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

Date: 2020-06-08
Views: 1248

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


Product Features


Excellent in Affinity & Specificity


High Correlation to Gold Standard PRNT


High Correlation to FDA EUA Neutralizing Antibody Test Kit


High Compatibility with Wide Application Range



Product Information


Catalog No.
Source
Tag
Buffer System
Platform
GECACE2S101
CHO
His
10mMPB+150mMNaCl, pH 7.4
ELISA/CLIA/CMIA
GECACE2S102
CHOhFC
10mMPB+150mMNaCl, pH 7.4ELISA/CLIA/CMIA
FPZ0557
CHOmFC
10mMPB+150mMNaCl, pH 7.4ELISA/CLIA/CMIA
FPZ0537
CHOHis10mMPB+150mMNaCl, pH 7.4ELISA/CLIA/CMIA
GEEACE2S101
CHOHis10mMPB+10% NBS+50% glycerol+0.1% p300, pH 7.4
ELISA
GEEACE2S102
CHOhFC10mMPB+10% NBS+50% glycerol+0.1% p300, pH 7.4ELISA
FPZ0565
CHOmFC10mMPB+10% NBS+50% glycerol+0.1% p300, pH 7.4ELISA
FPZ0540
CHOHis10mMPB+10% NBS+50% glycerol+0.1% p300, pH 7.4ELISA



Recommended Paris & Performance


Competitive ELISA


1. Product Information

Recommended Paris
Catalog No.
Recommended Usage
Reaction
Plaform
Pair 1
GECACE2S102
Coating
Indirect Coating & Direct Conjugate
ELISA
FPZ0537
Conjugate
Pair 2
GECACE2S101
Coating
FPZ0557
Conjugate
QC
FPZ0570
-


2. Sensitivity evaluation, the IC50 value of Fapon Biotech monoclonal NAb FPZ0570 is 71.2 ng/mL


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


3. Comparison with gold standard Plaque Reduction Neutralization Test (PRNT), the result of 6 monoclonal NAb strains showed a high correlation at R2=0.771



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


4. Comparison with FDA EUA Company G sVNT

A high correlation was shown  in the detection of convalescent patient serum at R2=0.9309


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


A high correlation was shown in the detection of vaccine A vaccinated specimens at R2=0.7688

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


5. Clinical Specificity

Used Pair 1 & 2 to test 1840 radom samples, no detection was found within cut off=20%


Competitive CLIA/CMIA


1. Product Information

Catalog No.
Recommended Usage
Reaction
Platform
GECACE2S102
Coating
Direct
AE-CLIA/CMIA
FPZ0557
Conjugate


2. Sensitivity & Linearity

Tested Fapon Biotech NAb FPZ0570,LOB<0.6 AU/mL,linearity=0.6-150 AU, R2=0.999


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


*  With no international quality control standard for NAb, the Fapon Biotech NAb FPZ0570 herein used as the reference material


3. Clinical Sensitivity & Specificity

Tested convalescent patient serum (1:10 dilution) with 19/20 detection rate; Tested vaccinated sample (1:3 dilution) with 22/23 detection rate, only found negative result in the sample used total antibody sandwich method; Tested 1026 healthy human samples with 1026/1026 specificity; Tested 14 respiratory samples with no obvious cross-reaction


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


4. Comparison with gold standard Plaque Reduction Neutralization Test (PRNT), the result showed a high correlation at R2=0.7278

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


5. Comparison with FDA EUA Company G sVNT

A high correlation was shown in the detection of convalescent patient serum at R2=0.9288

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


A high correlation was shown in the detection of vaccine A vaccinated specimens at R2=0.9012

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


Double-Antigen Sandwich CLIA/CMIA

1. Product Information

Catalog No.
Recommended Usage
Reaction
Platform
FPZ0557
Conjugate
Direct
AE-CLIA/CMIA
FPZ0537
Coating


2. Clinical Sensitivity & Specificity

Tested convalescent patient serum (1:20 dilution) with 20/20 detection rate; Tested vaccinated sample (1:3 dilution) with 22/23 detection rate, the negative result also found in the FDA EUA Company G reagent; Tested 1026 healthy human samples with 1010/1012 specificity; Tested 14 respiratory samples with no obvious cross-reaction

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


3. Comparison with FDA EUA Company G sVNT

A high correlation was shown in the detection of convalescent patient serum at R2=0.8813

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


A high correlation was shown in the detection of vaccinated specimens at R2=0.7155

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



Indirect IgG CLIA/CMIA


1. Product Information

Catalog No.
Recommended Usage
Reaction
Platform
BEEIGGI102
Conjugate
Direct
AE-CLIA/CMIA
FPZ0537
Coating


2. Clinical Sensitivity & Specificity

Tested convalescent patient serum (1:10 dilution) with 19/20 detection rate; Tested vaccinated sample with 17/19 detection rate; Tested 1017 healthy human samples with 996/1017 specificity; Tested 14 respiratory samples with no obvious cross-reaction

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


3. Comparison with FDA EUA Company G sVNT

A high correlation was shown in the detection of convalescent patient serum at R2=0.9112

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


A high correlation was shown in the detection of vaccinated specimens at R2=0.8302

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