title: Validation of a novel point-of-care nerve conduction device for the detection of diabetic sensorimotor polyneuropathy.
abstract: OBJECTIVE
  The diagnosis of diabetic sensorimotor polyneuropathy using objective electrophysiological tests is hindered by limited access to the specialized laboratories and technicians that perform and interpret them. We evaluated the performance characteristics of a novel portable and automated point-of-care nerve conduction study device, which can be operated by nontechnical personnel, and compared it with conventional nerve conduction studies performed in a specialist setting.
  
  
  METHODS
  Seventy-two consecutive patients with diabetes (8 type 1, 64 type 2) from a diabetes and a neuropathy outpatient clinic were evaluated concurrently with conventional nerve conduction studies (the reference standard) and the point-of-care device for sural nerve function (sural nerve amplitude potentials in microvolts [microV]).
  
  
  RESULTS
  Sural nerve amplitude potentials measured by the point-of-care device shared very strong correlation with the reference standard (Spearman's correlation coefficient 0.95, P < 0.001). The Bland and Altman method yielded agreement despite a small systematic underestimation by the point-of-care device of 1.2 +/- 3.4 microV. Despite this small systematic bias, the sensitivity and specificity of normal and abnormal sural nerve amplitude potentials measured by the point-of-care device for the detection of diabetic sensorimotor polyneuropathy defined by standard clinical and electrophysiological criteria were 92 and 82%, respectively.
  
  
  CONCLUSIONS
  A novel point-of-care device has excellent diagnostic accuracy for detecting electrophysiological abnormality in the sural nerve of patients who have diabetes. This automated device represents an alternative to conventional nerve conduction studies for the diagnosis of diabetic sensorimotor polyneuropathy.
authors.affiliation: Toronto General Hospital, 200 Elizabeth St., Room EN-12-217, Toronto, Ontario, Canada M5G 2C4. bruce.perkins@uhn.on.ca
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Perkins
authors.forename: Jaspreet
authors.initials: J
authors.lastname: Grewal
authors.forename: Eduardo
authors.initials: E
authors.lastname: Ng
authors.forename: Mylan
authors.initials: M
authors.lastname: Ngo
authors.forename: Vera
authors.initials: V
authors.lastname: Bril
mesh_terms: D000368:Aged; D003920:Diabetes Mellitus / Q000175:diagnosis* / Q000503:physiopathology; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis / Q000503:physiopathology; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000503:physiopathology; D003929:Diabetic Neuropathies / Q000175:diagnosis* / Q000503:physiopathology; D004568:Electrodiagnosis / Q000295:instrumentation* / Q000379:methods; D004594:Electrophysiology / Q000295:instrumentation / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009431:Neural Conduction / Q000502:physiology*; D011115:Polyneuropathies / Q000175:diagnosis / Q000503:physiopathology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity