Analytical performance assessment
- Lab directed vs. vendor directed vs. third party independent assessments
- Accuracy relative to lab reference method
- Patient comparisons
- Clinically acceptable bias/Total allowable error (TEa)
- Precision: Within run and between run
- Analytical specificity/interferences
- Cost assessment
- Start-up/implementation costs
- Operational costs
- End user acceptability
- Focus groups
A survey of laboratorians showed that, when developing new POC devices for disasters, high clinical sensitivity (>90%), high clinical specificity (>90%), rapid processing speed, and the ability to operate on battery power were all predictive of device selection by survey respondents. A high value attribute of POCT is the ability for flexibility and adaptability; therefore, POCT should be easy to use and function in austere low resource environments (91).
Processes and Outcomes
Does faster turnaround time (secondary to POCT) lead to improved processes and outcomes?
Unarguably, POCT generates faster test result TAT when compared to central lab (CL) testing secondary to markedly reduced collect to in-lab and in-lab to result time segments. In turn, end-user clinical providers (especially those in time sensitive/critical care such as the Emergency Department ( ED) and Intensive Care Unit (ICU) clinical areas) believe that faster TAT necessarily translates into improved patient care because there is the opportunity for quicker clinical responses leading to better patient outcomes or quicker patient care processes; hence, their desires to continually expand POCT menus.
The intent of this discussion was to review existing literature to determine what available evidence, if any, exists to support the hypotheses that faster TATs secondary to POCT; improve outcomes (decreased morbidity and mortality) or patient care processes (decreased admissions or shortened length of stay (LOS).
This review did not include studies assessing POCT vs. CL methods in terms of method characteristics (accuracy, linearity, and precision) nor were speculative studies about the ability of specific POCT to improve outcomes/processes included. In addition, outcomes evidence associated with POCT self-monitoring was not reviewed for this discussion.
PUBMED free text literature searches were performed using the following terms: POC, POCT, point of care, point of care test, or point of care testing combined with emergency, length of stay, LOS, throughput and outcome, hemoglobin A1c or HbA1c. Strict cost analysis comparing POCT to CL were also not included In addition, PUBMED “related articles” searches were performed on key references initially identified, as well as for identified as use/utility review articles.
References were reviewed (and selected if identified) by title, abstract, and body (if necessary) to see if either of these two topics were discussed:
- Did POCT improve patient care processes (e.g., length of stay or decreased admissions).
- Was the impact of POCT compared against comparable central lab processes with respect to specific patient populations and disease states to see if patient care improved in terms of, outcome, prognosis, morbidity or mortality.
As several “meta-analytic” reviews on this topic (67, 92–96) have already been done, they were cited instead of their cited references with uncited or prominent references cited individually. Of note (92), provided the general structure used in this discussion to breakdown POCT by scenario. This reference was the most complete summary of POCT related evidence; however, it was not solely used without identification of additional references.
With respect to this study, there is a hazy boundary between improved process and improved outcome with overlap between the two. Studies were classified as either “process” or “outcome” based on which appeared to be more prominent in the discussion.
Creatinine (92, 97–99): Creatinine testing prior to contrast radiology studies speaks for itself with respect to how it improves patient process. Glomerular filtration rate (GFR) based on blood creatinine levels is used to assess for underlying chronic kidney disease; a risk factor for contrast induced nephropathy (CIN), and an individual’s subsequent risk for CIN. Provision of creatinine near/prior to such radiology studies allows for a rapid assessment of renal function without waiting for a CL assayed result. POCT in this process should theoretically improve radiology throughput; however, no studies were identified in the literature confirming faster throughput.
Drug of abuse screening (92, 100): Only one study was clearly identified; it showed a decreased LOS in the ED with testing. Hypothetically, the lack of outcomes related studies is due to analytic limitations of POCT drug of abuse testing (i.e., possibility of false negatives or false positives). For example, in the presumed drug intoxicated individual, a negative test requires CL confirmation; whereas, in term of compliance monitoring, a positive test would require CL confirmation. For the former situation, presence or absence of a rapid result should not hinder or limit urgent, as needed, clinical care.
Human chorionic gonadotropin (hCG) (92): With respect to hCG testing, there is the dilemma of POCT qualitative result vs. CL quantitative result complicated by the dilemma of the “indeterminate” POCT result. Per the review, there is a difference of opinion between radiologists and non-radiologists on which test is preferred. In one study, no reduction in LOS was seen with the use of POCT.
D-Dimer (92): One study noted that emergency department D-Dimer testing (negative result) use was able to decrease admission by 14% and increased discharges by 21% in cases of suspected pulmonary embolism.
Influenza (101–105): There were numerous references supporting ED use of POCT influenza diagnosis. They all reported decreased antibiotic use, reduced testing, and decreased admissions for the “positive” testing patients. There was inclusive evidence that ED LOS was reduced.
Emergency Department (ED)/Urgent care (92, 106–121): Mixed results on whether POCT could shorten LOS or admissions with the majority showing some decreases in LOS. One study noted that implementation of POCT resulted in a 20% reduction in treatment time compared to a non-POCT track. Electrolytes were shown to decrease LOS. ED POCT troponin testing is included in the troponin discussion.
Glucose (92, 122): Multiple studies have conclusively demonstrated that improved glycemic control in the inpatient population decreases morbidity and improves outcome, provided that the glycemic threshold is not too low (140–180 mg/dL); however, the data in those studies are CL based. In spite of multiple search strategies, no studies were identified reviewing the impact of POCT glucose on inpatient processes or outcomes. The absence of studies is probably associated with the fact that there are analytic concerns regarding inpatient specimen quality secondary to underlying illness and acuity, as well as medication-related interferences. These findings apply to intra- and peri- operative testing as well.
HbA1c (92, 122–125): Multiple studies have confirmed that POCT HbA1c testing not only is a physician/patient satisfier (an immediate result to confirm/deny glycemic status with subsequent one-on-one discussion) but also showed improved HbA1c level and changes in treatment as needed, as well as improved costs by decreased testing, fewer clinic visits, and less hospital admissions. One study indicated that ED use was useful in detecting additional cases of diabetes independent of blood glucose levels.
Blood gases/electrolytes (Intraoperative) (92): No outcome studies for POCT intra- or peri- operatively were identified.
Blood gases/electrolytes (ICU/ED) (92): Multiple studies identified that showed quicker result turnaround time with varying responses as to whether they impacted LOS or prognosis. One study showed that clinical decision time increased; however, without any changes in LOS, mortality or rate of hospital admission due to other inherent hospital barriers (availability of physician or bed space). Interestingly, one study showed that ICU clinicians prefer CL over POCT results because of the former’s better accuracy.
Troponin (92, 96, 125, 126): In spite of numerous references discussing POCT troponin, there are few outcomes-related studies. Improved outcomes were noted in remote/rural settings. POCT was able to improve outcome by stratifying patients requiring, and not requiring, transfer for sophisticated cardiac care. In the DISPOACS (US), use of POCT was associated a significant reduction in time to discharge and in the RATPAC (UK) study, there was increased rate of successful discharge and a reduced LOS.
Brain natriuretic peptide (BNP and NT-ProBNP) (127–131): Circulating concentrations of the hormone brain natriuretic peptide (BNP) and its precursor molecule, NT-proBNP, are increased in those with heart failure. Normal levels of these hormones have established the role of these biomarkers in ruling-out the diagnosis of congestive heart failure. Results of POCT of natriuretic peptides have demonstrated earlier rule-out of heart failure and lower healthcare costs compared to clinical diagnosis based on history and clinical symptoms and hospital laboratory analysis. A recent meta-analysis also indicates that BNP/NT-ProBNP may have clinical application for excluding a diagnosis of ischemic stroke, specifically cardioembolic stroke. Incorporation of rapid POCT BNP in early stroke management guidelines has been suggested to improve stroke risk stratification and accelerate the start of secondary preventive measures, further diagnostic examinations, and rehabilitation interventions; however, the demonstration of improved patient outcomes from this strategy has yet to be published.
Hemoglobin (92): One study was identified that showed multi parameter POCT in the NICU reduced blood transfusions in the very low birthweight infant.
Platelets: No studies were identified.
Activated clotting time (ACT): No studies were identified; however, this test was designed to be a near patient test for real time assessments of clotting status, especially for those patients on heparin during vascular related procedures.
Thromboelastography (TEG): No studies were identified. However, this test was designed to be a near patient test for real time assessments of intra-operative and trauma related clotting status.
Sepsis (Lactate) (92): Lactate was found to reduce ICU admission rates and mortality in one study, as well as to increase time to administer IV fluids but not antibiotics. Another study identified a lack of evidence for the use of lactate in community settings.
Remote rural communities (92): Multiple studies were identified that focused on regions (Australia and New Zealand) where centralized medical facilities were markedly distant from remote hospitals. In all of these studies, POCT reduced transfers and increased diagnostic certainty at the remote locations, allowing for overall cost savings. In one study, use of POCT cardiac markers as part of remote risk stratification reduced 30-day mortality by better determination of which patients should be transferred to tertiary care centers for invasive treatment. Similar improvements in morbidity were also noted with POCT lipid testing, significantly reducing total cholesterol in the patients tested locally instead of specimens sent to a CL. Mention is made of the use of HbA1c and albumin/creatinine ratio (ACR) in remote communities to assist with diagnosis, glycemic control, and monitor for renal complications, but no mention is made of its impact. Lastly, the Canadian Agency for Drugs and Technology (CADTH) sponsored a Health Technology Assessment project with respect to the use of POCT troponin (Tn) in remote/rural locations. It concluded that in locations without laboratory testing, POCT Tn testing reduced transfer to central locations.
Primary care practice (92): Limited data on whether POCT affected outcomes in primary care practices. The few studies available were confounded by the cost/benefit of POCT vs. central laboratory (CL) testing. POCT was more expensive than CL but clinically effective in ACR but not HbA1c testing (see specific section on HbA1c).
Community pharmacy (92): Utilization in this area is widely available but it has not been studied as to whether it improves patient outcomes.
AACC, American Association for Clinical Chemistry; NACB, National Academy of Clinical Biochemistry; POCT, point-of-care testing; LMPG, Laboratory Medicine Practice Guidelines; TAT, turnaround; PT, proficiency testing; EQA, external quality assessment; CLSI, Clinical and Laboratory Standards Institute; NICU, neonatal intensive care unit; QAAMS, Quality Assurance of Aboriginal Medical Services; INR, international normalized ratio; HbA1c, hemoglobin A1C; CAP, College of American Pathologists; ED; Emergency Department; ICU, Intensive Care Unit; LOS, length of stay.
Author Contributions: All authors confirmed they have contributed to the intellectual content of this paper and have met the following 4 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; (c) final approval of the published article; and (d) agreement to be accountable for all aspects of the article thus ensuring that questions related to the accuracy or integrity of any part of the article are appropriately investigated and resolved.
Authors’ Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the author disclosure form. Disclosures and/or potential conflicts of interest:
Employment or Leadership: J.H. Nichols, The Journal of Applied Laboratory Medicine, AACC; D. Alter, College of American Pathologists; T.S. Isbell, AACC Point of Care Professional Certification Board; E. Jacobs, Abbott Rapid Diagnostics; N. Moore, Abbott. Consultant or Advisory Role: E. Jacobs, Quidel Corp. Stock Ownership: E. Jacobs, Abbott Diagnostics; N. Moore, Abbott. Honoraria: T.S. Isbell, Abbott Laboratories. Research Funding: None declared. Expert Testimony: None declared. Patents: None declared.
Role of Sponsor: No sponsor was declared.
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