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Fapon COVID-19 Neutralizing Antibody Titer Testing Solution for ELISA & CLIA

Date: 2020-06-08
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To address the unmet medical needs during this COVID-19 pandemic, Fapon once again manifests the strength of R&D capabilities to the world by being one of the leading biotechnology companies to launch the COVID-19 Naturalizing Antibodies Titer Testing Solution for ELISA and CLIA. This solution provides raw materials and quality controls to aid the evaluation of vaccine efficacy, antibody-drug effectiveness, convalescent plasma therapy, and seroepidemiological investigation. 



What is COVID-19 Neutralizing Antibodies

 

Neutralizing antibodies (NAbs) have significant preventive and therapeutic effects by playing crucial roles in controlling viral infection. NAbs target the viral S protein and block the binding ability of S protein to the human angiotensin-converting enzyme 2 (ACE2) receptor, thus preventing viral entry into host cells.


 

Clinical Applications


Vaccine Efficacy——The clinical therapeutic effect after vaccination is determined by the titers of NAbs produced by the immune response, hence the detection of NAbs can evaluate the vaccine efficacy. 


Antibody-Drug Effectiveness——NAbs are regarded as important therapeutic agents for COVID-19 treatment. In antibody drug development, results of NAbs detection reflect on the neutralizing abilities against the virus, serving as one of the assessing criteria for drug effectiveness evaluation.


Convalescent Plasma Therapy——Convalescent plasma therapy is an experimental treatment for patients with COVID-19. Because people who recovered from COVID-19 have the antibodies to fight off infections, given them to people with severe COVID-19 can boost their ability to combat the virus. The detection of neutralizing antibody levels can identify the ideal recovered plasma donors and indicate the effectiveness of treatment.


Seroepidemiological Investigation——Suggested by the WHO standardized protocol “Population-based age-stratified seroepidemiological investigation protocol for COVID-19 virus infection”, NAbs tests should ideally be performed if samples are positive or equivocal for either IgM, IgA or IgG. Hence it can be used to determine social immunity and assist seroepidemiological study.


 

Comparison of Different Test Methods for NAbs

 

Fapon COVID-19 NAbs Titer Testing Solution features raw materials and quality controls that apply in sVNT, which is less time consuming than other test methods, making it more efficient and suitable for academic research and clinical needs.



VNT (Virus Neutralization Tes-t)


pVNT (Pseudovirus-based Virus Neutralization Test)


sVNT (Surrogate Virus Neutralization Test)

Facility Required

A specialized biosafety level 3  laboratory (BSL3)

A specialized biosafety level 2 la-boratory (BSL2)

A specialized biosafety level 2 laboratory (BSL2)

Live Virus

Require

Can be replaced with pseudovirus-based virus


Can be replaced with the purified    receptor-binding domain (RBD) protein from the viral spike (S) protein


Detection Time

2-4 days

2-4 days

1-2 hours



ELISA Platform



Catalog No.

Source

Tag

Buffer System

GECACE2S101

CHO

His

10mMPB+150mMNaCl, pH7.4

GEEACE2S101

His

10mMPB+10% NBS+50% glycerol +0.1% P300, pH7.4

GECACE2S102 

hFC

10mMPB+150mMNaClpH7.4

GEEACE2S102  

hFC

10mMPB+10% NBS+50% glycerol +0.1% P300, pH7.4

FPZ0557

mFC

10mMPB+150mMNaCl, pH7.4

FPZ0565

mFC

10mMPB+10% NBS+50% glycerol +0.1% P300, pH7.4

FPZ0537

His

10mMPB+150mMNaCl, pH7.4

FPZ0540

His

10mMPB+10% NBS+50% glycerol +0.1% P300, pH7.4



The IC50 of quality control is 0.5623 nM (FPZ0570)

Fapon COVID-19 Neutralizing Antibody Titer Testing Solution for ELISA & CLIA


Fapon sVNT exhibits high clinical correlation to VNT

Fapon COVID-19 Neutralizing Antibody Titer Testing Solution for ELISA & CLIA


CLIA Platform



Catalog No.

Source

Tag

Buffer System

GECACE2S101

CHO

His

10mMPB+150mMNaCl, pH7.4

GECACE2S102

hFC

FPZ0557

mFC

FPZ0537

His


sVNT Test Component

Concentrated AE Solution (GECACE2S102)

Concentrated Bead Solution (FPZ0537)

AE Diluent Buffer

Beads Diluent Buffer

Sample Diluent Buffer

Quality Control (FPZ0570)



The affinity level between RBD and ACE2 via ForteBio is Nm (FPZ0537 & GECACE2S102)

Fapon COVID-19 Neutralizing Antibody Titer Testing Solution for ELISA & CLIA


No significant cross-reactivity with samples of respiratory tract infection and samples of the elderly people

* ACE2, as a cell receptor, plays an essential role in blood pressure regulation. As hypertension is prevalent in the elderly, most elderly samples are associated with hypertension

Fapon COVID-19 Neutralizing Antibody Titer Testing Solution for ELISA & CLIA



Fapon Nabs exhibits high sensitivity and specificity in clinical performance (FPZ0537 & GECACE2S102)


Fapon COVID-19 Neutralizing Antibody Titer Testing Solution for ELISA & CLIA



The IC50 of quality control is 0.1755 nM (FPZ0570)


Fapon COVID-19 Neutralizing Antibody Titer Testing Solution for ELISA & CLIA





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