Lab Med Online.  2023 Oct;13(4):324-331. 10.47429/lmo.2023.13.4.324.

Survey on the Implementation of Delta Checks and Panic Values in Immunoassays in Korea

Affiliations
  • 1Department of Laboratory Medicine, International St. Mary’s Hospital, College of Medicine, Catholic Kwandong University, Incheon, Korea
  • 2Department of Laboratory Medicine, Pusan National University Hospital, Busan, Korea
  • 3Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea
  • 4Department of Laboratory Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea
  • 5Department of Laboratory Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea

Abstract

Background
This study aimed to inquire about the implementation of delta checks and panic values for immunoassays in clinical laboratories through an online survey.
Methods
A questionnaire survey was conducted on laboratory medicine specialists working in laboratories that perform five tumor markers, including alpha-fetoprotein, cancer antigen 125, cancer antigen 19-9 (CA19-9), carcinoembryonic antigen, and prostate-specific antigen (PSA), and thyroid function tests, including triiodothyronine, free thyroxine (T4), and thyroid-stimulating hormone.
Results
A total of 87 institutions responded to the questionnaire, and 75 laboratories (86.2%) were performing all 8 tests. The delta check was most used in the PSA test (38.8%, 33/85) and less used in CA19-9 (34.1%, 28/82). The delta percent change (DPC) formula was the most commonly used (65.6–92.6%). The criteria of DPC varied from 4.5 to 200%, and the most common was 50%, followed by 20%. Approximately 50% of laboratories using DPC did not use time intervals, and some laboratories used time limits as 1, 3, 6, or 12 months. The panic checks were most performed in CA19-9 test (51.2%, 42/82) and less performed in free T4 (36.0%, 31/86). The criteria for the panic value were mainly established based on the in-house laboratory data or data provided by reagent companies.
Conclusions
Many laboratories do not apply delta or panic checks in immunoassays. Further research on the suitable delta check criteria and panic values for the assay and patient characteristics is needed.

Keyword

Immunoassay; Delta check; Survey; Tumor marker; Thyroid function test

Reference

1. Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, et al. 2009; Causes, consequences, detection, and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med. 47:143–53. DOI: 10.1515/CCLM.2009.045. PMID: 19099525.
2. Randell EW, Yenice S. 2019; Delta Checks in the clinical laboratory. Crit Rev Clin Lab Sci. 56:75–97. DOI: 10.1080/10408363.2018.1540536. PMID: 30632840.
3. Clinical and Laboratory Standards Institute. 2019. Autoverification of medical laboratory results for specific disciplines. 1st ed. CLSI guideline AUTO15. Clinical and Laboratory Standards Institute;Wayne, PA:
4. Gómez-Rioja R, Alvarez V, Ventura M, Alsina MJ, Barba N, Cortés M, et al. 2013; Current status of verification practices in clinical biochemistry in Spain. Clin Chem Lab Med. 51:1739–46. DOI: 10.1515/cclm-2012-0659. PMID: 23612663.
5. Krasowski MD, Davis SR, Drees D, Morris C, Kulhavy J, Crone C, et al. 2014; Autoverification in a core clinical chemistry laboratory at an academic medical center. J Pathol Inform. 5:13. DOI: 10.4103/2153-3539.129450. PMID: 24843824. PMCID: PMC4023033.
6. Wang Z, Peng C, Kang H, Fan X, Mu R, Zhou L, et al. 2019; Design and evaluation of a LIS-based autoverification system for coagulation assays in a core clinical laboratory. BMC Med Inform Decis Mak. 19:123. DOI: 10.1186/s12911-019-0848-2. PMID: 31269951. PMCID: PMC6609390.
7. Aarsand AK, Fernandez-Calle P, Webster C, Coskun A, Gonzales-Lao E, Diaz-Garzon J, et al. EFLM Biological Variation Database. https://biologicalvariation.eu/. Last accessed on Jan 2023.
8. Ovens K, Naugler C. 2012; How useful are delta checks in the 21 century? A stochastic-dynamic model of specimen mix-up and detection. J Pathol Inform. 3:5. DOI: 10.4103/2153-3539.93402. PMID: 22439125. PMCID: PMC3307229.
9. Li J, Cheng B, Ouyang H, Xiao T, Hu J, Cai Y. 2018; Designing and evaluating autoverification rules for thyroid function profiles and sex hormone tests. Ann Clin Biochem. 55:254–63. DOI: 10.1177/0004563217712291. PMID: 28490181.
10. Dorizzi R, Caruso B, Meneghelli S, Rizzotti P. 2006; The DNSev (TM) expert system in the auto-verification of tumour markers and hormones results. Accredit Qual Assur. 11:303–7. DOI: 10.1007/s00769-006-0160-6.
11. Thomas M, Tim M, Dan NT, Ronald T, Thorkild T, Martin CW. Do panic values cause panic? Reporting of critical laboratory results in a tertiary hospital in Kenya. This article is a preprint and has not been peer-reviewed. DOI: https://doi.org/10.1101/2022.04.25.22274278. Posted April 27, 2022. DOI: 10.1101/2022.04.25.22274278.
12. Lundberg GD. 1972; When to panic over abnormal values. MLO Med Lab Obs. 4:47–54.
13. Yoon YA. 2022; Survey and proposal of critical value reporting and management in clinical chemistry. Soonchunhyang Medical Science. 28:23–7. DOI: 10.15746/sms.22.004.
14. Song JK, Ahn HJ, Kim YA. 2017; Critical value report: survey and literature review. J Lab Med Qual Assur. 39:31–41. DOI: 10.15263/jlmqa.2017.39.1.31.
15. Piva E, Plebani M. 2013; From "panic" to "critical" values: which path toward harmonization? Clin Chem Lab Med. 51:2069–71. DOI: 10.1515/cclm-2013-0459. PMID: 23828428.
16. Campbell CA, Horvath AR. 2014; Harmonization of critical result management in laboratory medicine. Clin Chim Acta. 432:135–47. DOI: 10.1016/j.cca.2013.11.004. PMID: 24246790.
17. He S, Kang F, Wang W, Chen B, Wang Z. 2020; National survey on delta checks in clinical laboratories in China. Clin Chem Lab Med. 58:569–76. DOI: 10.1515/cclm-2019-1131. PMID: 31927514.
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