Validation Report

Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2)

(Lateral Flow)

IgM Antibody to Coronavirus (SARS-CoV-2)

Test description The product is intended for qualitative detection of Coronavirus (SARS-CoV-2)
IgM antibody in human serum, plasma or whole blood samples in vitro, which is
an auxiliary diagnosis method for the infection of Coronavirus (SARS-CoV-2).
Sample type：serum, plasma or whole blood samples
Storage Condition: 2~ 30℃
Analytical 1. Sensitivity and Specificity
performance Sensitivity: 79.0% (95%CI: 73.9%～83.3%)
Specificity: 99.7% (95%CI: 98.4%～100.0%)
Total agreement: 90.5% (95%CI: 88.0%～92.6%)

2. limit of detection (LOD)

The dilution matrix is used to dilute a positive serum sample in different series.
Repeatedly testing for 20 times, the results show that when the IgM antibody titer
is ≥1:256, the positive detection rate is ≥95%. So the LOD of the kit is
determined as no less than 1:256.

3. Cross-reactivity
Samples which show IgM positive to the following agents are tested with the kit.
The results showed no cross reactivity.
Endemic human coronaviruses (HKU1, OC43, NL63 and 229E), Influenza A,
Influenza B, Nasal virus, EB virus, Mumps virus, Measles virus,
Cytomegalovirus, Mycoplasma pneumoniae, Chlamydia pneumonia, Adenovirus,
Enterovirus ,Respiratory syncytial virus and Varicella-zoster virus IgM antibody
positive samples.

4. Interferences
The substance at the following concentration will not interfere the result of the
kit.
Substance Concentration
Bilirubin 50mg/dL
Hemoglobin 50mg/mL
Triglyceride 500mg/dL
Cholesterol 500mg/dL
Rheumatoid factor 920 IU/mL
HAMA 300ng/mL

5. Precision
1) Within run precision: The negative agreement rate and the positive agreement
 rate are both 100%.
2) Between run precision: The negative agreement rate and the positive
agreement rate are both 100%.

Clinical 1. A total of 644 serum/plasma patient samples suspected of COVID-19 are

performance tested, the diagnosis criteria used during our clinical study is based on the
clinical symptoms and RT- PCR result. The results are as follows:
The sensitivity and specificity are 79.0% (95% CI: 73.9%～83.3%) and
99.7% (95% CI: 98.4%～100.0%) respectively, and the total coincidence rate
with the clinical diagnosis is 90.5% (95% CI: 88.0%～92.6%).
2. The combined sensitivity (either IgM or IgG is positive) is 90.6% (95% CI:
86.6%～93.4%). The combined specificity (neither IgM nor IgG is positive)
is 99.2% (95% CI: 97.6%～99.7%), and the combined total coincidence rate
with the clinical diagnosis is 95.3% (95% CI: 93.4%～96.7%).
3. 176 homologous serum/plasma and whole blood samples are tested for
comparison, among which 50 samples are positive for IgM and 126 samples
are negative. The positive coincidence rate is 100% (95% CI: 92.9%～
100%), the negative coincidence rate is 100% (95% CI: 97%～100%), and
the total coincidence rate is 100% (95% CI: 97.9%～100%).

IgG Antibody to Coronavirus (SARS-CoV-2)

Test description The product is intended for qualitative detection of Coronavirus (SARS-CoV-2)
IgG antibody in human serum, plasma or whole blood samples in vitro, which is
an auxiliary diagnosis method for infection of Coronavirus (SARS-CoV-2)
Sample type：serum, plasma or whole blood samples.
Storage Condition: 2~ 30 ℃
Analytical 1. Sensitivity and Specificity
performance Sensitivity: 84.3% (95% CI: 79.6%～88.0%)
Specificity: 99.4% (95% CI: 98.0%～99.8%)
Total agreement: 92.7% (95% CI:90.4%～94.5%)

2. limit of detection (LOD)

The dilution matrix is used to dilute a positive serum sample in different series.
Repeatedly testing for 20 times, the results show that when the IgG antibody titer
is ≥1:128, the positive detection rate is ≥95%. So the LOD of the kit is
determined as no less than 1:128.

3. Cross-reactivity
Samples which show IgG positive to the following agents are tested with the kit.
The results showed no cross reactivity.
Endemic human coronaviruses (HKU1, OC43, NL63 and 229E), Influenza A,
Influenza B, Nasal virus, EB virus, Mumps virus, Measles virus,
Cytomegalovirus, Mycoplasma pneumoniae, Chlamydia pneumonia,
Adenovirus, Enterovirus, Respiratory syncytial virus and Varicella-zoster virus
 IgG antibody positive samples.

4. Interferences
The substance at the following concentration will not interfere the result of the
kit.
Substance Concentration
Bilirubin 50mg/dL
Hemoglobin 50mg/mL
Triglyceride 500mg/dL
Cholesterol 500mg/dL
Rheumatoid factor 920 IU/mL
HAMA 300ng/mL

5. Precision
1) Within run precision: The negative agreement rate and the positive agreement
rate are both 100%.
2) Between run precision: The negative agreement rate and the positive
agreement rate are both 100%.
Clinical 1. A total of 644 serum/plasma patient samples suspected of COVID-19 are
performance tested, the diagnosis criteria used during our clinical study is based on the
clinical symptoms and RT- PCR result. The results are as follows:
The sensitivity and specificity are 84.3% (95% CI: 79.6%～88.0%) and
99.4% (95% CI: 98.0%～99.8%) respectively, and the total coincidence rate
with the clinical diagnosis is 92.7% (95% CI: 90.4%～94.5%).
2. The combined sensitivity (either IgM or IgG is positive) is 90.6% (95% CI:
86.6%～93.4%). The combined specificity (neither IgM nor IgG is positive)
is 99.2% (95% CI: 97.6%～99.7%), and the combined total coincidence rate
with the clinical diagnosis is 95.3% (95% CI: 93.4%～96.7%).
3. 176 homologous serum/plasma and whole blood samples are tested for
comparison, among which 52 samples are positive for IgG and 124 samples
are negative. The positive coincidence rate is 100%(95% CI:93.1%～
100%), the negative coincidence rate is 99.2%(95% CI:95.6%～99.9%), and
the total coincidence rate is 99.4%(95% CI:96.9%～99.9%).