Home Raw Materials New/Featured Products
COVID-19 NAb Test Solution

COVID-19 NAb Test Solution for Latex-Enhanced Immunoturbidimetry

Innovative patented methodology for both neutralizing antibody and total antibody detection

Quantitative analysis and dynamic monitoring of vaccine antibody titer and effect evaluation

Less detection time, no P3 lab required, break the limitations of testing requirement on environment and personnel

Achieve high-throughput detection, meet the needs of different application scenarios

High versatility to meet applications in automatic/semi-automatic biochemical instruments, specific protein analyzers, blood-cell counters and other detection platforms


Product Information

Cat. No

Product Name

Product Form

Component

Parameter

Applicable Analyzer

S03001

COVID-19 NAb & Total Ab Test Kit

OEM

R1/R2/R3

15:135:15:50; 700nm

Automatic Biochemical Instruments

S03001C

Calibrator

C1-C6 (FPZ0570)

Spline

S03001Q

QC

L/H (FPZ0570)

-



Principle


Performance


Parameters

Analyzer

Sample

Sample size

R1 (buffer)

R2 (RBD latex reagent)

R3 (ACE2 latex reagent)

Wavelength

Testing method

Calibration

Automated Biochemistry Analyzer

Human serum

15μL

135μL

15μL

50μL

700nm

Endpoint

Spline


Specificity & Cut-off Value

The cut-off values for NAb and Total Ab are ≤10AU/mL. Tested 528 random samples, the specificity for NAb and Total Ab is 98.48% and 97.92%


Linearity & Hook Curve

For NAb, the linear range is within 4-160 AU/mL, the linear correlation coefficient is r > 0.990, the absolute deviation is ≤ ±1AU/mL in the range of 4-10 AU/mL, and the relative deviation is ≤ 10% in the range of 10-160 AU/mL

For Total Ab, the linear range is within 2-70 AU/mL, the linear correlation coefficient is r > 0.990, the absolute deviation is ≤ ±6AU/mL in the range of 2-6 AU/mL, and the relative deviation is ≤ 10% in the range of 6-70 AU/mL



Clinical Correlation

The Correlation between Fapon NAb immunoturbidimetry and FDA EUA approved competitive enzyme-linked immunoassay is R = 0.73

The Correlation between Fapon Total Ab immunoturbidimetry and CLIA indirect IgG is R = 0.86



Sensitivity

The sensitivity of NAb and Total Ab is LOQ=4 AU/mL and LOQ=1.076 AU/mL


Precision

The precision of NAb and Total Ab is CV ≤ 6%

 

Cross-reaction 

No cross-reaction was shown in mycoplasma pneumonia (n=32) and influenza A (n=7) positive samples


COVID-19 NAb Test Solution for Immunoassay

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, pH7.4

ELISA/CLIA/CMIA

GECACE2S102

CHO

hFC

10mMPB+150mMNaCl, pH7.4

ELIS/CLIA/CMIA

FPZ0557

CHO

mFC

10mMPB+150mMNaCl, pH7.4

ELIS/CLIA/CMIA

FPZ0537

CHO

His

10mMPB+150mMNaCl, pH7.4

ELIS/CLIA/CMIA

GEEACE2S101

CHO

His

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

ELISA

GEEACE2S102

CHO

hFC

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

ELISA

FPZ0565

CHO

mFC

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

ELISA

FPZ0540

CHO

His

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

ELISA


Competitive ELISA

Recommended Pair

Catalog No.

Recommended Usage

Reaction

Platform

Pair 1

GECACE2S102

Coating

Indirect Coating & Direct Conjugate

ELISA

FPZ0537

Conjugate

Pair 2

GECACE2S101

Coating

FPZ0557

Conjugate

QC

FPZ0570

-


Sensitivity

The IC50 value of Fapon Biotech monoclonal NAb FPZ0570 is 71.2ng/mL


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



Comparison with FDA EUA Company G sVNT

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

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


Clinical Specificity

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


Competitive CLIA/CMIA

Catalog No.

Recommended Usage

Reaction

Platform

GECACE2S102

Coating

Direct

AE-CLIA/CMIA

FPZ0557

Conjugate


Sensitivity & Linearity

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


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

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

Comparison with FDA EUA Company G sVNT,A high correlation was shown in the detection of convalescent patient serum at R =0.9288, A high correlation was shown in the detection of vaccine A vaccinated specimens at R =0.9012

Double-Antigen Sandwich CLIA/CMIA

Catalog No.

Recommended Usage

Reaction

Platform

FPZ0557

Conjugate

Direct

AE-CLIA/CMIA

FPZ0537

Coating

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



Comparison with FDA EUA Company G sVNT

A high correlation was shown in the detection of convalescent patient serum at R 2 =0.8813, A high correlation was shown in the detection of vaccinated specimens at R =0. 7155


Indirect IgG CLIA/CMIA

Catalog No.

Recommended Usage

Reaction

Platform

BEEIGGI102

Conjugate

Direct

AE-CLIA/CMIA

FPZ0537

Coating


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



Comparison with FDA EUA Company G sVNT

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

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