Ortho® HCV Version 3.0 ELISA Test System

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Ortho HCV Version 3.0 ELISA Test System

Overview

Hepatitis C Testing System

ORTHO® HCV, Version 3.0, ELISA Test System

HCV Genome and Recombinant Proteins

Hepatitis C Testing System

ORTHO® HCV, Version 3.0 ELISA Test System

The specificity of ORTHO HCV Version 3.0 ELISA Test System in low-risk populations is based on a population of blood donors from four different test sites. A total of 33,025 specimens were tested. These consisted of 30,025 specimens from presumably healthy volunteer blood donors (sites 1, 2 and 3) and 3,000 specimens from commercial plasma donors (site 4). Rates of initial and repeat reactivities are shown in the table below. Correlation between initial and repeat reactivity was 87.1%.

Prevalence of Anti-HCV Reactivity in Blood Donors
Site Number Tested Nonreactive Initially Reactive Repeatedly Reactive
1 10,208 10,169 47 (0.46%) 39 (0.38%)
2 9,772 9,722 54 (0.55%) 50 (0.51%)
3 10,045 9,998 54 (0.54%) 47 (0.47%)
4 3,000 2,987 16 (0.53%) 13 (0.43%)
Total 33,025 32,876 171 (0.52%) 149 (0.45%)


Specimens repeatedly reactive by ELISA were tested by supplemental strip immunoblot assay (SIA). Upon removal of specimens that were positive or indeterminate by SIA, specificity* in this low prevalence population was 99.95% (5 units per 10,000 donations).

*Specificity was calculated as follows: Specificity = (TN/TN+FP)

  • Where TN = true negatives, that is, the number of specimens nonreactive by ELISA.
  • Where FP = false positives, that is, repeatedly reactive by ELISA and negative by SIA.
Hepatitis C Testing System

ORTHO® HCV, Version 3.0 ELISA Test System

Performance Data: Detection of Anti-HCV Seroconversion in Transfusion Recipients with Transfusion-Associated NANBH (TA-NANBH)

Serial specimens collected from 21 patients with clinically documented TA-NANBH were tested at clinical (patient) site 2 by both ORTHO HCV Version 3.0 ELISA Test System and ORTHO HCV 2.0 ELISA Test System. HCV Version 3.0 detected seroconversion to anti-HCV in earlier bleeds in 5/21 (24%) patients. HCV 2.0 detected seroconversion to anti-HCV in an earlier bleed in 1/21 (5%) patients. In 15 patients, HCV Version 3.0 and HCV 2.0 detected anti-HCV in the same serial bleed.

Difference in Detection of Anti-HCV in 21 TA-NANBH Patients
Patient Number Earlier Detection by
HCV ELISA
Difference in Detection
Bleeds (Days)
1 HCV Version 3.0 2 (20)
2 HCV Version 3.0 1 (34)
3 HCV Version 3.0 1 (27)
4 HCV Version 3.0 2 (20)
5 HCV Version 3.0 2 (29)
6 HCV 2.0 1 (35)

There was no difference in the time to detection of anti-HCV ELISA reactivity in the remaining 15 patients.

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INTENDED USE

ORTHO® HCV Version 3.0 ELISA Test System is an enzyme-linked, immunosorbent assay for the qualitative detection of antibody to hepatitis C virus (anti-HCV) in human serum, plasma, and cadaveric specimens. This product is intended for use as a donor screening test to detect antibodies to hepatitis C virus in plasma and serum samples from individual human donors, including volunteer donors of Whole Blood, blood components, source plasma, and other living donors. It is also intended for use to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. This test is not intended for use on samples of cord blood. The ORTHO® HCV Version 3.0 ELISA Test System is intended for use in a fully manual mode, in semi-automated mode using the ORTHO® Summit Sample Handling System (ORTHO® Summit Pipetter) and/or the ORTHO VERSEIA™ Pipetter, or in automated mode with the ORTHO® Summit System (OSS).

CAUTION: HANDLE AS IF CAPABLE OF TRANSMITTING INFECTIOUS AGENTS.

PRODUCT DESCRIPTION

The Ortho® HCV Version 3.0 ELISA Test System uses three recombinant antigens developed by Chiron® Corporation to detect antibodies to hepatitis C virus (HCV) with excellent sensitivity and enhanced specificity (99.95 percent). These antigens (c22-3, c200 and NS5) cover 60 percent of the HCV genome, allowing broad detection of HCV antibodies. Early detection of HCV helps to eliminate potentially infectious units and improves the safety of the world’s blood supply.

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Ortho HCV Version 3.0 ELISA Test System

930740
480 tests using 3 recombinant antigens developed by Chiron® Corp. to detect antibodies to hepatitis C virus

0 930740 /templatedata/internet/product_SKU/data/CDG/Blood-Virus/Reagents/930740_0921120822533.xml 930740 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 07:06:24 930740-ortho-hcv-version-3-0-elisa-test-system 930740 Ortho HCV Version 3.0 ELISA Test System Ortho HCV Version 3.0 ELISA Test System 480 tests using 3 recombinant antigens developed by Chiron<sup>&reg;</sup> Corp. to detect antibodies to hepatitis C virus 480 tests using 3 recombinant antigens developed by Chiron Corp. to detect antibodies to hepatitis C virus 480 tests using 3 recombinant antigens developed by Chiron<sup>&reg;</sup> Corp. to detect antibodies to hepatitis C virus /webroot/web/images/cdg/products/blood_virus/sku_thumb/global/bvd_930740_tn.jpg /webroot/web/images/cdg/products/blood_virus/sku_view/global/bvd_930740_view.jpg /webroot/web/images/cdg/products/blood_virus/sku_feature/global/bvd_930740_feature.jpg Ortho HCV Version 3.0 ELISA Test System RepEx Ortho HCV Version 3.0 ELISA Test System 480 tests using 3 recombinant antigens developed by Chiron Corp. to detect antibodies to hepatitis C virus hcv, eia, 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>INTENDED USE</strong></p> <p>ORTHO&reg; HCV Version 3.0 ELISA Test System is an enzyme-linked, immunosorbent assay for the qualitative detection of antibody to hepatitis C virus (anti-HCV) in human serum, plasma, and cadaveric specimens. This product is intended for use as a donor screening test to detect antibodies to hepatitis C virus in plasma and serum samples from individual human donors, including volunteer donors of Whole Blood, blood components, source plasma, and other living donors. It is also intended for use to screen organ donors when specimens are obtained while the donor&rsquo;s heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. This test is not intended for use on samples of cord blood. The ORTHO&reg; HCV Version 3.0 ELISA Test System is intended for use in a fully manual mode, in semi-automated mode using the ORTHO&reg; Summit Sample Handling System (ORTHO&reg; Summit Pipetter) and/or the ORTHO VERSEIA&trade; Pipetter, or in automated mode with the ORTHO&reg; Summit System (OSS).</p> <p><strong>CAUTION: HANDLE AS IF CAPABLE OF TRANSMITTING INFECTIOUS AGENTS.</strong></p> <p><strong>PRODUCT DESCRIPTION</strong></p> <p>EIA test for detection of antibodies to the hepatitis C virus (HCV 3.0). The test uses 3 recombinant antigens. The test is manufactured by Ortho Clinical Diagnostics. The kit includes 480 tests.</p> /webroot/web/html/cdg/products/SKUs/autopopulated/ 930740_0921120822533_en.html /webroot/web/html/cdg/products/SKUs/autopopulated//930740_0921120822533_en.html false false false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=930740&CartQuote=QT&quantity= false true false null false null /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=930740&AddToDefaultWishList=true&quantity= false false true true false true false true /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=930740&quantity= 930740
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Ortho HCV Version 3.0 ELISA Stop Solution

933040
2 x 500 mL solution to stop assays, for Ortho HCV ELISA test system

1 933040 /templatedata/internet/product_SKU/data/CDG/Blood-Virus/Reagents/933040_0921120822514.xml 933040 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 07:06:24 933040-ortho-hcv-version-3-0-elisa-stop-solution 933040 Ortho HCV Version 3.0 ELISA Stop Solution Ortho HCV Version 3.0 ELISA Stop Solution 2 x 500 mL solution to stop assays, for Ortho HCV ELISA test system 2 x 500 mL solution to stop assays, for Ortho HCV ELISA test system 2 x 500 mL solution to stop assays, for Ortho HCV ELISA test system /webroot/web/images/cdg/products/blood_virus/sku_thumb/global/bvd_933040_tn.jpg /webroot/web/images/cdg/products/blood_virus/sku_view/global/bvd_933040_view.jpg /webroot/web/images/cdg/products/blood_virus/sku_feature/global/bvd_933040_feature.jpg Ortho HCV Version 3.0 ELISA Stop Solution preview RepEx Ortho HCV Version 3.0 ELISA Stop Solution 2 x 500 mL solution to stop assays, for Ortho HCV ELISA test system hcv, stop, solution 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>Stop solution for HCV 3.0 EIA. This solution comes in two 500 ml bottles and must be ordered separately from test kit.</p> /webroot/web/html/cdg/products/SKUs/autopopulated/ 933040_0921120822514_en.html /webroot/web/html/cdg/products/SKUs/autopopulated//933040_0921120822514_en.html false false false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=933040&CartQuote=QT&quantity= false true false null false null /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=933040&AddToDefaultWishList=true&quantity= false false true true false true false true /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=933040&quantity= 933040
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Ortho HCV Version 3.0 ELISA Wash Buffer

933730
6 x 150 mL wash buffer for Ortho HCV ELISA test system

2 933730 /templatedata/internet/product_SKU/data/CDG/Blood-Virus/Reagents/933730_0921120822551.xml 933730 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 07:06:24 933730-ortho-hcv-version-3-0-elisa-wash-buffer 933730 Ortho HCV Version 3.0 ELISA Wash Buffer Ortho HCV Version 3.0 ELISA Wash Buffer 6 x 150 mL wash buffer for Ortho HCV ELISA test system 6 x 150 mL wash buffer for Ortho HCV ELISA test system 6 x 150 mL wash buffer for Ortho HCV ELISA test system /webroot/web/images/cdg/products/blood_virus/sku_thumb/global/bvd_933730_tn.jpg /webroot/web/images/cdg/products/blood_virus/sku_view/global/bvd_933730_view.jpg /webroot/web/images/cdg/products/blood_virus/sku_feature/global/bvd_933730_feature.jpg Ortho HCV Version 3.0 ELISA Wash Buffer preview RepEx Ortho HCV Version 3.0 ELISA Wash Buffer 6 x 150 mL wash buffer for Ortho HCV ELISA test system hcv, wash, solution 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>Wash solution for HCV 3.0 EIA. This solution comes in six 150 ml bottles and must be ordered separately from test kit.</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/ 933730_0921120822551_en.html /webroot/web/html/cdg/products/SKUs/autopopulated//933730_0921120822551_en.html false false false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=933730&CartQuote=QT&quantity= false true false null false null /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=933730&AddToDefaultWishList=true&quantity= false false true true false true false true /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=933730&quantity= 933730
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