Multicenter evaluation of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system for the quantification of HIV-1 plasma viral load
•The cobas 4800 HIV-1 viral load test is highly sensitive, precise and accurate.•Results from cobas 4800 HIV-1 and two other commercial tests were highly correlated.•High levels of agreement between the 3 tests were obtained at 50 and 200 copies/ml.•Automated platforms like cobas 4800 HIV-1 enable t...
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Veröffentlicht in: | Journal of clinical virology 2019-05, Vol.114, p.43-49 |
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creator | Adams, Phillip Vancutsem, Ellen Nicolaizeau, Cyrielle Servais, Jean-Yves Piérard, Denis François, Jean-Hugues Schneider, Tanja Paxinos, Ellen E. Marins, Ed G. Canchola, Jesse A. Seguin-Devaux, Carole |
description | •The cobas 4800 HIV-1 viral load test is highly sensitive, precise and accurate.•Results from cobas 4800 HIV-1 and two other commercial tests were highly correlated.•High levels of agreement between the 3 tests were obtained at 50 and 200 copies/ml.•Automated platforms like cobas 4800 HIV-1 enable the global scale-up of viral load.
Measurement of HIV-1 viral load (VL) is necessary to monitor treatment efficacy in patients receiving antiretroviral therapy. We evaluated the performance of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system (“cobas 4800 HIV-1”).
Limit of detection, linearity, accuracy, precision, and specificity of cobas 4800 HIV-1, COBAS® AmpliPrep/COBAS® Taqman® HIV-1 version 2.0 (CAP/CTM HIV-1 v2) and Abbott RealTime HIV-1 were determined in one or two out of three sites.
The limit of detection of the cobas 4800 HIV-1 for 400 μL and 200 μL input volumes was 14.2 copies/mL (95% CI: 12.5–16.6 copies/mL) and 43.9 copies/mL (37.7–52.7 copies/mL), respectively. Cobas 4800 HIV-1 demonstrated 100% specificity, and results were linear for all analyzed group M HIV-1 subtypes. Precision was high (SD |
doi_str_mv | 10.1016/j.jcv.2019.03.008 |
format | Article |
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Measurement of HIV-1 viral load (VL) is necessary to monitor treatment efficacy in patients receiving antiretroviral therapy. We evaluated the performance of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system (“cobas 4800 HIV-1”).
Limit of detection, linearity, accuracy, precision, and specificity of cobas 4800 HIV-1, COBAS® AmpliPrep/COBAS® Taqman® HIV-1 version 2.0 (CAP/CTM HIV-1 v2) and Abbott RealTime HIV-1 were determined in one or two out of three sites.
The limit of detection of the cobas 4800 HIV-1 for 400 μL and 200 μL input volumes was 14.2 copies/mL (95% CI: 12.5–16.6 copies/mL) and 43.9 copies/mL (37.7–52.7 copies/mL), respectively. Cobas 4800 HIV-1 demonstrated 100% specificity, and results were linear for all analyzed group M HIV-1 subtypes. Precision was high (SD < 0.19 log10) across all measured ranges, reagent lots and input volumes. Correlation between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 or RealTime HIV-1 was high (R2 ≥ 0.95). Agreement between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 was 96.5% (95.0%–97.7%) at a threshold of 50 copies/mL, and 97.2% (95.8%–98.3%) at 200 copies/mL. Agreement between cobas 4800 HIV-1 and RealTime HIV-1 was 96.6% (93.4%–98.5%) at 50 copies/mL, and 97.0% (94.0%–98.8%) at 200 copies/mL. The mean difference between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 or RealTime HIV-1 was -0.10 log10 or 0.01 log10, respectively.
The cobas 4800 HIV-1 test is highly sensitive, accurate and correlated well with other assays, including agreement around clinically relevant thresholds, indicating minimal overall VL quantification differences between tested platforms.</description><identifier>ISSN: 1386-6532</identifier><identifier>EISSN: 1873-5967</identifier><identifier>DOI: 10.1016/j.jcv.2019.03.008</identifier><identifier>PMID: 30991164</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Antiretroviral therapy ; HIV Infections - blood ; HIV Infections - diagnosis ; HIV-1 ; Humans ; Limit of Detection ; Nucleic Acid Amplification Techniques - methods ; Nucleic Acid Amplification Techniques - standards ; Reagent Kits, Diagnostic - standards ; Real-time PCR ; Reproducibility of Results ; RNA, Viral - blood ; Sensitivity and Specificity ; Viral load ; Viral Load - methods ; Viral Load - standards</subject><ispartof>Journal of clinical virology, 2019-05, Vol.114, p.43-49</ispartof><rights>2019</rights><rights>Copyright © 2019. Published by Elsevier B.V.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c396t-457ff351d2a6ace39d47ec25b5a94df919cbb62778eadcd63ee2194fd652cd0d3</citedby><cites>FETCH-LOGICAL-c396t-457ff351d2a6ace39d47ec25b5a94df919cbb62778eadcd63ee2194fd652cd0d3</cites><orcidid>0000-0002-1326-5177 ; 0000-0003-4738-6644</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jcv.2019.03.008$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30991164$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Adams, Phillip</creatorcontrib><creatorcontrib>Vancutsem, Ellen</creatorcontrib><creatorcontrib>Nicolaizeau, Cyrielle</creatorcontrib><creatorcontrib>Servais, Jean-Yves</creatorcontrib><creatorcontrib>Piérard, Denis</creatorcontrib><creatorcontrib>François, Jean-Hugues</creatorcontrib><creatorcontrib>Schneider, Tanja</creatorcontrib><creatorcontrib>Paxinos, Ellen E.</creatorcontrib><creatorcontrib>Marins, Ed G.</creatorcontrib><creatorcontrib>Canchola, Jesse A.</creatorcontrib><creatorcontrib>Seguin-Devaux, Carole</creatorcontrib><title>Multicenter evaluation of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system for the quantification of HIV-1 plasma viral load</title><title>Journal of clinical virology</title><addtitle>J Clin Virol</addtitle><description>•The cobas 4800 HIV-1 viral load test is highly sensitive, precise and accurate.•Results from cobas 4800 HIV-1 and two other commercial tests were highly correlated.•High levels of agreement between the 3 tests were obtained at 50 and 200 copies/ml.•Automated platforms like cobas 4800 HIV-1 enable the global scale-up of viral load.
Measurement of HIV-1 viral load (VL) is necessary to monitor treatment efficacy in patients receiving antiretroviral therapy. We evaluated the performance of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system (“cobas 4800 HIV-1”).
Limit of detection, linearity, accuracy, precision, and specificity of cobas 4800 HIV-1, COBAS® AmpliPrep/COBAS® Taqman® HIV-1 version 2.0 (CAP/CTM HIV-1 v2) and Abbott RealTime HIV-1 were determined in one or two out of three sites.
The limit of detection of the cobas 4800 HIV-1 for 400 μL and 200 μL input volumes was 14.2 copies/mL (95% CI: 12.5–16.6 copies/mL) and 43.9 copies/mL (37.7–52.7 copies/mL), respectively. Cobas 4800 HIV-1 demonstrated 100% specificity, and results were linear for all analyzed group M HIV-1 subtypes. Precision was high (SD < 0.19 log10) across all measured ranges, reagent lots and input volumes. Correlation between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 or RealTime HIV-1 was high (R2 ≥ 0.95). Agreement between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 was 96.5% (95.0%–97.7%) at a threshold of 50 copies/mL, and 97.2% (95.8%–98.3%) at 200 copies/mL. Agreement between cobas 4800 HIV-1 and RealTime HIV-1 was 96.6% (93.4%–98.5%) at 50 copies/mL, and 97.0% (94.0%–98.8%) at 200 copies/mL. The mean difference between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 or RealTime HIV-1 was -0.10 log10 or 0.01 log10, respectively.
The cobas 4800 HIV-1 test is highly sensitive, accurate and correlated well with other assays, including agreement around clinically relevant thresholds, indicating minimal overall VL quantification differences between tested platforms.</description><subject>Antiretroviral therapy</subject><subject>HIV Infections - blood</subject><subject>HIV Infections - diagnosis</subject><subject>HIV-1</subject><subject>Humans</subject><subject>Limit of Detection</subject><subject>Nucleic Acid Amplification Techniques - methods</subject><subject>Nucleic Acid Amplification Techniques - standards</subject><subject>Reagent Kits, Diagnostic - standards</subject><subject>Real-time PCR</subject><subject>Reproducibility of Results</subject><subject>RNA, Viral - blood</subject><subject>Sensitivity and Specificity</subject><subject>Viral load</subject><subject>Viral Load - methods</subject><subject>Viral Load - standards</subject><issn>1386-6532</issn><issn>1873-5967</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU1u1TAURi0EoqWwACbIQyYJ_omdWIxQBbRSERNgajn2tfCTk7zaTqSuhh2wCFaGHykVI0a-ks_3XV0dhF5S0lJC5ZtDe7BbywhVLeEtIcMjdE6HnjdCyf5xnfkgGyk4O0PPcj4QQgXv-qfojBOlKJXdOfrxaY0lWJgLJAybiaspYZnx4nH5Dtguo8m_fuKr628NxbermUsoldgAz6uNECw2NjhcIBfsl4TXDLjG_812AyE43-UC0x_k9Lc3-WAftu0bjtHkyeAtJBNxXIx7jp54EzO8uH8v0NcP779cXjU3nz9eX767aSxXsjSd6L3ngjpmpLHAlet6sEyMwqjOeUWVHUfJ-n4A46yTHIBR1XknBbOOOH6BXu-9x7TcrvUaPYVsIUYzw7JmzRglSig1sIrSHbVpyTmB18cUJpPuNCX65EUfdPWiT1404bp6qZlX9_XrOIF7SPwVUYG3OwD1yC1A0tkGmC24kMAW7Zbwn_rf_rahLw</recordid><startdate>201905</startdate><enddate>201905</enddate><creator>Adams, Phillip</creator><creator>Vancutsem, Ellen</creator><creator>Nicolaizeau, Cyrielle</creator><creator>Servais, Jean-Yves</creator><creator>Piérard, Denis</creator><creator>François, Jean-Hugues</creator><creator>Schneider, Tanja</creator><creator>Paxinos, Ellen E.</creator><creator>Marins, Ed G.</creator><creator>Canchola, Jesse A.</creator><creator>Seguin-Devaux, Carole</creator><general>Elsevier B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-1326-5177</orcidid><orcidid>https://orcid.org/0000-0003-4738-6644</orcidid></search><sort><creationdate>201905</creationdate><title>Multicenter evaluation of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system for the quantification of HIV-1 plasma viral load</title><author>Adams, Phillip ; Vancutsem, Ellen ; Nicolaizeau, Cyrielle ; Servais, Jean-Yves ; Piérard, Denis ; François, Jean-Hugues ; Schneider, Tanja ; Paxinos, Ellen E. ; Marins, Ed G. ; Canchola, Jesse A. ; Seguin-Devaux, Carole</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c396t-457ff351d2a6ace39d47ec25b5a94df919cbb62778eadcd63ee2194fd652cd0d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Antiretroviral therapy</topic><topic>HIV Infections - blood</topic><topic>HIV Infections - diagnosis</topic><topic>HIV-1</topic><topic>Humans</topic><topic>Limit of Detection</topic><topic>Nucleic Acid Amplification Techniques - methods</topic><topic>Nucleic Acid Amplification Techniques - standards</topic><topic>Reagent Kits, Diagnostic - standards</topic><topic>Real-time PCR</topic><topic>Reproducibility of Results</topic><topic>RNA, Viral - blood</topic><topic>Sensitivity and Specificity</topic><topic>Viral load</topic><topic>Viral Load - methods</topic><topic>Viral Load - standards</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Adams, Phillip</creatorcontrib><creatorcontrib>Vancutsem, Ellen</creatorcontrib><creatorcontrib>Nicolaizeau, Cyrielle</creatorcontrib><creatorcontrib>Servais, Jean-Yves</creatorcontrib><creatorcontrib>Piérard, Denis</creatorcontrib><creatorcontrib>François, Jean-Hugues</creatorcontrib><creatorcontrib>Schneider, Tanja</creatorcontrib><creatorcontrib>Paxinos, Ellen E.</creatorcontrib><creatorcontrib>Marins, Ed G.</creatorcontrib><creatorcontrib>Canchola, Jesse A.</creatorcontrib><creatorcontrib>Seguin-Devaux, Carole</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical virology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Adams, Phillip</au><au>Vancutsem, Ellen</au><au>Nicolaizeau, Cyrielle</au><au>Servais, Jean-Yves</au><au>Piérard, Denis</au><au>François, Jean-Hugues</au><au>Schneider, Tanja</au><au>Paxinos, Ellen E.</au><au>Marins, Ed G.</au><au>Canchola, Jesse A.</au><au>Seguin-Devaux, Carole</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multicenter evaluation of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system for the quantification of HIV-1 plasma viral load</atitle><jtitle>Journal of clinical virology</jtitle><addtitle>J Clin Virol</addtitle><date>2019-05</date><risdate>2019</risdate><volume>114</volume><spage>43</spage><epage>49</epage><pages>43-49</pages><issn>1386-6532</issn><eissn>1873-5967</eissn><abstract>•The cobas 4800 HIV-1 viral load test is highly sensitive, precise and accurate.•Results from cobas 4800 HIV-1 and two other commercial tests were highly correlated.•High levels of agreement between the 3 tests were obtained at 50 and 200 copies/ml.•Automated platforms like cobas 4800 HIV-1 enable the global scale-up of viral load.
Measurement of HIV-1 viral load (VL) is necessary to monitor treatment efficacy in patients receiving antiretroviral therapy. We evaluated the performance of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system (“cobas 4800 HIV-1”).
Limit of detection, linearity, accuracy, precision, and specificity of cobas 4800 HIV-1, COBAS® AmpliPrep/COBAS® Taqman® HIV-1 version 2.0 (CAP/CTM HIV-1 v2) and Abbott RealTime HIV-1 were determined in one or two out of three sites.
The limit of detection of the cobas 4800 HIV-1 for 400 μL and 200 μL input volumes was 14.2 copies/mL (95% CI: 12.5–16.6 copies/mL) and 43.9 copies/mL (37.7–52.7 copies/mL), respectively. Cobas 4800 HIV-1 demonstrated 100% specificity, and results were linear for all analyzed group M HIV-1 subtypes. Precision was high (SD < 0.19 log10) across all measured ranges, reagent lots and input volumes. Correlation between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 or RealTime HIV-1 was high (R2 ≥ 0.95). Agreement between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 was 96.5% (95.0%–97.7%) at a threshold of 50 copies/mL, and 97.2% (95.8%–98.3%) at 200 copies/mL. Agreement between cobas 4800 HIV-1 and RealTime HIV-1 was 96.6% (93.4%–98.5%) at 50 copies/mL, and 97.0% (94.0%–98.8%) at 200 copies/mL. The mean difference between cobas 4800 HIV-1 and CAP/CTM HIV-1 v2 or RealTime HIV-1 was -0.10 log10 or 0.01 log10, respectively.
The cobas 4800 HIV-1 test is highly sensitive, accurate and correlated well with other assays, including agreement around clinically relevant thresholds, indicating minimal overall VL quantification differences between tested platforms.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>30991164</pmid><doi>10.1016/j.jcv.2019.03.008</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-1326-5177</orcidid><orcidid>https://orcid.org/0000-0003-4738-6644</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Antiretroviral therapy HIV Infections - blood HIV Infections - diagnosis HIV-1 Humans Limit of Detection Nucleic Acid Amplification Techniques - methods Nucleic Acid Amplification Techniques - standards Reagent Kits, Diagnostic - standards Real-time PCR Reproducibility of Results RNA, Viral - blood Sensitivity and Specificity Viral load Viral Load - methods Viral Load - standards |
title | Multicenter evaluation of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system for the quantification of HIV-1 plasma viral load |
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