Validation of a Portable Coagulometer for Routine In-Hospital Use for Newborns

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Abstract

Objectives:

To verify the reliability and clinical benefits of the coagulation tests made by a point of care device in newborn admitted to a neonatal unit.

Design:

We made a statistical comparison between results obtained by the point of care device versus conventional laboratory analysis.

Setting:

Level 3 neonatal unit.

Patients:

Thirty-one infants admitted to the neonatal unit at the San Cecilio University Hospital (Granada, Spain) were recruited to this study.

Interventions:

All underwent a double analytical determination: a small drop of blood was taken for analysis with a portable coagulometer (qLabs Electrometer Plus) and the rest of the blood sample was analyzed with conventional hospital laboratory equipment.

Measurements and Main Results:

According to the linearity test performed, the measuring methods presented a good linear regression fit. Lin’s concordance coefficient showed a “good” agreement for activated partial prothrombin time and international normalized ratio (>0.61) and a moderate one for prothrombin time (0.41–0.6) for the sample of newborns.

Conclusions:

The portable coagulometer qLabs Electrometer Plus device has the potential to be an alternative to standard hospital coagulation autoanalyzers in a subset of patients where the amount of blood drawn can have significant risks. Our study is the first of its kind to analyze the use of this device with severely ill newborns.

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