Point-of-care testing (POCT) represents a significant shift in clinical diagnostics, moving laboratory analyses closer to the patient. This approach, defined as clinical laboratory testing conducted at or near the site of patient care, offers rapid results that can immediately influence treatment decisions. This immediacy is crucial, potentially leading to improved patient outcomes and more efficient healthcare resource utilization compared to traditional laboratory testing. The evolution of technology, particularly in miniaturization and instrumentation, has been instrumental in advancing POCT, creating smaller, more precise, and user-friendly devices. POCT is now performed by a diverse group of healthcare providers and, in certain situations, by patients themselves. This article will delve into the methodology, advantages, applications, and potential challenges of POCT, emphasizing the vital role of a collaborative healthcare team in effectively utilizing POCT for enhanced patient care.
Objectives:
- Recognize suitable scenarios for point-of-care testing based on patient symptoms and clinical context.
- Implement robust quality control procedures, including routine maintenance and calibration of POCT equipment, to guarantee the accuracy and reliability of test results.
- Execute POCT procedures in strict adherence to established protocols, encompassing proper methods for collecting, handling, and storing specimens.
- Foster collaboration with other healthcare professionals in interpreting POCT results and integrating them into comprehensive patient management strategies.
Introduction to Point-of-Care Testing
What Is Point Of Care testing? In essence, it’s bringing the clinical laboratory directly to the patient’s location. Point-of-Care Testing (POCT) is formally defined as diagnostic testing performed outside of a central laboratory, directly at or near the point of patient care.[1] The primary driver for POCT is the need for rapid results. By providing quick turnaround times for test results, POCT enables clinicians to make prompt treatment decisions, potentially improving both clinical and economic outcomes compared to the delays associated with conventional laboratory testing.[2]
Traditional laboratory testing follows a multi-stage process. It begins with sample collection at the patient’s bedside or in the clinic, followed by transportation to a centralized laboratory, often located off-site. Once at the lab, samples undergo various processing steps before analysis.[3] This time-consuming process can significantly delay treatment initiation and impede timely clinical decision-making. POCT overcomes these hurdles by decentralizing testing. Portable, handheld devices empower healthcare professionals to perform rapid analyses on patient samples right where they are, dramatically shortening the time required for medical decisions.
The concept of on-site blood analysis emerged in England in the 1950s, initially termed “near-patient testing.”[4] The term “point-of-care testing” was coined in the early 1980s by Dr. Gerald J. Kost, following his extensive research on biosensor applications for monitoring ionized calcium levels in whole blood.[5] Subsequently, “point-of-care testing” became the standardized term, defined as “testing at or near the site of patient care.”[3]
Advances in technology have been crucial to the evolution of POCT. Miniaturization of electronics and improvements in instrumentation have led to the development of increasingly compact and accurate POCT devices.[6] Cutting-edge POCT technologies are now integrating microneedles and microfluidics to enhance patient comfort, testing speed, and result accuracy.[7, 8]
Key characteristics of effective POCT devices include:[9]
- Ease of Use: POCT systems should be simple to operate, even for users with limited laboratory training.
- Robust Reagents: Reagents and consumables must be stable and durable under various storage and usage conditions.
- Result Concordance: POCT results should be consistent with those obtained from standard laboratory methods.
- Safety Assurance: POCT devices must incorporate safety features to protect both users and patients during testing.
Several guidelines exist to standardize and ensure the quality of POCT. The World Health Organization (WHO) ASSURED criteria are particularly relevant for infectious disease POCT, especially for sexually transmitted infections (STIs).[9] The ASSURED acronym highlights crucial features: Affordable, Sensitive, Specific, User-friendly, Rapid, Robust, Equipment-free, and Delivered. These criteria emphasize accessibility and practicality, particularly in resource-limited settings. “Affordable” ensures tests are accessible to at-risk populations, and “equipment-free” highlights the need for simple devices without complex infrastructure.
The National Academy of Clinical Biochemistry (NACB) has also developed evidence-based guidelines for POCT, providing recommendations based on scientific research and clinical evidence to optimize POCT utilization.[10] These guidelines underscore the importance of rapid results and cost-effectiveness, alongside the necessity for high sensitivity and specificity to support informed clinical decision-making.
Specimen Requirements and Procedures in POCT
The POCT process is generally divided into three distinct phases: pre-analytical, analytical, and post-analytical. The pre-analytical phase encompasses all steps that occur before the actual test is performed on the sample. This includes specimen collection, transport, preparation, and loading onto the POCT device. The pre-analytical phase is critical as it is the most significant source of controllable variability in POCT. Adherence to personnel training guidelines, proper patient and specimen preparation (including appropriate collection containers and any necessary additives), and strict compliance with patient and specimen identification protocols are essential for accurate and reliable results. Furthermore, thorough clinical documentation and appropriate specimen storage are vital to maintain the integrity, accuracy, and safety of the entire testing process.
The analytical phase is the stage where the POCT device performs the actual testing sequence to generate a result.
The post-analytical phase begins once the test is complete and a result is available. This phase involves communicating the test result for clinical action, typically through electronic medical records (EMR) or direct communication (written or verbal) to the healthcare team. The post-analytical phase is also when critical values are identified and acted upon. Critical values are results that deviate significantly from normal ranges and may indicate a life-threatening condition. Interpretation of test values during this phase is crucial for guiding appropriate clinical interventions.
Given that POCT is performed directly on the collected specimen, proper specimen collection and handling are paramount.[11] It is crucial to strictly follow the manufacturer’s instructions for use (MIFU) or package insert for each POCT device to ensure accurate testing. This is particularly important for sample preparation steps, such as centrifugation time if required, which can vary between manufacturers and sample types. While some POCT methods are designed for whole blood analysis, eliminating the need for centrifugation, others may require specific preparation. Furthermore, it’s essential to verify that sample collection containers are within their expiration dates to maintain the quality and reliability of the testing process.
Compared to conventional laboratory tests, POCT methods often use smaller sample sizes, making them more susceptible to interfering substances and having a narrower margin for error. Proper technique is essential during sample collection, especially when drawing samples from central lines.[12] This involves flushing the line with heparin and discarding a sufficient volume (typically 2 to 5 mL, at least twice the line volume) before collecting the sample to avoid contamination. It is also generally recommended to wait at least 15 minutes after a blood transfusion before drawing a sample for POCT to ensure accurate results.
Samples collected for blood gas analysis are particularly sensitive to changes in oxygen partial pressure. Therefore, maintaining anaerobic conditions during sample collection is critical for obtaining accurate blood gas values.[13] This includes carefully removing air bubbles from the sample, using plastic syringes for collection, and controlling the time and temperature of sample storage before analysis if storage is necessary.
Diagnostic Tests in Point-of-Care Testing
POCT devices can be categorized based on their testing modality and test size.[9] The scale of POCT devices varies widely, with ongoing research focused 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 capable of performing multiple tests, including comprehensive whole blood analysis for cardiac markers, blood gases, and various hematologic and endocrine analytes. On the larger end, benchtop POCT units, while still intended for near-patient use, require dedicated space and can offer a broader range of testing capabilities.
Many benchtop POCT units are multi-functional, supporting diverse diagnostic tests on a single platform. Common examples include tests for hemoglobin A1c (HbA1c), C-reactive protein (CRP), and general chemistry analytes. The demand for smaller, more precise benchtop POCT devices has been a major driver for innovation in instrument miniaturization. Advances in technology have enabled the development of compact yet highly accurate benchtop POCT units.
Testing Strips and Lateral-Flow Assays
POCT encompasses a broad spectrum of testing modalities tailored to different clinical needs. The simplest POCT methods rely on the interaction between an analyte and a reagent substance, often impregnated or contained within a testing strip. Urine test strips are a prime example. These strips are typically composed of dried, porous matrices containing reagent-impregnated pads that react with specific analytes in the sample. The reaction often results in a color change, which can be interpreted qualitatively (presence or absence of the analyte) or semi-quantitatively using a visual scale (e.g., trace, 1+, 2+, 3+ for protein).
Lateral-flow assays represent a more complex POCT approach. These assays utilize a supporting material, such as porous paper or cellulose fiber, containing capillary beds that facilitate fluid sample transport to reaction zones. These zones contain reagents that react with target analytes. A common example is the home pregnancy test, which typically uses an immunoassay to detect human chorionic gonadotropin (hCG) in urine. Urine is applied to the sample application area of the device, and capillary action draws the urine through the supporting material to reaction lines. These tests typically include 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 invalidates the test, suggesting a manufacturing defect, damage, or expired test kit. Many POCTs using simple test strips or lateral-flow assays provide qualitative or semi-quantitative results and may not offer precise analyte concentration measurements.
Immunoassays in POCT
POCT immunoassays utilize antibodies to detect specific target analytes when their concentration exceeds a certain threshold.[14] The targets in POCT immunoassays can be diverse, including proteins, drugs, and pathogens. POCT immunoassays are available as individual tests or as multi-test platforms. Generally, multi-test platforms require more space, specialized training, and expertise to operate, which scales with the number of tests offered. The choice between a testing platform and individual tests depends on workflow and testing volume. Higher sample volumes may be more efficiently processed using a POCT testing platform. However, the suitability of a particular platform is determined by the specific tests required and the platform’s capabilities.
Direct immunoassays offer a straightforward approach for analyte detection. In a direct immunoassay, the target analyte is directly bound by a specific antibody. This binding event is then detected, often using fluorescence, by an optical sensor. The fluorescence signal intensity is proportional to the amount of analyte present in the sample, providing quantitative results.
Competitive immunoassays are used when direct assays are not feasible. These assays rely on competitive binding between the target analyte and a measurable, secondary analyte for a limited number of antibody binding sites. As more target analyte is present, more of it binds to the antibodies, reducing the binding of the measurable secondary analyte. This competitive binding mechanism allows for the quantification of the target analyte. Unlike simple test strip POCT, immunoassay-based POCT often provides quantitative information for specific analytes.[15, 16]
Antigen-Based Point-of-Care Testing
Antigen-based POCT is widely used for rapid detection of specific diseases or disease states by identifying known antigens or antibodies.[17] Immunoassay-based POCT is commonly employed for the rapid detection of group A Streptococcus, mononucleosis, and influenza A and B. These tests utilize immunoassays that bind to specific antigens or antibodies associated with these conditions. While antigen-based POCT offers rapid turnaround times, they may have lower sensitivity and specificity compared to traditional laboratory and molecular testing methods.
Molecular Point-of-Care Testing
The demand for POCT with high sensitivity and specificity, coupled with relatively rapid turnaround times (though generally longer than antigen-based tests), has driven the development of molecular POCT.[17] Molecular POCT detects DNA or RNA sequences indicative of the presence of disease. Nucleic acid amplification testing (NAAT) is a core technology in molecular POCT. NAAT methods amplify specific DNA or RNA sequences from small samples, increasing their concentration to detectable levels.[18] Various NAAT techniques are used in POCT, 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 achieves higher sensitivity and specificity compared to antigen-based POCT, this is not universally true. Furthermore, the enhanced sensitivity and specificity of molecular POCT may not always translate to improved clinical outcomes, as the mere detection of an analyte does not always indicate active disease or the necessity for treatment. For example, detecting small amounts of Clostridium difficile in stool does not automatically warrant treatment for C. difficile infection.[19]
Testing Procedures for Point-of-Care Testing
POCT testing procedures are device-specific and vary depending on the manufacturer, the type of test, and the sample being analyzed. To ensure accurate results with most POCT units, proper setup and calibration of the specific test before use are essential. Strict adherence to the manufacturer’s instructions for use (MIFU) or the package insert for each POCT device is crucial for achieving accurate and reliable testing outcomes.
General POCT Testing Procedures typically involve these steps:
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Sample Acquisition: A sample is obtained for analysis. This might be a drop of blood for glucose measurement using a glucometer or a urine sample for a pregnancy test. Specific requirements regarding patient preparation, specimen type, and pre-test preparations are detailed in the “Specimen Requirements and Procedures” and “Quality Control and Lab Safety” sections.[20]
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Sample Application: The sample is applied to the POCT device. In some cases, a reagent may be required to facilitate accurate testing. For instance, some COVID-19 POCT kits require nasal or throat swab samples to be placed in a reagent solution to release and stabilize the antigen.[21] This ensures even distribution of the antigen in the solution, enhancing test accuracy. In other POCT systems, the sample can be applied directly to a disposable cartridge that contains the reagents and performs the analysis. These disposable cartridges are designed for single use, minimizing the risk of cross-contamination.
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Result Acquisition and Reporting: Once the test is performed, the result is displayed on the POCT device. If the POCT device is integrated with the facility’s electronic medical record (EMR) system, results can be directly and automatically transferred to the patient’s record, streamlining reporting and data management.
Interfering Factors in Point-of-Care Testing
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 levels can be more pronounced in POCT environments compared to central laboratories. A significant proportion of interfering factors in POCT occur in the pre-analytical phase, before the actual test is performed.[22]
Pre-analytical errors can arise from various sources, including patient misidentification, specimen misidentification, incorrect collection procedures, improper handling, processing delays, transport issues, and inappropriate storage. Specific examples of pre-analytical errors include hemolysis (rupture of red blood cells), clotting, underfilling or overfilling specimen containers, inadequate sealing of containers during transport, prolonged tourniquet application during blood collection, and changes in sample concentration due to improper aliquoting.
Detecting hemolysis in POCT, especially in whole blood samples obtained via fingerstick, can be challenging.[23] Errors during sample transfer and loading onto the POCT device, such as air bubbles, microclots, or gross clotting, can also occur if procedures are not followed precisely or if there is inadequate oversight. Extended time between sample collection and testing can also interfere with POCT results, as observed in blood glucose testing of whole blood. Adequate training is a critical factor in minimizing pre-analytical errors, as operator experience is inversely correlated with the incidence of these errors.
Patient-related factors can also interfere with POCT results. For example, high biotin intake from vitamin supplements can interfere with certain immunoassays, including some HIV POCT assays.[24] This interference arises from the interaction between biotin and streptavidin, a common component in many immunoassays. Assays affected by biotin interference include, but are not limited to, POCT for pancreatic, prostate, and ovarian cancer, as well as pituitary and thyroid function tests. It is crucial to consult the MIFU or package insert for each POCT, as certain medications or supplements can interfere with the test and compromise accuracy. Some POCT glucose monitoring systems may report falsely elevated glucose levels in patients treated with maltose, icodextrin, galactose, or xylose.[25]
Interferences from hemolysis, icterus (jaundice), and lipemia (excess lipids in the blood) can lead to inaccurate or uninterpretable POCT results. Potassium measurements are particularly susceptible to these interferences. Conventional laboratories often include serum indices to assess hemolysis, lipemia, and icterus in addition to analyte-specific testing.[13] These indices are commonly referred to as hemoglobin (H), lipemia (L), and icterus (I) indices, or collectively as HIL indices.[26] They are typically determined spectrophotometrically. In POCT, however, hemolysis, icterus, and lipemia are usually only detectable through visual inspection of a centrifuged aliquot of the sample, if centrifugation is even possible. High turbidity or an excess of untested components in the sample, such as high lipid concentrations in whole blood, can also skew test results or lead to errors.[27]
Strategies to mitigate these interferences vary depending on the POCT device and the MIFU. In some cases, dilution may resolve errors related to excess bilirubin, and ultracentrifugation may help with lipemia-related errors. Patients with compromised peripheral circulation, such as those in sepsis, shock, or diabetic ketoacidosis, may have inadequate capillary blood flow, making fingerstick sampling challenging and potentially affecting result accuracy.[28]
Results, Reporting, and Critical Findings in POCT
Results Interpretation and Action
POCT results that fall into critical value ranges typically require immediate clinical action, potentially leading to rapid changes in patient management.[29] A common example is a reflex beta-hCG test performed after a positive urine pregnancy test in the emergency department. Whenever a critical value is obtained from POCT, it is essential to document the result and the clinical actions taken in response.
Critical values are defined as test results that significantly deviate from established normal ranges, regardless of the patient’s overall condition. This is distinct from STAT (urgent) tests, which are designated as such by the ordering clinician based on their knowledge of the patient’s clinical status. Critical values trigger an alert for potentially life-threatening conditions and demand immediate attention.
Reporting Critical Findings
Critical values obtained from POCT should always be treated as reportable events, even if previous critical values are already documented for the same patient.[29] A consistent critical value reporting policy should be strictly adhered to for every instance of a critical result. Deviation from this policy should only be considered in exceptional circumstances, such as clear evidence of testing errors or pre-analytical errors that convincingly invalidate the critical value. Any such deviation should be thoroughly justified and documented.
Clinical Significance of Point-of-Care Testing
The clinical significance of POCT is substantial due to its rapid turnaround time and versatility in various healthcare settings. POCT results are routinely used to guide immediate patient treatment and management decisions. Compared to conventional laboratory testing, POCT offers several advantages, with benefits varying depending on the specific clinical context.[20, 30]
POCT, performed close to the patient, generally improves patient satisfaction and experience by eliminating sample transport, reducing result turnaround time (TAT), and avoiding delays in procedures. POCT facilitates timely patient counseling, prevents unnecessary treatment escalation, and provides rapid results in outpatient settings, potentially avoiding hospitalizations or confirming viral illnesses to reduce antibiotic overuse.
POCT offers specific advantages depending on the test type. For instance, fingerstick blood glucose measurements can replace venipuncture for serum glucose testing, requiring less training, posing lower risks of complications and infection, and enhancing patient comfort and safety.[31] In vulnerable patient populations like neonates or individuals prone to blood loss from phlebotomy, the smaller sample volumes required for POCT are particularly beneficial.
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 variations in personnel training and less stringent control over pre-analytical, analytical, and post-analytical variables, which are more tightly managed in a centralized laboratory setting. POCT can also be more expensive on a per-test basis, primarily due to the single-use nature of most POCT devices, contributing to higher overall costs.[32] Documentation challenges and potential errors in recording or documenting POCT results can arise due to diverse personnel practices and workflows within clinical environments.
Quality Control and Lab Safety in Point-of-Care Testing
In the United States, all facilities performing diagnostic testing or medical treatment using human specimens are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88).[33] CLIA classifies tests as “waived” if they are simple to perform and have a low risk of producing incorrect results. The majority of point-of-care tests are CLIA-waived; however, some POCTs are categorized as non-waived, specifically as moderately complex tests. While CLIA-waived tests are exempt from competency assessment requirements by the Centers for Medicare & Medicaid Services (CMS), some state and accrediting bodies may still maintain these requirements. Non-waived tests are subject to stringent quality standards, including proficiency testing, quality control (QC), and personnel competency requirements.
Effective quality control for POCT relies on using verified control materials to ensure that the POCT system is functioning as intended and will generate accurate patient results.[34] QC materials contain known concentrations of the analytes being tested. The frequency of QC testing should be determined based on the complexity and risks associated with the specific test. For high-throughput POCT devices, QC should be performed at least once daily. New lots of reagents must be tested with QC materials before being used for patient samples. QC testing also plays a crucial role in troubleshooting issues with individual tests or operator performance. Thorough QC documentation, including the date and time of testing, reagent lot numbers, and user identification, is essential for effective QC management.
Patient testing must be linked to the specific lot numbers of all products used, including the POCT device, reagents, and sample collection materials. Many modern POCT devices electronically record this information; however, historically, this data was manually recorded in logbooks. Key elements for ongoing quality assurance include monitoring expiration dates for reagents, controls, and sample collection materials, ensuring proper storage and handling of all POCT-related materials, and establishing and regularly reviewing acceptable ranges for test values.[34]
Due to the decentralized nature of POCT, effective personnel management and individual competency are critical. Ideally, all personnel performing POCT should be fully competent in the safe and accurate operation of each POCT device they use. Many larger healthcare institutions implement electronic training modules and regularly assess individual competency for POCT, aligning with requirements set by accrediting bodies such as CLIA. Accrediting bodies, including CLIA, typically require documentation of six core competency elements: 1) direct observation of test performance, 2) monitoring the recording and reporting of test results, 3) review of intermediate test 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.[35]
Lab Safety Practices in POCT
Laboratory safety is paramount in POCT to protect patients, sample collectors, and POCT operators. A unique aspect of POCT is that the same individual often performs both sample collection and test execution. Therefore, it is crucial to prevent task overload and errors during collection, transport, and analysis. Contamination of POCT devices can have widespread implications, affecting multiple patients and operators, especially if the POCT is frequently used. Proper use of personal protective equipment (PPE) and adherence to established safety protocols are essential for personnel protection and test accuracy.[36]
Universal precautions should be rigorously applied in POCT settings. Protective measures, such as splash shields and biosafety cabinets, should be used based on manufacturer guidelines and relevant government agency recommendations. Competency requirements for lab safety in POCT vary depending on the type of test and the specimens collected. For example, POC molecular testing using nasal swabs, such as for COVID-19, generally necessitates specific PPE to minimize exposure to airborne pathogens during testing.[37, 38]
Lab safety also extends to the proper disposal of samples and waste materials generated during POCT.[39] All applicable laws, regulations, and accreditation requirements for medical waste disposal must be strictly followed. After venipuncture, needles must be immediately recapped or safety-engineered needles used. Fingerstick lancets must be single-use devices. All needles and lancets must be disposed of in designated sharps containers. Proper disposal of POCT swabs depends on local and facility-specific waste disposal procedures. However, a general guideline is that swabs used for POCT where the sample is extracted from the swab (e.g., swabs rinsed or swirled in fluid) may not require biohazard disposal.[8] Swabs visibly contaminated with biological material should be disposed of in appropriate biohazard bags. Finally, when applicable, ensuring the proper removal or masking of protected health information (PHI) on all samples and sample containers is crucial, for both physical and electronic records.
Enhancing Healthcare Team Outcomes with POCT
POCT is utilized across a wide spectrum of healthcare settings, from inpatient and outpatient facilities to non-clinical environments like homes, airports, and cruise ships. The COVID-19 pandemic dramatically expanded POCT usage, with billions of rapid tests developed and deployed globally to manage virus spread and facilitate timely identification of infected individuals.
A diverse range of healthcare professionals, including physicians, nurses, medical technologists, and trained support staff, perform point-of-care testing to obtain immediate results that inform and guide clinical patient management decisions. Given the wide range of personnel and workflows involved in POCT, providing comprehensive training, fostering effective interprofessional communication, and establishing clear protocols are crucial to ensure accurate testing and efficient relay of test results to the treatment team.
Interprofessional committees dedicated to the implementation, management, and continuous quality improvement of POCT programs are highly recommended. These committees play a vital role in enhancing the overall quality of healthcare delivery within health systems by promoting collaboration, standardization, and effective oversight of POCT practices, ultimately benefiting patient care.[40] [Level 1 evidence] Numerous randomized clinical trials have demonstrated that utilizing POCT can lead to improved patient outcomes compared to relying solely on conventional laboratory testing.[41, 42, 43] [Level 1 evidence]
A key advantage of POCT is the ability to update patient electronic medical records (EMR) with real-time test results. This immediate data availability empowers the interprofessional team to access the most current and accurate patient information, leading to a more complete and actionable clinical picture. For example, pharmacists can make more informed and timely decisions regarding medication dosing adjustments for drugs like warfarin or aminoglycosides, based on the patient’s current POCT results.
POCT also facilitates closer patient monitoring by nursing staff. Real-time access to test results through the EMR allows nurses to promptly detect significant changes in a patient’s condition and alert the physician or other appropriate healthcare professionals for timely clinical intervention. Effective interprofessional coordination and collaboration among physicians, advanced practice providers, specialists, pharmacists, laboratory personnel, 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 deliver timely, targeted care based on POCT results. [Level 5 evidence]
Review Questions
(Note: Review questions are omitted as per instructions to only include title and content)
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