Exact Diagnostics SARS-CoV-2

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Exact Diagnostics SARS-CoV-2

Overview

Standard and Run Controls to monitor presence of E, N, ORF1ab, RdRP and S Genes of SARS-CoV-2
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Description

The EDX SARS-CoV-2 Standard and Run Controls have been quantitated using digital PCR. The Standard is used as a reference material for research testing of the novel coronavirus allowing laboratories to validate assays. Additionally, the EDX SARS CoV-2 Standard can be validated for use by the laboratory as an external run control. Routine use of the Run Controls allow laboratories to evaluate the day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency.

  • Contains E, N, ORF1ab, RdRP and S genes
  • Quantitation with digital droplet PCR
  • Human genomic DNA (gDNA) background
  • High quality matrix to ensure lot-to-lot reproducibility
  • Synthetic Matrix, including Human Genomic DNA (gDNA)
  • 12 month shelf life from date of manufacture
  • 24 hour stability when stored at 2-8°C

Targets

  • E
  • N
  • ORF1ab
  • RdRP
  • S
   
 
 
Refer to exactdiagnostics.com or the package insert of currently available lots for specific analyte and stability claims.

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SARS-CoV-2 Standard

COV019
The EDX SARS-CoV-2 Standard is manufactured with synthetic RNA transcripts containing five gene targets (E, N, ORF1ab, RdRP and S Genes of SARS-CoV-2). 5 x 0.3mL

COV019 templatedata/internet/product_SKU/data/CDG/Quality-Control/Quality-Control-Products/COV019_1587588895.xml COV019 04/22/20 08:42 PM en_US true internet/product_SKU 2020-10-03 00:20:02 /default/main/bio-rad/STAGING AL,DZ,AI,AM,AU,AT,AZ,BH,BD,BE,BA,BW,BN,BG,BF,KH,CM,CN,HR,CY,CZ,DK,EG,ER,EE,ET,FO,FI,FR,GF,PF,GA,GE,DE,GH,GR,GP,HK,HU,IS,IN,ID,IE,IL,IT,JP,JO,KZ,KE,KR,XK,KW,LV,LB,LI,LT,LU,MO,MK,MG,MY,ML,MT,MQ,MU,FM,MD,MS,MA,NP,NL,NZ,NG,NO,OM,PK,PW,PS,PG,PH,PL,PT,QA,RO,RU,ST,SA,SN,RS,SG,SK,SI,SB,ZA,ES,LK,SE,CH,TW,TZ,TH,TG,TO,TN,TR,UG,UA,AE,UK,UZ,VU,VA,VN,EH,YE,AR,BO,BR,CA,CL,CO,CR,DO,EC,SV,GU,GT,HT,HN,JM,MX,NI,PA,PY,PE,PR,TT,US,UY,VE templatedata/internet/product_SKU/data/CDG/Quality-Control/Quality-Control-Products/COV019_1587588895.xml /default/main/bio-rad/WORKAREA/default k8uw760j 2020-04-22 20:54:56 true k8uw760j templatedata/internet/product_SKU/data/CDG/Quality-Control/Quality-Control-Products/COV019_1587588895.xml CDG N /default/main/bio-rad en 04/22/30 10:53 AM 1594486914408 2020-10-03 00:20:02 /default/main/bio-rad/WORKAREA/default/templatedata/internet/product_SKU/data/CDG/Quality-Control/Quality-Control-Products/COV019_1587588895.xml cov019-sars-cov-2-standard 1 COV019 SARS-CoV-2 Positive 5x0.3mL SARS-CoV-2 Standard The EDX SARS-CoV-2 Standard is manufactured with synthetic RNA transcripts containing five gene targets (E, N, ORF1ab, RdRP and S Genes of SARS-CoV-2). 5 x 0.3mL The EDX SARS-CoV-2 Standard is manufactured with synthetic RNA transcripts containing five gene targets (E, N, ORF1ab, RdRP and S Genes of SARS-CoV-2). 5 x 0.3mL /webroot/web/images/cdg/products/quality_control/sku_thumb/global/COV019_tn.jpg /webroot/web/images/cdg/products/quality_control/sku_view/global/COV019_view.jpg /webroot/web/images/cdg/products/quality_control/sku_feature/global/COV019_qsd_SARS_CoV_2_positive_feature.jpg preview Ana Davidson SARS-CoV-2 Standard The EDX SARS-CoV-2 Standard is manufactured with synthetic RNA transcripts containing five gene targets (E, N, ORF1ab, RdRP and S Genes of SARS-CoV-2). 5 x 0.3mL EDX, SARS-CoV-2, Standard, synthetic, RNA, transcripts, five gene, targets, E, N, ORF1ab, RdRP, S Genes 04/22/20 08:42 PM 04/22/30 10:53 AM AL,DZ,AI,AM,AU,AT,AZ,BH,BD,BE,BA,BW,BN,BG,BF,KH,CM,CN,HR,CY,CZ,DK,EG,ER,EE,ET,FO,FI,FR,GF,PF,GA,GE,DE,GH,GR,GP,HK,HU,IS,IN,ID,IE,IL,IT,JP,JO,KZ,KE,KR,XK,KW,LV,LB,LI,LT,LU,MO,MK,MG,MY,ML,MT,MQ,MU,FM,MD,MS,MA,NP,NL,NZ,NG,NO,OM,PK,PW,PS,PG,PH,PL,PT,QA,RO,RU,ST,SA,SN,RS,SG,SK,SI,SB,ZA,ES,LK,SE,CH,TW,TZ,TH,TG,TO,TN,TR,UG,UA,AE,UK,UZ,VU,VA,VN,EH,YE,AR,BO,BR,CA,CL,CO,CR,DO,EC,SV,GU,GT,HT,HN,JM,MX,NI,PA,PY,PE,PR,TT,US,UY,VE CDG /CDG/Quality-Control/Quality-Control-Products N 0 <div class="corner-box corner-box-promo wraptxt hidden AL-only DZ-only AI-only AM-only AT-only AZ-only BH-only BE-only BA-only BW-only BG-only BF-only CM-only HR-only CY-only CZ-only DK-only EG-only ER-only EE-only ET-only FO-only FI-only FR-only GF-only PF-only GA-only GE-only DE-only GH-only GR-only GP-only HU-only IS-only IE-only IL-only IT-only JO-only KZ-only KE-only XK-only KW-only LV-only LB-only LI-only LT-only LU-only MK-only MG-only ML-only MT-only MQ-only MU-only MD-only MS-only MA-only NL-only NG-only NO-only OM-only PK-only PS-only PL-only PT-only QA-only RO-only RU-only ST-only SA-only SN-only RS-only SK-only SI-only ZA-only ES-only SE-only CH-only TZ-only TG-only TN-only TR-only UG-only UA-only AE-only UK-only UZ-only VA-only EH-only YE-only"> <h2>Also available <span>as CE-IVD Run Controls</span></h2> <span style="display: inline;"></span> <p class="wraptxt">EDX SARS-CoV-2 Positive Run Control is an external quality control intended to be used with SARS-CoV-2 assays to monitor the performance of that given assay.</p> <span style="display: inline;"><a class="bttn-block" href="/en-us/sku/cov019CE-sars-cov-2-positive-run-control?ID=COV019CE"><span class="bttn-orange">Learn more</span></a></span></div> <p class="wraptxt">The EDX SARS-CoV-2 Standard is manufactured with synthetic RNA transcripts containing five gene targets (E, N, ORF1ab, RdRP and S Genes of SARS-CoV-2). The product contains genomic DNA allowing laboratories to validate for operator testing of the entire process of a molecular assay including extraction, amplification, and detection.</p> <p class="wraptxt"><span>The EDX SARS-CoV-2 Standard contains E, N, ORF1ab, RdRP and S genes that are each quantitated at 200,000 cp/mL using Bio-Rad Digital Droplet PCR (ddPCR).</span></p> <p><strong>5 Vials, 0.3mL Fill Volume, -20&deg;C Storage</strong></p> <p><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/pi0103_edx_sars-cov-2_standard_rev_03.00.pdf" target="_blank" rel="noopener noreferrer">Product Insert</a><br /><br /><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/sds0103_edx_sars-cov-2_standard_sds_rev_01.00.pdf" target="_blank" rel="noopener noreferrer">Safety Data Sheet</a><br /><br /> Certificate of Analysis<br /><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/edx_sars-cov-2_standard_coa_ln_20030813.pdf" target="_blank" rel="noopener noreferrer">20030813</a><br /><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/edx_sars-cov-2_standard_coa_ln_20031301.pdf" target="_blank" rel="noopener noreferrer">20031301</a><br /><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/edx_sars-cov-2_standard_coa_ln_20032101.pdf" target="_blank" rel="noopener noreferrer">20032101</a></p> <p><strong>INTENDED USE:</strong></p> <p>The EDX SARS-CoV-2 Standard is intended for use as a reference material for research testing of the novel coronavirus allowing laboratories to validate assays. <br /> Additionally, the SARS CoV-2 Standard can be validated for use by the laboratory as an external run control.</p> <p><strong>LIMITATIONS:</strong></p> <p>For Research Use Only. Not for use in diagnostic procedures.</p> 1 0 Q-1675-E templatedata/internet/documentation/data/en_US/CDG/Literature/Q-1675-E_1587701765.xml COV000 templatedata/internet/product_SKU/data/CDG/Quality-Control/Quality-Control-Products/COV000_1587599946.xml false null false $ null false false true true false USD true false true /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=COV019&quantity= false false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=COV019&CartQuote=QT&quantity= 3195 false true false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=COV019&AddToDefaultWishList=true&quantity= 41116100 null Product detail page COV019
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SARS-CoV-2 Negative

COV000
The product is negative for SARS-CoV-2. The product is formulated in a synthetic matrix and contains genomic DNA at 75,000 copies/mL 5 x 0.3mL

COV000 templatedata/internet/product_SKU/data/CDG/Quality-Control/Quality-Control-Products/COV000_1587599946.xml COV000 04/22/20 11:51 PM en_US true internet/product_SKU 2020-10-03 00:19:19 /default/main/bio-rad/STAGING AL,DZ,AI,AM,AT,AZ,BH,BE,BA,BW,BG,BF,CM,HR,CY,CZ,DK,EG,ER,EE,ET,FO,FI,FR,GF,PF,GA,GE,DE,GH,GR,GP,HU,IS,IE,IL,IT,JO,KZ,KE,XK,KW,LV,LB,LI,LT,LU,MK,MG,ML,MT,MQ,MU,MD,MS,MA,NL,NG,NO,OM,PK,PS,PL,PT,QA,RO,RU,ST,SA,SN,RS,SK,SI,ZA,ES,SE,CH,TZ,TG,TN,TR,UG,UA,AE,UK,UZ,VA,EH,YE,AR,BO,BR,CA,CL,CO,CR,DO,EC,SV,GU,GT,HT,HN,JM,MX,NI,PA,PY,PE,PR,TT,US,UY,VE,AU,BD,BN,KH,CN,HK,IN,ID,JP,KR,MO,MY,FM,NP,NZ,PW,PG,PH,SG,SB,LK,TW,TH,TO,VU,VN templatedata/internet/product_SKU/data/CDG/Quality-Control/Quality-Control-Products/COV000_1587599946.xml /default/main/bio-rad/WORKAREA/default k8uw760p 2020-04-22 23:59:06 true k8uw760p templatedata/internet/product_SKU/data/CDG/Quality-Control/Quality-Control-Products/COV000_1587599946.xml CDG N /default/main/bio-rad en 04/22/30 01:58 PM 1594486914355 2020-10-03 00:19:19 /default/main/bio-rad/WORKAREA/default/templatedata/internet/product_SKU/data/CDG/Quality-Control/Quality-Control-Products/COV000_1587599946.xml cov000-sars-cov-2-negative 1 COV000 SARS-CoV-2 Negative 5x0.3mL SARS-CoV-2 Negative The product is negative for SARS-CoV-2. The product is formulated in a synthetic matrix and contains genomic DNA at 75,000 copies/mL 5 x 0.3mL The product is negative for SARS-CoV-2. The product is formulated in a synthetic matrix and contains genomic DNA at 75,000 copies/mL 5 x 0.3mL /webroot/web/images/cdg/products/quality_control/sku_thumb/global/COVO00_tn.jpg /webroot/web/images/cdg/products/quality_control/sku_view/global/COVO00_view.jpg /webroot/web/images/cdg/products/quality_control/sku_feature/global/qsd_COV019_SARS_CoV_2_negative_feature.jpg preview Ana Davidson SARS-CoV-2 Negative The product is negative for SARS-CoV-2. The product is formulated in a synthetic matrix and contains genomic DNA at 75,000 copies/mL 5 x 0.3mL negative, SARS-CoV-2, synthetic, matrix, genomic, DNA, COVID-19, coronavirus 04/22/20 11:51 PM 04/22/30 01:58 PM AL,DZ,AI,AM,AT,AZ,BH,BE,BA,BW,BG,BF,CM,HR,CY,CZ,DK,EG,ER,EE,ET,FO,FI,FR,GF,PF,GA,GE,DE,GH,GR,GP,HU,IS,IE,IL,IT,JO,KZ,KE,XK,KW,LV,LB,LI,LT,LU,MK,MG,ML,MT,MQ,MU,MD,MS,MA,NL,NG,NO,OM,PK,PS,PL,PT,QA,RO,RU,ST,SA,SN,RS,SK,SI,ZA,ES,SE,CH,TZ,TG,TN,TR,UG,UA,AE,UK,UZ,VA,EH,YE,AR,BO,BR,CA,CL,CO,CR,DO,EC,SV,GU,GT,HT,HN,JM,MX,NI,PA,PY,PE,PR,TT,US,UY,VE,AU,BD,BN,KH,CN,HK,IN,ID,JP,KR,MO,MY,FM,NP,NZ,PW,PG,PH,SG,SB,LK,TW,TH,TO,VU,VN CDG /CDG/Quality-Control/Quality-Control-Products N 0 <div class="corner-box corner-box-promo wraptxt hidden AL-only DZ-only AI-only AM-only AT-only AZ-only BH-only BE-only BA-only BW-only BG-only BF-only CM-only HR-only CY-only CZ-only DK-only EG-only ER-only EE-only ET-only FO-only FI-only FR-only GF-only PF-only GA-only GE-only DE-only GH-only GR-only GP-only HU-only IS-only IE-only IL-only IT-only JO-only KZ-only KE-only XK-only KW-only LV-only LB-only LI-only LT-only LU-only MK-only MG-only ML-only MT-only MQ-only MU-only MD-only MS-only MA-only NL-only NG-only NO-only OM-only PK-only PS-only PL-only PT-only QA-only RO-only RU-only ST-only SA-only SN-only RS-only SK-only SI-only ZA-only ES-only SE-only CH-only TZ-only TG-only TN-only TR-only UG-only UA-only AE-only UK-only UZ-only VA-only EH-only YE-only"> <h2>Also available as CE-IVD Run Controls</h2> <span style="display: inline;"></span> <p class="wraptxt">EDX SARS-CoV-2 Negative Run Control is an external quality control intended to be used with SARS-CoV-2 assays to monitor the performance of that given assay.</p> <span style="display: inline;"><a class="bttn-block" href="/en-us/sku/cov000CE-sars-cov-2-negative-run-control?ID=COV000CE"><span class="bttn-orange">Learn more</span></a></span></div> <p class="wraptxt">The product is negative for SARS-CoV-2. The product is formulated in a synthetic matrix and contains genomic DNA at 75,000 copies/mL allowing laboratories to validate for operator testing of the entire process of a molecular assay including extraction, amplification, and detection.</p> <p class="wraptxt"><span><strong>5 Vials, 0.3mL Fill Volume, -20&deg;C Storage</strong></span></p> <p class="wraptxt"><span><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/pi0104_edx_sars-cov-2_negative_pi_rev_01.00.pdf" target="_blank" rel="noopener noreferrer">Product Insert</a><br /><br /><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/sds0104_edx_sars-cov-2_negative_sds_rev_01.00.pdf" target="_blank" rel="noopener noreferrer">Safety Data Sheet</a><br /><br /> Certificate of Analysis<br /><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/edx_sars-cov-2_standard_coa_ln_20030813.pdf" target="_blank" rel="noopener noreferrer">20030814</a><br /><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/edx_sars-cov-2_negative_coa_ln_20031302.pdf" target="_blank" rel="noopener noreferrer">20031302</a><br /><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/edx_sars-cov-2_negative_coa_ln_20032102.pdf" target="_blank" rel="noopener noreferrer">20032102</a><br /><a href="http://www.exactdiagnostics.com/uploads/5/1/6/5/51657029/edx_sars-cov-2_negative_coa_ln_20033002.pdf" target="_blank" rel="noopener noreferrer">20033002</a></span></p> <p><strong>INTENDED USE:</strong></p> <p>The EDX SARS-CoV-2 Negative is intended for use as a negative reference material for research testing of the novel coronavirus allowing laboratories to validate assays.<br /><br />Additionally, EDX SARS-CoV-2 Negative can be validated for use by the laboratory as a negative external run control.</p> <p><strong>LIMITATIONS:</strong></p> <p>For Research Use Only. Not for use in diagnostic procedures.</p> 1 0 Q-1675-E templatedata/internet/documentation/data/en_US/CDG/Literature/Q-1675-E_1587701765.xml COV019 templatedata/internet/product_SKU/data/CDG/Quality-Control/Quality-Control-Products/COV019_1587588895.xml false null false $ null false false true true false USD true false true /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=COV000&quantity= false false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=COV000&CartQuote=QT&quantity= 3195 false true false /prd/en/US/adirect/biorad?cmd=ajaxAddToCart&AddToCartProductID=COV000&AddToDefaultWishList=true&quantity= 41116100 null Product detail page COV000
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