MONOLISA™ Anti-HBs EIA

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Overview

MONOLISA™ Anti-HBs EIA

Excellent Percent Agreement with Other Anti-HBs FDA Approved Assays

The percent agreement between the MONOLISA™ Anti-HBs EIA and the reference anti-HBs assays was evaluated for each specimen classification.

Percent Agreement: MONOLISA Anti-HBs EIA versus Reference Anti-HBs EIA

HBV Classification Total Number of Samples Positive Percent Agreement Negative Percent Agreement
Acute Infection 14 100.0% (1/1) 100.0% (13/13)
Chronic Infection 81 66.7% (4/6) 94.7% (71/75)
Early Recovery 107 75.0% (3/4) 85.4% (88/103)
Recovery 176 94.7% (160/169) 0.0% (0/3)
Recovered 12 0.0% (0/1) 0.0% (0/5)
Past Infection 96 94.8% (91/96) NA (0/0)
HBV Vaccine Response 316 97.2% (307/316) NA (0/0)
HBV Vaccine Response Status Indeterminate 32 0.0% (0/7) 5.9% (1/17)
Not Previously Infected 609 NA (0/0) 98.2% (598/609)
Uninterpretable 9 100.0% (1/1) 100.0% (8/8)
TOTAL 1452 94.3% (567/601) 93.5% (779/833)


The positive percent agreement with the reference method is 94.3% (567/601) with a 95% confidence interval of 92.2–95.9%. The negative percent agreement with the reference method is 93.5% (779/833) with a 95% confidence interval of 91.6–95.0%.
The 18 specimens that were indeterminate by both assays were not included in the percent agreement calculations.

MONOLISA™ Anti-HBs EIA

MONOLISA™ Anti-HBs EIA

Excellent Correlation with the Official WHO Reference Standard Panel

Dilutions of the WHO First International Reference Preparation for Antibody to HBsAg (1977) were run in the Bio-Rad MONOLISA Anti-HBs quantitative assay. A linear regression of the mean anti-HBs EIA result versus the calculated concentration of each WHO dilution was used to determine the anti-HBs concentration.

Quantification and Wide Calibration Range: MONOLISA Anti-HBs Calibrator Kit

MONOLISA Anti-HBs Calibrator Kit allows measurement of a wide range of values in a calibration curve from 0 to 1000 mIU/mL without the need for dilution of high-titer samples.

Anti-HBs EIA: WHO Standard

MONOLISA™ Anti-HBs EIA Testing Procedure

MONOLISA™ Anti-HBs EIA Testing Procedure

Test Format   Color of well
BEFORE addition
  Color of well
AFTER addition
 
  • Microplate coated with human HB antigen, subtypes ad and ay
     
  • 75 μL of control or sample and 25 μL of Specimen Diluent
  • Incubate for 1 hour at 37°C
 
Wash
 
  • 100 μL of Working Conjugate Solution
  • Incubate for 1 hour at 37°C
 
Wash
 
  • 100 μL of Working TMB Solution
  • Incubate for 30 minutes in the dark at room temperature (18–30°C)
  • 100 μL of Stopping Solution
  • Cutoff = Mean OD of
    10 mIU/mL Cutoff Calibrator
 
READ at dual wavelength 450/615–630 nm and 405/615–630 nm
Human HBs antigen   HBs antigen labeled with peroxidase   Anti-HBs Ab from sample   * Reactive samples after 30 minute incubation
Hepatitis B Serology

Serology Profiles

Hepatitis B: Example of Acute Hepatitis

Hepatitis Testing

Comprehensive Product Line for Hepatitis Testing

   
Fast incubation time:
2.5 hours
  Standardized procedure
for all Bio-Rad assays
  Microplate strip identification
   
Common reagents for
all Bio-Rad kits
  Color-coded reagent
and kit labels
  Color changes during
protocol steps
   
Manual and automated use   Barcoded reagents   Controls with
color-coded caps

MONOLISA™ Anti-HBs EIA is for the qualitative and quantitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma. The MONOLISA™ Anti-HBs EIA is intended for manual use and for use with the Bio-Rad EVOLIS™ Automated Microplate System in the detection of antibodies to hepatitis B surface antigen.

Bio-Rad offers a full range of sensitive and specific hepatitis B microplate assays to detect every stage of hepatitis B virus (HBV) infection. All Bio-Rad hepatitis B enzyme immunoassays (EIA) feature common reagents and procedures for use with other Bio-Rad assays, fast incubation time (2.5 hours), and easy automation. Advanced safety features include: barcoded reagents, color-coded reagents and reagent labels, microplate strip identification, color monitoring for sample and conjugate addition steps, and color changes during protocol steps.

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MONOLISA™ Anti-HBs Calibrator Kit
MONOLISA™ Anti-HBs Calibrator Kit

25219
1 set of calibrators for 20 calibrations of MONOLISA™ Anti-HBs EIA

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MONOLISA™ Anti-HBs EIA
MONOLISA™ Anti-HBs EIA

25220
192 tests for detection of antibody to hepatitis B surface antigen in human serum and plasma

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P-136 MONOLISA™ Anti-HBs EIA Brochure (U.S. Only) Click to download [ Add to Cart (Free) ]
P-130 Hepatitis Product Brochure (U.S. Version) Click to download [ Add to Cart (Free) ]