Introduction
Point-of-care testing (POCT) represents a significant shift in clinical diagnostics, moving laboratory analyses closer to the patient. Instead of sending samples to a centralized lab, POCT, also known as near-patient testing, brings the testing directly to the location where patient care is being delivered. This proximity allows for rapid results, potentially leading to quicker clinical decisions and improved patient outcomes compared to traditional laboratory workflows.[1]
Traditional laboratory testing involves several steps: sample collection, transportation to a central lab (which can be geographically distant), and multiple processing stages.[2] This process can be time-consuming, delaying treatment and hindering timely medical decision-making. What Is Point Of Care Testing in this context? It’s the answer to these delays. POCT streamlines this process by utilizing portable, user-friendly devices that healthcare professionals can operate directly at the patient’s side. This drastically reduces the time required to obtain test results and initiate appropriate treatment.
The concept of testing blood samples at or near the patient emerged in England in the 1950s, initially termed “near-patient testing.”[3] The term “point-of-care testing” was later popularized in the early 1980s by Dr. Gerald J. Kost, who studied biosensor applications for monitoring ionized calcium levels in whole blood.[4] The definition of point-of-care testing was subsequently formalized as “testing at or near the site of patient care.”[2]
Advances in technology, particularly the miniaturization of electronics and enhanced instrumentation, have been instrumental in the evolution of POCT devices. These advancements have led to smaller, more precise, and increasingly sophisticated POCT tools.[5] Modern POCT innovations incorporate microneedles and microfluidics to enhance patient comfort, testing speed, and result accuracy.[6, 7]
Effective POCT devices are characterized by several key features:[8]
- Simplicity: They should be easy to operate for various healthcare personnel.
- Durability: Reagents and consumables must be stable during storage and use.
- Accuracy: POCT results must be consistent with established laboratory methods.
- Safety: Testing procedures should be safe for both the operator and the patient.
Several guidelines support the effective implementation of POCT. The World Health Organization (WHO) ASSURED criteria, particularly relevant for infectious disease POCT like sexually transmitted infections (STIs), emphasizes that tests should be Affordable, Sensitive, Specific, User-friendly, Rapid, Robust, Equipment-free, and Delivered to those who need them.[8] “Affordable” ensures accessibility for at-risk populations, and “equipment-free” highlights the simplicity and minimal infrastructure required.
The National Academy of Clinical Biochemistry (NACB) has also developed evidence-based guidelines for POCT, offering recommendations based on scientific evidence and clinical research to optimize POCT utilization.[9]
These guidelines generally underscore the rapid turnaround time and cost-effectiveness of POCT, alongside the critical need for high sensitivity and specificity to ensure reliable clinical decision-making.
Specimen Requirements and Procedure
The POCT process is typically divided into three distinct phases: pre-analytical, analytical, and post-analytical.
The pre-analytical phase encompasses all steps taken before the actual test is performed. This includes specimen collection, transport, preparation, and loading onto the POCT device. This phase is arguably the most critical as it introduces the most potential for errors. Following personnel regulations, correctly preparing the patient and specimen collection materials (including appropriate fixatives or media), and strictly adhering to patient and specimen identification protocols are paramount for accurate results. Proper clinical documentation and specimen storage conditions are also crucial to maintain sample integrity and ensure the reliability and safety of the entire testing process.
The analytical phase is the testing sequence itself – when the POCT device analyzes the sample.
The post-analytical phase begins once the test is complete and a result is available. This phase involves communicating the test results for clinical action. This communication may occur through electronic medical records (EMR), written reports, or verbal instructions directly to the care team. The post-analytical phase is also when “critical values” are identified and managed. Critical values are results that fall significantly outside the normal reference range and may indicate a life-threatening condition. Interpretation of these results during this phase guides subsequent clinical actions and interventions.
Following the manufacturer’s instructions for use (MIFU) or the package insert is absolutely essential for accurate POCT results. This is especially important for sample preparation steps, such as centrifugation time, which can vary depending on the manufacturer and the type of sample. Healthcare professionals using POCT must carefully adhere to the specific instructions for each device. Some POCT methods are preferred because they can use whole blood, eliminating the need for centrifugation or other pre-processing steps. Furthermore, it is crucial to verify that sample collection containers are within their expiration date to maintain the quality and reliability of the testing process.
Compared to conventional laboratory tests, POCT methods are often more susceptible to interferences and may have a narrower margin of error due to the smaller sample volumes used.
Proper technique is vital when collecting samples, especially when drawing from a central line.[10] This involves flushing the line with heparin and discarding a sufficient volume (at least twice the line volume, typically 2-5 mL) before collecting the sample. It’s also recommended to wait at least 15 minutes after a blood transfusion before drawing a sample for POCT.
Samples intended for blood gas analysis are particularly sensitive to changes in oxygen partial pressure. Therefore, maintaining anaerobic conditions during collection is critical for obtaining accurate blood gas values.[11] This includes removing all air bubbles from the sample, using a plastic syringe for collection, and carefully controlling the time and temperature of sample storage (if storage is necessary) prior to analysis.
Diagnostic Tests
POCT devices are broadly categorized based on their testing modality and test size.[8] Test size in POCT varies considerably, and ongoing research focuses on further miniaturization. Handheld POCT devices, such as dipsticks and meters like glucometers, represent the smaller end of the spectrum.
More advanced handheld devices utilize cartridges that can perform multiple tests simultaneously, including comprehensive whole blood analysis for cardiac markers, blood gases, and various hematologic and endocrine analytes. At the larger end, benchtop POCT units, while still considered point-of-care due to their bedside or near-patient placement, require more dedicated space.
Many benchtop POCT units are multi-functional, capable of performing a wide array of diagnostic tests within a single device. Common tests performed on benchtop POCT units include hemoglobin A1c, C-reactive protein (CRP), and general chemistry panels. The demand for smaller, more precise benchtop POCT devices has been a significant driver for innovation in instrument miniaturization. Technological and engineering advancements have led to the development of compact yet highly accurate benchtop POCT units.
Testing Strips and Lateral-flow Testing
POCT encompasses diverse testing methods tailored to specific applications. The simplest POCT methods leverage the interaction between an analyte and a reactive substance, often impregnated or contained within a testing strip.[12] Urine test strips are a prime example. These strips consist of dried, porous matrices with embedded reagent elements that react with target analytes when exposed to a sample. This reaction typically involves a chemical change that produces a visible color change. This color change can provide a binary result (analyte present or absent) or a semi-quantitative indication of analyte concentration using a color scale (e.g., for urine protein: trace, 1+, 2+, 3+).
Lateral-flow testing represents a more complex POCT approach. This technique utilizes a supporting material, such as porous paper, cellulose fiber filters, or woven meshes, containing capillary beds. These capillary beds wick fluid samples to specific locations on the material where they encounter substances that react with the target analytes. A familiar example is the at-home pregnancy test, which commonly uses an immunoassay to detect human chorionic gonadotropin (hCG, specifically beta-hCG) in urine.
Urine is applied to one end of the lateral-flow test device. Capillary action draws the urine through the supporting material to reaction zones containing reagents that react with beta-hCG. These tests typically have two reactive lines: a control line and a test line. A positive result (pregnancy) is indicated by the appearance of both lines, while a negative result shows only the control line. Failure of the control line to appear indicates an invalid test, possibly due to manufacturing defects, damage, or expiration.
POCT methods using simple test strips or lateral-flow assays often provide qualitative or semi-quantitative results, lacking precise concentration measurements of the target analyte.
Immunoassays
POCT immunoassays rely on antibodies to detect specific targets when their concentration exceeds a certain threshold.[12] These targets can include a wide range of substances, such as proteins, drugs, and pathogens. POCT immunoassays are available in various formats, from individual tests to platforms that integrate multiple tests. Generally, multi-test platforms require more space, expertise, and training, especially as the number of tests offered increases.
The choice between a testing platform and individual tests (or a combination of individual tests) depends on workflow and throughput needs. Higher sample volumes may be more efficiently handled using a POCT testing platform. However, the suitability of a particular platform depends on the specific tests required and the platform’s capabilities.
Direct immunoassays are a straightforward type of immunoassay for analyte detection. In a direct assay, the target analyte is directly bound by a specific antibody. This binding event is then detected, typically using fluorescence and an optical sensor. The fluorescence signal is proportional to the presence and quantity of the analyte in the sample.
When a direct assay is not feasible, competitive immunoassays can be used. These assays utilize competitive binding between the target analyte and a measurable, secondary analyte. As antibodies bind more of the primary analyte, the binding of the measurable secondary analyte decreases due to competition. This inverse relationship allows for the quantification of the primary analyte’s concentration. Unlike simple test strip POCT, immunoassay-based POCT can provide quantitative results for specific analytes.[13, 14]
Antigen-based Testing
POCT for detecting known antigens or antibodies specific to a particular disease is a common practice in healthcare.[15] Immunoassay-based POCT is frequently used for rapid detection of group A Streptococcus, mononucleosis, and influenza A and B. These tests utilize immunoassays that bind to specific antigens or antibodies. While offering fast turnaround times (TAT), antigen-based POCT may have lower sensitivity and specificity compared to traditional laboratory and molecular testing methods.
Molecular POCT
The need for molecular POCT with high sensitivity and specificity, combined with a relatively short turnaround time (though longer than antigen-based tests), has driven its development.[15] Molecular POCT detects DNA or RNA sequences indicative of disease presence. Nucleic acid amplification testing (NAAT) is employed to identify DNA or RNA in small samples. The target nucleic acids are replicated (amplified) to increase their concentration, making them easier to detect.[16]
Various NAAT methods exist, including reverse transcription polymerase chain reaction (RT-PCR) and isothermal amplification methods like nicking endonuclease amplification reaction (NEAR) and transcription-mediated amplification (TMA).
While molecular POCT often offers higher sensitivity and specificity than antigen-based POCT, this is not always the case. Furthermore, the enhanced sensitivity and specificity of molecular POCT may not always translate to improved clinical outcomes, as analyte detection doesn’t always equate to active disease or the need for treatment. For instance, detecting a small amount of Clostridium difficile in stool doesn’t necessarily indicate the need to treat C. difficile infection.[17]
Testing Procedures
POCT testing procedures vary based on the specific manufacturer, test type, and sample type. For most POCT units, proper setup and calibration before use are essential for accurate results. Strict adherence to the manufacturer’s instructions for use (MIFU) or package insert for each POCT device is crucial for achieving reliable testing.
General POCT Testing Procedures
- Sample Acquisition: A sample is obtained for analysis. This may be a blood drop for glucose measurement using a glucometer or urine for beta-hCG detection. Specific requirements regarding patient preparation, specimen type, and handling for accurate testing exist and are detailed in sections on “Specimen Requirements and Procedures” and “Quality Control and Lab Safety.”[18]
- Sample Application: The sample is applied to the POCT device. Immediately prior to this, a reagent may be required to facilitate accurate testing. For example, some COVID-19 POCT kits require nasopharyngeal or oropharyngeal swabs to be placed in a reagent solution to release and stabilize the antigen.[19] This ensures antigen distribution throughout the solution, improving test accuracy. In other POCT types, the sample can be applied directly to a disposable cartridge within the device. After use, the cartridge is discarded, minimizing the risk of cross-contamination.
- Result Acquisition and Reporting: Once the test is performed, the result is generated and can be directly transferred to the patient’s electronic medical record (EMR) if the POCT device is integrated with the EMR system.
Interfering Factors
The portable nature of POCT means that reagents, tests, and samples are often exposed to environmental conditions that differ from controlled laboratory settings. Fluctuations in humidity, temperature, time to testing, and oxygen content are more likely in POCT environments than in traditional labs. Most factors that interfere with POCT occur during the pre-analytical phase.[20]
Pre-analytical errors can arise from patient misidentification, specimen misidentification, and errors during collection, handling, processing, transport, or storage. These errors can include hemolysis, clotting, underfilling or overfilling specimen containers, inadequate container closure, prolonged tourniquet application, and alterations in sample concentration (e.g., during aliquoting).
Detecting hemolysis in POCT using whole blood samples (including fingerstick tests) can be particularly challenging.[21] Errors during sample transfer and loading, such as air bubbles, microclots, and gross clotting, can also occur, especially if procedures are not strictly followed or lack oversight. Increased time to testing can also interfere with POCT results, as seen with blood glucose testing in whole blood. Adequate training is critical in mitigating pre-analytical errors, as operator experience is inversely correlated with their occurrence.
Patient-specific factors can also interfere with POCT results. For example, high biotin intake (from vitamin supplements) can interfere with certain immunoassays, including HIV POCT.[22] This interference arises from the interaction between biotin and streptavidin used in the assay. Affected assays include, but are not limited to, POCT for pancreatic, prostate, and ovarian cancer, as well as pituitary and thyroid function tests. Consulting the MIFU or package insert is crucial, as certain medications can also interfere with POCT accuracy. Some point-of-care glucose monitoring systems may report falsely elevated glucose levels in patients treated with maltose, icodextrin, galactose, or xylose.[23]
Hemolysis, icterus (jaundice), and lipemia (excess lipids) in the sample can lead to inaccurate or unreportable results, particularly for potassium measurements. Traditional laboratories often include a serum index assessment alongside analyte testing to detect these interferences.[11] These indices, collectively known as HIL indices (hemoglobin, lipemia, icterus), are typically determined spectrophotometrically.[24] However, in POCT, hemolysis, icterus, and lipemia are usually only detectable through visual inspection of a centrifuged aliquot of the sample. High turbidity or an excess of untested components in the sample, such as high lipid concentrations in whole blood, can also skew results or cause errors.[25]
Solutions for these errors vary depending on the device and MIFU. In some cases, dilution can resolve errors due to excess bilirubin, and ultracentrifugation can help with errors related to excess lipids. Patients with compromised peripheral circulation, such as those with sepsis, shock, or diabetic ketoacidosis, may have inadequate capillary blood samples for POCT.[26]
Results, Reporting, and Critical Findings
Results
POCT results that fall into the critical value range require prompt action and can lead to immediate changes in patient management.[27] For example, a positive urine pregnancy test in the emergency department might be followed by a reflexive serum beta-hCG test. It is essential to document both the critical value result and any actions taken in response.
Critical values are distinct from urgent or STAT tests. Critical values are defined by their significant deviation from established normal ranges, regardless of the patient’s immediate condition. STAT or urgent tests are designated as such by the ordering clinician, typically based on their knowledge of the patient’s status.
Reporting Critical Findings
Critical values should always be treated as reportable events, even if previous critical values are known for the same patient.[27] The established critical value reporting policy should be consistently followed for every instance. Deviations from this policy should only be considered in exceptional circumstances, supported by substantial evidence, such as obvious testing or pre-analytical errors that clearly invalidate the result.
Clinical Significance
POCT’s rapid turnaround time and versatility across various healthcare settings give it significant clinical value. POCT results are routinely used to guide patient treatment and management decisions. Compared to conventional lab testing, POCT offers several advantages, although these benefits can vary depending on the specific clinical context.[18, 28]
POCT, performed near the patient, generally enhances patient satisfaction and experience. It eliminates sample transport, reduces turnaround time (TAT), and avoids delays in procedures. POCT enables immediate patient counseling, prevents unnecessary treatment escalation, and provides rapid results outside of hospital settings (e.g., in outpatient clinics) to avoid hospitalizations or to confirm viral illnesses and reduce antibiotic use.
POCT offers specific benefits depending on the test type. For example, fingerstick blood glucose measurements can replace venipuncture for serum glucose testing, requiring less training and posing lower risks of complications and infections, thus improving patient experience and safety.[29] In specific patient populations, such as neonates or patients prone to blood loss from phlebotomy, the smaller sample volumes required for POCT are particularly advantageous.
However, POCT also has limitations. A primary concern is the potential for less accurate results compared to traditional laboratory testing. This can be attributed to variability in personnel training and control over pre-analytical, analytical, and post-analytical variables, which are more tightly managed in a central laboratory. POCT can also be more expensive per test than traditional lab testing, primarily because most POCT devices are single-use, increasing overall costs.[30] Documentation challenges and potential errors in recording or documenting POCT results can arise due to varying personnel practices and workflows in clinical settings.
Quality Control and Lab Safety
All facilities in the US that perform diagnostic testing or medical treatment using human specimens are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88).[31] CLIA categorizes tests based on complexity and risk. Tests deemed simple to perform with a low risk of incorrect results are classified as “waived tests.” Most POCTs are waived tests; however, some are non-waived and classified as moderately complex. While waived tests are exempt from competency assessment requirements by the Centers for Medicare & Medicaid (CMS), state and accrediting bodies may still maintain these requirements. Non-waived tests are subject to specific quality standards, including proficiency testing, quality control (QC), and personnel requirements.
Effective quality control in laboratory testing relies on verified controls to ensure POCT devices are functioning as expected and producing accurate results.[32] QC materials contain known concentrations of the analytes being tested. The frequency of QC testing should be determined based on the test’s complexity and associated risks. For high-throughput devices, QC should be performed at least daily. New reagent lots are tested with controls before being used for patient samples. Controls also aid in troubleshooting issues with individual tests or operators. Internal QC documentation, including test date and time, lot number, and user identification, is essential for effective QC.
Patient testing must be linked to the specific lot numbers of all materials used, including the device, reagents, and sample collection materials. Many POCT devices electronically record this information, although historically, it was documented in logbooks. Critical variables for ongoing quality assurance include expiration dates for reagents, controls, and collection materials, proper storage and handling of all POCT materials, and establishing acceptable ranges for test values.[32]
Given the decentralized nature of POCT, effective personnel management at the individual level is crucial. Ideally, every person performing POCT should be competent in the safe and accurate operation of each device. Many larger institutions use electronic training modules and routinely track individual competency for POCT, aligning with accreditation body requirements such as CLIA. Accreditation bodies, including CLIA, mandate six core competency elements: 1) direct observation of test performance, 2) monitoring of result recording and reporting, 3) review of intermediate steps (test results, QC records), 4) direct observation of preventative maintenance and function checks, 5) assessment of test performance using previously analyzed specimens, and 6) evaluation of personnel problem-solving skills.[33]
Lab Safety
Lab safety is a paramount aspect of effective POCT, protecting patients, sample collectors, and POCT operators. A unique aspect of POCT is that the same individual often handles both sample collection and test execution. This necessitates careful attention to prevent task overload and errors in collection, transport, and analysis. Contamination of POCT devices can impact multiple patients and operators, particularly for frequently used devices. Proper use of personal protective equipment (PPE) and adherence to safety protocols are critical for personnel protection and test accuracy.[34]
Universal precautions should be applied to all POCT procedures. Protective measures such as splash shields and biosafety cabinets should be used according to manufacturer and regulatory guidelines. Competency requirements for POCT vary depending on the test type and samples collected. For example, POC molecular testing using nasal swabs, such as COVID-19 testing, generally requires specific PPE to prevent exposure to airborne pathogens during testing.[35, 36]
Lab safety also extends to proper disposal of samples and waste after POCT completion.[37] All medical waste disposal laws, regulations, and accreditation requirements must be followed. After venipuncture, needles must be recapped (if required by local policy and deemed safe); fingerstick lancets must be single-use. All needles and lancets must be disposed of in designated sharps containers.
Proper disposal of POCT swabs depends on local and facility waste disposal procedures. However, a general guideline is that swabs used for POCT where the sample is removed from the swab (e.g., swabs washed or swirled in fluid) may not require biohazard disposal.[7] Swabs contaminated with biological material must be disposed of in biohazard bags. Finally, when applicable, protected health information (PHI) must be appropriately removed or obscured on all samples and sample containers, both physical and electronic.
Enhancing Healthcare Team Outcomes
POCT is utilized in diverse clinical settings, from inpatient and outpatient facilities to non-clinical environments like homes, airports, and cruise ships. The COVID-19 pandemic dramatically expanded POCT use, with billions of tests rapidly developed and distributed globally to control virus spread and facilitate prompt identification of infected individuals.
A wide range of healthcare professionals, including physicians, nurses, medical technologists, and trained support staff, perform point-of-care testing to obtain rapid results that inform and guide immediate patient management decisions. Given the diverse personnel and workflows involved in POCT, adequate training, effective interprofessional communication, and clear guidelines are crucial to ensure accurate testing and efficient relay of results to the treatment team.
Interprofessional committees dedicated to POCT implementation, management, and continuous quality improvement are highly recommended. These committees are vital for enhancing healthcare quality across health systems by promoting collaboration, standardization, and effective oversight of POCT practices, ultimately improving patient care.[38] [Level 1 evidence] Numerous randomized clinical trials have demonstrated improved patient outcomes with POCT compared to conventional laboratory testing.[39, 40, 41] [Level 1 evidence]
A key advantage of POCT is its ability to directly update patient electronic medical records (EMRs) with real-time test results. This provides the interprofessional team with the most current and accurate data, leading to a more comprehensive clinical picture. Pharmacists, for example, can make more informed and efficient decisions regarding medication dosing, such as adjusting warfarin or aminoglycoside dosages based on the patient’s current POCT results.
POCT also facilitates closer patient monitoring by nurses. Real-time access to test results via the EMR allows nurses to promptly identify significant changes in a patient’s condition and alert physicians or other appropriate healthcare professionals for timely intervention. Effective interprofessional coordination and collaboration among physicians, advanced practice providers, specialists, pharmacists, lab technicians, and nurses are essential for maximizing the benefits of POCT and ultimately improving patient outcomes. By working collaboratively, the healthcare team can make well-informed decisions and provide timely, targeted care based on POCT findings.[Level 5 evidence]
Review Questions
(Note: Review questions are present in the original article but are excluded as per instructions.)
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