Point of Care Testing

Point of care testing describes testing using handheld or benchtop technology, where the result will be used in the screening for, or the diagnosis and/or the management of, disease. It is an alternative to using the services of a centralized facility such as a laboratory.The successful use of point of care testing technology demands that the quality of the result can be assured and that a clinical and/or economic benefit can be demonstrated. As with benchtop technology, handheld technologies have features to deal with all the steps in the analytical process. The quality of the result depends on the manufacturing process of the device and the competence of the operator.The potential for clinical and/or economic benefit will exist wherever the rapid provision of the result enables a decision to be made immediately and appropriate action implemented. This may include making or ruling out a diagnosis; the latter leading to an alternative diagnostic pathway or discharge of the patient. The clinical benefits, however, will also depend on the implementation of an intervention and will be measured in terms of improved morbidity and mortality. However, in both the design of outcome studies as well as the routine management of patients, surrogate markers of outcome may be used to assess the value of the test and intervention.In patients with chronic diseases a test may be used to assess the status of the patient and the effectiveness of the intervention, thus playing an important role in maintaining patient compliance. Diabetes mellitus provides an excellent exemplar of point of care testing producing both positive clinical and economic outcomes in the management of a chronic disease. The speedy availability of results has also been shown to facilitate rapid decision making in acute medical situations such as in the emergency room and operating room.As a more patient-focussed approach to healthcare is being adopted leading to the requirement for faster access to results, as well as more testing being undertaken in the home and the primary care setting, the demand for point of care testing technology is set to increase dramatically. Changes in clinical practice will need to be made to maximize the benefits of testing to the patient and healthcare provider. Furthermore, a wider perspective will have to be adopted with regard to resource allocation because point of care testing, as a testing modality, will be expensive but the wider economic benefit will be greater.

[1]  Point-of-care testing in the intensive care unit. The intensive care physician's perspective. , 1995, American journal of clinical pathology.

[2]  L. Sokoll,et al.  Outpatient minimally invasive parathyroidectomy: a combination of sestamibi-SPECT localization, cervical block anesthesia, and intraoperative parathyroid hormone assay. , 1999, Surgery.

[3]  E. Spitznagel,et al.  Use of point-of-care test in identification of patients who can benefit from desmopressin during cardiac surgery: a randomised controlled trial , 1999, The Lancet.

[4]  B. Sibbald,et al.  Impact of introducing near patient testing for standard investigations in general practice. , 1993, BMJ.

[5]  S J Steindel,et al.  Cost analysis for decision support: the case of comparing centralized versus distributed methods for blood gas testing. , 1999, Journal of healthcare management / American College of Healthcare Executives.

[6]  R. Jones,et al.  An evaluation of near‐patient testing for Helicobacter pylori in general practice , 1997, Alimentary pharmacology & therapeutics.

[7]  L. Brandi,et al.  Five to 10 years follow-up after total parathyroidectomy and autotransplantation of parathyroid tissue: evaluation of parathyroid function by use of ischaemic blockade manoeuvre. , 1996, Scandinavian journal of clinical and laboratory investigation.

[8]  R. Grieve,et al.  Near patient testing in diabetes clinics: appraising the costs and outcomes. , 1999, Health technology assessment.

[9]  R K Ditchburn,et al.  A study of microscopical and chemical tests for the rapid diagnosis of urinary tract infections in general practice. , 1990, The British journal of general practice : the journal of the Royal College of General Practitioners.

[10]  B Littenberg,et al.  The diagnostic accuracy of rapid dipstick tests to predict urinary tract infection. , 1991, American journal of clinical pathology.

[11]  S. Genuth,et al.  The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. , 1993, The New England journal of medicine.

[12]  J Lindemans,et al.  Portable blood gas and electrolyte analyzer evaluated in a multiinstitutional study. , 1999, Clinical chemistry.

[13]  Dry Reagent Chemistries , 1983 .

[14]  L. Goodnough,et al.  Monitoring of hemostasis in cardiac surgical patients: impact of point-of-care testing on blood loss and transfusion outcomes. , 1997, Clinical chemistry.

[15]  U. Müller,et al.  Blood-glucose self-monitoring in insulin treated type 2 diabetes mellitus a cross-sectional study with an intervention group. , 1999, Diabetes & metabolism.

[16]  J A Brunelle,et al.  Simultaneous measurement of total hemoglobin and its derivatives in blood using CO-oximeters: analytical principles; their application in selecting analytical wavelengths and reference methods; a comparison of the results of the choices made. , 1996, Scandinavian journal of clinical and laboratory investigation. Supplementum.

[17]  N. D. de Wit,et al.  Tests for Helicobacter pylori infection: a critical appraisal from primary care. , 2000, Family practice.

[18]  D. Nathan,et al.  Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. , 1999, Diabetes care.

[19]  C A Parvin,et al.  Impact of point-of-care testing on patients' length of stay in a large emergency department. , 1996, Clinical chemistry.

[20]  D. Burnett Accreditation and point-of-care testing , 2000, Annals of clinical biochemistry.

[21]  W. Palatnick,et al.  Effect of point of care testing on length of stay in an adult emergency department. , 1999, The Journal of emergency medicine.

[22]  P. St-Louis Status of point-of-care testing: promise, realities, and possibilities. , 2000, Clinical biochemistry.

[23]  R. Winkens,et al.  The validity of urine examination for urinary tract infections in daily practice. , 1995, Family practice.

[24]  G. Dahlquist,et al.  Effect of angiotensin converting enzyme inhibitor or beta blocker on glomerular structural changes in young microalbuminuric patients with Type I (insulin-dependent) diabetes mellitus , 1999, Diabetologia.

[25]  M. Gulliford,et al.  Monitoring blood glucose control in diabetes mellitus: a systematic review. , 2000, Health technology assessment.

[26]  Yaochun Shen,et al.  Advances in photoacoustic noninvasive glucose testing. , 1999, Clinical chemistry.

[27]  J. Lott,et al.  Comparison of instrument‐read dipsticks for albumin and creatinine in urine with visual results and quantitative methods , 1998, Journal of clinical laboratory analysis.

[28]  D. Fitzmaurice,et al.  Anticoagulation management in primary care: a trial-based economic evaluation. , 2000 .

[29]  S. Walters,et al.  Costs and benefits of community postnatal support workers: a randomised controlled trial. , 2000, Health technology assessment.

[30]  O. C. Olson Diagnosis and Management of Diabetes Mellitus , 1988 .

[31]  Paul Fenn,et al.  Cost effectiveness of an intensive blood glucose control policy in patients with type 2 diabetes: economic analysis alongside randomised controlled trial (UKPDS 41) , 2000, BMJ : British Medical Journal.

[32]  M. Clancy,et al.  Point of care testing: randomised controlled trial of clinical outcome , 1998, BMJ.

[33]  M. Berkus,et al.  Intensified versus conventional management of gestational diabetes. , 1994, American journal of obstetrics and gynecology.

[34]  J. Widness,et al.  Clinical performance of an in-line point-of-care monitor in neonates. , 2000, Pediatrics.

[35]  J. W. A. S. Sander,et al.  IMMEDIATE ANTICONVULSIVE DRUG MONITORING IN MANAGEMENT OF EPILEPSY , 1987, The Lancet.

[36]  E. DeLong,et al.  Impact of Glucose Self-Monitoring on Non-lnsulin-Treated Patients With Type II Diabetes Mellitus: Randomized Controlled Trial Comparing Blood and Urine Testing , 1990, Diabetes Care.

[37]  R. Holman,et al.  Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. , 1998 .

[38]  O. Khalil,et al.  Spectroscopic and clinical aspects of noninvasive glucose measurements. , 1999, Clinical chemistry.

[39]  S. Griffin,et al.  Diabetes care in general practice: meta-analysis of randomised control trials. , 1998, BMJ.

[40]  C. Price Evidence-based laboratory medicine: supporting decision-making. , 2000, Clinical chemistry.

[41]  A. Simor,et al.  Rapid detection of infectious mononucleosis-associated heterophile antibodies by a novel immunochromatographic assay and a latex agglutination test , 1993, Journal of clinical microbiology.

[42]  J A Lott,et al.  Comparison of urine dipsticks with quantitative methods for microalbuminuria. , 1997, European journal of clinical chemistry and clinical biochemistry : journal of the Forum of European Clinical Chemistry Societies.

[43]  H. Bodansky,et al.  A Novel Device for the Rapid In‐clinic Measurement of Haemoglobin A1c , 1993, Diabetic medicine : a journal of the British Diabetic Association.

[44]  John Pickup,et al.  In vivo glucose sensing for diabetes management: progress towards non-invasive monitoring , 1999, BMJ.

[45]  M. Clancy,et al.  The Portable Laboratory: An Evaluation of the Accuracy and Reproducibility of i-STAT© , 1999, Annals of clinical biochemistry.

[46]  C. Price,et al.  Validation of a point-of-care assay for the urinary albumin:creatinine ratio. , 1999, Clinical chemistry.

[47]  M. Scott Faster is better--it's rarely that simple! , 2000, Clinical chemistry.

[48]  M. Galloway,et al.  An audit of waiting times in a haematology clinic before and after the introduction of point-of-care testing. , 1999, Clinical and laboratory haematology.

[49]  W. Maughan,et al.  Clinical outcomes of point-of-care testing in the interventional radiology and invasive cardiology setting. , 2000, Clinical chemistry.

[50]  B Walter,et al.  Solid-phase reagent strips for detection of therapeutic drugs in serum by substrate-labeled fluorescent immunoassay. , 1983, Analytical chemistry.

[51]  K. Nicolaides,et al.  One stop clinic for assessment of risk for fetal anomalies: a report of the first year of prospective screening for chromosomal anomalies in the first trimester , 2000 .

[52]  R. Bellazzi,et al.  Building telemedicine systems for supporting decisions in diabetes care: a report from a running experience. , 2000, Diabetes technology & therapeutics.

[53]  J. Piette,et al.  Do automated calls with nurse follow-up improve self-care and glycemic control among vulnerable patients with diabetes? , 2000, The American journal of medicine.

[54]  K. Porter,et al.  Randomized trial of hydroxyethyl starch versus gelatine for trauma resuscitation. , 1999, The Journal of trauma.

[55]  E. Antman,et al.  Evaluation of a rapid bedside assay for detection of serum cardiac troponin T. , 1995, JAMA.

[56]  B. Luce,et al.  The Economic and Clinical Efficiency of Point-of-Care Testing for Critically Ill Patients: A Decision-Analysis Model , 1998, American journal of medical quality : the official journal of the American College of Medical Quality.

[57]  M. Farrow,et al.  Evaluation of anticoagulant control in a pharmacist operated anticoagulant clinic. , 1995, Journal of clinical pathology.

[58]  G. Irvin,et al.  Improved success rate in reoperative parathyroidectomy with intraoperative PTH assay. , 1999, Annals of surgery.

[59]  J. Bonnar,et al.  Personal hormone monitoring for contraception. , 1999, The British journal of family planning.

[60]  E. Furth,et al.  AccuStat whole blood fingerstick test for Helicobacter pylori infection: a reliable screening method. , 1998, Journal of clinical gastroenterology.

[61]  H. Chin,et al.  Successful implementation of a comprehensive computer-based patient record system in Kaiser Permanente Northwest: strategy and experience. , 1998, Effective clinical practice : ECP.

[62]  A. Turner,et al.  Quinoprotein glucose dehydrogenase and its application in an amperometric glucose sensor. , 1986, Biosensors.

[63]  G. Valkirs,et al.  ImmunoConcentration--a new format for solid-phase immunoassays. , 1985, Clinical chemistry.

[64]  M. Moia,et al.  Assessment of patient capability to self-adjust oral anticoagulant dose: a multicenter study on home use of portable prothrombin time monitor (COAGUCHECK). , 2000, Haematologica.

[65]  E. Ohman,et al.  Relation between inhibition of platelet aggregation and clinical outcomes. , 1998, American heart journal.

[66]  J A Lott,et al.  Evaluation of an automated urine chemistry reagent‐strip analyzer , 1995, Journal of clinical laboratory analysis.

[67]  Prithipal Singh,et al.  A noninstrumented quantitative test system and its application for determining cholesterol concentration in whole blood. , 1990, Clinical chemistry.

[68]  J. Donovan,et al.  Diagnosis, management and screening of early localised prostate cancer. , 1997, Health technology assessment.

[69]  H. Katus,et al.  Multicentre evaluation of an immunological rapid test for the detection of troponin T in whole blood samples. , 1996, European journal of clinical chemistry and clinical biochemistry : journal of the Forum of European Clinical Chemistry Societies.

[70]  F D Hobbs,et al.  Oral anticoagulation management in primary care with the use of computerized decision support and near-patient testing: a randomized, controlled trial. , 2000, Archives of internal medicine.

[71]  L. Jovanovic,et al.  Noninvasive glucose monitoring: comprehensive clinical results. Cygnus Research Team. , 1999, JAMA.

[72]  P. Sawicki,et al.  A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. Working Group for the Study of Patient Self-Management of Oral Anticoagulation. , 1999, JAMA.

[73]  J. Marx,et al.  Value of point-of-care blood testing in emergent trauma management. , 2000, The Journal of trauma.

[74]  R. Holman,et al.  Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study , 2000, BMJ : British Medical Journal.

[75]  P Wilding,et al.  Evaluation of a novel point-of-care system, the i-STAT portable clinical analyzer. , 1993, Clinical chemistry.

[76]  A. Shenhav,et al.  Simultaneous detection of seven drugs of abuse by the Triage panel for drugs of abuse. , 1992, Clinical chemistry.

[77]  R. Califf,et al.  Risk stratification with a point-of-care cardiac troponin T test in acute myocardial infarction. GUSTOIII Investigators. Global Use of Strategies To Open Occluded Coronary Arteries. , 1999, The American journal of cardiology.

[78]  Doug Hirst,et al.  Keeping the spotlight on quality from a distance , 2000 .

[79]  D. Fitzmaurice,et al.  A review of near patient testing in primary care. , 1997, Health technology assessment.

[80]  E. Spitznagel,et al.  The impact of heparin concentration and activated clotting time monitoring on blood conservation. A prospective, randomized evaluation in patients undergoing cardiac operation. , 1995, The Journal of thoracic and cardiovascular surgery.

[81]  T. Northfield,et al.  Screening dyspeptic patients for Helicobacter pylori prior to endoscopy: laboratory or near‐patient testing? , 1998, European journal of gastroenterology & hepatology.

[82]  B. Peterson,et al.  Nurse Case Management To Improve Glycemic Control in Diabetic Patients in a Health Maintenance Organization , 1998, Annals of Internal Medicine.

[83]  R H Christenson,et al.  Simultaneous rapid measurement of whole blood myoglobin, creatine kinase MB, and cardiac troponin I by the triage cardiac panel for detection of myocardial infarction. , 1999, Clinical chemistry.