SARS CoV2 Neutralization Antibody Detection
SureMed Solutions can help you identify which members of your organizations have the ability to fight off the SARS CoV2 (COVID-19) virus. Their immune status means they cannot catch or spread the virus when in proximity of non-immune people. Identifying these people helps reduce the money your company is spending on unnecessary COVD testing.
How does the virus infect the cell?
For the virus to invade the human cells, it needs to attach to the ACE2 receptor with the receptor-binding domain (RBD) of the Spike Protein.
If this interaction is blocked, with a Neutralization/blocking antibody, the virus can not invade the cell.
What is the advantage of conventional VNT assay?
Conventional Method
(Live Virus)
Virus Neutralization Assay
• Requires strict safety conditions – BSL3
• Takes days to perform
• Requires high level expertise to read
• Expensive and not scalable
New Method
(Recombinant Proteins)
Neutralization Antibody Test
• Fast and Automatable
• Works in any laboratory setting
• Can be done at high throughput
• More Consistent
What is the advantage of a regular antibody detection test
Current IgG/IgM Antibody Tests
• Test for all binding antibodies
• Does not indicate neutralizing function
• Need secondary antibody which is isotype and species dependent
Neutralization Antibody Test
• Test for Neutralizing antibodies only
• Confirms neutralizing function
• Does not need secondary antibody
• Isotype and species independent
FDA EUA
Device
SARS-CoV-2 Neuralization Antibody Detection Kit
Indication
Qualitive detection of total neutralization antibodied to SARS-CoV-2 in human serum and K2-EDTA plasma. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that met requirements to perform high complexity tests.
Test Comparison
Sensitivity
NCP IgG
Value: 90.91%
95% CI: 58.72% to 99.77%
Comp M IgG
Value: 100.00%
95% CI: 96.15% to 100.00%
Neutralization Antibody Test
Value: 100.00%
95% CI: 96.15% to 100.00%
Specificity
NCP IgG
Value: 100.00%
95% CI: 95.70% to 100.00%
Comp M IgG
Value: 97.67%
95% CI: 91.85% to 99.74%
Neutralization Antibody Test
Value: 100.00%
95% CI: 91.85% to 99.74%
Positive Likelihood Ratio
NCP IgG
Value: ————
95% CI: ————
Comp M IgG
Value: 43.00%
95% CI: 10.93% to 196.17%
Neutralization Antibody Test
Value: ————
95% CI: 10.93% to 196.17%
Negative Likelihood Ratio
NCP IgG
Value: 0.09%
95% CI: 0.01% to 0.59%
Comp M IgG
Value: 0.00%
95% CI: ————
Neutralization Antibody Test
Value: 0.00%
95% CI: ————
Disease Prevalence (*)
NCP IgG
Value: 5.00%
95% CI: ————
Comp M IgG
Value: 5.00%
95% CI: ————
Neutralization Antibody Test
Value: 5.00%
95% CI: ————
Positive Predictive Value (*)
NCP IgG
Value: 100.00%
95% CI: ————
Comp M IgG
Value: 69.35%
95% CI: 36.52% to 89.90%
Neutralization Antibody Test
Value: 100.00%
95% CI: 36.52% to 89.90%
Negative Predictive Value (*)
NCP IgG
Value: 99.52%
95% CI: 96.99% to 99.93%
Comp M IgG
Value: 100.00%
95% CI: ————
Neutralization Antibody Test
Value: 100.00%
95% CI: ————
Accuracy (*)
NCP IgG
Value: 99.55%
95% CI: 95.32% to 100.00%
Comp M IgG
Value: 97.79%
95% CI: 92.49% to 99.71%
Neutralization Antibody Test
Value: 100.00%
95% CI: 92.49% to 99.71%
Comparison Summary: 84 negative samples | 10 positive samples | Some competitors had fewer than 10 positives | The Neutralization antibody test was the only test to achieve 100% on all measures.
