Performance data
Data evaluated on BioMajesty® JCA-BM6010/C
Measuring range: 0.27 – 50 ng/mL
Onboard stability (with chimney): 8 weeks
Calibration stability (with chimney): 4 weeks
Minimized interference by standard blood components, various antibiotics and other drugs commonly used in sepsis and ICU patients
Precision
| In Series | Mean [ng/mL] | CV [%] |
|---|---|---|
| Sample 1 | 0.602 | 5.11 |
| Sample 2 | 1.96 | 2.96 |
| Sample 3 | 9.43 | 2.49 |
| Total precision | Mean [ng/mL] | CV [%] |
|---|---|---|
| Sample 1 | 0.566 | 5.94 |
| Sample 2 | 2.23 | 2.90 |
| Sample 3 | 10.8 | 2.04 |
Method comparison
Outstanding performance - scientifically proven
A peer-reviewed publication shows the outstanding performance of Procalcitonin FS [22]. The study compared the DiaSys assay with BRAHMS PCT Kryptor© and another turbidimetric assay. The determinations with DiaSys Procalcitonin FS were performed on cobas c 502 module obtaining LOQ below 0.2 ng/mL in this study. In a method comparison of 138 samples against BRAHMS PCT Kryptor© the DiaSys assay revealed high correlation. Covering the clinical decision points of 0.5 and 2 ng/mL, Passing-Bablok regression and Bland-Altman analysis confirmed the good correlation for samples in the range of 0 - 2 ng/mL (PCT DiaSys = 0.994 x PCT Kryptor + 0.11).The agreement at different clinical cut-offs was also monitored. Compared to BRAHMS, only 9 samples were overestimated by DiaSys at 0.5 ng/mL. Despite the different analytic results, some values still agreed to the final diagnosis, revealing false negative and false positive results for BRAHMS and the other PETIA as well. Finally, global kappa coefficients indicated a good strength of agreement for DiaSys Procalcitonin FS.