1) COVID-19 IgG/IgM RAPID TEST CASSETTE (Kit A) | 2) 2019-nCoV IgG/IgM Test Card (Kit B) | 3) Coronavirus (COVID-19) IgM/IgG Rapid Test Kit (Kit C) | 4) COVID-19 Human IgM/IgG Rapid Test (Kit D) | 5) GenBody COVID-19 IgM/IgG (Kit E) | 6) STANDARD STANDARDTM Q COVID-19 IgM/IgG Duo Test (Kit F) | 7) Nadal COVID-19 IgG/IgM Rapid Test (Kit G) | |
---|---|---|---|---|---|---|---|
Targeting antibody | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG | IgM and IgG |
Qualitative analysis | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Protein labeled | Spike protein | Spike protein S1 domain Nucleocapsid protein |
Nucleocapsid protein | Nucleocapsid protein Receptor binding domain (RBD) protein |
Nucleocapsid protein | Nucleocapsid protein | Spike protein |
Specimen type(s) | Whole blood, serum or plasma | Whole blood, serum or plasma | Whole blood, serum or plasma | Whole blood, serum or plasma | Whole blood, serum or plasma | Whole blood, serum or plasma | Whole blood, serum or plasma |
Specimen amount required | 10 μL | 2 μL | Add 25 μL of sample to the Diluent, and add 2-3 drops to the pad section. | Whole blood: 20 μL Serum or plasma: 10 μL |
Whole blood: 20 μL Serum or plasma: 10 μL |
Whole blood: 20 μL Serum or plasma: 10 μL |
10 μL |
Turnaround time | 10 min | 15 min | 20 min | 15 min | 10 min | 10-15 min | 10 min |
Sensitivity (95% CI) | IgM: 91.8% (83.8-96.6%) IgG: 100.0% (96.1-100.0%) |
87.8% | 84.1% | 91.89% | 91.7% | 94.51% | 94.1% (86.8-98.1%) |
Specificity (95% CI) | IgM: 99.2% (97.7-99.8%) IgG: 99.5% (98.1-99.9%) |
99.0% | 92.3% | 100.00% | 97.5% | 95.74% | 99.2% (97.7-99.8%) |
Accuracy (95% CI) | IgM: 97.8% (96.0-98.9%) IgG: 99.6% (98.4-99.9%) |
96.8% | NA | NA | 96.5% | NA | 98.2% (96.6-99.2%) |
Limit of detection | NA | NA | NA | NA | NA | IgM: 9.37 μg/mL IgG: 3.75 μg/mL |
NA |
Confirmed no cross reactivity with antibodies to non-coronaviruses | Influenza A and B, RSV, Adenovirus, HBV, Syphilis, H. Pylori, HIV, HCV, HANA | Influenza A and B, Adenovirus, Rotavirus, Mycoplasma Pneumoniae | Influenza A and B, RSV, HBV, HCV | Influenza A and B, RSV | RSV IgG, Mycoplasma pneumonia IgM/IgG, HCV, HIV, Dengue, Zika IgG, Chikungunya IgG, Yellow fever IgG, Adenovirus IgM, Leptospira IgG | HIV, Japanese Encephalitis, Zika virus, Chikungunya, Dengue, Salmonella typhi IgM, Rubella IgM, CMV IgM/IgG, Tick borne encephalitis IgM, West Nile virus, Treponema palladium, HAV IgM/IgG, HBV Ab, HCV Ab, Influenza vaccine, Leishmania, Brucella IgM, Chagas, Toxoplasma, Filariasis, Mycoplasma pneumonia IgM/IgG, Influenza A IgM, Influenza B IgM, Influenza A and B IgG+IgM, Tuberculosis | Influenza A and B, RSV, Adenovirus, HBV, T. pallidum, H. pylori, HIV, HCV, HANA |
Cross reactivity with antibodies to other coronaviruses | HKU1, NL63, OC43, 229E | NA | HKU1, NL63, OC43, 229E | HKU1, NL63, OC43, 229E | HKU1, NL63, OC43, 229E | HKU1, NL63, OC43, 229E | HKU1, NL63, OC43, 229E |
Cross reactivity with antibodies to SARS or MERS | MERS-CoV | NA | NA | NA | NA | NA | SARS-CoV, MERS-CoV |
Confirmed no cross reactivity with antibodies to blood compounds | Hemoglobin: 1000 mg/dL Albumin: 2 g/dL Bilirubin: 1 g/dL Uric acid: 20 mg/mL Creatine: 200 mg/dL |
Rheumatoid Factor: 80 IU/mL Hemoglobin: 10 mg/mL Bilirubin: 342 μmol/L Triglyceride: 37 mmol/L |
NA | NA | NA | Hemoglobin, Triglycerides, Cholesterol, Bilirubin | Hemoglobin: 10000 mg/dL Albumin: 20 g/dL Bilirubin: 10000 mg/dL Uric acid: 20 mg/mL Creatine: 2000 mg/L |
Cross reactivity with antibodies to blood compounds | Rheumatoid Factor | NA | NA | NA | NA | NA | Rheumatoid Factor |
Confirmed no cross reactivity with antibodies to common drugs | Acetaminophen: 20 mg/dL Acetylsalicylic Acid: 20 mg/dL Ascorbic Acid: 2g/dL Caffeine: 20 mg/dL Ethanol: 1% Gentistic acid: 20 mg/dL Oxalic acid: 60 mg/dL |
Histamine Hydrochloride, Interferon-α, Zanamivir, Ribavirin, Oseltamivir, Peramivir, Lopinavir, Ritonavir, Arbidol, Levofloxacin, Azithromycin, Ceftriaxone, Meropenem, Tobramycin | NA | NA | NA | Zanamivir, Oseltamivir, Artemether-lumefantrine, Doxycycline hyclate, Quinine, Lamivudine, Ribavirin, Daclatasvir, Acetaminophen, Acetylsalicylic acid, Ibuprofen, Erythromycin, Ciprofloxacin, Caffeine, Ethanol, Biotin | Acetaminophen: 200 mg/L Acetylsalicylic Acid: 200 mg/L Ascorbic Acid: 20000 mg/L Caffeine: 200 mg/L Ethanol: 1% Gentistic acid: 200 mg/L Oxalic acid: 600 mg/L |
Positive Group Median (interquartile range) (n=10) |
Negative Group Median (interquartile range) (n=10) |
p-value | |
---|---|---|---|
Age, years | 44.0 (25.3) | 39.5 (7.0) | 0.37 |
Sex [n (%)] | |||
Male | 6 (60) | 6 (60) | 1.00 |
Female | 4 (40) | 4 (40) | |
Duration from onset, days | 30.5 (4.0) | - | - |
Symptoms [n (%)] | |||
Fever | 8 (80) | - | - |
Cough | 6 (60) | - | - |
Fatigue | 7 (70) | - | - |
Sore throat | 4 (40) | - | - |
Nausea/Vomit | 2 (20) | - | - |
Diarrhea | 4 (40) | - | - |
Headache | 4 (40) | - | - |
Loss of appetite | 4 (40) | - | - |
Body aches | 3 (30) | - | - |
Olfactory disorder | 5 (50) | - | - |
Taste disorder | 4 (40) | - | - |
BMI (Body mass index), kg/m2 | 23.5 (8.9) | 20.9 (2.4) | 0.09 |
Comorbidity [n (%)] | |||
Hypertension | 2 (20) | - | - |
Hyperlipidaemia | 1 (10) | - | - |
Diabetes mellitus | 2 (20) | - | - |
COPD/Asthma | 1 (10) | - | - |
CKD | 1 (10) | - | - |
Liver diseases | 1 (10) | - | - |
Pneumonia [n (%)] | 4 (40) | - | - |
Antiviral drugs [n (%)] | |||
Favipiravir | 1 (10) | - | - |
Remdesivir | 2 (20) | - | - |
Inhaled Oxygen [n (%)] | 1 (10) | - | - |
Hospitalisation [n (%)] | 8 (80) | - | - |
Patients No. gender (age) | Duration post symptom onset (Days) |
BMI(kg/m2) | Comorbidity | Pneumonia | Antiviral drugs | Inhaled O2 | Hospitalisation | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
HT | HL | DM | COPD/asthma | CKD | Liver diseases | Favipiravir | Remdesivir | ||||||
Patients 1 male (27) |
43 | 19.8 | - | - | - | - | - | - | - | - | - | - | + |
Patients 2 female (30) |
35 | 20.2 | - | - | - | - | - | - | - | - | - | - | - |
Patients 3 male (56) |
32 | 23.1 | - | - | - | - | - | + | - | - | - | - | - |
Patients 4 male (60) |
33 | 26.5 | - | - | - | + | - | - | + | - | + | - | + |
Patients 5 female (30) |
29 | 17.5 | - | - | - | - | - | - | - | - | - | - | + |
Patients 6 male (45) |
29 | 35.8 | + | - | + | - | + | - | - | + | - | - | + |
Patients 7 male (64) |
29 | 32.9 | + | - | + | - | - | - | + | - | - | - | + |
Patients 8 female (53) |
29 | 23.8 | - | - | - | - | - | - | - | - | - | - | + |
Patients 9 female (25) |
33 | 16.8 | - | - | - | - | - | - | + | - | - | - | + |
Patients 10 male (43) |
29 | 29.6 | - | + | - | - | - | - | + | - | + | + | + |
Patients No.gender (age) | 1) COVID-19 IgG/IgM RAPID TEST CASSETTE (Kit A) | 2) 2019-nCoV IgG/IgM Test Card (Kit B) | 3) Coronavirus (COVID-19) IgM/IgG Rapid Test Kit (Kit C) | 4) COVID-19 Human IgM/IgG Rapid Test (Kit D) | 5) GenBody COVID-19 IgM/IgG (Kit E) | 6) STANDARD STANDARDTM Q COVID-19 IgM/IgG Duo Test (Kit F) | 7) Nadal COVID-19 IgG/IgM Rapid Test (Kit G) | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
IgM | IgG | IgM | IgG | IgM | IgG | IgM | IgG | IgM | IgG | IgM | IgG | IgM | IgG | |
Patients 1 male (27) |
+ | + | - | + | - | - | - | - | - | - | - | - | + | + |
Patients 2 female (30) |
- | + | - | + | - | - | - | - | - | - | - | - | - | + |
Patients 3 male (56) |
++ | ++ | - | + | - | - | - | - | - | - | + | + | ++ | ++ |
Patients 4 male (60) |
++ | ++ | - | + | + | + | - | - | - | + | + | + | ++ | ++ |
Patients 5 female (30) |
+ | ++ | - | + | - | - | - | - | - | + | + | + | + | ++ |
Patients 6 male (45) |
++ | ++ | - | + | - | + | + | + | - | + | + | ++ | ++ | ++ |
Patients 7 male (64) |
++ | ++ | - | + | - | + | - | - | - | + | + | ++ | ++ | ++ |
Patients 8 female (53) |
+ | ++ | - | + | - | - | + | - | - | + | - | ++ | + | ++ |
Patients 9 female (25) |
- | + | - | - | - | - | - | - | - | - | - | + | - | + |
Patients 10 male (43) |
++ | ++ | - | + | - | - | - | - | - | + | + | + | ++ | ++ |
1) COVID-19 IgG/IgM RAPID TEST CASSETTE (Kit A) | 2) 2019-nCoV IgG/IgM Test Card (Kit B) | 3) Coronavirus (COVID-19) IgM/IgG Rapid Test Kit (Kit C) | 4) COVID-19 Human IgM/IgG Rapid Test (Kit D) | 5) GenBody COVID-19 IgM/IgG (Kit E) | 6) STANDARD STANDARDTM Q COVID-19 IgM/IgG Duo Test (Kit F) | 7) Nadal COVID-19 IgG/IgM Rapid Test (Kit G) | |
---|---|---|---|---|---|---|---|
IgM | |||||||
Sensitivity | 80.0% | 0% | 10.0% | 20.0% | 0% | 60.0% | 80.0% |
Specificity | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
FPR | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
FNR | 20.0% | 100% | 90.0% | 80.0% | 100% | 40.0% | 20.0% |
Accuracy | 90.0% | 50.0% | 55.0% | 60.0% | 50.0% | 80.0% | 90.0% |
IgG | |||||||
Sensitivity | 100% | 90.0% | 30.0% | 10.0% | 60.0% | 80.0% | 100% |
Specificity | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
FPR | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
FNR | 0% | 10% | 70.0% | 90.0% | 40.0% | 20.0% | 0% |
Accuracy | 100% | 95.0% | 65.0% | 55.0% | 80.0% | 90.0% | 100% |