Table 2.
Serological tests that have some certification to date, FDA. Include: % sensitivity, %, specificity, cross reactivity, interferences, mark, country.
| Diagnostic | Country Manufacturer |
Tech | Specificity | Sensitivity | Cross Reactivity | Interferences | Date EUA Issued | Ref |
|---|---|---|---|---|---|---|---|---|
| Babson Diagnostics aC19G1 | USA Babson Diagnostics, Inc. |
IgG CLIA | 100% | 100% | Anti-HIV 1 + 2, Anti-HCV, CMV IgG, Anti-HBs, Anti-HAV EIA | N/A | 23/6/2020 | [196] |
| Access SARS-CoV-2 IgG | USA Beckman Coulter, Inc. |
IgG CLIA | 99.6% | 96.8% | Human chorionic gonadotropin (hCG), HIV antibody, Influenza antibody, Influenza A antibody, Influenza B antibody, Measles antibody, Mycoplasma pneumoniae IgG, Parvovirus B19 antibody, Respiratory pathogen antibodies, Respiratory syncytial virus (RSV) antibody | Hemoglobin, Bilirubin (conjugated), Bilirubin (unconjugated), Triglycerides (Intralipid) | 26/6/2020 | [197] |
| Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit | USA, Diazyme Laboratories, Inc. | IgG CLIA | 97.4% | 100% | Influenza A H1N1 IgM/IgG, Influenza A H7N9 IgM/IgG, Rhinovirus Type A IgM/IgG, Rotavirus IgM/IgG, Human coronavirus HKU1 IgM/IgG, Human coronavirus NL63 IgM/IgG, ANA | Triglycerides, Hemoglobin, Rheumatoid Factor, Anti-Mitochondrial, HAMA, Total IgG, Total IgM, Interferon α, Ribavirin | 8/7/2020 | [198] |
| SCoV-2 Detect IgG ELISA | USA, InBios International, Inc. | IgG ELISA | 98.9% | 97.8% | VIH 1 y 2, hepatitis C and B | Hemoglobin Bilirubin Triglycerides Cholesterol | 10/6/2020 | [199] |
| SARS-CoV-2 RBD IgG test | USA, Emory Medical Laboratories | IgG ELISA | 96.4% | 100% | Anti-Influenza B, Anti-HCV, Anti-HBV, Anti-Haemophilus, Anti-Rhinovirus influenzae, ANA, Anti-HIV | N/A | 15/6/2020 | [200] |
| xMAP SARS-CoV-2 Multi-Antigen IgG Assay | USA, Luminex Corporation | IgG FMIA | 99.3% | 96.3% | N/A | (dipotassium EDTA) | 16/7/2020 | [201] |
| ADVIA Centaur SARS-CoV-2 IgG (COV2G) | Germany, Siemens Healthcare Diagnostics Inc. | IgG Semi-quantitative | 99.9% | 100% | Chlamydia trachomatis IgM, Cytomegalovirus (CMV) IgM, Epstein Barr virus (EBV) IgG, Epstein Barr virus (EBV) IgM, Hepatitis A virus (HAV) IgM, Hepatitis B core (Anti-HBc) IgM, Hepatitis B core (Anti-HBc) total antibody, Hepatitis C virus (HCV) antibody, Herpes simplex virus (HSV) IgM | Hemoglobin, Bilirubin (conjugated), Bilirubin (unconjugated), Triglycerides (Intralipid), Biotin | 31/7/2020 | [202] |
| Atellica IM SARS-CoV-2 IgG (COV2G) | Germany, Siemens Healthcare Diagnostics Inc. | IgG Semi-quantitative | 99.9% | 100% | Human chorionic gonadotropin (hCG), Human immunodeficiency virus (HIV) antibody, Influenza antibody, Influenza A antibody, Influenza B antibody, Measles antibody | Hemoglobin, Bilirubin (conjugated), Bilirubin (unconjugated), Triglycerides (Intralipid), Biotin, Cholesterol, Protein, total | 7/31/2020 | [203] |
| Anti-SARS-CoV-2 ELISA (IgG) | Germany, EUROIMMUN US Inc. | Serology IgG | 99.6% | 86.7% | Influenza, Acute EBV infection, Rheumatoid factor, other Human coronavirus | Hemoglobin, triglycerides, and bilirubin | 4/5/2020 | [204] |
| SARS-CoV-2 IgG assay | USA, Abbott Laboratories Inc. | Serology IgG | 99% | 100% | CMV, Hepaitis A,B, RSV, Rubella, Herpes virus | Adenovirus, pregnant female, lupus | 26/4/2020 | [205] |
| LIAISON SARS-CoV-2 S1/S2 IgG | Italy, DiaSorin Inc. | Serology IgG | 99.3% | 97.6% | Anti-Human CoV OC43; Anti-Human CoV HKU1, 4 Anti-Human CoV unknown strain. | Triglycerides, Hemoglobin, Unconjugated bilirubin | 24/4/2020 | [206] |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack | USA, Ortho-Clinical Diagnostics, Inc. | Serology IgG | 100% | 83.3% | Adenovirus Antibody, Influenza A IgG, Influenza A IgM, Influenza B IgG, Influenza B IgM, Coxsackie Virus Antibody, Echovirus Antibody, Polio Virus, Anti-respiratory syncytial virus (RSV), HCV Antibody, Anti Nuclear Antibody | Bilirubin (conjugated), Bilirubin (unconjugated), Biotin, Hemoglobin, Intralipid | 24/4/2020 | [207] |
| COVID-19 ELISA IgG Antibody Test | USA, Mount Sinai Laboratory | Serology IgG | 100% | 92% | Varicella, Infleunza, Hepatitis, HIV, CMV | Ascorbic Acid, Hemoglobin, Bilirubin, Albumin, Triglyceride | 15/4/2020 | [208] |
| SCoV-2 Detect IgM ELISA | USA, InBios International, Inc. | IgM ELISA | 100% | 100% | Anti-Influenza A/B, Anti-Hepatitis B, Anti-Hepatitis C, Anti-Nuclear Antibody, Rheumatoid Factor, Human Anti-Mouse Antibody, Anti-HIV, Anti-Respiratory Syncytial Virus, Normal Human Sera | Hemoglobin, Bilirubin (conjugated and unconjugated), Triglycerides, Buffer (SDB), Cholesterol | 30/6/2020 | [199] |
| VIDAS SARS-CoV-2 IgM | France, bioMérieux SA | IgM ELFA | 99.4% | 100% | SARS-CoV(-1) Infection (2005), SARS-CoV(-1) Infection (2020), HCoV-NL63 Infection, HCoV-229E Infection, HCoV-OC43 Infection HCoV-HKU1 Infection MERS-CoV Infection, Acute EBV infections with heterophile antibodies, ANA | Hemoglobin, Lipids, Albumin, Bilirubin (conjugated), Bilirubin (unconjugated) | 6/8/2020 | [209] |
| RightSign COVID-19 IgG/IgM Rapid Test Cassette | China, Hangzhou Biotest Biotech Co., Ltd. | IgM and IgG Lateral Flow | 100% | 93.3% | Anti-FLU A, Anti-FLU B, Anti-Respiratory Syncytial, Virus Anti-Adenovirus, Anti-HBsAg, Anti-Syphilis, Anti-H. Pylori, Anti-HIV, Anti-HCV, Anti-SARS-COV | Acetaminophen, Caffeine, Albumin, Acetylsalicylic Acid, Gentisic Acid, Ethanol, Ascorbic Acid | 4/6/2020 | [210] |
| LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) | China, Hangzhou Laihe Biotech Co., Ltd. | IgM and IgG Lateral Flow | 98.8% | 96.7% | H1N1-1~H1N1-3, H7N9-1~H7N9-2, ANA-1, Staphyl. -1~Staphyl.-2, EBV-1~EBV-5, RSV-1~RSV-2, Chlamydia-1~Chlamydia-3 | N/A | 19/6/2020 | [211] |
| Assure COVID-19 IgG/IgM Rapid Test Device | China, Assure Tech. (Hangzhou Co., Ltd.) | IgM and IgG Lateral Flow | 100% | 98.8% | Human coronavirus HKU1 IgM/IgG, Human coronavirus NL63 IgM/IgG | Icteric (Bilirubin), Lipemicicines Acetylsalicylic acid Ascorbic acid (Vitamin C), Amoxicillin | 6/7/2020 | [212] |
| Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette | Finland, Salofa Oy | IgM and IgG Lateral Flow | 99.2% | 94.9% | HCV, HBV, ANA Metapneumovirus | Ascorbic Acid, Hemoglobin, Bilirubin, Albumin, Triglyceride | 13/7/2020 | [213] |
| Rapid COVID-19 IgM/IgG Combo Test Kit | USA, Megna Health, Inc. | IgM and IgG Lateral Flow | 97.5% | 100% | Influenza A Virus, Influenza B Virus, Adenovirus, Rotavirus and Mycoplasma Pneumoniae. | Rheumatoid Factor, Bilirubin, Triglyceride, Hemoglobin | 17/7/2020 | [211] |
| CareStart COVID-19 IgM/IgG | USA, Access Bio, Inc. | IgM and IgG Lateral Flow | 100% | 98.8% | Anti-Influenza A, Anti-HCV, Anti-229E (alpha coronavirus), Anti-OC43 (beta coronavirus), Anti-HKU1 (beta coronavirus), Antinuclear antibodies (ANA), Anti-respiratory syncytial virus, Anti-Rhinovirus | Acetaminophen, HAMA, Acetylsalicylic acid, Hemoglobin, Albendazole, Ibuprofen, Chloroquine diphosphate, Rifampicin | 24/7/2020 | [214] |
| BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test | China, Xiamen Biotime Biotechnology Co., Ltd. | IgM and IgG Lateral Flow | 98.8% | 100% | Anti-OC43 (beta coronavirus), Anti-HKU1 (beta coronavirus), Antinuclear antibodies (ANA) | N/A | 24/7/2020 | [215] |
| Vibrant COVID-19 Ab Assay | USA, Vibrant America Clinical Labs | IgM and IgG CLIA | 98.3% | 97.1% | Anti-Influenza A, Anti- Influenza B, Anti-HCV, Anti-HBV, ANA, Anti-respiratory syncytial virus, Anti-Haemophilus influenzae | Bilirubin, Triglycerides Hemoglobin Rheumatoid Factor (RF) Cholesterol, HAMA, Ribavirin, Levofloxacin, Azithromycin, Ceftriaxone sodium | 4/6/2020 | [216] |
| Anti-SARS-CoV-2 Rapid Test | China, Autobio Diagnostics Co. Ltd. | Serology IgM and IgG | 97% | 93% | Other human coronavirus, Influenza | HAMA positive sample, Rheumatoid factor, Antinuclear antibody (ANA), Anti-mitochondrial antibody (AMA), Bilirubin | 24/4/2020 | [217] |
| DPP COVID-19 IgM/IgG System | Usa, Chembio Diagnostic System, Inc. | Serology IgM and IgG | 100% | 95% | Human coronavirus, Zika, Influenza A, B, Mononucleosis, Chikungunya, Yellow fever virus, Dengue virus | Biotin Hemoglobin | 14/4/2020 | [218] |
| qSARS-CoV-2 IgG/IgM Rapid Test | USA, Cellex Inc. | Serology IgM and IgG | 96.0% | 93.8% | Human coronavirus, Adenovirus, Influenza A, B, Rhinovirus, Chlamydia pneumoniae, Streptococcus pneumoniae, Mycobacterium tuberculosis, Mycoplasma pneumoniae | Hemoglobin, Bilirubin (conjugated), Triglycerides, Cholesterol | 1/4/2020 | [219] |
| COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | USA, Healgen Scientific LLC | Serology IgM and IgG | 96.7% | 97% | Influenza A virus IgG, Influenza B virus IgG, Respiratory syncytial virus IgG, Adenovirus IgG, Rhinovirus IgG, Human metapneumovirus IgG, Mycoplasma pneumoniae IgG, Chlamydia pneumoniae IgG, HCV IgG, Haemophilus influenza IgG, HBV core antibody IgG | Ascorbic Acid, Hemoglobin, Bilirubin, Albumin, Triglyceride | 29/5/2020 | [210] |
| Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) | USA, Siemens Healthcare Diagnostics Inc. | Total Antibody CLIA | 99.9% | 100% | Anti-influenza A, Anti-influenza B, AntiHBV Antinuclear, antibody (ANA), Hepatitis B core antigen (anti-HBc) IgM, Hepatitis B surface antigen (HBs Ag), Hepatitis C virus (HCV) antibody, HIV antibody, influenza antibody | Hemoglobin, Bilirubin, conjugated, Bilirubin, Lipemia (Intralipid) | 8/6/2020 | [220] |
| WANTAI SARS-CoV-2 Ab ELISA | China, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | Total Antibody ELISA | 100% | 94.5% | HBsAg and antibodies to HIV 1/2, HCV, TP | N/A | 5/8/2020 | [221] |
| WANTAI SARS-CoV-2 Ab Rapid Test | China, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | Total Antibody Lateral Flow | 98.8% | 100% | alpha COV 229E, alpha COV NL63, beta COV OC43, beta COV HKU1 Flu A, Flu B, HCV, HBV, ANA | N/A | 10/7/2020 | [222] |
| New York SARS-CoV Microsphere Immunoassay for Antibody Detection | USA, Wadsworth Center, New York State Department of Health | Serology Total Antibody | 99.1% | 99% | HCV, HIV, Measles, Mumps, Rubella, Varicella Zoster virus, WNV, Herpes Simplex virus, ZIKV, Enterovirus, Rheumatoid factor | Biotin Hemoglobin | 30/4/2020 | [223] |
| Platelia SARS-CoV-2 Total Ab assay | USA, Bio-Rad Laboratories, Inc. | Serology Total Antibody | 98% | 99% | Influenza, Mycoplasma pneumoniae, Rheumatoid factor, Other human coronavirus | 29/4/2020 | [224] | |
| Elecsys Anti-SARS-CoV-2 | Germany, Roche Diagnostics | Serology Antibody | 99.8% | 100% | Other human coronavirus, Influenza | Biotin Hemoglobin | 2/5/2020 | [225] |