Diagnostic utility of immunofixation and free light chain assay in AL amyloidosis: a systematic review and meta-analysis
Year: 2026
Type: review
Study designs: Systematic Review, Meta-Analysis
Abstract: ABSTRACT: In this systematic review, we aimed to assess the sensitivity of serum immunofixation (SIFE), urine immunofixation (UIFE), and serum free light chain (sFLC) in detecting plasma cell dyscrasia associated with light chain (AL) amyloidosis. We searched the literature using PubMed, Embase, and CENTRAL databases since inception through March 2024. We included studies reporting the diagnostic accuracy of immunofixation and/or sFLC in patients with AL amyloidosis. 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. After deduplication, 29 237 records were screened, and 44 studies (n = 18 071) were included. 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). 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). When SIFE, UIFE, and sFLC ratio were combined, the sensitivity reached 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.
Source: Blood Advances
Authors: Muayad Azzam, Qais Hamarsha, Hassan Kawtharany, Jamil Nazzal, Aseel Alkhader, Tala Khraise, Mohammad Mahmoud AlMasri, Hadi Khaled Abou Zeid, Iktimal Alwan, Nour Jaber, Matthew D. Seftel, Maria Adela Aguirre, Deborah Boedicker, Naresh Bumma, Antonia Carroll, Raymond Comenzo, Joselle Cook, Noel Dasgupta, Alfredo H. De La Torre, Angela Dispenzieri, Faizi Jamal, Jack Khouri, Maria M. Picken, Shahzad Raza, Nelson Leung, Vaishali Sanchorawala, Nitasha Sarswat, Hira Shaikh, Daulath Singh, Vishal Kukreti, Reem A. Mustafa
Institutions: University of Kansas Medical Center, Saint Louis University, Community Health Systems - Northwest Health - Porter, King Hussein Cancer Center, Wake Forest University Health Sciences, Wake Forest University, AdventHealth Tampa, University of British Columbia, Hospital Italiano de Buenos Aires, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, St Vincent's Hospital Sydney, Tufts Medical Center, Mayo Clinic, Indiana University Indianapolis, Indiana University School of Medicine, Queen Elizabeth II Health Sciences Centre, City Of Hope National Medical Center, Cleveland Clinic, Loyola University Medical Center, Loyola Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Boston University, Boston Medical Center, University of Chicago, University of Iowa, University of Iowa Health Care, University of Iowa Holden Comprehensive Cancer Center, Princess Margaret Cancer Centre
Language: English
Subfield: Molecular Biology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,800
OpenAlex ID: W7154282765