Evaluation of the Hitachi 717 Analyser
Author Information
Author(s): Carmen Biosca, Felipe Antoja, Cristina Sierra, Helene Douezi, Magda Maci, Maria-Jesus Alsina, Romin Galimany
Primary Institution: Servei d'Anlisis Cliniques, Hospital Germans Trias Pujol, Badalona, Barcelona, Spain
Hypothesis
The Hitachi 717 analyser's performance will meet the evaluation criteria set by clinical standards.
Conclusion
The Hitachi 717 analyser demonstrated acceptable levels of imprecision and inaccuracy for various tests.
Supporting Evidence
- The within-run imprecision ranged from 0.6% for total protein to 6.9% for iron.
- The photometric inaccuracy was acceptable for both 340 and 405 nm.
- The routine procedure can be interrupted by stat samples at any time.
- The Hitachi 717 can perform up to 35 different tests on one sample.
- Seven determinations were studied to cover nearly all performance criteria of the instrument.
- Imprecision was evaluated under routine working conditions.
- Statistical evaluation was done using a non-parametric method of Passing and Bablok.
Takeaway
The Hitachi 717 analyser works well for testing different substances in blood, showing good accuracy and reliability.
Methodology
The evaluation included photometric studies, imprecision testing, and comparisons with other analysers using human sera.
Potential Biases
Potential contamination from carry-over effects was noted.
Limitations
Some contamination was found in the carry-over study, and the between-run imprecision was not acceptable for iron.
Participant Demographics
Fresh human sera were used for testing.
Statistical Information
P-Value
p<0.05
Statistical Significance
p<0.05
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