interpretation and integration of point-of-care test results into patient management plans.

Introduction

Point-of-care testing (POCT) is a type of clinical laboratory testing conducted at or near the site of patient care.[1] POCT provides rapid turnaround of test results, with the potential to generate results quickly, allowing for the implementation of appropriate treatment and leading to improved clinical or economic outcomes compared to laboratory testing.[2]

Traditional laboratory testing typically involves a multiple-step process that includes collecting samples from the patient at the bedside or the clinic, transporting them to a centralized laboratory, often located far away, and then subjecting the samples to several processing steps.[3] The delay in treatment caused by the time-consuming traditional laboratory testing can hinder timely clinical decision-making. POCT addresses this challenge by bringing the laboratory to the patient. Portable and handheld testing devices enable healthcare professionals to perform rapid testing on samples, significantly reducing the time needed for medical decision-making.

The concept of on-site or near-patient testing for blood analysis was initially explored in England during the 1950s and was referred to as near-patient testing.[4] In the early 1980s, Dr Gerald J Kost introduced the term point-of-care testing after extensive research on the application of biosensors for monitoring ionized calcium levels in whole blood.[5] The term point-of-care testing was subsequently defined as the testing at or near the site of patient care.[3]

Technological advances, including the miniaturization of electronics and improved instrumentation, have facilitated the development of increasingly smaller and more accurate POCT devices.[6] Cutting-edge POCT integrates microneedles and microfluidics for improved comfort, speed, and accuracy.[7][8]

Essential features of point-of-care testing include simplicity of use, with reagents and consumables that remain stable and reliable during storage and use. Test results should be consistent with those obtained from established laboratory methods, and procedures must ensure safety for both patients and healthcare personnel throughout the testing process.[9] 

Various international guidelines define key attributes of POCT. The ASSURED framework, proposed by the World Health Organization, is one of the most well-known models, particularly for infectious disease diagnostics, such as those related to sexually transmitted infections. The acronym ASSURED highlights that POCT should be affordable, sensitive, specific, user-friendly, rapid, robust, equipment-free, and deliverable to end-users. Affordability makes tests accessible to at-risk patients, whereas being equipment-free means they do not need complex tools. More recently, this framework has been updated to the REASSURED criteria, which keep all the main features of ASSURED but add 2 new aspects—real-time connectivity, which links tests with health information systems, and ease of specimen collection, supporting minimally invasive sampling. Together, these criteria serve as a complete standard for developing and implementing effective POCT solutions in diverse healthcare settings.[9]

The National Academy of Clinical Biochemistry has developed evidence-based guidelines for POCT, providing grading and recommendations to optimize the use of POCT based on scientific research and clinical evidence.[10] Developing trends in POCT include the integration of artificial intelligence and machine learning in the execution and interpretation of lab testing, as well as the continued miniaturization of POCT devices.[11] POCT guidelines generally emphasize the rapid results and cost-effectiveness of POCT, along with the importance of high sensitivities and specificities to support informed clinical decision-making.

Specimen Requirements and Procedure

There are 3 main stages in POCT—pre-analytical, analytical, and post-analytical. The pre-analytical stage occurs before testing and involves collecting, transporting, preparing, and loading the sample. The analytical stage is the period during which the test is performed. The post-analytical stage begins once results are available. At this point, findings are communicated to the treatment team through the electronic medical record, written notes, or verbal reporting. Critical values, which are results that fall far outside normal ranges and signal potential pathology, are also addressed during this stage. Interpretation of results in the post-analytical phase guides clinical decisions and interventions.

Specimen collection and handling are critical components of POCT since testing is performed directly on the collected specimen.[12] The pre-analytical phase of specimen collection and handling is crucial and represents the most critical controllable variable in POCT. Adhering to personnel regulations, appropriately preparing patient and specimen collection containers—including fixatives or special media—and ensuring compliance with patient and specimen identification requirements are essential for effective collection and handling. Additionally, accurate clinical documentation and proper specimen storage are necessary to maintain the integrity, accuracy, and safety of the testing process.

Adherence to the manufacturer's instructions is critical for ensuring the accuracy of POCT, particularly during sample preparation. Specific requirements—such as centrifugation time—may vary based on the device and sample type, underscoring the importance of following protocol precisely. Each apparatus may have unique steps, so healthcare professionals must carefully follow the directions provided. Many prefer point-of-care tests that use whole blood, as these eliminate the need for additional processing steps, such as centrifugation. Additionally, all sample collection containers must be used within the manufacturer's date stamp to ensure the preservation of both the quality and reliability of the testing process.

POCTs are more susceptible to interfering substances and have a narrow margin of error due to smaller sample sizes compared to conventional laboratory tests. Proper technique is crucial when drawing samples, particularly when accessing a central line.[13] These steps involve flushing the line with heparin and discarding at least twice the volume of the line (2-5 mL) before sample collection. Additionally, it is recommended to wait at least 15 minutes after a blood transfusion before drawing a sample for POCT.

Samples collected for blood gas analysis are susceptible to changes in oxygen partial pressure. Therefore, it is crucial to maintain anaerobic conditions during sample collection to ensure accurate laboratory values.[14] Controlling factors, such as removing all air bubbles from a sample, using a plastic syringe for collection, and ensuring the time and temperature of sample storage before analysis, are crucial for accurate blood gas analysis.

Diagnostic Tests

POCT testing devices are classified based on testing modality and test size.[9] Test size in POCT spans a wide range, and ongoing research focuses on miniaturization. Handheld POCT devices, such as dipsticks and glucometers, represent smaller-scale options within this spectrum.

The most recent iterations of these devices feature cartridges that enable multiple tests, including whole blood analysis for cardiac markers, blood gases, and various hematologic and endocrine analytes. On the larger end of this spectrum, there are larger benchtop POCT units that require dedicated space near a patient to qualify as a POCT.

Many of these benchtop POCT units are equipped with multiple testing types and modalities, allowing for a wide range of diagnostic tests to be performed within a single device. Common examples of tests performed on benchtop POCT units include hemoglobin A_1c, C-reactive protein, and general chemistry analytes. The demand for smaller and more precise benchtop POCT devices has been a significant catalyst for innovation in reducing the size of these instruments. Advancements in technology and engineering have enabled the development of compact and highly accurate benchtop POCT units.

Testing Strips and Lateral-flow Testing

POCT encompasses a wide range of testing modalities tailored to specific applications. The most basic form of POCT relies on the interaction between an analyte and a substance, typically impregnated or contained, allowing a sample to be added or mixed in a controlled manner.[15] A common example is the use of test strips, such as urine dipsticks. These strips are generally dried, porous matrices with impregnated carrier elements that interact with the analyte(s) when exposed. The interaction between the analyte and the testing reagents often involves a chemical reaction that produces a color change. This color change can be interpreted as a binary value indicating the presence or absence of the analyte or as an indication of the analyte concentration using a scale (eg, trace protein, 1+, 2+, and 3+).

A more complex approach to POCT is lateral-flow testing. This type of diagnostic testing uses a layer of supporting material, such as porous cellulose fiber filters or woven meshes. The supporting material contains capillary beds to whisk fluid samples to location(s) on the support material with substances that react with measured analytes in the sample. The at-home pregnancy test is a well-known example, which commonly uses an immunoassay to detect the presence of human chorionic gonadotropin (hCG), specifically beta-hCG, in urine.

Urine is exposed to one end of the supporting material in the test device; capillary beds then move the urine through the supporting material to specific sites that react with beta-hCG. This configuration typically consists of 2 lines of reactive material—one serving as the control and the other providing a binary yes-or-no indication. The test is positive if both lines (also known as stripes) appear or change color, and negative if only the control line is visible. The failure of the control line to appear indicates an invalid or faulty test, which could result from a manufacturing defect, damage, or an expired test.

In many instances, POCTs that use simple test strips or lateral-flow testing provide qualitative or semi-quantitative results and do not provide precise information regarding the specific concentration of the measured analyte.

Immunoassay Testing

POCT testing that uses immunoassays relies on antibodies to bind to a specific target when the concentration exceeds a certain threshold.[15] Targets in immunoassays for POCT can encompass a wide range of substances, including proteins, drugs, and pathogens. POCTs are available in various formats, including both individual tests and platforms with multiple built-in tests. In general, testing platforms require more space and greater expertise and training, which generally scale with the number of tests offered.

Deciding between using a testing platform versus individual tests, or even utilizing a combination of individual tests, depends on the workflow and throughput required. Higher sample volume can often be accommodated more effectively using a POCT testing platform. However, the suitability of a specific platform depends on the type of testing and the platform's capabilities.

One subset of immunoassays is the direct assay, which provides a straightforward method for detecting an analyte. In a direct immunoassay, the analyte of interest is directly bound by an antibody that specifically recognizes and binds to it. This binding event is then detected by an optical sensor, typically through fluorescence. The fluorescence signal indicates the presence and quantity of the analyte in the sample.

In situations where a direct assay is not feasible, competitive immunoassays can be employed. These assays use the principle of competitive binding between a measurable, secondary analyte and the target analyte. As the test antibodies bind to more of the primary analyte, the level of bound, measurable analyte decreases due to competitive binding, allowing for the determination of the primary analyte's concentration. Unlike simple test strip-based POCT, immunoassay POCT provides quantitative information for specific analytes.[16][17]

Antigen-Based Testing

POCT, which detects specific antigens or antibodies associated with a disease or condition, is now widely used as a standard practice in healthcare.[18] Immunoassay-based POCT is commonly used to rapidly detect group A Streptococcus, mononucleosis, and influenza A and B. These tests use immunoassays that bind specific antigens or antibodies. Immunosay-based POCT offers a fast turnaround time but may have lower sensitivities and specificities compared to traditional laboratory and molecular testing methods.

Molecular Testing

The need for molecular POCT that offers high sensitivity and specificity, along with a relatively short turnaround time compared to traditional methods, has driven its development, despite being slower than antigen-based testing.[18] This form of testing detects DNA or RNA sequences that indicate the presence of a disease. Nucleic acid amplification testing detects DNA or RNA in small samples by replicating the target nucleic acids, increasing their concentration to facilitate easier detection.[19]

Various forms of molecular testing exist, including reverse transcription polymerase chain reaction and isothermal amplification methods, such as nicking endonuclease amplification reaction and transcription-mediated amplification.

Notably, although molecular POCTs often have higher sensitivities and specificities compared to antigen-based POCTs, this is not always the case. Additionally, the increased sensitivity and specificity provided by this POCT modality may not always be clinically beneficial, as the detection of an analyte does not necessarily correlate with a specific disease state or the need for treatment (eg, the presence of a small amount of Clostridium difficile in a patient's stool does not always indicate the need for treatment of a C difficile infection.[20]

Testing Procedures

Testing procedures for POCT vary based on the specific manufacturer, test, and sample type. For accurate results in most POCT units, proper setup and calibration of the test before use are essential. Following the manufacturer's instructions for use or package insert for each POCT apparatus is crucial in achieving accurate testing.

General POCT Testing Procedures

• A sample is first obtained for analysis, such as a drop of blood for blood glucose concentration with a glucometer or urine for beta-hCG testing. Various requirements exist regarding the patient's state, the specimen's state, and the preparation necessary for accurate testing. Please refer to the Specimen Requirements and Procedure, as well as the Quality Control and Lab Safety sections, for more information.[21] 
• The sample is applied to the POCT device. Immediately before this step, a reagent may be used to facilitate accurate testing. For example, some COVID-19 POCT units require nasopharyngeal or oropharyngeal swab samples to be placed in a reagent solution, which facilitates the release and distribution of antigens, thereby improving test accuracy.[22] In other types of POCT, the sample can be directly applied to the device, which typically includes a disposable cartridge for analyzing the analyte. This disposable cartridge can be disposed of after use, reducing the risk of cross-contamination.
• Once the test is performed, the result is obtained and can be directly transferred to the patient's electronic medical records if the POCT device is integrated or interfaced with the electronic medical record system.

Interfering Factors

Due to the portable nature of POCT, the reagents, tests, and samples are often exposed to conditions that may differ from those in a traditional laboratory setting. Humidity, temperature, time to testing, and oxygen content can fluctuate more in the POCT setting than in the conventional laboratory environment. Most interfering factors with POCT occur during the pre-analytical phase before the test is run.[23]

Pre-analytical errors can occur during patient or specimen identification, as well as during specimen collection, handling, processing, transport, and storage. These errors may include hemolysis, clotting, underfilling or overfilling a specimen container, improper securing of specimen containers before transport, prolonged tourniquet time, and changes in the sample concentration (eg, during aliquoting).

Notably, the detection of hemolysis in POCT using whole blood samples, including fingerstick tests, is challenging.[24] Errors during specimen transfer and loading, such as bubbles, microclots, and gross clotting, can occur, especially if the procedure is not followed appropriately or lacks oversight. Increased time to testing can interfere with POCT, as observed in the case of blood glucose testing in whole blood. Adequate training is a critical component of POCT, as pre-analytical errors have an inverse association with test operator experience.

Other interfering factors may be directly related to the patient's physical state. For instance, high biotin intake (eg, from vitamin supplementation) can interfere with certain immunoassays, such as HIV POCT.[25] This interference occurs due to the interaction between biotin and streptavidin in the assay. Affected assays include, but are not limited to, pancreatic, prostate, and ovarian cancer POCT and pituitary and thyroid function tests. Reading the manufacturer's instructions for use or package insert is essential for POCT, as certain drugs can interfere with the test and affect accuracy. Some POC glucose monitoring systems may report erroneously elevated glucose levels in patients treated with maltose, icodextrin, galactose, or xylose.[26] Hemolysis, icterus, and lipemia may result in inaccurate or incalculable results. Potassium measurements are susceptible to this error. Testing in conventional laboratories often includes a step to determine the serum index in addition to testing for a specific analyte.[14]

Collectively, these indices are often referred to as hemoglobin (H), icterus (I), and lipemia (L), or HIL indices.[27] These indices are typically obtained via spectrophotometric assessment. However, in POCT, hemolysis, icterus, and lipemia can only be detected by visual inspection of a centrifuged sample aliquot. High turbidity or an excess of an untested component in a sample, such as in whole blood samples with high concentrations of lipids, can also skew test results or lead to an error.[28]

Methods for addressing these errors vary depending on the device and the manufacturer's instructions. In some cases, dilution can resolve sample errors related to excess bilirubin, and ultracentrifugation can help fix errors related to excess lipids. Patients with reduced or compromised peripheral circulation, such as those with sepsis, shock, or diabetic ketoacidosis, may have inadequate capillary blood samples.[29]

Results, Reporting, and Critical Findings

Results

POCT results that indicate critical values are typically addressed promptly, often prompting changes in clinical management.[30] An example could be a reflexive beta-hCG performed after a positive urine pregnancy test in the emergency department. Because of their potential impact, it is essential to document both the result and any actions taken whenever a critical value is obtained.

Critical values differ from urgent or STAT tests in that they are defined solely by how far they deviate from the established normal range, regardless of the patient's condition. In contrast, STAT or urgent tests are designated by the ordering clinician and generally require prior knowledge of the patient's status.

Reporting Critical Findings

Critical values should be treated as reportable events, even if previous critical values are already known for a particular patient.[30] The critical value reporting policy should be consistently followed for each instance of obtaining a critical value. Deviation from this policy should only be considered in exceptional cases supported by sufficient evidence, such as obvious testing errors or pre-analytical errors, that justify the decision to ignore the critical value.

Clinical Significance

Due to its rapid turnaround time and integration into various workflows, POCT holds significant clinical value. The information gleaned from POCT is used routinely to guide patient treatment and management. POCT offers several advantages compared to conventional lab testing, with benefits that vary depending on the specific setting in which the testing is conducted.[21][31] 

POCT typically enhances patient satisfaction and experience by eliminating the need for sample transport, reducing turnaround time, and avoiding procedure delays. POCT enables patient counseling, prevents unnecessary treatment escalation, and provides rapid results outside the hospital setting, such as in outpatient testing, to avoid hospitalization or confirm viral illness, thereby reducing antibiotic use.

POCT offers advantages in different test types. For example, fingerstick blood glucose measurements can replace venipuncture for serum testing, requiring less training and posing lower risks of complications and infection, thereby improving patient experience and safety.[32] In specific patient populations, such as neonates or those prone to increased blood loss from phlebotomy, the smaller sample volume required for POCT is particularly advantageous.

POCT has some drawbacks, primarily related to the potential for less accurate results compared to traditional laboratory testing. This discrepancy often stems from inconsistent personnel training and control over pre-analytical, analytical, and post-analytical variables, which can be better managed in a laboratory setting. POCT is often more expensive per test than traditional laboratory testing, mainly because most devices are single-use, which increases overall costs.[33] Challenges in documenting POCT results and potential errors can arise from differences in staff practices and variations in workflow within a clinical setting.

Quality Control and Lab Safety

All facilities or sites in the United States that conduct diagnostic testing or medical treatment using human specimens are subject to regulation under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.[34] The CLIA designates tests that are simple to perform and have a low risk of producing incorrect results as waived tests. Most POCTs are waived; however, some are nonwaived and are subcategorized as moderately complex tests. Waived tests are excluded from competency assessment requirements, according to the Centers for Medicare and Medicaid, although various state and accrediting bodies may still maintain this requirement. Nonwaived tests are subject to specific quality standards, including proficiency testing, quality control, and personnel requirements.

Establishing robust quality control in laboratory testing necessitates the use of verified controls to confirm that POCT is performing as intended and producing reliable results.[35] Quality control material contains the analytes of known concentrations. The frequency of quality control testing should be determined based on the complexity and associated risks of the test. For high-throughput devices, quality control should be run at least once daily. New lots of reagents are tested with these controls before being used to run patient samples. Additionally, such controls allow for troubleshooting among different individual tests and operators. The internal quality control documentation, which includes the date and time of testing, lot number, and user identification, is essential for effective quality control.

Patient testing must be associated with the specific lot numbers for all products used for POCT, including the device, reagents, and sample collection materials. Many POCTs contain electronic records of such information, though historically, this information has been recorded in a logbook. Significant variables to ensure ongoing quality assurance include expiration dates for reagents, controls, and sample collection materials, proper storage and management of all materials involved in POCT, and proper establishment of acceptable ranges for test values.[35]

Because POCT is decentralized, effective personnel management at the individual level is essential. Ideally, all operators should be fully competent in the safe and accurate use of each POCT device. To ensure this, many larger institutions employ electronic training modules and regularly monitor individual competency, consistent with the standards required by accreditation bodies such as CLIA.

Accreditation bodies, including CLIA, require 6 main competency elements:

• Direct observation of test operation.
• Monitoring of both recording and reporting of test results.
• Review of intermediate steps of POCT (test results and quality control records).
• Direct observation of preventative maintenance and function check performance.
• Assessment of test performance using specimens previously analyzed.
• Assessment of personnel problem-solving skills.[36]

Lab Safety

Lab safety is a critical component of effective POCT for the patient, the sample collector, and the person who runs the POCT. A unique aspect of POCT is that the same person often carries out the collection and test execution. Because of this, care must be taken to prevent task overload and errors in collection, transport, and analysis. Contamination of a POCT can impact multiple patients and operators, especially if the POCT is frequently used. The proper use of personal protective equipment and corresponding protocols is crucial for protecting personnel and ensuring the accuracy of testing.[37]

The rules of universal precaution should be applied to POCT, and protective measures such as splash shields and biosafety cabinets should be employed based on manufacturer and government agency guidelines. Recommendations for competency elements in POCT vary depending on the type of test and the samples collected. For example, POC molecular testing for nasal swabs, such as in the case of COVID-19 testing, generally requires specific personal protective equipment to prevent exposure to airborne pathogens during testing.[38][39]

Lab safety also applies to adequately disposing of samples and waste after completing POCT.[40] All laws, regulations, and accreditation requirements for the disposal of medical waste must be followed. After sample collection via venipuncture, the needle must be covered. Fingerstick lancets must be single-use. All needles and lancets must be appropriately disposed of in a hazardous waste container designated for needles (a sharps container).

Proper disposal of POCT swabs depends on local and facility-specific waste management procedures. As a general guideline, swabs used in POCT procedures that involve sample removal—such as washing or swirling in fluid—may not require disposal in designated biohazard receptacles.[8] Swabs contaminated with biological material must be disposed of in a proper biohazard bag. Finally, when appropriate, the proper removal or covering of protected health information must be considered on all samples and sample containers. This requirement applies to both physical and electronic information.

Enhancing Healthcare Team Outcomes

POCT occurs in a wide range of clinical settings, including inpatient, outpatient, and nonclinical settings, such as homes, airports, and cruise ships. The COVID-19 pandemic significantly increased the use of POCT, with billions of tests rapidly developed and distributed worldwide to help control the spread of the virus and facilitate the timely identification of infected individuals.

Various healthcare professionals, including primary care clinicians, medical technologists, and trained personnel, perform POCT to obtain immediate results that inform and guide clinical patient management decisions. Due to the diverse range of healthcare professionals and workflows involved in POCT, providing adequate training, facilitating interprofessional communication, and establishing clear guidance to ensure accurate testing and effective relay of test results to the treatment team are crucial.

Interprofessional committees dedicated to implementing, executing, and continuously managing the quality of POCT have been recommended, as they play a crucial role in enhancing the quality of healthcare delivery within healthcare systems. These committees promote collaboration, standardization, and effective oversight of POCT practices, ultimately benefiting patient care.[41] Various randomized clinical trials using POCT demonstrate improved patient outcomes compared to conventional laboratory testing.[42][43][44]

A key advantage of POCT is its ability to integrate real-time results directly into the patient's electronic medical record. This immediate data availability enables the interprofessional team to access the most accurate and updated data, leading to a more comprehensive and functional clinical picture. As a result, healthcare professionals, such as pharmacists, can make more efficient and informed decisions regarding medication dosing, such as adjusting warfarin or aminoglycoside dosages.

POCT enables nurses to monitor patients' conditions more closely. With real-time access to test results through the electronic medical record, nurses can promptly detect any significant changes and alert the attending clinician or appropriate healthcare professionals for clinical intervention. Effective use of POCT relies on strong interprofessional coordination and collaboration among clinicians, pharmacists, and laboratory personnel, as this teamwork is essential for optimizing patient outcomes. By working together, the healthcare team can make informed decisions and provide timely, targeted care based on POCT results.

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Disclosure: Michael Larkins declares no relevant financial relationships with ineligible companies.

Disclosure: Muhammad Zubair declares no relevant financial relationships with ineligible companies.

Disclosure: Aparna Thombare declares no relevant financial relationships with ineligible companies.