回顾性评估南非全国性隐球菌抗原筛查计划：通过侧向流动检测结果的实验室间比较。
Retrospective Assessment of a National Reflex Cryptococcal Antigen Screening Program in South Africa Through Interlaboratory Comparison of Lateral Flow Assay Results.
机构信息
Centre for Healthcare-Associated Infections, Antimicrobial Resistance and Mycoses, National Institute for Communicable Diseases, a Division of the National Health Laboratory Service, Johannesburg, South Africa.
School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
出版信息
Lab Med. 2022 Nov 3;53(6):614-618. doi: 10.1093/labmed/lmac037.
OBJECTIVE
Reflex cryptococcal antigen (CrAg) screening of blood specimens with a CD4 count of <100 cells/µL was performed at 45 South African CD4 laboratories using a lateral flow assay (LFA). Our objective was to evaluate the reliability of routine LFA results through comparative interlaboratory testing.
METHODS
All CrAg-positive and a selected number of CrAg-negative samples from the CD4 laboratories were retested at paired microbiology laboratories using the same LFA. Samples with discordant results were tested at a reference laboratory, using the LFA (with CrAg titers).
RESULTS
During interlaboratory testing, 12,502 samples were retested, with 93 (0.7%) discordant results and a between-laboratory agreement of 99.3% (Cohen's kappa, 0.98). The proportion of retested samples with discordant results ranged from 0.17% to 5.31% per laboratory pair (median 0.28%), with 3 reporting >3% of results as discordant.
CONCLUSION
Routine CrAg screening results were reliable, with <1% of samples having discordant results, mainly due to interpretation and transcription errors.
目的
在南非 45 家 CD4 实验室中，对 CD4 计数<100 个/µL 的血液标本进行了反射性隐球菌抗原（CrAg）筛选，采用侧向流动检测法（LFA）。我们的目的是通过实验室间比较测试来评估常规 LFA 结果的可靠性。
方法
从 CD4 实验室中所有 CrAg 阳性和部分 CrAg 阴性的样本，在配对的微生物学实验室中使用相同的 LFA 进行重新检测。对出现不一致结果的样本，在参考实验室使用 LFA（CrAg 滴度）进行检测。
结果
在实验室间测试期间，重新检测了 12502 个样本，有 93 个（0.7%）结果不一致，实验室间的一致性为 99.3%（Cohen 的 kappa 值，0.98）。每个实验室对出现不一致结果的重新检测样本比例在 0.17%到 5.31%之间（中位数为 0.28%），有 3 家实验室报告>3%的结果不一致。
结论
常规 CrAg 筛查结果可靠，<1%的样本结果不一致，主要是由于解释和转录错误。
Zotero 插件