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Abstract

Background

Point-of-care testing has been developed to provide rapid test results. Most published studies focus on analytical performance, neglecting its impact on patient outcomes.

Objective

To review the analytical performance and accuracy of point-of-care testing specifically planned for immunoassay and to evaluate the impact of faster results on patient management.

Methods

A search of electronic databases for studies reporting immunoassay results obtained in both point-of-care testing and central laboratory scenarios was performed. Data were extracted concerning the study details, and the methodological quality was assessed. The analytical characteristics and diagnostic accuracy of six points-of-care testing: troponin, procalcitonin, parathyroid hormone, brain natriuretic peptide, C-reactive protein and neutrophil gelatinase-associated lipocalin were evaluated.

Results

A total of 116 scientific papers were analysed. Studies measuring procalcitonin, parathyroid hormone and neutrophil gelatinase-associated lipocalin reported a limited impact on diagnostic decisions. Seven studies measuring C-reactive protein claimed a significant reduction of antibiotic prescription. Several authors evaluated brain natriuretic peptide or troponin reporting faster decision-making without any improvement in clinical outcome. Forty-four per cent of studies reported analytical data, showing satisfactory correlations between results obtained through point-of-care testing and central laboratory setting. Half of studies defined the diagnostic accuracy of point-of-care testing as acceptable for troponin (median sensitivity and specificity: 74% and 94%, respectively), brain natriuretic peptide (median sensitivity and specificity: 82% and 88%, respectively) and C-reactive protein (median sensitivity and specificity 85%).

Conclusions

Point-of-care testing immunoassay results seem to be reliable and accurate for troponin, brain natriuretic peptide and C-reactive protein. The satisfactory analytical performance, together with an excellent practicability, suggests that it could be a consistent tool in clinical practice, but data are lacking regarding the patient outcomes.

Keywords

Analytes analytical systems immunoassay laboratory methods proteins

Background

The technology of point-of-care testing (POCT) aims to generate appropriate test results quickly, thereby improving clinical outcomes and reducing associated costs.¹ The effect of POCT should therefore be evaluated in terms of correct diagnosis, improvement of therapeutic strategies and patient outcomes in the healthcare setting. A test implicates a benefit if its result leads to appropriate action. Few studies have been conducted to evaluate the effect of the results obtained in POCT on clinical outcomes, and, usually indicate the decrease of turn-around-time (TAT) as a critical factor in determining positive effect on patient management.² As evaluated in a previous survey, most studies evaluated surrogate outcomes only, which do not directly impact clinical outcomes.³

The implementation of POCT is successful when the performed assay is helpful for medical decision-making and does not need additional testing for confirmation from a central laboratory.⁴ New technologies in POCT should deliver to clinicians rapid and reliable test results, and high analytical and diagnostic performance, to reduce the incidence of false-negative or false-positive results which could lead to unjustified medical interventions.⁵ Several studies, evaluating the benefit of POCT in emergency department (ED), reported a significant decrease of TAT, but this effect did not lead to shorter length of stay (LOS)⁶ or to drive the decision-making process.⁷ Furthermore, the main advantages of POCT may be the early and appropriate support to diagnosis and treatment, but there are few studies evaluating how POCT results influence clinical decisions.

The aim of this research is to systematically revise the current state of six immunometric tests performed in POCT: brain natriuretic peptide (BNP), C-reactive protein (CRP), neutrophil gelatinase-associated lipocalin (NGAL), procalcitonin (PCT), parathyroid hormone (PTH), and cardiac troponin (Tn) and assess the impact of POCT on patients’ management.

Methods

We reported this review according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (Prisma) guideline.⁸

Eligibility criteria

Studies were included if they met the following criteria: (i) randomized controlled trial (RCT), prospective cohort, case-control or diagnostic test accuracy studies; (ii) specimens analysed by POCT and laboratory instruments; (iii) at least one indicator of patient outcomes.

Identification of studies

We performed a comprehensive systematic literature search and scanned the reference lists of articles. This search was applied to Medline (1995 – February 2016) and adapted for Embase (1995 – February 2016) to collect all potentially relevant scientific papers published in English. Databases were searched using the following search terms: POCT, BNP, CRP, NGAL, PCT, PTH and Tn. Duplicate articles were removed from the search results.

Selecting published studies

One reviewer examined the search results, screened the titles, abstracts and reference lists of identified articles and evaluated the eligibility of the individual studies. The full texts of the selected articles were obtained and examined for inclusion. If there was doubt about the inclusion of a study, eligibility was discussed by two authors.

Assessment of methodological quality

The Cochrane Collaboration risk of bias tool for cohort studies was adapted, and three questions were considered appropriate for the current study.

Was the study design adequate for the objective of the study?

Were outcome data adequately reported?

Where results discussed adequately?

Outcomes were classified as ‘adequate’ or ‘inadequate’ based on the quality of information reported. ‘Adequate’ was considered when the study design was randomized or prospectively designed, included sufficient information about diagnostic data (sensitivity [Sn] and specificity [Sp], positive and negative predictive values [PPV and NPV]) or analytical results (value of coefficient of variation, test ‘r’, mean and standard deviation) and the discussion supported the reported study results. ‘Unclear’ was assigned to the question if the information reported in the articles was incomplete.

Data extraction and analysis

One author extracted information on the general features of each study using a standardized extraction form, and a second author checked the data. The details included: (a) characteristic of the study: authors, reference, study design; (b) characteristics of patients (age, sex, number of sample for each patients group); (c) data about analytical performance of the test; (d) diagnostic accuracy outcomes: Sn, Sp, PPV and NPV; (e) patient important outcomes: number of myocardial injuries, infections or re-interventions, recurrence of hyperparathyroidism and renal failure; (f) information about clinical impact of POCT: antibiotic prescription, time to clinical decision, TAT, LOS.

Results

Study selection

Our literature search identified 519 references. Duplicates and irrelevant references excluded 100 records. After the initial screening of the abstracts, 176 studies proved to be eligible for inclusion and their full texts were analysed in more detail. A further 64 studies were excluded because they: (i) had no comparison with laboratory (n = 23); (ii) did not evaluate POCT (n = 15); (iii) were narrative review (n = 11); or evaluated only the implementation of the method (n = 15). After screening of the study references, further four studies were included. A total of 116 studies were included, dedicated to BNP or NTpro-BNP (n = 31), CRP (n = 25), NGAL (n = 5), PCT (n = 3), PTH (n = 6) and Tn (n = 46) (Figure 1).

Figure 1.

The literature flow diagram.

Study characteristics

The included trials corresponded to RCT (n = 14), prospective (n = 32), observational (n = 14) and diagnostic accuracy studies (n = 8), compared POCT and central laboratory results (n = 43), reported analytical evaluations (n = 2) and were cross-sectional studies (n = 3). Main features of the studies are summarized in Table 1. Overall, 65,119 samples were considered. Serial POCT multimarkers including Tn, CK-MB and myoglobin were evaluated in 15 studies.

Table 1.

Characteristics of included studies.

Marker	Author	Study design	Number of patients	Setting	Quality
NT-proBNP	Alehagen and Janzon⁹	Comparative	440	Coronary care unit	Adequate
BNP, NT-proBNP	Cleric ort al.¹⁰	Comparative	451	Not specify	Adequate
BNP	Del Ry et al.¹¹	Comparative	83 Samples	Laboratory of cardiovascular end.	Adequate
BNP	Di Somma et al.¹²	Prospective	180	WD	Adequate
BNP	Fischer et al.¹³	Comparative	145	Triage	Adequate
NT-proBNP	Gils et al.¹⁴	Comparative	95	Not specified	Unclear
BNP, TnI, CK-MB, Myo	Hamilton et al.¹⁵	Diagnosis	546	ED	Adequate
BNP	Harrison et al.¹⁶	Diagnosis	325	ED	Adequate
BNP	Howell et al.¹⁷	Observational	15	Intensive care	Unclear
NT-proBNP	Khezri et al.¹⁸	Comparative	98	Department of Clinical Chemistry Pharm	Adequate
BNP	Knudsen et al.¹⁹	Diagnosis	155	ED	Unclear
BNP	Kosowsky et al.²⁰	Observational	88	ED	Unclear
BNP	Ishida et al.²¹	Comparative	57 Samples	Not specified	Unclear
NT-proBNP	Jorgensen et al.²²	Comparative	627	Not specified	Adequate
BNP	Lang et al.²³	Comparative	172	Out-patient clinics	Unclear
NT-proBNP	Lee-Lewandrowski et al.²⁴	Comparative	606	ED	Adequate
NT-proBNP	Lepoutre et al.²⁵	Comparative	114	Not specified	Adequate
BNP	Olausson et al.²⁶	Comparative	82	Not specified	Adequate
BNP	Prontera et al.²⁷	Comparative	305	Triage	Adequate
BNP	Prontera et al.²⁸	Comparative	88	Not specified	Unclear
NT-proBNP	Prosen et al.²⁹	Prospective	218	ED	Adequate
BNP	Ro et al.³⁰	Prospective	250	Triage	Adequate
BNP	Shah et al.³¹	Comparative	114	ED	Adequate
BNP	Tjeerdsma et al.³²	Comparative	78	Clinic	Adequate
NT-proBNP	Verdù et al.³³	Diagnostic accuracy	220	Primary care	Adequate
BNP	Vogeser and Jacob³⁴	Analytical	70	Not specified	Unclear
BNP	Wei et al.³⁵	Diagnostic	84	Cardiology department	Adequate
BNP	Wieczorek et al.³⁶	Comparative	882	Triage	Adequate
BNP	Wu et al.³⁷	Prospective	172	ED	Adequate
NT-proBNP	Zaninotto et al.³⁸	Comparative	100	ED	Adequate
NT-proBNP	Zugck et al.³⁹	Comparative	674	Not specified	Adequate
CRP	Andreeva and Melbye⁴⁰	RCT	101	Primary care	Adequate
CRP	Aydin et al.⁴¹	Prospective	63	Pediatric	Adequate
CRP	Brouwer and van Pelt⁴²	Comparative	574	Not defined	Unclear
CRP	Cals et al.⁴³	RCT	258	Primary care	Adequate
CRP	Cals et al.⁴⁴	RCT	431	Primary care	Adequate
CRP	Dahler-Eriksen et al.⁴⁵	RCT	1853	Primary care	Adequate
CRP	Diar et al.⁴⁶	Prospective	209	Paediatric	Adequate
CRP	Esposito et al.⁴⁷	Cohort	231	Paediatric	Adequate
CRP	Gonzales et al.⁴⁸	RCT	131	ED	Adequate
CRP	Jakobsen et al.⁴⁹	Prospective	803	Primary care	Adequate
CRP	Lindström et al.⁵⁰	Observational	340	Primary care	Adequate
CRP	Marcus et al.⁵¹	Prospective	44	Paediatric	Unclear
CRP	Marcus et al.⁵²	Prospective	50	ED	Adequate
CRP	Markovic et al.⁵³	Comparative	104	Not defined	Unclear
CRP	Minnaard et al.⁵⁴	Comparative	Not clear	Not defined	Unclear
CRP	Minnaard et al.⁵⁵	Diagnostic accuracy	200	Primary care	Adequate
CRP	Monteny et al.⁵⁶	Cross-sectional	76	Paediatric	Adequate
CRP	Oh et al.⁵⁷	Comparative	150	Not defined	Unclear
CRP	Papa et al.⁵⁸	Prospective	150	Paediatric	Unclear
CRP	Peters et al.⁵⁹	Cohort	1472	Not defined	Adequate
CRP	Sambursky and Shapiro⁶⁰	Prospective	60	Tertiary care	Adequate
CRP	Seamark et al.⁶¹	Comparative	NR	Primary care	Inadequate
CRP	Siebenhaar et al.⁶²	Comparative	66	Not defined	Adequate
CRP	Van den Bruel et al.⁶³	Observational + RCT	200	Primary care	Adequate
CRP	Yebyo et al.⁶⁴	Cross-sectional	414	Primary care	Unclear
NGAL, BNP, NT-proBNP	De Berardinis et al.⁶⁵	Prospective	101	ED	Adequate
NGAL	Dent et al.⁶⁶	Prospective	120	Paediatric	Unclear
NGAL	Di Somma et al.⁶⁷	Prospective	160	ED	Adequate
NGAL	Hollmen et al.⁶⁸	Comparative	176	Dialysis	Adequate
NGAL	Howell et al.¹⁷	Comparative	15	Intensive care	Unclear
PCT, BNP, NGAL	Hur et al.⁶⁹	Prospective	340	ED	Adequate
PCT	Kutz et al.⁷⁰	Diagnostic accuracy	303	Not defined	Adequate
PCT	Meisner et al.⁷¹	Comparative	237 samples	Intensive care	Adequate
PTH	Agarwal et al.⁷²	Prospective	92	Surgery	Adequate
PTH	Carneiro and Irvin⁷³	Comparative	16	Surgery	Adequate
PTH	Farrag et al.⁷⁴	Prospective	14	Surgery	Adequate
PTH	Johnson et al.⁷⁵	Cohort	55	Surgery	Unclear
PTH	Sokoll et al.⁷⁶	Cohort	200	Surgery	Adequate
PTH	Terris et al.⁷⁷	Cohort	8	Surgery	Adequate
TnI	Aldous et al.⁷⁸	Comparative	1184	ED	Adequate
hs cTnT	Andersson et al.⁷⁹	Observational	115	Not defined	Adequate
TnI	Apple et al.⁸⁰	Observational	186 samples	ED	Adequate
TnI	Apple et al.⁸¹	Prospective	400	ED	Adequate
TnT	Asha et al.⁶	RCT	881	ED	Adequate
TnT	Asha et al.⁸²	RCT	452	ED	Adequate
TnI, CK-MB	Birkhahn et al.⁸³	Comparative	151	ED	Adequate
TnI	Blick⁸⁴	Comparative	377	ED	Adequate
TnI	Bock et al.⁸⁵	Comparative	5909	ED	Adequate
TnT	Collinson et al.⁸⁶	Comparative	319	Not defined	Unclear
TnT	Collinson et al.⁸⁷	RCT	263	Coronary care unit	Adequate
TnI, CK-MB	Collinson et al.⁸⁸	RCT	2263	ED	Adequate
TnT, TnI	Cramer et al.⁸⁹	Comparative	358	ED	Unclear
TnI	Diercks et al.⁹⁰	Observational	858	ED	Adequate
TnI	Di Serio et al.⁹¹	Comparative	85	Not defined	Adequate
TnT	Dupuy et al.⁹²	Comparative	68	Emergency and cardiology department	Adequate
TnI	Ezekowitz et al.⁹³	RCT	601	ED	Adequate
TnI	Farsi et al.⁹⁴	Prospective	262	ED	Adequate
TnT	Goldmann et al.⁹⁵	Prospective	741	Clinical routine	Adequate
TnI, CK-MB, Myo	Goodacre et al.⁹⁶	RCT	2243	ED	Adequate
TnT	Hallani et al.⁹⁷	Comparative	133	ED or CCU	Adequate
TnI, CK-MB, Myo	Hamilton et al.¹⁵	Diagnosis	546	ED	Adequate
TnI, CK-MB, Myo	Heeschen et al.⁹⁸	Comparative	302	Not defined	Adequate
TnI, CK-MB, Myo	Heeschen et al.⁹⁹	Observational	412	ED	Adequate
TnI, CK-MB	Hjortshøj et al.¹⁰⁰	Observational	458	ED	Adequate
TnI, CK-MB, Myo	Lee-Lewandrowski et al.¹⁰¹	Comparative	204	ED	Adequate
TnI	Loten et al.¹⁰²	Observational	332	ED	Adequate
TnI	Loten et al.¹⁰³	RCT	1194	ED	Adequate
TnI, CK-MB, Myo	McCord et al.¹⁰⁴	Observational	817	ED	Adequate
TnT, CK-MB	Muller-Bardorff et al.¹⁰⁵	Analytical evaluation	252	Not defined	Adequate
hs TnT	Monneret et al.¹⁰⁶	Comparative	NR	Not defined	Inadequate
TnI, CK-MB, Myo	Ng et al.¹⁰⁷	Prospective	1285	ED	Adequate
TnT	Nilsson et al.¹⁰⁸	Cross-sectional	196	Primary care	Adequate
TnT	Ohman et al.¹⁰⁹	Prospective	12666	ED	Adequate
TnI, CK-MB, Myo	Ordóñez-Llanos et al.¹¹⁰	Prospective	1410	ED	Unclear
TnI	Palamalai et al.¹¹¹	Observational	169	ED	Adequate
TnI, CK-MB, Myo	Baxter et al.¹¹²	Prospective	721	ED	Adequate
TnI	Renaud et al.⁵	RCT	833	ED	Adequate
TnI	Schneider et al.¹¹³	Comparative	195	ED	Adequate
TnT	Schuchert et al.¹¹⁴	Observational	158	ED	Adequate
TnT	Stengaard et al.¹¹⁵	Prospective	985	Ambulances	Adequate
TnT	Sørensen et al.¹¹⁶	Observational	4905	ED	Adequate
hs TnT	ter Avest et al.¹¹⁷	Prospective	261	ED	Adequate
TnT, proBNP	Tomonaga et al.¹¹⁸	RCT	369	Primary care	Adequate
TnI	Venge et al.¹¹⁹	Prospective	1069	ED	Adequate
TnI, CK-MB	Wu et al.¹²⁰	Comparative	180	Not defined	Adequate

BNP: brain natriuretic peptide; CRP: C-reactive protein; NGAL: neutrophil gelatinase-associated lipocalin; PCT: procalcitonin; PTH: parathyroid hormone; Tn: troponin; CK-MB: creatine kinase-myocardial band; Myo: myoglobin; ED: emergency department; RCT: randomized controlled trial; CCU: critical care unit.

Most studies were performed in ED (n = 49, 42%), in primary care (n = 13), in paediatric setting (n = 7), in surgery (6 studies on PTH), but also in triage (n = 4), intensive care (n = 2) or coronary care (n = 2), ambulance and department of clinical chemistry.

Methodological quality

Overall, we evaluated most studies as adequate in terms of methodological quality (Table 1). Most studies (n = 93, 80%) were judged adequate because had randomized or prospective design and satisfactorily reported relevant results that were discussed appropriately. The quality was considered as ‘unclear’ in 21 studies (18%), because they did not report enough information in the results section for a proper evaluation. Two studies were classified as ‘inadequate’ due to poor reporting of patients’ enrolment and methodology design used.

Evaluation of clinical impact of POCT

Information about the impact of POCT on patient management was reported in 51 studies (44%) (Table 2). Ten studies dedicated to BNP or pro-BNP reported that test markers provided by POCT resulted in myocardial injury diagnosis, especially in ED.

Table 2.

Number of studies evaluating specific outcomes.

	Diagnostic accuracy data	Analytical performance and agreement with lab	TAT	LOS	Clinical impact
BNP or NT-proBNP	16	19	7	0	10	Detection of heart failure
CRP	8	9	0	1	4	Identification of infection
					7	Antibiotic therapy modification
NGAL	3	2	ne	ne	4	Usefulness for kidney conditions
PCT	3	1	ne	ne	2	Management of infections
PTH	2	4	3	ne	2	Support intraoperative decisions
Tn	25	14	9	6	13	Correct identification of patients with myocardial disease
					9	Association with decision-making

BNP: brain natriuretic peptide; CRP: C-reactive protein; NGAL: neutrophil gelatinase-associated lipocalin; PCT: procalcitonin; PTH: parathyroid hormone; Tn: troponin; TAT: turn-around-time; LOS: length of stay; ne: not evaluated.

Seven studies (28%) dedicated to CRP evaluated the antibiotic therapy modification when CRP was determined by POCT compared with the same test performed in a central laboratory. In particular, three studies^40,43,59 reported a significant reduction of antibiotic prescription in POCT group compared with the control group. Instead, three studies reported a significant prediction of antibiotic prescription using CRP in POCT (odds ratio was 0.2,⁴⁸ 8.9⁴⁹ and 1.6,⁵⁰ respectively). Moreover, four studies (16%) evaluated CRP in the identification of patients with bacterial infections. Of these, one study⁶⁰ proved that the POCT test successfully identified patients with bacterial or viral infection, two studies^51,52 reported a good PPV for bacterial aetiology and one study⁵⁵ reported no difference between the intervention and the control group in infection prediction.

Four authors,^12,17,65,66 reported in the discussion section that the POCT testing of NGAL is an effective early biomarker for acute kidney disease, providing important information regarding renal perfusion status.

One study⁷⁰ suggested the implementation of PCT as a helpful biomarker for antibiotic decision-making in ED.

Two studies about PTH^72,73 reported that faster results timely reported to the surgical team, improved patient outcome and care.

Half of the studies about Tn (n = 22, 48%) assessed the impact of POCT on patients outcomes. Thirteen studies reported data about the accuracy of POCT to identify myocardial infarction or acute coronary syndrome and the relevant concordance between POCT and laboratory results.^{15,78,82,83,87,95,97,98,105,107,108,113,117,118} Nine studies discussed the POCT usefulness on decision-making, concluding that a small reduction in time to result availability may facilitate early diagnosis^88,100 and accelerate clinical decision,^5,98 but did not reduce LOS.⁶ In contrast, opinions on patient improvement outcomes were discordant: some authors reported a benefit for patients^78,83 and others concluded that there was no difference.^93,100 Only one study evaluated the diagnostic accuracy of physicians’ decision-making in primary care, reporting sensitivity of 67% and specificity of 100% for acute myocardial infarction (AMI).¹⁰⁸

Nineteen studies (17%) reported a significant decrease in TAT using POCT technology compared with tests performed in a central laboratory. Seven studies evaluated the effect of POCT on LOS reduction, concluding that generally POCT applied to Tn testing in ED reduces LOS. However, a comparison with a control group did not result in any significant difference. Furthermore, it is worthy to note that the decreased TAT did not correspond to any decrease in LOS.

Analytical performance

Forty-nine studies evaluated the analytical performance of BNP (n = 19), CRP (n = 9), N-GAL (n = 2), PCT (n = 1), PTH (n = 4) and Tn (n = 14) (Table 2). All studies showed a good correlation between results obtained by POCT and central laboratory as defined by ‘r’. Moreover, the coefficient of variation (intra- and inter-assay) was lower than 20% in all studies, proving an optimal reproducibility.

Diagnostic accuracy

Twenty-five studies on Tn (54%), 16 on BNP (52%) and 8 on CRP (30%) evaluated the diagnostic accuracy of POCT. Tn in POCT was proven to be effective in identifying patients with cardiac disease: Sn ranged from 39% to 100% and Sp ranged from 57% to 100%. In these studies, the PPV ranged from 20% to 100% and the NPV from 31% to 100% for predicting the presence or the absence of cardiac disease. Likewise, the measurement of BNP or pro-BNP in POCT showed a good accuracy: Sn ranged from 67% to 100% and Sp from 29% to 99%, the PPV ranged from 72% to 95%, and the NPV from 84% to 100%. The diagnostic accuracy was also acceptable for CRP with Sn ranging from 84% to 100% and Sp from 79% to 95%.

Discussion

In our review, we explored the clinical usefulness of POCT for immunoassay for BNP and proBNP, CRP, PCT, PTH, NGAL and Tn. The advantages and limits of these biomarkers determined by POCT were analysed in terms of patients’ management.

A total of 116 scientific papers were included, 49 of these studies (44%) reported analytical data, showing satisfactory correlations between results obtained through POCT instruments and those in a central laboratory setting. Forty-nine studies evaluating the diagnostic accuracy of Tn, BNP and CRP, reported sensitivity and specificity data that show an acceptable precision level of test results for the correct and prompt diagnosis of myocardial injury or infection.

Moreover, we investigated the possible clinical impact of POCT testing in 51 studies. Five studies performed on PCT, PTH and NGAL were available on this issue and reported a limited impact on diagnostic decisions. Seven studies evaluating CRP showed a significant decrease of antibiotic prescription, also proven in a previous systematic review.¹²¹ Several studies evaluating BNP or Tn highlighted the usefulness of rapid tests especially in ED. However, there was insufficient evidence defining an improvement in clinical outcomes. In ED, where POCT for immunoassay is commonly applied, the availability of early and reliable diagnostic biomarkers for cardiac disease is especially useful in the provision of timely and accurate AMI diagnosis,¹²² thereby reducing the incidence of inappropriate diagnosis.¹²³ Despite the rapid TAT, early POCT had a lower sensitivity compared with hs-cTn performed in a central laboratory, which is more effective in excluding AMI in patients accessing ED with higher accuracy.¹²⁴ Our analysis confirms that POCT for cardiac markers does not seem to significantly improve the clinical outcomes, as concluded by a previous systematic review.¹²⁵

The usefulness of POCT should be strongly associated with the requirement of a technology able to provide appropriate results together with optimal analytical performances to support clinical decision in the light of patients’ characteristics. Most evaluated studies simply evaluated the decrease of TAT, suggesting that the decrease of time elapsed from test request and release of results could produce an advantage to patients’ management.^{5,6,17,74,77,87,89,93,95} Available studies evaluated scientific dimensions only, which are considered surrogate outcomes, whereas an effective evaluation should include clinical outcomes and the relevant impact of timely results on patients’ management.³

It seems logical that the reduction of time between test request and result availability facilitates early treatment intervention and clinical actions, thereby improving the disease management. However, the time to clinical action also depends on factors such as doctors’ experience, elaboration and interpretation of data or the need for further investigations, clinical organization, other technology and facilities present in each clinical setting. Thus, for patients with suspected deep venous thrombosis, acute coronary syndrome or acute appendicitis, POCT significantly reduced TAT but was proven to have a limited effect on time to action.^126,127 Furthermore, some authors showed as the usefulness of POCT in faster decision-making, influencing treatment and further care,¹²⁸ supporting clinical decisions and stratifying patients,⁵ but only in specific environments when access to care is limited or in case of environmental disasters.^129,130

The literature evaluation showed that POCT is part of a healthcare system in which the patient is the central point. Our systematic review confirms that POCT is characterized by good agreement with central laboratory system, and analytical and diagnostic accuracy. However, our research showed that, although POCT is widely adopted, its impact on time to clinical decision and patient management has not been consistently investigated. Evaluation of patient outcome is an important issue in the assessment of POCT effectiveness in clinical practice. Studies evaluating the impact of tests on patient outcomes remain partial, and consequently, this systematic review cannot offer suggestions or strong recommendations. Studies evaluating the impact of POCT in terms of patient outcome are indispensable for harmonization. In the process of harmonization, the issue of request pertinence was debatable, and the agreement in terms of interpretation of results, analytical performance and reference values for POCT was reached, but evidence about the improvement in the quality of healthcare after TAT reduction are not available.

Moreover, while interpreting the results of this review, some aspects should be considered. The included studies were performed in heterogeneous setting (especially in primary care or ED) and enrolled heterogeneous patients. Further, different POCT technologies were used, different cut-offs were considered and different operators carried out the tests in different conditions and organizational contexts. All these aspects contribute to generate inharmonious results and this renders the generalization of the data presented in the different research difficult.

In conclusion, POCT for immunometric markers offers several clinical advantages: faster test results with minimal analytical engagement. They have a potential to improve patient outcome, although this aspect is inadequately recorded in current clinical studies.

To introduce POCT in daily practice, the instrument should be adequate to guarantee, in a short TAT, the requested analytical and diagnostic performance, to avoid misleading results, to identify and classify patients according to the risk of injury¹²² and to guarantee the best clinical outcomes.

It is recommended that future publications on this topic include the impact on clinical decisions and patient outcomes.

Footnotes

Acknowledgements

The authors wish to thank Johanna Chester who assisted with an editorial evaluation of this review.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Ethical approval

Ethical approval was not required because this work is a review of biomedical literature.

Guarantor

VP.

Contributorship

All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission. VP conceived and designed the study. VP and TT wrote the protocol. VP designed and implemented the search strategies. VP selected studies, assessed validity, and extracted data. VP entered and analysed the data. All authors interpreted the data, prepared the full review and contributed to its revision, interpretation of results, and approval.

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A systematic evaluation of immunoassay point-of-care testing to define impact on patients’ outcomes

Abstract

Background

Objective

Methods

Results

Conclusions

Keywords

Background

Methods

Eligibility criteria

Identification of studies

Selecting published studies

Assessment of methodological quality

Data extraction and analysis

Results

Study selection

Study characteristics

Methodological quality

Evaluation of clinical impact of POCT

Analytical performance

Diagnostic accuracy

Discussion

Footnotes

Acknowledgements

Declaration of conflicting interests

Funding

Ethical approval

Guarantor

Contributorship

References