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OBJECTIVES: To survey the World Wide Web for critical limits/critical values, assess changes in quantitative low/high thresholds since 1990-93, streamline urgent notification practices, and promote global accessibility. METHODS: We identified Web-posted lists of critical limits/values at university hospitals. We compared 2023 to 1990-93 archived notification thresholds. RESULTS: We found critical notification lists for 26 university hospitals. Laboratory disciplines ranged widely (1-10). The median number of tests was 62 (range 21-116); several posted policies. The breadth of listings increased. Statistically significant differences in 2023 vs. 1990 critical limits were observed for blood gas (pO2, pCO2), chemistry (glucose, calcium, magnesium), and hematology (hemoglobin, platelets, PTT, WBC) tests, and for newborn glucose, potassium, pO2, and hematocrit. Twenty hospitals listed ionized calcium critical limits, which have not changed. Fourteen listed troponin (6), troponin I (3), hs-TnI (3), or troponin T (2). Qualitative critical values expanded across disciplines, encompassing anatomic/surgical pathology. Bioterrorism agents were listed frequently, as were contagious pathogens, although only three hospitals listed COVID-19. Only one notification list detailed point-of-care tests. Two children's hospital lists were Web-accessible. CONCLUSIONS: Urgent notifications should focus on life-threatening conditions. We recommend that hospital staff evaluate changes over the past three decades for clinical impact. Notification lists expanded, especially qualitative tests, suggesting that automation might improve efficiency. Sharing notification lists and policies on the Web will improve accessibility. If not dependent on the limited scope of secondary sources, artificial intelligence could enhance knowledge of urgent notification and critical care practices in the 21st Century.
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Point-of-care testing (POCT) is becoming an increasingly popular way to perform laboratory tests closer to the patient. This option has several recognized advantages, such as accessibility, portability, speed, convenience, ease of use, ever-growing test panels, lower cumulative healthcare costs when used within appropriate clinical pathways, better patient empowerment and engagement, and reduction of certain pre-analytical errors, especially those related to specimen transportation. On the other hand, POCT also poses some limitations and risks, namely the risk of lower accuracy and reliability compared to traditional laboratory tests, quality control and connectivity issues, high dependence on operators (with varying levels of expertise or training), challenges related to patient data management, higher costs per individual test, regulatory and compliance issues such as the need for appropriate validation prior to clinical use (especially for rapid diagnostic tests; RDTs), as well as additional preanalytical sources of error that may remain undetected in this type of testing, which is usually based on whole blood samples (i.e., presence of interfering substances, clotting, hemolysis, etc.). There is no doubt that POCT is a breakthrough innovation in laboratory medicine, but the discussion on its appropriate use requires further debate and initiatives. This collective opinion paper, composed of abstracts of the lectures presented at the two-day expert meeting "Point-Of-Care-Testing: State of the Art and Perspective" (Venice, April 4-5, 2024), aims to provide a thoughtful overview of the state-of-the-art in POCT, its current applications, advantages and potential limitations, as well as some interesting reflections on the future perspectives of this particular field of laboratory medicine.
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The World Health Organization and the Centers for Disease Control and Prevention (CDC) have established guidelines recommending the performance of hand hygiene routines for healthcare workers following glove removal. However, the completion of frequent hygiene routines can cause allergic and adverse skin reactions. This double-blind, randomized study aimed to address this concern by developing and evaluating a modified glove removal technique that minimizes contamination risk during routine phlebotomy procedures. Furthermore, this study used fluorescent detection to compare the frequency of contamination associated with the CDC-recommended technique and the modified technique using fluorescent detection. One hundred healthcare personnel were enrolled and divided into two groups: one group followed the CDC technique, while the other group implemented the modified technique. Participants received instructional videos and practiced under supervision. They subsequently performed blood collection using a simulation arm covered with fluorescent cream as a contamination marker. After removing gloves, hand contamination was assessed under a black light. The median time required for glove removal in the modified group was four seconds longer than that in the group that followed the CDC technique (p < 0.001). Contamination was observed in 2% (1/50) of subjects using the CDC-recommended technique, while no contamination was detected with the modified technique (p ≥ 0.05). Both the group that followed the CDC technique and the group that used modified glove removal techniques demonstrated the potential to prevent contamination during phlebotomy, thereby reducing the need for hand hygiene and the occurrence of contamination and adverse skin reactions. These findings prompt further exploration into whether proper glove removal can reduce the frequency of completing a hand hygiene routine after each glove removal, specifically within the context of phlebotomy. However, it is essential to note that hand hygiene following glove removal is still recommended to prevent contamination. Further research is warranted to validate these findings.
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The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Committee on Point-of-Care Testing (C-POCT) supports the use of point-of-care testing (POCT) outside of the hospital setting performed by healthcare professionals without formal laboratory education because of its numerous benefits. However, these benefits are associated with risks that must be managed, to ensure the provision of reliable test results and minimize harm to the patient. Healthcare professionals, local regulatory bodies, accredited laboratories as well as manufacturers should actively be engaged in education, oversight and advice to ensure that the healthcare professional selects the appropriate equipment and is able to analyze, troubleshoot and correctly interpret the point-of-care (POC) test results.
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Hospitales , Pruebas en el Punto de Atención , Humanos , Consenso , Laboratorios , Atención a la Salud , Sistemas de Atención de PuntoRESUMEN
OBJECTIVES: To perform geographic contour analysis of sea and land ambulance rescue times in an archipelago subject to super typhoons; to design point-of-care testing strategies for medical emergencies and weather disasters made more intense by global warming and rising oceans; and to assess needs for prehospital testing on spatial care paths that accelerate decision making, increase efficiency, improve outcomes, and enhance standards of care in island nations. METHODS: We performed needs assessments, inspected healthcare facilities, and collected ambulance rescue times from professionals in the Bantayan Archipelago, Philippines. We mapped sea/land ambulance rescue routes and time contours. To reveal gaps, we statistically compared the fastest and slowest patient rescue times from islands/islets and barangays to the District Hospital on Bantayan Island. We developed spatial care paths (the fastest routes to care) for acute myocardial infarction, community care, and infectious diseases. We generated a compendium of prehospital diagnostic testing and integrated outcomes evidence, diagnostic needs, and public health goals to recommend point-of-care strategies that build geographic health resilience. RESULTS: We observed limited access to COVID-19 assays, absence of blood gas/pH testing for critical care support, and spatial gaps in land and airborne rescues that worsened during inclement weather and sea swells. Mean paired differences (slowest-fastest) in ambulance rescue times to the District Hospital for both islands and barangays were significant (P < 0.0001). Spatial care path analysis showed where point-of-care cardiac troponin testing should be implemented for expedited care of acute myocardial infarction. Geospatial strengths comprised distributed primary care that can be facilitated by point-of-care testing, logical interisland transfers for which decision making and triage could be accelerated with onboard diagnostics, and healthcare networks amenable to medical advances in prehospital testing that accelerate treatment. CONCLUSIONS: Point-of-care testing should be positioned upstream close to homes and island populations that have prolonged rescue time contours. Geospatially optimized point-of-need diagnostics and distributed prehospital testing have high potential to improve outcomes. These improvements will potentially decrease disparities in mortality among archipelago versus urban dwellers, help improve island public health, and enhance resilience for increasingly adverse and frequent climate change weather disasters that impact vulnerable coastal areas. [350 words].
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Desastres , Infarto del Miocardio , Humanos , Sistemas de Atención de Punto , Calentamiento Global , Tiempo (Meteorología) , Planificación de Atención al PacienteRESUMEN
Strategic integration of point-of-care (POC) diagnostic tools during crisis response can accelerate triage and improve management of victims. Timely differential diagnosis is essential wherever care is provided to rule out or rule in disease, expedite life-saving treatment, and improve utilization of limited resources. POC testing needs to be accurate in any environment in which it is used. Devices are exposed to potentially adverse storage and operating conditions, such as high/low temperature and humidity during emergencies and field rescues. Therefore, characterizing environmental conditions allows technology developers, operators, and responders to understand the broad operational requirements of test reagents, instruments, and equipment in order to improve the quality and delivery of care in complex emergencies, disasters, and austere environmental settings. This review aims to describe the effects of environmental stress on POC testing performance and its impact on decision-making, to describe how to study the effects, and to summarize ways to mitigate the effects of environmental stresses through good laboratory practice, development of robust reagents, and novel thermal packaging solutions.
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Ambiente , Equipos y Suministros , Personal de Salud , Sistemas de Atención de Punto , Desastres , Humanos , Indicadores y ReactivosRESUMEN
INTRODUCTION: During disasters and complex emergencies, environmental conditions can adversely affect the performance of point-of-care (POC) testing. Knowledge of these conditions can help device developers and operators understand the significance of temperature and humidity limits necessary for use of POC devices. First responders will benefit from improved performance for on-site decision making. OBJECTIVE: To create dynamic temperature and humidity profiles that can be used to assess the environmental robustness of POC devices, reagents, and other resources (eg, drugs), and thereby, to improve preparedness. METHODS: Surface temperature and humidity data from the National Climatic Data Center (Asheville, North Carolina USA) was obtained, median hourly temperature and humidity were calculated, and then mathematically stretched profiles were created to include extreme highs and lows. Profiles were created for: (1) Banda Aceh, Indonesia at the time of the 2004 Tsunami; (2) New Orleans, Louisiana USA just before and after Hurricane Katrina made landfall in 2005; (3) Springfield, Massachusetts USA for an ambulance call during the month of January 2009; (4) Port-au-Prince, Haiti following the 2010 earthquake; (5) Sendai, Japan for the March 2011 earthquake and tsunami with comparison to the colder month of January 2011; (6) New York, New York USA after Hurricane Sandy made landfall in 2012; and (7) a 24-hour rescue from Hawaii USA to the Marshall Islands. Profiles were validated by randomly selecting 10 days and determining if (1) temperature and humidity points fell inside and (2) daily variations were encompassed. Mean kinetic temperatures (MKT) were also assessed for each profile. RESULTS: Profiles accurately modeled conditions during emergency and disaster events and enclosed 100% of maximum and minimum temperature and humidity points. Daily variations also were represented well with 88.6% (62/70) of temperature readings and 71.1% (54/70) of relative humidity readings falling within diurnal patterns. Days not represented well primarily had continuously high humidity. Mean kinetic temperature was useful for severity ranking. CONCLUSIONS: Simulating temperature and humidity conditions clearly reveals operational challenges encountered during disasters and emergencies. Understanding of environmental stresses and MKT leads to insights regarding operational robustness necessary for safe and accurate use of POC devices and reagents. Rescue personnel should understand these principles before performing POC testing in adverse environments.
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Técnicas de Laboratorio Clínico/instrumentación , Medicina de Desastres/instrumentación , Planificación en Desastres , Servicios Médicos de Urgencia/normas , Humedad , Sistemas de Atención de Punto/normas , Temperatura , Tormentas Ciclónicas , Toma de Decisiones , Terremotos , Falla de Equipo , Haití , Hawaii , Humanos , Indonesia , Japón , Massachusetts , Nueva Orleans , Ciudad de Nueva York , TsunamisRESUMEN
Glucose meters provide a rapid blood glucose status for evidence-based diagnosis, monitoring, and treatment of diabetes mellitus. We aimed to evaluate the commutability of processed blood materials (PBMs) and their use in the performance evaluation of glucose meters. Two PBMs obtained by the fixed-cell method were analyzed for homogeneity, stability, and commutability. The compatibility of ten pairs between mass spectrometry and each glucose meter was categorized as compatible (mean paired difference ≤ 5%) and incompatible (mean paired difference > 5%). The performance of glucose meter 1 (n = 767) and glucose meter 2 (n = 266) was assessed. The glucose in the PBMs remained homogenized and stable for at least 180 days. Six out of ten pairs had commutable PBMs. Commutability of PBMs was observed in both well-compatible and incompatible glucose results. Target glucose values from mass spectrometry were significantly different (p ≤ 0.05) from consensus values in one group of glucose meters. When commutable PBMs were used, glucose meter 1 showed better performance than glucose meter 2, and the percentage of satisfaction was associated when using target values for glucose from mass spectrometry and consensus values, but the performance of glucose meter 2 was not associated. PBM from a fixed-cell method could be mass produced with acceptable homogeneity and stability. Commutability testing of PBMs is required prior to use in the performance evaluation of glucose meters, as the commutability of glucose in the PBMs obtained by a fixed-cell method was variable and depended on the individual glucose meter.
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Objectives: The objectives were to evaluate blood additives that combined lithium heparin (LH)-salt with glyceraldehyde (GLY) or d-mannose (MAN) for preserving glucose levels in plasma samples and to simultaneously determine the compatibility of these additives with 14 other biochemical tests. Methods: Blood samples from 40 subjects, equally divided into healthy and diabetic groups, were collected using five different additives. The three most effective additives, LH/GLY, LH/MAN, and LH/GLY/MAN, were selected for ensuring the best preservation of glucose levels and compatibility with 14 biochemical tests. One-way analysis of variance was used to analyze the mean paired differences of glucose level and biochemical tests. Simultaneously, the clinical criteria from Johns Hopkins Hospital were used to guide the interpretation and set acceptable thresholds for measurements that exceeded the standards. Results: The combination of 160 mmol/L GLY, 8.4 mmol/L MAN, and LH, maintained glucose levels at approximately 93.4-93.7 % for healthy subjects and 91.3-92.8% for subjects with diabetes mellitus over 8 h. The mean paired differences of glucose levels in preservation were statistically insignificant. The biases in 14 biochemical tests for LH/GLY/MAN and LH/MAN remained within the acceptable clinical criteria during the 8 h. Conclusions: Combining 160 mmol/L GLY, 8.4 mmol/L MAN, and LH, proved more effective in maintaining glucose levels than individual additives or the conventional sodium fluoride preservative. It did not yield clinical discrepancies in the 14 biochemical tests during 8 h at room temperature.
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A prevalence boundary (PB) marks the point in prevalence in which the false omission rate, RFO = FN/(TN + FN), exceeds the tolerance limit for missed diagnoses. The objectives were to mathematically analyze rapid antigen test (RAgT) performance, determine why PBs are breeched, and evaluate the merits of testing three times over five days, now required by the US Food and Drug Administration for asymptomatic persons. Equations were derived to compare test performance patterns, calculate PBs, and perform recursive computations. An independent July 2023 FDA-NIH-university-commercial evaluation of RAgTs provided performance data used in theoretical calculations. Tiered sensitivity/specificity comprise the following: tier (1) 90%, 95%; tier (2) 95%, 97.5%; and tier (3) 100%, ≥99%. Repeating a T2 test improves the PB from 44.6% to 95.2% (RFO 5%). In the FDA-NIH-university-commercial evaluation, RAgTs generated a sensitivity of 34.4%, which improved to 55.3% when repeated, and then improved to 68.5% with the third test. With RFO = 5%, PBs are 7.37/10.46/14.22%, respectively. PB analysis suggests that RAgTs should achieve a clinically proven sensitivity of 91.0-91.4%. When prevalence exceeds PBs, missed diagnoses can perpetuate virus transmission. Repeating low-sensitivity RAgTs delays diagnosis. In homes, high-risk settings, and hotspots, PB breaches may prolong contagion, defeat mitigation, facilitate new variants, and transform outbreaks into endemic disease. Molecular diagnostics can help avoid these potential vicious cycles.
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The Abbott i-STAT and Siemens Healthineers epoc are commonly used in the provision of care during emergency medical services calls and other settings. Maintaining these systems within manufacturer's temperature claims in these settings poses challenges across the world. This review summarizes solutions that have been reported in the peer-reviewed literature and proposes additional strategies to further address these challenges. A literature search was performed with Clarivate's Web of Science from inception to August 3, 2022. Search terms included i-STAT, epoc, temperature, cold, hot, heat, freeze, frozen, prehospital, disaster, POCT, point of care, blood gas, helicopter, airplane, and ambulance. One author also reviewed manually every issue of the Journal of Paramedic Practice. The search identified 17 solutions for addressing temperature-related challenges with the i-STAT device, nine solutions for i-STAT cartridges, one solution for the epoc device, and one solution for the epoc test card. The majority of solutions were highly portable and consisted of widely available, inexpensive components. The solutions demonstrated only partial or entirely questionable effectiveness in achieving temperature control. The search also identified five reports on the impact of storage temperatures on cartridges and test cards. The reports suggested that these reagents may be able to withstand storage at temperatures outside of manufacturer's claims with only minimal deterioration in performance. The heterogeneity of solutions and the paucity of evidence on their effectiveness suggest that additional strategies are needed to better understand and further address temperature-related challenges with these systems. A collaborative approach and shared decision making are recommended.
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Servicios Médicos de Urgencia , Humanos , Temperatura , Paramédico , Sistemas de Atención de PuntoRESUMEN
CONTEXT.: Timely reperfusion improves the recovery of patients with acute ischemic stroke. Laboratory results are crucial to guide treatment decisions in patients when abnormal laboratory tests are suspected. OBJECTIVE.: To implement a new laboratory workflow for acute stroke patients and compare laboratory turnaround time (TAT) preimplementation and postimplementation. DESIGN.: We conducted a retrospective pre-post intervention study of patients with suspected acute stroke during the 4-month periods before and after the implementation of a new laboratory workflow process. The improvement process included relocating the specimen registration site, laboratory notification before specimen arrival, a color-coding system on tubes, timing at all processes, and eliminating the smear review if platelets were normal. TATs of the laboratory and door-to-clinical intervention times before and after the improvement process were compared. RESULTS.: Postintervention, median specimen transportation time decreased from 11 (interquartile range [IQR], 8.4-16.4) to 9 minutes (IQR, 6.3-12.8), P < .001. The intralaboratory and total TATs of complete blood cell count, coagulation tests, and creatinine significantly decreased (P < .001 for all). Blood drawn-to-laboratory reported time decreased from 43 (IQR, 36.0-51.5) to 33 minutes (IQR, 29.2-35.8, P < .001). However, door-to-needle time for thrombolysis and door-to-puncture time and door-to-recanalization time for mechanical thrombectomy were not statistically different (P = .11, .69, and .50, respectively). CONCLUSIONS.: The new laboratory workflow significantly decreased transportation time, TAT of individual tests, and the blood drawn-to-laboratory reported time. However, the time to treatment of acute ischemic stroke patients was not different between preimplementation and postimplementation.
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Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Estudios Retrospectivos , Factores de Tiempo , Accidente Cerebrovascular/terapia , Accidente Cerebrovascular/tratamiento farmacológico , Reperfusión , Tiempo de Tratamiento , Resultado del TratamientoRESUMEN
This research uses mathematically derived visual logistics to interpret COVID-19 molecular and rapid antigen test (RAgT) performance, determine prevalence boundaries where risk exceeds expectations, and evaluate benefits of recursive testing along home, community, and emergency spatial care paths. Mathematica and open access software helped graph relationships, compare performance patterns, and perform recursive computations. Tiered sensitivity/specificity comprise: (T1) 90%/95%; (T2) 95%/97.5%; and (T3) 100%/≥99%, respectively. In emergency medicine, median RAgT performance peaks at 13.2% prevalence, then falls below T1, generating risky prevalence boundaries. RAgTs in pediatric ERs/EDs parallel this pattern with asymptomatic worse than symptomatic performance. In communities, RAgTs display large uncertainty with median prevalence boundary of 14.8% for 1/20 missed diagnoses, and at prevalence > 33.3−36.9% risk 10% false omissions for symptomatic subjects. Recursive testing improves home RAgT performance. Home molecular tests elevate performance above T1 but lack adequate validation. Widespread RAgT availability encourages self-testing. Asymptomatic RAgT and PCR-based saliva testing present the highest chance of missed diagnoses. Home testing twice, once just before mingling, and molecular-based self-testing, help avoid false omissions. Community and ER/ED RAgTs can identify contagiousness in low prevalence. Real-world trials of performance, cost-effectiveness, and public health impact could identify home molecular diagnostics as an optimal diagnostic portal.
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CONTEXT.: Coronavirus disease 2019 (COVID-19) rapid antigen tests generate intrinsically fast, inherently spatial, and immediately actionable results. They quickly confirm COVID-19, but weakly rule out infection. Test performance depends on prevalence and testing protocol. Both affect predictive values. OBJECTIVES.: To use original mathematics and visual logistics for interpreting COVID-19 rapid antigen test performance patterns, gauge the influence of prevalence, and evaluate repeated testing. DESIGN.: Mathematica and open access software helped graph relationships, perform recursive computations, and compare performance patterns. PubMed retrieved articles addressing endemic COVID-19 were reviewed. RESULTS.: Tiered sensitivity/specificity comprise the following: T1 (90%/95%), T2 (95%/97.5%), and T3 (100%/≥99%). Performance of self-tests and home antigen tests with US Food and Drug Administration Emergency Use Authorization peaks in low prevalence. Fall-off in performance appears with increasing prevalence because suboptimal sensitivity creates false negatives. The rate of false omissions limits clinical use because of prevalence boundaries based on tolerance for risk. Mathematical analysis supports testing twice to improve predictive values and extend prevalence boundaries nearly to levels of herd immunity. CONCLUSIONS.: COVID-19 is quickly becoming endemic. Suboptimal sensitivity of rapid antigen tests limits performance in high prevalence. Risk of contagion in packed spaces (eg, airplanes) might be avoided with dual testing 36 hours apart, allowing time for viral load to increase. Awareness of community prevalence and proof of improved performance with repeated testing will help manage COVID-19 risk, while meeting rapid decision-making needs for highly contagious and new variants (eg, Delta). New COVID-19 variants call for high-quality, low cost, readily accessible, fast, user friendly, and ubiquitous point-of-care testing.
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COVID-19 , Prueba de COVID-19 , Humanos , SARS-CoV-2 , Sensibilidad y EspecificidadRESUMEN
Our primary objectives were (a) to determine the need for and the availability of point-of-care testing (POCT) for infectious diseases and (b) to recommend point-of-care testing strategies and Spatial Care PathsTM (SCPs) that enhance public health preparedness in the regional districts of Thua Thien Hue Province (TTHP), Central Vietnam, where we conducted field surveys. Medical professionals in seven community health centers (CHCs), seven district hospitals (DHs) and one provincial hospital (PH) participated. Survey questions (English and Vietnamese) determined the status of diagnostic testing capabilities for infectious diseases and other acute medical challenges in TTHP. Infectious disease testing was limited: six of seven CHCs (86%) lacked infectious disease tests. One CHC (14%, 1/7) had two forms of diagnostic tests available for the detection of malaria. All CHCs lacked adequate microbiology laboratories. District hospitals had few diagnostic tests for infectious diseases (tuberculosis and syphilis), blood culture (29%, 2/7), and pathogen culture (57%, 4/7) available. The PH had broader diagnostic testing capabilities but lacked preparedness for highly infectious disease threats (e.g., Ebola, MERS-CoV, SARS, Zika, and monkeypox). All sites reported having COVID-19 rapid antigen tests; COVID-19 RT-PCR tests were limited to higher-tier hospitals. We conclude that infectious disease diagnostic testing should be improved and POC tests must be supplied near patients' homes and in primary care settings for the early detection of infected individuals and the mitigation of the spread of new COVID-19 variants and other highly infectious diseases.
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BACKGROUND: The objectives of this article were 1) to identify current trends in critical values practices in North America, Europe, and other regions; 2) to describe progress toward harmonization of critical limits; and 3) to synthesize strategies that will encourage global consensus. Critical limits are described in national surveys. Critical value practices are guided by federal statutes, The Joint Commission regulations, and accreditation requirements in the US; by provincial healthcare agencies in Canada; by thought leaders and ISO EN 15189:2007 in Europe; and in SE Asia, mostly by ad hoc policies lacking statutory grip. METHODS: Review of databases, literature, websites, federal statutes, litigation, official policies, current affairs, and accreditation agency requirements. RESULTS AND CONCLUSIONS: Practical strategies will accelerate harmonization of critical values practices, as follows: a) continue national and international survey comparisons; b) clarify age, ethnic, and subject dependencies; c) standardize qualitative and quantitative decision levels for urgent clinician notification; d) monitor compliance and timeliness for safety; and e) alert high frequencies of critical values related to adverse events. New expectations and communication technologies present opportunities for enhanced performance using wireless closed-loop reporting with recipient acknowledgment to reduce phone calls and improve efficiency. Hospitals worldwide can benefit from developing consensus for critical values practices.
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Pruebas de Química Clínica/normas , Enfermedad Crítica , Cooperación Internacional , Internacionalidad , Humanos , Pediatría , Valores de ReferenciaRESUMEN
BACKGROUND: The goal is to introduce visual performance mapping efficient for establishing acceptance criteria and facilitating decisions regarding the utility of hospital point-of-care devices. This approach uniquely reveals the quality of performance locally, as opposed to globally. METHODS: After presenting theoretical foundations, this study illustrates the approach by applying it to six hospital glucose meter systems (GMSs) using clinical multi-center (n=2767) and multi-system (n=613, n=100) observations. RESULTS: LS MAD curves identified breakouts, that is, points where the locally-smoothed median absolute difference (LS MAD) curve exceeds the recommended error tolerance limit of 5 mg/dL (0.28 mmol/L). LS maximum absolute difference (MaxAD) breakthroughs, which occur where the LS MaxAD curve exceeds the 99th percentile of MaxADs from x=30-200 mg/dL (1.67-11.10 mmol/L), showed extreme error locations. A multi-sensor interference- and hematocrirt-correcting GMS displayed a flat LS MAD curve until it reached a breakout of 179 mg/dL (9.94 mmol/L) and generated breakthroughs that could affect bedside decision-making, but less erratically than other systems with inadequate performance for hospital critical care. We discovered Class I (meter high, reference low) and Class II (converse) discrepant values in some systems. Class I errors could lead to inappropriate insulin dosing and hypoglycemic episodes in tight glucose control. CONCLUSIONS: LS MAD-MaxAD curves help assess the performance of point-of-care testing. Visual mapping of systematic and random errors locally over the entire analyte measurement range in a single integrated display is an advantage when considering the adverse impact of zones of poor quantitative performance on specific clinical applications, threshold-driven bedside decisions and the care of critically ill patients.
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Glucemia , Toma de Decisiones Asistida por Computador , Sistemas de Atención de Punto , Humanos , Estudios Multicéntricos como Asunto , Sistemas de Atención de Punto/normas , Sistemas de Atención de Punto/estadística & datos numéricosRESUMEN
GOAL: The goal is to present key principles of point-of-care testing (POCT) in educational curricula that meet critical needs for rapid decision-making in disasters, outbreaks of highly infectious diseases, emergency management, and complex crises. OBSERVATIONS: The coronavirus disease 19 (COVID-19) pandemic unequivocally proved the value of POC strategies. Striking needs identified by COVID-19 challenges have yet to be entirely fulfilled. A comprehensive national survey showed absence of POCT training in public health colleges, schools, and programs. Fundamental improvements in national structuring of POC knowledge, skills, experience, training, dissemination, accreditation, and licensing are necessary, so that multidisciplinary public health teams can respond effectively and efficiently by geospatially optimizing the control and mitigation of highly infectious diseases and other critical challenges. CONCLUSIONS: Four sets of POCT learning objectives were developed for public health and other educational institutions. Global implementation of POC diagnostics in the hands of trained personnel will help avoid untimely worldwide crises, huge economic losses, uncounted excess mortality, and sudden disruptive surges of dangerous infectious threats to personal security and cultural stability.
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CONTEXT.: Coronavirus disease 2019 (COVID-19) test performance depends on predictive values in settings of increasing disease prevalence. Geospatially distributed diagnostics with minimal uncertainty facilitate efficient point-of-need strategies. OBJECTIVES.: To use original mathematics to interpret COVID-19 test metrics; assess US Food and Drug Administration Emergency Use Authorizations and Health Canada targets; compare predictive values for multiplex, antigen, polymerase chain reaction kit, point-of-care antibody, and home tests; enhance test performance; and improve decision-making. DESIGN.: PubMed/newsprint-generated articles documenting prevalence. Mathematica and open access software helped perform recursive calculations, graph multivariate relationships, and visualize performance by comparing predictive value geometric mean-squared patterns. RESULTS.: Tiered sensitivity/specificity comprised: T1, 90%, 95%; T2, 95%, 97.5%; and T3, 100%, ≥99%. Tier 1 false negatives exceeded true negatives at >90.5% prevalence; false positives exceeded true positives at <5.3% prevalence. High-sensitivity/specificity tests reduced false negatives and false positives, yielding superior predictive values. Recursive testing improved predictive values. Visual logistics facilitated test comparisons. Antigen test quality fell off as prevalence increased. Multiplex severe acute respiratory syndrome (SARS)-CoV-2)*influenza A/B*respiratory syncytial virus testing performed reasonably well compared with tier 3. Tier 3 performance with a tier 2 confidence band lower limit will generate excellent performance and reliability. CONCLUSIONS.: The overriding principle is to select the best combined performance and reliability pattern for the prevalence bracket. Some public health professionals recommend repetitive testing to compensate for low sensitivity. More logically, improved COVID-19 assays with less uncertainty conserve resources. Multiplex differentiation of COVID-19 from influenza A/B-respiratory syncytial virus represents an effective strategy if seasonal flu surges next year.