Assessing the Reliability of Commercially Available Point of Care in Various Clinical Fields
Federica Pezzuto1, Antonio Scarano2, Carlotta Marini3, Giacomo Rossi3, Roberta Stocchi3, Alfredo Di Cerbo4, Alessandro Di Cerbo3, *
1 University of Modena and Reggio Emilia, Modena, Italy
2 Department of Medical, Oral and Biotechnological Sciences, Dental School, University G. d`Annunzio of Chieti-Pescara, Chieti, Italy
3 School of Biosciences and Veterinary Medicine, University of Camerino, Matelica, Italy
4 Leonardo da Vinci Private Clinic, Foggia, Italy
Updated and precise molecular diagnostics are essential in disease identification, treatment and management. Conventional technologies are limited to laboratories, which are expensive, require moderate to great volumes of biological fluids and generally create great discomfort among patients. This review discusses some key features of commercially available point of care (POC) devices, such as time to provide results, accuracy and imprecision, in several medical and veterinary fields. We searched Pubmed/Medline using the keywords “point” “of” “care” “device”, selected papers from 1984 to 2019 on the basis of their content and summarized the features in tables.
Fast turnaround time and overall good reliability, in terms of accuracy and imprecision, were observed for most of POCs included in the research.
POC devices are particularly useful for clinicians since they hold the potential to deliver rapid and accurate results in an inexpensive and less invasive way with an overall improvement of patients' quality of life in terms of time spent at the point-of-care and sample volume withdrawn. These features gain great relevance also in the veterinary practice, where patients’ compliance is generally poor, available sample volumes are quite far from the human ones and analysis costs are higher.
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* Address correspondence to this author at the School of Biosciences and Veterinary Medicine, University of Camerino, Via Circonvallazione, 93/95, 62024 Matelica (MC) – Italy; Tel: +39 0737403457; Fax: +39 0737403402;
Assessing the Reliability of Commercially Available Point of Care in Various Clinical Fields
The point-of-care (POC) is generally used outside the central laboratory to facilitate the patient’s faster diagnosis and treatment. It is one of the innovations that impact potentially on the quality and rapidity of care, as well as on system redesign of a more patient-centred care approach [1St John A, Price CP. Existing and emerging technologies for point-of-care testing. Clin Biochem Rev 2014; 35(3): 155-67. [PMID: 25336761] , 2Lippi G, Plebani M, Favaloro EJ, Trenti T. Laboratory testing in pharmacies. Clin Chem Lab Med 2010; 48(7): 943-53. [http://dx.doi.org/10.1515/CCLM.2010.184] [PMID: 20441470] ]. POCs are commercially available either as small bench-top analyzers or as hand-held devices. The latter are used by patients for homecare and by healthcare professionals. If, on one hand, laboratory results can take from several hours to few days, on the other hand, POCs reduce analysis time from hours to few seconds, therefore, gaining relevant importance especially in emergency conditions (Table 1).
To evaluate a safe and reliable POC, it is important to consider its sensitivity (the percentage of true positive results), specificity (percentage of true negative results) and positive and negative predictive values (PPV, NPV, respectively) according to the disease prevalence in the considered population [3McNerney R, Daley P. Towards a point-of-care test for active tuberculosis: obstacles and opportunities. Nat Rev Microbiol 2011; 9(3): 204-13. [http://dx.doi.org/10.1038/nrmicro2521] [PMID: 21326275] ]. The analytical performance of a device is assessed through imprecision, quantified by calculating the within-run coefficient of variation (CV) from the test result data of a given device, and accuracy, estimated by means of a coefficient of correlation (r) from the set of data obtained from the two devices-analyzer (POC) and a reference or standard instrument [4Bénéteau-Burnat B, Pernet P, Pilon A, et al. Evaluation of the GEM Premier 4000: A compact blood gas CO-Oximeter and electrolyte analyzer for point-of-care and laboratory testing. Clin Chem Lab Med 2008; 46(2): 271-9. [http://dx.doi.org/10.1515/CCLM.2008.043] [PMID: 18076351] ].
This review firstly considers the commercially available POCs, sorting them by medical application and analyzing some key features such as time to provide results, accuracy and imprecision. In fact, most of the current reviews on POC dealt with singular medical applications providing information about their performance with respect to centralized laboratory instruments. In this sense, the aim of this review was to provide human and animal healthcare a useful tool for a correct choice of a POC for a specific disease, particularly, in this modern era where the concepts efficiency and costs have become a public health concern.
2. MATERIALS AND METHODS
The aim of this review was to provide the actual status of point of care (POC) devices highlighting some key features, such as time to result, accuracy and imprecision, in several medical fields including ematobiochemistry, cardiology, infectious disease, andrology and gynecology, toxicology, oncology, genetics, dentistry ophthalmology ultrasology and even veterinary medicine.
We searched Pubmed/Medline and other external sources using the keywords “point of care device”. Selected papers from 1984 to 2019 were chosen on the basis of their content and included. Moreover, some technical data were also downloaded from website of the POC’s manufacturer.
2.2. Point of Care in Human Practice
Rapid evaluation of blood parameters, in particular, glucose, electrolyte and metabolic parameters, gained even more attention in the last years due to the wide diffusion of POC devices also among non-laboratory trained individuals including patients themselves [5Shaw JLV. Practical challenges related to point of care testing. Pract Lab Med 2015; 4: 22-9. [http://dx.doi.org/10.1016/j.plabm.2015.12.002] [PMID: 28856189] , 6Asimos AW, Gibbs MA, Marx JA, et al. Value of point-of-care blood testing in emergent trauma management. J Trauma 2000; 48(6): 1101-8. [http://dx.doi.org/10.1097/00005373-200006000-00017] [PMID: 10866258] ]. Most of these devices are based on a photometric method, share an overall high degree of accuracy and are characterized by a rapid turnaround time of test results providing them an edge over conventional central laboratory analyzers (Table 1).
Glucose meters are used worldwide providing fast analysis of blood glucose, glycated hemoglobin, β-hydroxybutyrate, TSH and free T4 levels, allowing the management of hypoglycemic and hyperglycemic disorders [115Tonyushkina K, Nichols JH. Glucose meters: A review of technical challenges to obtaining accurate results. J Diabetes Sci Technol 2009; 3(4): 971-80. [http://dx.doi.org/10.1177/193229680900300446] [PMID: 20144348] ]. They mainly rely on an electrochemically-based measurement test, which reduced the time-to-result from minutes to few seconds requiring blood volumes as little as few microliters [116Gubala V, Harris LF, Ricco AJ, Tan MX, Williams DE. Point of care diagnostics: Status and future. Anal Chem 2012; 84(2): 487-515. [http://dx.doi.org/10.1021/ac2030199] [PMID: 22221172] ]. Besides the need to monitor glycemia to reduce morbidity and mortality, the primary requirement of clinicians is the reliability of glucose meters (inaccuracy and imprecision remain fundamental) even in the presence of interfering substances including but not limited to ascorbate, hematocrit and maltose [117O’Kane MJ. The accuracy of point-of-care glucose measurement. Ann Clin Biochem 2012; 49(Pt 2): 108-9. [http://dx.doi.org/10.1258/acb.2011.011283] [PMID: 22383751] ]. Despite the presence of many other factors able to undermine the accuracy of such devices, the degree of precision reached by current POCs is very high, although their handling should be generally left to a well-trained staff (Table 2) [118Hopf S, Graf B, Gruber M. Comparison of point-of-care testing glucose results from intensive care patients measured with network-ready devices. Diabetes Technol Ther 2011; 13(10): 1047-56. [http://dx.doi.org/10.1089/dia.2011.0051] [PMID: 21721924] ].
The need for enabling a rapid assessment of patients with chest discomfort, both in an ambulance and emergency rooms, as well as the management of bleeding and clotting risks and myocardial infarction prevention led to a rapid increase in technological advancements of POC devices [155King K, Grazette LP, Paltoo DN, et al. Point-of-Care Technologies for Precision Cardiovascular Care and Clinical Research: National Heart, Lung, and Blood Institute Working Group. JACC Basic Transl Sci 2016; 1(1-2): 73-86. [http://dx.doi.org/10.1016/j.jacbts.2016.01.008] [PMID: 26977455] ]. Among cardiac biomarkers, cardiac troponins gained great relevance with respect to creatine kinase [156Amundson BE, Apple FS. Cardiac troponin assays: A review of quantitative point-of-care devices and their efficacy in the diagnosis of myocardial infarction. Clin Chem Lab Med 2015; 53(5): 665-76. [http://dx.doi.org/10.1515/cclm-2014-0837] [PMID: 25324453] , 157Apple FS, Murakami MM. The diagnostic utility of cardiac biomarkers in detecting myocardial infarction. Clin Cornerstone 2005; 7(Suppl. 1): S25-30. [http://dx.doi.org/10.1016/S1098-3597(05)80011-0] [PMID: 15899366] ]. B-Type Natriuretic Peptide has been successfully used to discriminate between heart failure symptoms and shortness of breath due to pulmonary causes [158Morrison LK, Harrison A, Krishnaswamy P, Kazanegra R, Clopton P, Maisel A. Utility of a rapid B-natriuretic peptide assay in differentiating congestive heart failure from lung disease in patients presenting with dyspnea. J Am Coll Cardiol 2002; 39(2): 202-9. [http://dx.doi.org/10.1016/S0735-1097(01)01744-2] [PMID: 11788208] ], nevertheless also high sensitivity c-reactive protein, D-dimer, myoglobin and N-terminal pro-B-type natriuretic peptide are also assessed [159Freyburger G, Reboul MP, Labrouche S, Saillour F, Grenier N. Diagnosis accuracy of a new challenger for thrombosis exclusion, the Stratus CS DDMR. Clin Chim Acta 2005; 354(1-2): 181-9. [http://dx.doi.org/10.1016/j.cccn.2004.11.027] [PMID: 15748615] ].
Moreover, a rapid turnaround time, ranging from less than 20 minutes to few seconds, has now been generally achieved by all POC devices, thus allowing an immediate and effective patient triage (Table 3) [160Guo X, Feng J, Guo H. The predictive value of the bedside troponin T test for patients with acute chest pain. Exp Clin Cardiol 2006; 11(4): 298-301. [PMID: 18651021] , 161Christenson RH, Azzazy HM. Cardiac point of care testing: A focused review of current National Academy of Clinical Biochemistry guidelines and measurement platforms. Clin Biochem 2009; 42(3): 150-7. [http://dx.doi.org/10.1016/j.clinbiochem.2008.09.105] [PMID: 18929551] ].
Table 1 Differences between laboratory analysis and POCTs times.
Table 2 Commercially available POC devices in Ematobiochemistry.
Table 3 Commercially available POC devices for diabetes management.
Table 4 Commercially available POC devices in cardiology.
2.2.4. Viral Infections
Infectious diseases require an accurate and rapid diagnosis in order to limit the spread of infection. Their management mainly relies on the identification of the cause of the infection and on the initiation of a therapy to control host reaction against infection. In clinical practice, the time required to reach the final diagnosis generally exceeds 24 hours leading to unnecessary sufferings and even deaths. In the last few years, nucleic acid-based testing for infectious diseases have become particularly useful in those situations where fast turnaround times are required and centralized laboratories are overloaded. Moreover, conventional instruments are PCR-based, are limited to well-trained hospital staff and are expensive [174Niemz A, Ferguson TM, Boyle DS. Point-of-care nucleic acid testing for infectious diseases. Trends Biotechnol 2011; 29(5): 240-50. [http://dx.doi.org/10.1016/j.tibtech.2011.01.007] [PMID: 21377748] ]. In the case of HIV infection, enumeration of CD4 lymphocytes accomplished by POCs is a pivotal diagnostic tool for initiating therapy and monitoring its efficacy, thus decentralizing the laboratories and providing results during the course of the patient visit [175Laursen L. Point-of-care tests poised to alter course of HIV treatment. Nat Med 18 United States 2012; 1156. [http://dx.doi.org/10.1038/nm0812-1156] ]. Implementation of rapid HIV POCs may improve the prevention of such diseases by increasing testing uptake rates, timely diagnosis and access to treatment, and consequently reducing the further virus transmission (Table 5).
2.2.5. Bacterial Infections
Among bacterial infections, syphilis is one of the most commonly worldwide occurring infection since it can be sexually and congenitally transmitted, with more than 6 million of new cases yearly [243French P. Syphilis. BMJ 2007; 334(7585): 143-7. [http://dx.doi.org/10.1136/bmj.39085.518148.BE] [PMID: 17235095] , 244Korenromp EL, Rowley J, Alonso M, et al. Global burden of maternal and congenital syphilis and associated adverse birth outcomes-Estimates for 2016 and progress since 2012. PLoS One 2019; 14(2)e0211720 [http://dx.doi.org/10.1371/journal.pone.0211720] [PMID: 30811406] ].
Syphilis diagnosis can be accomplished either on clinical manifestations or on serological assays, also accomplished by POCs, which detect IgM, IgG and IgA antibodies from whole blood, serum or plasma, exploiting immunochromatographic strips. Results are available within 30 minutes and the overall procedure requires minimal equipment and training (Table 6).
Table 5 Commercially available POC devices for viral infections detection.
Table 6 Commercially available POC devices for bacterial infections detection.
2.2.6. Fertility and Pregnancy
Infertility phenomenon affects 10–15% of couples and usually male factors account approximately half of the cases. Due to the difficulty in diagnose of male subfertility on the basis of only sperm count, simple diagnostic sperm tests have been marketed to allow men to monitor their sperm concentration, motility but also the testosterone concentration [114Diagnostics S. Available from: https://www.sekisuidiagnostics.com/products-all/fastpack-ip-automated-system/, 284Agarwal A, Panner Selvam MK, Sharma R, et al. Home sperm testing device versus laboratory sperm quality analyzer: comparison of motile sperm concentration. Fertil Steril 2018; 110(7): 1277-84. [http://dx.doi.org/10.1016/j.fertnstert.2018.08.049] [PMID: 30424879] ]. As to the female counterpart, self-tests of pregnancy are increasing due to women’s preferences for confidentiality, accessibility of the test tool and rapid results [285Braunstein GD. False-positive serum human chorionic gonadotropin results: Causes, characteristics, and recognition. Am J Obstet Gynecol 2002; 187(1): 217-24. [http://dx.doi.org/10.1067/mob.2002.124284] [PMID: 12114913] , 286Tate J, Ward G. Interferences in immunoassay. Clin Biochem Rev 2004; 25(2): 105-20. [PMID: 18458713] ] (Table 7)
2.2.7. Drug of Abuse
Drug abuse either recreational or in competitive sports is considered a significant social problem worldwide. In the last few years, many tests using alternative specimens for drug analysis have been developed in several formats, ranging dipsticks to cup devices, cards or plastic cassettes. Current POCs are immunoassay-based and can discriminate from one class to multiple classes of drugs, i.e., cannabinoids and cocaine and amphetamines. These provide a line or color when the drug of interest is at or above the defined threshold and can utilize paper, thin-layer, or gas chromatography methods. It is crucial for users to understand the strengths, weaknesses, and limitations of these devices to facilitate accurate interpretation of results in order to avoid false-positive results due to cross-reactivity with foods, over-the-counter preparations or commonly prescribed drugs. This latter condition is exacerbated in the case of POC manufacturers who use misleading nomenclature. Among possible available samples saliva is a good candidate being a noninvasive way to evaluate the presence of a drug (Table 8).
Cancer is considered as the second cause of death in the world, with prostate and breast cancer as the most common type of cancers in men and women, respectively (326). Most of the diagnostics tests are based on ELISA technique but unfortunately provide protein markers levels that correspond to advanced stages of the disease. Thus, cancer biomarkers-based POCs are of fundamental importance to diagnose, monitor but also to provide a prognostic approach and treatment of the disease (Table 9).
Table 7 Commercially available POC devices for pregnancy and infertitlity.
Table 8 Commercially available POC devices for drugs of abuse detection.
Table 9 Commercially available POC devices for cancer detection.
Table 10 Commercially available POC devices for genetic disorders detection.
Table 11 Commercially available POC devices in dentistry.
Traditional DNA tests are used to detect genotypes related to a heritable disease or phenotype of interest for clinical purposes. These methods generally require days to weeks before results are available, thus limiting the clinical practice in different circumstances, whereas POC, employ sophisticated techniques able to identify variations in the genetic sequence requiring a time ranging from few minutes to few hours (Table 10).
One of the challenges in dentistry is the rapid management of diseases such as chronic periodontitis, generally caused by Porphyromonas gingivalis, the rapid detection of which is important for an effective treatment [357Evans RT, Klausen B, Sojar HT, et al. Immunization with Porphyromonas (Bacteroides) gingivalis fimbriae protects against periodontal destruction. Infect Immun 1992; 60(7): 2926-35. [PMID: 1351883] , 358Simonson LG, Robinson PJ, Pranger RJ, Cohen ME, Morton HE. Treponema denticola and Porphyromonas gingivalis as prognostic markers following periodontal treatment. J Periodontol 1992; 63(4): 270-3. [http://dx.doi.org/10.1902/jop.1922.214.171.1240] [PMID: 1315388] ]. In this sense, a novel immunochromatographic device for the rapid detection and quantification of Porphyromonas gingivalis in subgingival plaque has been recently developed [359Imamura K, Takayama S, Saito A, et al. Evaluation of a novel immunochromatographic device for rapid and accurate clinical detection of Porphyromonas gingivalis in subgingival plaque. J Microbiol Methods 2015; 117: 4-10. [http://dx.doi.org/10.1016/j.mimet.2015.07.002] [PMID: 26159910] , 360Nakayama Y, Ogata Y, Hiromatsu Y, et al. Clinical usefulness of novel immunochromatographic detection device for porphyromonas gingivalis in evaluating effects of scaling and root planing and local antimicrobial therapy. J Periodontol 2016; 87(10): 1238-47. [http://dx.doi.org/10.1902/jop.2016.160147] [PMID: 27353439] ]. Also, ultrasonology has now acquired great relevance in dentistry, particularly in those situations where computed tomography may prove hazardous, such as pediatric patients, where a rapid identification of mandibular fractures may rule out the necessity for operative management [361Zapolsky N, Zapolsky IJ, Lim CA. Point-of-Care ultrasound diagnosis of multiple mandibular fractures in an adolescent presenting to the pediatric emergency department. Pediatr Emerg Care 2017; 33(9): 652-3. [http://dx.doi.org/10.1097/PEC.0000000000001253] [PMID: 28763407] ]. An updated overview of commercially available POC in dentistry is given below (Table 11).
Eye injuries and ocular complications frequently occur in emergency department visits, convenient care appointments or primary care evaluations requiring specific training and expert knowledge of ophthalmic diagnostic equipment, which generally are of high costs and are not portable. This latter feature results in problems in case of serious ocular injuries present outside the ophthalmology office. Seidel Test is conventionally used to evaluate the integrity of the anterior globe in trauma patients and the wound severity in post-operative patients. This test is based on a subjective and not standardized outcome due to the different amount of pressure and technique used by clinicians. Other devices used to aid in the diagnosis of eye injuries include X-ray, computed tomography, ultrasound and magnetic resonance imaging that are expensive and restricted to hospital settings due to their size and cost. The OcuCheck Biosensor™ is considered a valid alternative to the subjective Seidel Test providing an objective, rapid (5 minutes) and reliable result of ascorbic acid concentration within the ocular tear film, as a surrogate biomarker of anterior scleral or corneal wound integrity with a good accuracy degree (r = 0.89) [363Gartia MR, Misra SK, Ye M, et al. Point-of-service, quantitative analysis of ascorbic acid in aqueous humor for evaluating anterior globe integrity. Sci Rep 2015; 5: 16011. [http://dx.doi.org/10.1038/srep16011] [PMID: 26525715] ].
In the last 50 years, ultrasonography has become an integral part in many medicinal fields and ongoing technological advancements led to a rapid diffusion of POC ultrasound devices among medical wards, emergency rooms, intensive care units and outpatient clinics; due to high performance, reduced size and low costs (Table 12).
2.3. POCs in Veterinary Practice
Feline immunodeficiency virus (FIV) and feline leukaemia virus (FeLV) are the two most common viruses in cats associated with significant morbidity [377Hartmann K. Clinical aspects of feline retroviruses: A review. Viruses 2012; 4(11): 2684-710. [http://dx.doi.org/10.3390/v4112684] [PMID: 23202500] ]. One of the key challenges of POCT manufacturers is to identify infected cats, and beyond ELISA and other immunochromatographic tests, new in-house tests for FIV and FeLV diagnosis have been introduced to the market. Besides these two viruses, group A rotaviruses, parvovirus and influenza virus tests have also been successfully used in other species including dogs and horses. Moreover, biochemical parameters of POC devices, such as bilirubin, ketones, creatinine, hemoglobin, glucose, leucocytes, nitrites, specific weight, pH, proteins, urobilinogen, lactate, Cai and Mgi, have been investigated for other species including cow and cattle. The turnaround time of result of veterinary POC devices is generally below 20 minutes with an overall high degree of accuracy, providing the veterinarian with a good chance to clearly diagnose the disease, to the clients the possibility to save money and to the animals to minimize the discomfort and the sample volume required (Table 13).
Table 12 Commercially available POC devices in ultrasonology.
Table 13 Commercially available POC devices in veterinary.
POC devices are revolutionizing clinical and veterinary practice providing rapid test results in different clinical settings, located outside the human and veterinary hospital environment such as physician or vet office and pharmacy. POC technology is particularly helpful in the pre-analytical phase, reducing misidentification of patients and specimen, sample handling, transport and storage, but also in the post-analytical phase, limiting excessive turnaround time. The advancements in POCs have generally improved the quality of care, the health outcomes, and the affordability of the tests.
The use of POC by clinical personnel might have a positive impact on health-care by identifying patients at risk who need to be referred to the next level of care for an accurate diagnosis and treatment, involving patients in their own care, addressing therapeutic issues with the patients once the results are obtained and designing the disease management programs based on a POC device. Another key element of POC is connectivity, related to the possibility to link laboratory and hospital information systems with electronic the patient records. With the advent of the POCT1-A2 standard, it has now become possible to improve devices, data concentrators, and clinical information systems’ interoperability and communication [395 Available from: https://www.wipro.com/product-engineering/interoperability-for-point-of-care-testing-devices/]. Although there are many challenges related to the implementation of POCT1-A2 protocol in a POC, a framework-based approach has been shown to standardize implementation across devices with consequent ease of maintenance and a return on investment for POC vendors.
However, besides the growing need for connectivity of POC, the regulatory pressure for digitalization of all medical records and patient outcomes, led to another critical issue: the cybersecurity of such records. This latter becomes particularly critical among interconnected devices or through external interfaces (i.e. USB or Ethernet cables), with possible life-threatening consequences for patients. In fact, FDA imposed a serious vigilance to POC manufacturers in order to minimize the risk of cybersecurity threats by constantly monitoring, evaluating and updating their devices [396 Available from: https://www.invetechgroup.com/insights/2015/07/cybersecurity-for-diagnostic-devices/].
Since POC outcomes depend on the operator’s expertise, training and routine updating are crucial to reduce errors [397National Institute of Biomedical Imaging and Bioengineering/National Heart LaBINSFWF Price CP, Kricka LJ. Improving healthcare accessibility through point-of-care technologies Clinical chemistry 2007.]. Moreover, when used appropriately, POC devices are invaluable tools for patients but also for animal care, offering a rapid delivery of results and also allowing a reduction in costs due to: 1) Decreased facility costs [398St John A, Price CP. Economic evidence and point-of-care testing. Clin Biochem Rev 2013; 34(2): 61-74. [PMID: 24151342] ], 2) Decreased maintenance costs [398St John A, Price CP. Economic evidence and point-of-care testing. Clin Biochem Rev 2013; 34(2): 61-74. [PMID: 24151342] ], 3) Decreased waiting time [399Schilling M. The economic benefits of point-of-care testing 2015.], 4) Decreased hospitalization [399Schilling M. The economic benefits of point-of-care testing 2015.], 5) Decreased screening time [399Schilling M. The economic benefits of point-of-care testing 2015.] and 6) Improved home care delivery [398St John A, Price CP. Economic evidence and point-of-care testing. Clin Biochem Rev 2013; 34(2): 61-74. [PMID: 24151342] ].
Nanotechnology-based devices have revolutionized the concept of accuracy in diagnosis and therapy by integrating nanomaterials and biosensors, thus consequently minimizing costs and time to provide results.
CONSENT FOR PUBLICATION
CONFLICT OF INTEREST
The authors declare no conflict of interest, financial or otherwise.
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