MONOLISA™ Anti-HBc EIA

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MONOLISA Anti-HBc EIA

Overview

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
Hepatitis Testing

MONOLISA™ Anti-HBc EIA Procedure

Test Format

  Color of well
BEFORE addition
  Color of well
AFTER addition
  • Microplate coated with recombinant HBc antigen

  • 200 μL of Specimen Diluent
  • 20 μL of control or sample

  • Incubate for 60 minutes at 37°C
Wash
  • 100 μL of Working Conjugate Solution

  • Incubate for 60 minutes at 37°C
 
Wash
  • 100 μL of Working TMB Solution

  • Incubation for 30 minutes at room temperature (18–30°C) in the dark
  • 100 μL of Stopping Solution

  • Cutoff = Calibrator
    Cutoff Mean + 0.250
 
READ at dual wavelength 615/630 nm
HBcAg Recombinant Protein   Anti-HBc Ab   Anti-IgG/IgM Conjugate   * Reactive samples after 30 minute incubation
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NAME AND INTENDED USE

The MONOLISA™ Anti-HBc EIA is an enzyme immunoassay intended for use in the qualitative detection of total antibodies (IgG/IgM) to hepatitis B core antigen (anti-HBc) in human serum and plasma (potassium EDTA, sodium citrate, ACD [acid citrate dextrose], lithium heparin and sodium heparin). Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. The MONOLISA™ Anti-HBc EIA is intended for manual use and for use with the Bio-Rad EVOLIS™ Automated Microplate System in the detection of total antibodies to hepatitis B core antigen.

WARNING

This assay has not been FDA cleared or approved for the screening of blood or plasma donors

Federal law restricts this device to sale by or on the order of a physician.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.

PRODUCT DESCRIPTION

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

26186
192 tests for detection of total antibodies to hepatitis B nucleocapsid core antigen in human serum or plasma

0 26186 /templatedata/internet/product_SKU/data/CDG/Blood-Virus/Reagents/26186_0921120820817.xml 26186 09/21/09 12:08 PM N en 09/21/19 12:08 PM true true internet/product_SKU 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 CDG 2017-11-14 07:06:23 26186-monolisa-anti-hbc-eia 26186 MONOLISA Anti-HBc EIA MONOLISA&trade; Anti-HBc EIA 192 tests for detection of total antibodies to hepatitis B nucleocapsid core antigen in human serum or plasma 192 tests for detection of total antibodies to hepatitis B nucleocapsid core antigen in human serum or plasma 192 tests for detection of total antibodies to hepatitis B nucleocapsid core antigen in human serum or plasma /webroot/web/images/cdg/products/blood_virus/sku_thumb/global/bvd_26186_tn.jpg /webroot/web/images/cdg/products/blood_virus/sku_view/global/bvd_26186_view.jpg /webroot/web/images/cdg/products/blood_virus/sku_feature/global/bvd_26186_feature.jpg MONOLISA&trade; Anti-HBc EIA RepEx MONOLISA Anti-HBc EIA 192 tests for detection of total antibodies to hepatitis B nucleocapsid core antigen in human serum or plasma hbc, hepatitis b, total 09/21/09 12:08 PM 09/21/19 12:08 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 en CDG /CDG/Blood-Virus/Reagents N 0 <p><strong>NAME AND INTENDED USE</strong></p> <p>The MONOLISA&trade; Anti-HBc EIA is an enzyme immunoassay intended for use in the qualitative detection of total antibodies (IgG/IgM) to hepatitis B core antigen (anti-HBc) in human serum and plasma (potassium EDTA, sodium citrate, ACD [acid citrate dextrose], lithium heparin and sodium heparin). Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. The MONOLISA&trade; Anti-HBc EIA is intended for manual use and for use with the Bio-Rad EVOLIS&trade; Automated Microplate System in the detection of total antibodies to hepatitis B core antigen.</p> <p><strong>WARNING</strong></p> <p>This assay has not been FDA cleared or approved for the screening of blood or plasma donors</p> <p>Federal law restricts this device to sale by or on the order of a physician.</p> <p>Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.</p> <p><strong>PRODUCT DESCRIPTION</strong></p> <p>EIA test for the qualitative detection of total antibodies (IgG/IgM) to hepatitis B core antigen (Anti-HBc) in human serum and plasma (potassium EDTA, sodium citrate, ACD, lithium heparin, and sodium heparin). Color changes during protocol steps. Controls with color coded caps. Kit is for 192 tests.</p> <p><strong><span class="hidden CA-only" style="color: #ff0000;">Unlicensed for Sale in Canada<br /> Non-homologu&eacute; pour la vente au Canada.</span></strong></p> /webroot/web/html/cdg/products/SKUs/autopopulated/ 26186_0921120820817_en.html /webroot/web/html/cdg/products/SKUs/autopopulated//26186_0921120820817_en.html P-130 templatedata/internet/documentation/data/CDG/Global/English/Literature/P-130_0910140929197_en.xml false false false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=26186&CartQuote=QT&quantity= true true false null false null /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=26186&AddToDefaultWishList=true&quantity= false false true true false true false true /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=26186&quantity= 26186
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