GS HBsAg Confirmatory Assay 3.0

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GS HBsAg Confirmatory Assay 3.0

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
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The GS HBsAg Confirmatory Assay 3.0 is for the confirmatory neutralization of GS HBsAg EIA 3.0 reactive specimens. It relies on a human antibody to hepatitis B surface antigen (anti-HBsAg) for specificity.

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GS HBsAg Confirmatory Assay 3.0

32594
25 tests for confirmatory neutralization of GS HBsAg EIA 3.0 reactive specimens

2 32594 /templatedata/internet/product_SKU/data/CDG/Blood-Virus/Reagents/32594_0921120821114.xml 32594 09/21/09 12:08 PM en_US true internet/product_SKU 2019-05-04 13:54:57 /default/main/bio-rad/STAGING AE,AI,AL,AM,AR,AT,AU,AZ,BA,BD,BE,BF,BG,BH,BN,BO,BR,BW,CA,CH,CL,CM,CN,CO,CR,CY,CZ,DE,DK,DO,DZ,EC,EE,EG,EH,ER,ES,ET,FI,FM,FO,FR,GA,GE,GF,GH,GP,GR,GT,GU,HK,HN,HR,HT,HU,ID,IE,IL,IN,IS,IT,JM,JO,JP,KE,KH,KR,KW,KZ,LB,LI,LK,LT,LU,LV,MA,MD,MG,MK,ML,MO,MQ,MS,MT,MU,MX,MY,NG,NI,NL,NO,NP,NZ,OM,PA,PE,PF,PG,PH,PK,PL,PR,PS,PT,PW,PY,QA,RO,RS,RU,SA,SB,SE,SG,SI,SK,SN,ST,SV,TG,TH,TN,TO,TR,TT,TW,TZ,UA,UG,UK,US,UY,UZ,VA,VE,VU,XK,YE,ZA,VN templatedata/internet/product_SKU/data/CDG/Blood-Virus/Reagents/32594_0921120821114.xml /default/main/bio-rad/WORKAREA/default jo7tzjbf 2017-11-14 07:06:23 true jo7tzjbf templatedata/internet/product_SKU/data/CDG/Blood-Virus/Reagents/32594_0921120821114.xml CDG N /default/main/bio-rad en 12/31/37 11:59 PM 1555715204952 2019-05-04 13:54:57 /default/main/bio-rad/WORKAREA/default/templatedata/internet/product_SKU/data/CDG/Blood-Virus/Reagents/32594_0921120821114.xml 32594-gs-hbsag-confirmatory-assay-3-0 1 32594 GS HBsAg Confirmatory Assay 3.0 GS HBsAg Confirmatory Assay 3.0 25 tests for confirmatory neutralization of GS HBsAg EIA 3.0 reactive specimens 25 tests for confirmatory neutralization of GS HBsAg EIA 3.0 reactive specimens 25 tests for confirmatory neutralization of GS HBsAg EIA 3.0 reactive specimens /webroot/web/images/cdg/products/blood_virus_us/sku_thumb/global/bvd_32594_tn.jpg /webroot/web/images/cdg/products/blood_virus_us/sku_view/global/bvd_32594_view.jpg /webroot/web/images/cdg/products/blood_virus_us/sku_feature/global/bvd_32594_feature.jpg GS HBsAg Confirmatory Assay 3.0 preview ,VN RepEx GS HBsAg Confirmatory Assay 3.0 25 tests for confirmatory neutralization of GS HBsAg EIA 3.0 reactive specimens hbsag, confirmatory 09/21/09 12:08 PM 12/31/37 11:59 PM AE,AI,AL,AM,AR,AT,AU,AZ,BA,BD,BE,BF,BG,BH,BN,BO,BR,BW,CA,CH,CL,CM,CN,CO,CR,CY,CZ,DE,DK,DO,DZ,EC,EE,EG,EH,ER,ES,ET,FI,FM,FO,FR,GA,GE,GF,GH,GP,GR,GT,GU,HK,HN,HR,HT,HU,ID,IE,IL,IN,IS,IT,JM,JO,JP,KE,KH,KR,KW,KZ,LB,LI,LK,LT,LU,LV,MA,MD,MG,MK,ML,MO,MQ,MS,MT,MU,MX,MY,NG,NI,NL,NO,NP,NZ,OM,PA,PE,PF,PG,PH,PK,PL,PR,PS,PT,PW,PY,QA,RO,RS,RU,SA,SB,SE,SG,SI,SK,SN,ST,SV,TG,TH,TN,TO,TR,TT,TW,TZ,UA,UG,UK,US,UY,UZ,VA,VE,VU,XK,YE,ZA,VN en CDG /CDG/Blood-Virus/Reagents N 0 <p><strong>NAME AND INTENDED USE</strong></p> <p>The GS HBsAg Confirmatory Assay 3.0 is a qualitative assay intended for the confirmation of HBsAg reactive specimens detected in the GS HBsAg EIA 3.0.</p> <p><strong>WARNINGS FOR USERS</strong></p> <ol> <li>For In Vitro Diagnostic Use.</li> <li>Wear protective clothing, including lab coat, eye/face protection and disposable gloves (synthetic, non-latex gloves are recommended) while handling kit reagents. Wash hands thoroughly after performing the test.</li> <li>Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.</li> <li>Do not pipette by mouth.</li> <li>This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Wear appropriate protective clothing, gloves and eye/face protection and handle appropriately with the requisite Good Laboratory Practices. The following is a list of potential chemical hazards contained in kit components: <ol> <li>ProClin&trade; 950 (0.16%), a biocidal preservative that is irritating to eyes and skin, may be detrimental if enough is ingested, and may cause sensitization by skin contact; prolonged or repeated exposure may cause allergic reaction in certain sensitive individuals.</li> <li>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.</li> </ol> </li> </ol> <p><strong>PRODUCT DESCRIPTION</strong></p> <p>EIA test for confirmatory neutralization of Hepatitis B Surface Antigen (HBsAg) reactive specimens. This is a 25 test kit.</p> /webroot/web/html/cdg/products/SKUs/autopopulated/ 32594_0921120821114_en.html /webroot/web/html/cdg/products/SKUs/autopopulated//32594_0921120821114_en.html P-130 templatedata/internet/documentation/data/CDG/Global/English/Literature/P-130_0910140929197_en.xml false null false $ null false false true true false USD true false true /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=32594&quantity= false false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=32594&CartQuote=QT&quantity= 2310 false true false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=32594&AddToDefaultWishList=true&quantity= 41116100 null 32594
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