Table 3.
Selected rapid LFIA serological tests for COVID-19 detection and their performance.
| Company | Assay | Target | Capture Protein | Technology | Sensitivity (Day 15 after Symptom Onset) | Specificity | Time to Result |
|---|---|---|---|---|---|---|---|
| ADVAITE, Inc. [86] | RapCov Rapid COVID-19 Test | IgG | Recombinant SARS-CoV-2 N antigen | Colloidal Gold Nanoparticle-Based LFIA | 90% | 95.2% | Visual Read/ 15 min |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. [87] | Wantai SARS-CoV-2 Ab Rapid Test | Total Antibody | Recombinant SARS-CoV-2 S antigen | Colloidal Gold Nanoparticle-Based LFIA | 98.8% | 100% | Visual Read/ 10–20 min |
| Salofa Oy [88] | Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette | IgM/IgG | Recombinant SARS-CoV-2 S antigen | Colloidal Gold Nanoparticle-Based LFIA | 93.3% | 98.8% | Visual Read/ 10–20 min |
| Xiamen Biotime Biotechnology Co., Ltd. [89] | BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test | IgM/IgG | Recombinant SARS-CoV-2 S antigen | Colloidal Gold Nanoparticle-Based LFIA | 100% | 96.2%—Cross-reactivity with HIV+ | Visual Read/ 15 min |
| Healgen Scientific LLC [90] | COVID-19 IgG/IgM Rapid Test Cassette | IgM/IgG | Recombinant SARS-CoV-2 antigens (S, S1 subunit) | Colloidal Gold Nanoparticle-Based LFIA | 100% | 97.5% | Visual Read/ 10–15 min |
| Hangzhou Laihe Biotech Co. [91] | LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit | IgM/IgG | Recombinant SARS-CoV-2 antigens (S, S1 subunit) | Colloidal Gold Nanoparticle-Based LFIA | 100% | 98.8% | Visual Read/ 10 min |
| Hangzhou Biotest Biotech Co., Ltd. [92] | RightSign COVID-19 IgG/IgM Rapid Test Cassette | IgM/IgG | Recombinant SARS-CoV-2 antigen (S, RBD Domain) | Colloidal Gold Nanoparticle-Based LFIA | 100% | 100% | Visual Read/ 10–20 min |
| Megna Health, Inc. [93] | Rapid COVID-19 IgM/IgG Combo Test Kit | IgM/IgG | Recombinant SARS-CoV-2 N antigen | Colloidal Gold Nanoparticle-Based LFIA | 100% | 95.0% | Visual Read/ 10–20 min |
| Biohit Healthcare (Hefei) Co., Ltd. [94] | Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit | IgM/IgG | Recombinant SARS-CoV-2 N antigen | Colloidal Gold Nanoparticle-Based LFIA | 96.7% | 95.0% | Visual Read/ 10–20 min |
| Assure Tech (Hangzhou) Co., Ltd. [95] | Assure COVID-19 IgG/IgM Rapid Test Device | IgM/IgG | Recombinant SARS-CoV-2 S1 and N antigens | Colloidal Gold Nanoparticle-Based LFIA | 100% | 98% | Visual Read/ 20 min |
| Cellex, Inc. [96] | Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test | IgM/IgG | Recombinant SARS-CoV-2 S and N antigens | Colloidal Gold Nanoparticle-Based LFIA | 93.8% | 96.0% | Visual Read/ 15–20 min |
| TBG Biotechnology Corp. [82] | TBG SARS-CoV-2 IgG / IgM Rapid Test Kit | IgM/IgG | Recombinant SARS-CoV-2 S and N antigens | Colloidal Gold Nanoparticle-Based LFIA | 99.8% | 99.8% | Visual Read/ 15 min |
| Biocan Diagnostics Inc. [97] | Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test | IgM/IgG | Recombinant SARS-CoV-2 S and N antigens | Colloidal Gold Nanoparticle-Based LFIA | 96.2% | 99.4% | Visual Read/ 10 min |