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

Valentina Pecoraro, Giuseppe Banfi, Luca Germagnoli, Tommaso Trenti

Research output: Contribution to journalReview article

3 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)420-431
Number of pages12
JournalAnnals of Clinical Biochemistry
Volume54
Issue number4
DOIs
Publication statusPublished - Jul 1 2017

Fingerprint

Immunoassay
Troponin
Brain Natriuretic Peptide
Testing
C-Reactive Protein
Lipocalins
Gelatinases
Calcitonin
Parathyroid Hormone
Sensitivity and Specificity
Point-of-Care Testing
Prescriptions
Decision Making
Decision making
Databases
Anti-Bacterial Agents

Keywords

  • Analytes
  • analytical systems
  • immunoassay
  • laboratory methods
  • proteins

ASJC Scopus subject areas

  • Clinical Biochemistry

Cite this

A systematic evaluation of immunoassay point-of-care testing to define impact on patients’ outcomes. / Pecoraro, Valentina; Banfi, Giuseppe; Germagnoli, Luca; Trenti, Tommaso.

In: Annals of Clinical Biochemistry, Vol. 54, No. 4, 01.07.2017, p. 420-431.

Research output: Contribution to journalReview article

Pecoraro, Valentina ; Banfi, Giuseppe ; Germagnoli, Luca ; Trenti, Tommaso. / A systematic evaluation of immunoassay point-of-care testing to define impact on patients’ outcomes. In: Annals of Clinical Biochemistry. 2017 ; Vol. 54, No. 4. pp. 420-431.
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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.",
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