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Table 1. Product Description of the Seven Immunochromatography Kits of COVID-19.

From: Comparison of the Diagnostic Value of Immunochromatography Kits in Corona Virus Disease 2019 Patients: A Prospective Pilot Study

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
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Table 2. Baseline Characteristics of The Study Population.

From: Comparison of the Diagnostic Value of Immunochromatography Kits in Corona Virus Disease 2019 Patients: A Prospective Pilot Study

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) - -
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Table 3. The Detailed Clinical Information of the Ten Patients in the Positive Group.

From: Comparison of the Diagnostic Value of Immunochromatography Kits in Corona Virus Disease 2019 Patients: A Prospective Pilot Study

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 - + - - - - + - + + +
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Table 4. THe Details of the Reaction in Seven Immunochromatography Kits for Antibodies of SARS-CoV-2.

From: Comparison of the Diagnostic Value of Immunochromatography Kits in Corona Virus Disease 2019 Patients: A Prospective Pilot Study

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)		 ++ ++ - + - - - - - + + + ++ ++
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Table 5. The Quality in Seven Immunochromatography Kits for Antibodies of SARS-CoV-2

From: Comparison of the Diagnostic Value of Immunochromatography Kits in Corona Virus Disease 2019 Patients: A Prospective Pilot Study

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%
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