Diagnostic utility of immunofixation and free light chain assay in AL amyloidosis: a systematic review and meta-analysis.

We searched the literature using PubMed, Embase, and CENTRAL databases since inception through March 2024.

我们使用PubMed、Embase和CENTRAL数据库自创建以来至2024年3月进行了文献检索。

We included studies reporting the diagnostic accuracy of immunofixation and/or sFLC in patients with AL amyloidosis.

我们纳入了报告免疫固定和/或sFLC在AL淀粉样变性患者中诊断准确性的研究。

We used the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach to assess the certainty of the evidence and QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2) to assess the risk of bias.

我们使用了GRADE（推荐、评估、发展和评估的分级）方法来评估证据的确定性，并使用QUADAS-2（诊断准确性研究质量评估工具-2）来评估偏倚风险。

After deduplication, 29 237 records were screened, and 44 studies (n = 18 071) were included.

去重后，筛选了29 237条记录，纳入了44项研究（n = 18 071）。

For the meta-analysis, 28 studies reported sensitivity for SIFE (n = 3390), 24 studies for UIFE (n = 2830), 19 studies for SIFE and UIFE (n = 2819), 21 studies for sFLC ratio (n = 3678), 6 studies for SIFE and sFLC ratio (n = 372), 3 studies for UIFE and sFLC ratio (n = 242), and 10 studies for all 3 tests (n = 1430).

在进行荟萃分析时，28项研究报告了SIFE的敏感性（n = 3390），24项研究报告了UIFE的敏感性（n = 2830），19项研究同时报告了SIFE和UIFE（n = 2819），21项研究报告了sFLC比率（n = 3678），6项研究同时报告了SIFE和sFLC比率（n = 372），3项研究同时报告了UIFE和sFLC比率（n = 242），以及10项研究同时报告了这三项检测（n = 1430）。

Pooled sensitivities were as follows: SIFE, 0.68 (95% confidence interval[CI], 0.62-0.73); UIFE, 0.77 (95% CI, 0.72-0.81); SIFE and UIFE, 0.89 (95% CI, 0.84-0.93); and sFLC ratio, 0.82 (95% CI, 0.78-0.86).

综合敏感性如下：SIFE为0.68（95%置信区间[CI]，0.62-0.73）；UIFE为0.77（95% CI，0.72-0.81）；SIFE和UIFE联合为0.89（95% CI，0.84-0.93）；sFLC比率为0.82（95% CI，0.78-0.86）。

When SIFE, UIFE, and sFLC ratio were combined, the sensitivity reached 0.99 (95% CI, 0.96-1.00).

当SIFE、UIFE和sFLC比率联合使用时，敏感性达到0.99（95% CI，0.96-1.00）。

The high sensitivity of combining SIFE, UIFE, and sFLC ratio supports their use as a reliable initial testing strategy to raise suspicion for AL amyloidosis and guide decisions regarding future diagnostic modalities.

结合SIFE、UIFE和sFLC比率的高度敏感性支持将它们作为可靠的初步检测策略，以引起对AL淀粉样变性的怀疑，并指导未来诊断方式的决策。