Establishing the reference change value and applying in auto- verification of hsTNT result
Main Article Content
Abstract
RCV-delta check is a quality control method based on comparing the difference between two consecutive testing results from the same patient for assessment with reference change value (RCV). We used IQC data in 3 months to calculate the RCV according to the CLSI EP33 guideline. The estimated RCV of Troponin T hs on the Cobas 8000/e801 analyzer at Area A2 of the Laboratory Department of Hanoi Medical University Hospital was 44.37%. The automated validation system (LIS) applied the RCV-delta check algorithm according to the CLSI Auto 10-A guideline. Validation of 1501 TnT hs results, 1276 (15%) within the RCV-delta check, 225 (15%) out of range and be confirmed manually. Finally, 3 (0.2%) errors was present with actual patients repeated results, that was true positive result. Conclusion: The application of RCV-delta check for TnT hs using an automated verification system at Hanoi University of Medicine can release 85% of the results without manual verification, as required in the current process.
Article Details
Keywords
Delta check, RCV, consecutive testing results
References
2. Yu HYE, Lanzoni H, Steffen T, et al. Improving Laboratory Processes with Total Laboratory Automation. Lab Med. 2019; 50(1): 96-102. doi:10.1093/labmed/lmy031.
3. Shih MC, Chang HM, Tien N, Hsiao CT, Peng CT. Building and Validating an Autoverification System in the Clinical Chemistry Laboratory. Lab Med. 2011; 42(11): 668-673. doi:10.1309/LM5AM4IIXC4OIETD.
4. EP33 Ed2 | Use of Delta Checks in the Medical Laboratory, 2nd Edition. Clinical & Laboratory Standards Institute. Accessed September 19, 2024. https://clsi.org/standards/products/method-evaluation/documents/ep33/.
5. Burtis CA AE Bruns DE Tietz. Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed. ed. Missouri: Elsevier Saunders; 2006.
6. AUTO10AE: Autoverification of Clinical Lab Test Results. Clinical & Laboratory Standards Institute. Accessed September 19, 2024. https://clsi.org/standards/products/automation-and-informatics/documents/auto10/.
7. Fernandez DC, Avinash SS, Malathi M, Shivashankara AR, Kumar A, Fernandez PA. Establishing the reference change values (RCVs) and validating the delta check auto-verification in a clinical biochemistry laboratory. Muller J Med Sci Res. 2017; 8(1): 42. doi:10.4103/0975-9727.199363.
8. Park SH, Kim SY, Lee W, Chun S, Min WK. New decision criteria for selecting delta check methods based on the ratio of the delta difference to the width of the reference range can be generally applicable for each clinical chemistry test item. Ann Lab Med. 2012; 32(5): 345-354. doi:10.3343/alm.2012.32.5.345.