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55: Evaluation of the Clinical and Laboratory Standards Institute EP26-A

Guideline: A Protocol for Reagent Lot-to-Lot Verification

Article  in  American Journal of Clinical Pathology · May 2015

DOI: 10.1093/ajcp/143.suppl1.029

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Brooke Katzman Alicia Algeciras-Schimnich

Mayo Clinic - Rochester Mayo Foundation for Medical Education and Research
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 55
Evaluation of the Clinical and Laboratory Standards Institute EP26-A Guideline: A Protocol for Reagent Lot-
to-Lot Verification

Brooke M. Katzman, Karl M. Ness, and Alicia Algeciras-Schimnich. Department of Laboratory Medicine and
Pathology, Mayo Clinic, Rochester, MN.

Verification of reagent lot performance prior to clinical use is not only good laboratory practice, but a regulatory

Downloaded from https://academic.oup.com/ajcp/article-abstract/143/suppl_1/A028/1761017 by guest on 13 November 2019

requirement. Recently, the Clinical and Laboratory Standards Institute (CLSI) published the EP26-A guideline, User
Evaluation of Between-Reagent Lot Variation, which provides a protocol for lot-to-lot verification aiming to limit the
number of samples required to detect significant changes in test performance due to reagent lot variability. The aim of
this study was to compare the performance of EP26-A with our institution’s reagent lot verification process. Five
high-volume analytes were selected: thyroid stimulating hormone (TSH), thyroglobulin (Tg), thyroxine (T4),
triiodothyronine (T3), free triiodothyronine (FT3), and thyroid peroxidase antibody (TPO). Verification by our
process included testing 20 patient samples spanning the analytical measurement range with the current and potential
new lot. Comparison using Passing-Bablok regression analysis and evaluation based on an acceptance criteria of
slope between 0.90-1.10, r2 > 0.95, intercept <50% of lowest reportable value, and <10% mean result difference, was
performed. For the EP26-A protocol, method imprecision data and critical differences (CD) based on total allowable
error or desirable bias were used to define sample size requirements and rejection limits. Retrospective and
prospective lot evaluations were performed. When assay imprecision exceeded the CD, interpretation of the EP26-A
tables required modification. In contrast to the 20 samples used in our protocol, EP26-A required the following total
number of samples over various medical decision points: 27 for TSH, 17 for Tg, 33 for T4, 31 for T3, 48 for FT3, and
1 for TPO. By retrospective analysis of 10 potential TPO lots, 6 of 10 were acceptable by both lot verification
protocols; however, 4 were discordant (2 rejected by our criteria and 2 rejected by EP26-A). Prospective evaluations
for T3, T4, and Tg lots revealed 80% (4 of 5) agreement. One Tg lot rejected by EP26-A due to significant
measurement differences at the low medical decision point was acceptable by our protocol. Compared to our current
process, EP26-A is better suited for targeted evaluation of samples at medical decision points. The EP26-A protocol
arrived at the same conclusions as our protocol but required more samples for 2 of the 3 analytes prospectively tested.
Furthermore, EP26-A is not applicable for assays with imprecision exceeding the desired CD. Challenges associated
with the identification of rejection limits and the need for increased sample sizes may be critical factors that limit the
utility of this new CLSI guideline.

© American Society for Clinical Pathology Am J Clin Pathol 2015;143:A028

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