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
