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Related Experiment Videos

Point-of-care testing of neonatal coagulation.

K Tan1, D Booth, S J Newell

  • 1Neonatal Unit, St James's University Hospital, Leeds, UK. ktan@mcmaster.ca

Clinical and Laboratory Haematology
|April 25, 2006
PubMed
Summary

This study validated a point-of-care testing (POCT) device for newborn coagulation screening. The device showed promise for activated partial thromboplastin time (APTT) but was not sensitive enough for prothrombin time (PT) screening.

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Area of Science:

  • Neonatal Medicine
  • Clinical Pathology
  • Medical Device Validation

Background:

  • Coagulation screening is crucial for newborn infants in neonatal intensive care units.
  • Standard laboratory tests for coagulation parameters can be time-consuming.
  • Point-of-care testing (POCT) offers potential for rapid bedside assessments.

Purpose of the Study:

  • To validate the Rapidpoint Coag POCT device for measuring prothrombin time (PT) and activated partial thromboplastin time (APTT) in neonates.
  • To compare POCT results with standard laboratory coagulation tests.
  • To assess the diagnostic performance of the POCT device for detecting prolonged PT and APTT in newborns.

Main Methods:

  • A validation study comparing a POCT device (Rapidpoint Coag) with standard laboratory tests.

Related Experiment Videos

  • Subjects included newborn infants requiring coagulation screening in a neonatal intensive care unit.
  • Agreement, bias, precision, sensitivity, specificity, and positive predictive value (PPV) were calculated for PT and APTT.

    • Main Results:

    • For PT: bias ranged from -7.6 to 12.4 s, precision was 5.0 s. Sensitivity was 0.70, specificity 0.57, PPV 0.62 for prolonged PT (>16 s).
    • For APTT: bias ranged from -39.1 to 23.7 s, precision was 15.7 s. Sensitivity was 0.80, specificity 0.95, PPV 0.80 for prolonged APTT (>55 s).

    Conclusions:

    • The POCT device has limited utility for bedside screening of prolonged APTT in neonates.
    • The device is not sensitive enough for screening prolonged PT in newborns.
    • Further evaluation may be needed for specific clinical applications in neonatal coagulation monitoring.