title: Point-of-care testing of neonatal coagulation.
abstract: The aim of this validation study was to compare prothrombin time (PT) and activated partial thromboplastin time (APTT) results from a point-of-care testing (POCT) device (Rapidpoint Coag) with those from standard laboratory tests. The subjects were newborn infants needing coagulation screen for any clinical indications within a regional neonatal intensive care unit. The level of agreement between POCT and laboratory measurements of PT and APTT was determined. For PT: the bias was from -7.6 to 12.4 s and precision was 5.0 s. For the detection of prolonged PT at a level of 16 s, the sensitivity was 0.70, specificity was 0.57 and the positive predictive value (PPV) was 0.62. For APTT: the bias was from -39.1 to 23.7 s, and precision was 15.7 s. For the detection of prolonged APTT at a level of 55 s, the sensitivity was 0.80, specificity was 0.95 and the PPV was 0.80. The POCT device tested has limited utility as a cot-side device for screening for a prolongation of the APTT in the newborn but is not sensitive for screening for prolongation of the PT.
authors.affiliation: Neonatal Unit, St James's University Hospital, Leeds, UK. ktan@mcmaster.ca
authors.forename: K
authors.initials: K
authors.lastname: Tan
authors.forename: D
authors.initials: D
authors.lastname: Booth
authors.forename: S J
authors.initials: SJ
authors.lastname: Newell
authors.forename: P R F
authors.initials: PR
authors.lastname: Dear
authors.forename: C
authors.initials: C
authors.lastname: Hughes
authors.forename: M
authors.initials: M
authors.lastname: Richards
mesh_terms: D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010314:Partial Thromboplastin Time / Q000295:instrumentation / Q000379:methods*; D019095:Point-of-Care Systems; D011517:Prothrombin Time / Q000295:instrumentation / Q000379:methods*