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Analytical and clinical performance of Kroma iT, a compact fully-automated immunochemistry analyzer for fecal occult
Josep M Auge1, Cristina Rodriguez, Maria Pellise
1Biochemistry and Molecular Genetics Department, Hospital Clinic, C/Villarroel 170, 08036 Barcelona, Spain. jmauge@clinic.cat.
Insights
The Kroma iT analyzer effectively detects fecal occult blood, showing good analytical performance and clinical utility for early cancer detection. Its ease of use and safety make it suitable for clinical labs.
Area of Science:
- Clinical chemistry
- Immunoturbidimetry
- Gastroenterology
Background:
- Evaluation of the Kroma iT immunoturbidimetric analyzer for fecal occult blood detection.
- Assessment of analytical and clinical performance characteristics.
Purpose of the Study:
- To evaluate the Kroma iT analyzer for fecal occult blood detection.
- To determine its suitability for early detection of advanced neoplasms.
Main Methods:
- Laboratory evaluation included imprecision, linearity of dilution, and carry-over.
- Clinical evaluation involved 210 patients.
- Fecal immunochemical testing (FIT) was used to assess hemoglobin levels.
Main Results:
- Low imprecision (within-run 1.06-8.04%, between-run 3.11-13.09%) and no carry-over detected.
- High mean recovery (95.24%) for linearity of dilution.
- Significant difference in hemoglobin levels between patients with advanced neoplasms and controls; sensitivity ranged from 36.4% to 45.5% and specificity from 86.8% to 92.3%.
Conclusions:
- Kroma iT analyzer demonstrates reliable analytical performance.
- The analyzer is user-friendly and safe for laboratory personnel.
- Its performance supports its use in clinical chemistry labs for early detection of advanced neoplasms.
Background:
We performed a laboratory and clinical evaluation of Kroma iT (Linear Chemicals S.L), an immunoturbidimetric analyzer for the detection of fecal occult blood.
Materials And Methods:
After a familiarization period, the imprecision, linearity of dilution and carry-over were determined and a clinical evaluation was performed on 210 patients.
Results:
Within-run imprecision ranged between 1.06% and 8.04%. Between-run imprecision ranged between 3.11% and 13.09%. Linearity of dilution revealed a mean recovery of all dilutions of 95.24%, with a standard deviation of 7.47%. No carry-over was detected. The clinical evaluation demonstrated that the mean hemoglobin levels of the fecal immunochemical test values from patients with advanced neoplasms (colorectal cancer plus advanced adenoma) were significantly higher than those of cases with a normal colonoscopy examination. Sensitivity for advanced neoplasms at cut-off values between 80 and 300 ng/ml (6.4-24 mg Hb/Kg feces) ranged from 45.5% to 36.4% and the specificity ranged from 86.8% to 92.3%. The positive predictive values for detecting colorectal cancer and advanced adenomas were 5.4-6.4% and 27-34% respectively and the negative predictive value ranged from 92.5% to 91.7%. Using two samples per patient, a substantial increase of sensitivity was observed, with only a slight decrease in specificity.
Conclusion:
Kroma iT analyzer is easy to handle and safe for personnel to use. Its analytical and clinical performance makes it suitable for use in a clinical chemistry laboratory for the early detection of advanced neoplasms.
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