{"doi":"10.3390/diagnostics15111362","title":"Comparative Analysis of RT-PCR and a Colloidal Gold Immunochromatographic Assay for SARS-CoV-2 Detection","abstract":"Background/Objectives: The COVID-19 pandemic has highlighted the urgent need for rapid, accurate, and accessible diagnostic testing to effectively manage and contain the spread of SARS-CoV-2. RT-PCR is widely recognized as the gold standard for SARS-CoV-2 detection due to its high sensitivity and specificity. However, RT-PCR testing requires specialized laboratory equipment, highly trained personnel, and extended processing times, which limits its feasibility for large-scale screening and point-of-care applications. This study aims to systematically evaluate the diagnostic performance of RT-PCR and a colloidal gold immunochromatographic assay (GICA). Methods: By comparing these two methods, we seek to determine a GICA’s effectiveness as a complementary or alternative diagnostic tool, particularly in resource-limited settings and scenarios requiring rapid, large-scale testing. We assessed the following key clinical parameters: sensitivity, specificity, NPV, PPV, and accuracy. Additionally, we investigated the correlation between GICA signal intensity and RT-PCR Ct values using regression analysis, receiver operating characteristic curve analysis, and the calculated area under the curve. Results: Our findings indicate that while RT-PCR exhibits superior sensitivity, GICA results demonstrate a strong correlation with RT-PCR results and provide a rapid, cost-effective alternative for SARS-CoV-2 detection. Unlike RT-PCR, which requires extensive resources and prolonged turnaround times, a GICA delivers results within 20 min, making it a viable option for decentralized testing and real-time public health interventions. Conclusions: These results suggest that a GICA can serve as a complementary diagnostic tool alongside RT-PCR, particularly in resource-limited settings and high-throughput screening scenarios. By integrating GICAs into broader testing strategies, healthcare systems can enhance early detection efforts, improve accessibility to diagnostics, and strengthen pandemic response measures.","journal":"Diagnostics","year":2025,"id":521289,"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":5,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9572,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":766696,"name":"Dakai Liu","orcid":"0000-0003-0658-5866","position":1,"is_corresponding":false},{"id":1391612,"name":"Qiang Zhou","orcid":"0000-0002-0811-4702","position":2,"is_corresponding":false},{"id":1391613,"name":"George D. Rodriguez","orcid":"0000-0003-2209-205X","position":3,"is_corresponding":false},{"id":781764,"name":"Harlan L. Pietz","orcid":"0000-0003-4792-5708","position":4,"is_corresponding":false},{"id":1129051,"name":"Vishnu Singh","orcid":null,"position":5,"is_corresponding":false},{"id":1129052,"name":"Eric Konadu","orcid":null,"position":6,"is_corresponding":false},{"id":1129053,"name":"Keither K. James","orcid":null,"position":7,"is_corresponding":false},{"id":1129054,"name":"Calvin Lui","orcid":null,"position":8,"is_corresponding":false},{"id":1391614,"name":"Mingyu Shao","orcid":"0000-0003-2367-5097","position":9,"is_corresponding":false},{"id":78515,"name":"Junyu Chen","orcid":"0000-0003-2075-1314","position":10,"is_corresponding":false},{"id":1392123,"name":"Andrew M. Schreiner","orcid":null,"position":11,"is_corresponding":false},{"id":1128679,"name":"Carl Urban","orcid":"0000-0002-7322-0245","position":12,"is_corresponding":false},{"id":1391615,"name":"James Truong","orcid":"0000-0002-7980-2852","position":13,"is_corresponding":false},{"id":1128680,"name":"Nishant Prasad","orcid":"0000-0001-6445-3744","position":14,"is_corresponding":false},{"id":718214,"name":"William H. Rodgers","orcid":"0000-0003-3946-3136","position":15,"is_corresponding":false},{"id":1391611,"name":"Hui Li","orcid":"0000-0002-7031-8562","position":0,"is_corresponding":true}],"reference_count":41,"raw_metadata":null,"created_at":"2026-07-19T02:49:44.558743Z","pmid":"40506934","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":[]}