GS HBsAg EIA 3.0

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Overview

GS HBsAg EIA 3.0

Earliest Hepatitis B Infection Detection Demonstrated on
21 Commercial Seroconversion Panels*

GS HBsAg EIA 3.0 Reactivity on Comercial HBsAg
Seroconversion Panels Versus Competitors
(Earliest Detection Indicated in Bold Type)
Panel ID#
GS HBsAg EIA 3.0
HBsAg EIA
Competitor #1

(overnight)
HBsAg EIA
Competitor #2
Static
Shaker
902
7
7
9
9
903
3
2
5
5
904
2
1
3
3
905
1
1
1
1
906
2
2
2
3
907
6
5
6
6
908
6
4
7
7
909
4
3
4
5
910
3
3
3
4
911
20
20
21
22
912
7
6
8
8
914
2
2
5
5
915
1
1
9
11
917
2
2
3
3
918
2
2
3
3
919
5
4
6
7
920
3
3
3
3
924
3
2
3
4
931
5
3
NT
7
932
10
8
NT
10
40565L
2
1
3
NT


* The sensitivity of GS HBsAg EIA 3.0, procedures A and B, was assessed using 20 seroconversion panels purchased from Boston Biomedica, Inc. (West Bridgewater, MA), and 1 panel from Serologicals, Inc. (Clarkston, GA). The number of the bleed at which HBsAg was detected (S/C ≥ 1.0) by the GS HBsAg EIA 3.0, procedures A and B, is compared to other licensed HBsAg assays (as recorded in the certificates of analysis).


GS HBsAg 3.0 Static Procedure

  • Earlier detection on 12 out of 19 seroconversions for HBsAg 3.0 versus competitor assay number 1
  • Earlier detection on 16 out of 20 seroconversions for HBsAg 3.0 versus competitor assay number 2

GS HBsAg 3.0 Shaking Procedure

  • Earlier detection on 15 out of 19 seroconversions versus competitor assay number 1
  • Earlier detection on 18 out of 20 seroconversions versus competitor assay number 2
GS HBsAg EIA 3.0

GS HBsAg EIA 3.0 Testing Procedure

Test Format +   Sample/Reagent Addition Monitoring
  • Microplate coated with monoclonal antibody (Ab)
Color of well
BEFORE addition
  Color of well
AFTER addition
  • 100 µL of control or sample
  • Incubate 60–65 minutes at 37°C
Wash
  • 100 µL of Working Conjugate Solution
  • Incubate 60–65 minutes at 37°C
 
Wash
  • 100 µL of Working TMB Solution
  • Incubate 30 minutes at
    room temperature
  • 100 µL of Stopping Solution
 
READ within 30 minutes at 450 nm with the 615–630 nm filter as a reference
Anti-HBsAg
Monoclonal Ab
  HBsAg   Anti-HBsAg
Monoclonal Ab Conjugate

+

*

Static or Shaker

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


NAME AND INTENDED USE

The GS HBsAg EIA 3.0 is a qualitative enzyme immunoassay for detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma. It is indicated as a screening test for specimens from individual human donors, including donors of whole blood, blood components, and source plasma, and from other living donors. It is also intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. The assay is not intended for use on cord blood specimens.

The GS HBsAg EIA 3.0 is intended for manual use and use with the ORTHO® Summit System (OSS) in the screening of blood donors.

WARNINGS FOR USERS

  1. For In Vitro Diagnostic Use.
  2. This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Handle appropriately with the requisite Good Laboratory Practices. Wear protective clothing, including lab coat, eye/face protection, and disposable gloves (synthetic, non-latex gloves are recommended) while handling kit reagents and patient samples. Wash hands thoroughly after performing the test.
  3. Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.
  4. Do not pipette by mouth.
  5. The following is a list of potential chemical hazards contained in some kit components (refer to Product Description chart):
    1. 0.005% Gentamicin Sulfate, a biocidal preservative, which is a known reproductive toxin, photosensitizer, and sensitizer; prolonged or repeated exposure may cause allergic reaction in certain sensitive individuals.
    2. WARNING: Components C1, C2, R3, and R4 contain 0.5% ProClin 300

PRODUCT DESCRIPTION

GS HBsAg 3.0 is an enzyme immunoassay (EIA) intended for the detection of Hepatitis B surface antigen (HBsAg) in human serum, plasma and cadaveric serum specimens. 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: bar-coded reagents, color-coded reagents and reagent labels, microplate strip identification, color monitoring for sample and conjugate addition steps and color changes during protocol steps. A range of ordering options is available to suit unique laboratory needs and test volumes.

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GS HBsAg EIA 3.0
GS HBsAg EIA 3.0

32591
480 tests for detection of hepatitis B surface antigen (HBsAg) in human serum, plasma, and cadaveric serum specimens

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GS HBsAg EIA 3.0
GS HBsAg EIA 3.0

25258
4800 tests for detection of hepatitis B surface antigen (HBsAg) in human serum, plasma, and cadaveric serum specimens

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