Validation study: clarity multistrip urocheck.
OBJECTIVE
To test the interchangeability of a previously untested urine reagent strip, Clarity (RAC Medical), with the gold standard, Multistix (Bayer).


METHODS
Seventy-six urine samples were tested with both the comparator and the gold standard urine reagent strips. Pairs of reagent strips were analyzed in the Clinitek Analyzer, recording the following: leukocytes, nitrite, urobilinogen, protein, pH, blood, specific gravity, ketone, bilirubin, glucose, and color. Data was assessed using statistical comparison of ordinal data (chi-square, Fisher's Exact, kappa, and weighted kappa). This study was approved by the Indiana University-Purdue University at Indianapolis Institutional Review Board.


METHODS
The study took place at Wishard Health Services, Indianapolis IN.


METHODS
All urine tested was obtained from patients of the primary care clinic at Wishard Health Services.


METHODS
n/a.


METHODS
The ability for both reagent strips to generate (statistically significant) identical readings across all 11 measurements for each sample.


RESULTS
Kappa values were deemed the best indicator to consistently examine the reproducibility of all 11 measurements of the Clarity versus the Multistix. Ten of eleven measurements were concluded to be non-reproducible by the Clarity strips; nitrite readings achieved a kappa value above 0.85, whereas all other readings achieved kappa values well below the acceptable limits of this investigation (ranging from 0.00 to 0.65).


CONCLUSIONS
There was a lack of statistically significant agreement between the results of both products and therefore it was concluded that both products cannot be used interchangeably.
Hartgrove
Karla
K
Norton Suburban Hospital, Louisville, KY, USA.
Intrevado
Paul
P
Abel
Steven R
SR
D001331:Automation / Q000592:standards; D006029:Glycosuria / Q000175:diagnosis; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007657:Ketone Bodies / Q000652:urine; D007962:Leukocytes / Q000473:pathology; D009573:Nitrites / Q000652:urine; D011237:Predictive Value of Tests; D011507:Proteinuria / Q000175:diagnosis; D011934:Reagent Strips / Q000592:standards*; D015203:Reproducibility of Results; D013046:Specific Gravity; D016482:Urinalysis / Q000295:instrumentation / Q000379:methods*; D014556:Urine / Q000737:chemistry / Q000166:cytology
D007657:Ketone Bodies; D009573:Nitrites; D011934:Reagent Strips