Total PSA Test Performance Evaluation on Cobas Pure and Measurement System Comparison with Different Calibrators.
Clin Lab
; 69(4)2023 Apr 01.
Article
em En
| MEDLINE
| ID: mdl-37057943
ABSTRACT
BACKGROUND:
This study investigated the performance evaluation of total prostate specific antigen (tPSA) testing using Cobas Pure integrated solutions system (calibrated against WHO IS 96/670) and the comparison with established measurement systems with different traceability.METHODS:
The evaluation was performed in terms of imprecision, linearity, detection limit, and correlation with Alinity i (calibrated against WHO IS 96/670) and Unicel DxI 800 (calibrated against the manufacturer's working calibrators).RESULTS:
Within-laboratory reproducibility and repeatability were observed less than 1.2%. Linearity was achieved within the claimed analytical measurement range. The claimed LoB and LoD were experimentally verified. All the correlation coefficients among the assays indicated good correlation, but the significant mean bias with Unicel DxI 800 using a different calibrator were observed.CONCLUSIONS:
Since the tPSA calibrators against different traceability is still commercially available, our research could convey the impact of calibration on tPSA results as well as the performance information of a new assay for tPSA.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Próstata
/
Antígeno Prostático Específico
Tipo de estudo:
Diagnostic_studies
Limite:
Humans
/
Male
Idioma:
En
Revista:
Clin Lab
Ano de publicação:
2023
Tipo de documento:
Article