Validation of a point-of-care device for monitoring dyslipidemias in adults.

Introduction: Point-of-care (POC) devices such as
the Accutrend® Plus are helpful in the measurement
of lipid levels and have been validated in the
laboratory setting, but not in a busy general practitioners
office. Since the Accutrend® Plus device
has recently been recommended as an additional
tool in the personal management of dyslipidemias,
it's of the utmost importance to ensure that the
precision and accuracy of this POC device is satisfactory.
Materials and methods: The sample consisted of
61 randomly chosen individuals (? 18 years) without
known history of cardiovascular disease
events. Simultaneous capillary and venous blood
testing was undertaken on the Accutrend® Plus
handheld lipid analyzer and a reference instrument
(Vitros® 5.1 FSchemistry system) respectively.
To stimulate a true picture of the usual clinical setting
all blood samples were taken in the private office
of each subject's general practitioner after a
fasting period of at least eight hours.
Results: The results show that the Accutrend® Plus
system provided significantly lower values (P <0.01)
of total cholesterol (TC) but not of triglycerides (TG)
(P > 0.05) as compared to the values determined in
the laboratory. The agreement between methods
fell outside clinically acceptable limits for blood lipid
measurement (TC ? 8.9%, TG ? 15%), as stated by
NCEP recommendations. However, a good between-
day reproducibility (ICC: TC = 0.85, TG = 0.68,
P<0.001) and significant concordance (P <0.001)
with the laboratory method was found.
Conclusion: Accutrend® Plus lacks precision and
accuracy compared to a reference chemistry system.
However, its reproducibility also suggests
that this portable POC device might be useful for
the monitoring of metabolic disorders and cardiovascular
risk factors. Clinicians should be aware
that fluctuations of 0.75 mmol/L (29 mg/dL) for TC
and 0.88 mmol/L (78 mg/dL) for TG are to be considered
as non-significant under constant diet circumstances.