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. 2021 Sep 17;60(1):92-100.
doi: 10.1515/cclm-2021-0736. Print 2022 Jan 26.

The development of autoverification system of lymphocyte subset assays on the flow cytometry platform

Jue Shi  1   2 , Run-Qing Mu  3 , Pan Wang  1   2 , Wen-Qing Geng  1   2 , Yong-Jun Jiang  1   2 , Min Zhao  3 , Hong Shang  1   2   3 , Zi-Ning Zhang  1   2
Affiliations

The development of autoverification system of lymphocyte subset assays on the flow cytometry platform

Jue Shi et al. Clin Chem Lab Med. .

Abstract

Objectives: Peripheral blood lymphocyte subsets are important parameters for monitoring immune status; however, lymphocyte subset detection is time-consuming and error-prone. This study aimed to explore a highly efficient and clinically useful autoverification system for lymphocyte subset assays performed on the flow cytometry platform.

Methods: A total of 94,402 lymphocyte subset test results were collected. To establish the limited-range rules, 80,427 results were first used (69,135 T lymphocyte subset tests and 11,292 NK, B, T lymphocyte tests), of which 15,000 T lymphocyte subset tests from human immunodeficiency virus (HIV) infected patients were used to set customized limited-range rules for HIV infected patients. Subsequently, 13,975 results were used for historical data validation and online test validation.

Results: Three key autoverification rules were established, including limited-range, delta-check, and logical rules. Guidelines for addressing the issues that trigger these rules were summarized. The historical data during the validation phase showed that the total autoverification passing rate of lymphocyte subset assays was 69.65% (6,941/9,966), with a 67.93% (5,268/7,755) passing rate for T lymphocyte subset tests and 75.67% (1,673/2,211) for NK, B, T lymphocyte tests. For online test validation, the total autoverification passing rate was 75.26% (3,017/4,009), with 73.23% (2,191/2,992) for the T lymphocyte subset test and 81.22% (826/1,017) for the NK, B, T lymphocyte test. The turnaround time (TAT) was reduced from 228 to 167 min using the autoverification system.

Conclusions: The autoverification system based on the laboratory information system for lymphocyte subset assays reduced TAT and the number of error reports and helped in the identification of abnormal cell populations that may offer clues for clinical interventions.

Keywords: autoverification system; delta check; flow cytometry; lymphocyte subsets; reference change value.

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References

    1. Randell, EW, Yenice, S, Khine Wamono, AA, Orth, M. Autoverification of test results in the core clinical laboratory. Clin Biochem 2019;73:11–25. https://doi.org/10.1016/j.clinbiochem.2019.08.002.
    1. Durant, TJS, Merwede, J, Reynolds, J, Peaper, DR. Optimization of turnaround time for group A streptococcus PCR. J Clin Microbiol 2019;57:e00619-19. https://doi.org/10.1128/JCM.00619-19.
    1. Wongkrajang, P, Reesukumal, K, Pratumvinit, B. Increased effectiveness of urinalysis testing via the integration of automated instrumentation, the lean management approach, and autoverification. J Clin Lab Anal 2020;34:e23029. https://doi.org/10.1002/jcla.23029.
    1. Demirci, F, Akan, P, Kume, T, Sisman, AR, Erbayraktar, Z, Sevinc, S. Artificial neural network approach in laboratory test reporting. Am J Clin Pathol 2016;146:227–37. https://doi.org/10.1093/ajcp/aqw104.
    1. Li, J, Cheng, B, Yang, L, Zhao, Y, Pan, M, Zheng, G, et al.. Development and implementation of autoverification rules for ELISA results of HBV serological markers. J Lab Autom 2016;21:642–51. https://doi.org/10.1177/2211068215601612.

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