{"doi":"10.1109/tbme.2022.3218501","title":"A Novel Approach for Glycosylated Hemoglobin Testing Using Microchip Affinity Electrophoresis","abstract":"OBJECTIVE: Effective management of diabetes largely benefits from early diagnosis followed by intensive long-term regulation of blood glucose. The levels of glycohemoglobin (HbA1 and HbA1c) have been used as standard biomarkers to assess long-term blood glucose concentrations for diabetes diagnosis and management. Gold standard laboratory methods for HbA1 and HbA1c testing are often costly and not widely available. Moreover, currently available point-of-care (POC) immunoassay-based glycohemoglobin tests may produce inaccurate test results for patients with co-existing diseases such as hemoglobin disorders and anemia. Here, we report a POC platform, HemeChip-GHb, for quantitative HbA1 detection leveraging paper-based affinity electrophoresis. METHODS: We describe the design and development of the HemeChip-GHb test. Feasibility and accuracy of the HemeChip-GHb system were demonstrated by testing blood samples collected from healthy donors, patients with prediabetes, and patients with diabetes. RESULTS: HbA1 levels measured with HemeChip-GHb show 0.96 correlation to the levels reported from the clinical standard HPLC tests, and with a bias of -0.72% based on Bland-Altman analysis. 99.6% of the HbA1 levels for paired HemeChip-GHb and HPLC fell within A and B zones of no difference in clinical outcome based on error grid analysis. CONCLUSION: Using HemeChip-GHb we achieved accurate diabetes status detection with sensitivity and specificity of 100%. SIGNIFICANCE: We presented a novel POC paper-based affinity electrophoresis platform that has the potential for accurately diagnosing diabetes, and addressing an unmet need for accurate and affordable diagnostics in resource-challenged environments.","journal":"IEEE Transactions on Biomedical Engineering","year":2022,"id":267335,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9567,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":307415,"name":"Ran An","orcid":"0000-0002-4849-0120","position":1,"is_corresponding":false},{"id":821370,"name":"Alireza Avanaki","orcid":"0000-0002-7145-5921","position":2,"is_corresponding":false},{"id":307414,"name":"Arwa Fraiwan","orcid":"0000-0002-7745-409X","position":3,"is_corresponding":false},{"id":307428,"name":"Umut A. Gürkan","orcid":"0000-0002-0331-9960","position":4,"is_corresponding":false},{"id":821371,"name":"Zoe Sekyonda","orcid":"0000-0001-8249-809X","position":0,"is_corresponding":true}],"reference_count":37,"raw_metadata":null,"created_at":"2026-07-19T00:27:02.050512Z","pmid":"36315541","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}