Comprehensive comparison of the VERSANT HIV-1 RNA 3.0 (bDNA) and COBAS AMPLICOR HIV-1 MONITOR 1.5 assays on 1,000 clinical specimens
Plasma human immunodeficiency virus type 1 (HIV-1) RNA level is an important parameter for patient management, yet viral load assays from different manufacturers are not standardized. In this study, we evaluated the concordance between test results obtained for 1,000 plasma specimens collected from...
Gespeichert in:
| Veröffentlicht in: | Journal of clinical virology 2005-12, Vol.34 (4), p.245-252 |
|---|---|
| Hauptverfasser: | , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 252 |
|---|---|
| container_issue | 4 |
| container_start_page | 245 |
| container_title | Journal of clinical virology |
| container_volume | 34 |
| creator | Galli, Rick Merrick, Linda Friesenhahn, Michel Ziermann, Rainer |
| description | Plasma human immunodeficiency virus type 1 (HIV-1) RNA level is an important parameter for patient management, yet viral load assays from different manufacturers are not standardized.
In this study, we evaluated the concordance between test results obtained for 1,000 plasma specimens collected from HIV-1-infected individuals measured with the VERSANT HIV-1 RNA 3.0 assay (bDNA) and the COBAS AMPLICOR HIV-1 MONITOR 1.5 test (PCR). We compared viral load values obtained by each of these assays throughout their dynamic ranges, with particular focus on samples with low viral load (i.e. 50-250 copies/mL), and calculated the estimated distribution of distinct plasma viral load levels for the entire study population modeled from the data observed in the study.
We found that these two assays show excellent agreement, with a correlation (R(2)) of 0.957 and a slope of 1.004. The mean difference in viral load values between the two assays was less than 0.10-log(10) throughout the dynamic range and 98.2% of all samples had bDNA and PCR results within 0.5-log(10) of each other, a difference that is within the range considered to be a minimal change in plasma viremia. Moreover, the two assays show very similar results across all assay ranges tested. The estimated prevalence of samples with results |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_68800843</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>68800843</sourcerecordid><originalsourceid>FETCH-LOGICAL-p547-f241796782c5c54c5faff401e35651556f55c82a4d86da6aefb9f4e1692fec0a3</originalsourceid><addsrcrecordid>eNo1kEtLw0AYRbNQbK3-BflWomDKTOaR6TKm1QbaRNrQbZhOZuhIXmZaoXt_uAHr6nLhcC7cK2-MieA-ZyQYebfOfSKEGaHhjTfCPBAc0XDs_cRt3fX6oBtnvzWoocneuraB1sDxoGG32GyjNIdlsvMxbNIIyBTB036eRs8gmxLi7DXaQrT-WCVxtrlw6yxN8qHhKQPpnDw7GJT4BSEEqrKNVbIC12ll62H5zrs2snL6_pITL39b5PHSX2XvSRyt_I7R0DcBxeGMhyJQTDGqmJHGUIQ1YZxhxrhhTIlA0lLwUnKpzX5mqMZ8FhitkCQT7_FP2_Xt10m7Y1Fbp3RVyUa3J1dwIRASlAzgwwU87WtdFl1va9mfi__byC-TcGJY</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>68800843</pqid></control><display><type>article</type><title>Comprehensive comparison of the VERSANT HIV-1 RNA 3.0 (bDNA) and COBAS AMPLICOR HIV-1 MONITOR 1.5 assays on 1,000 clinical specimens</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><creator>Galli, Rick ; Merrick, Linda ; Friesenhahn, Michel ; Ziermann, Rainer</creator><creatorcontrib>Galli, Rick ; Merrick, Linda ; Friesenhahn, Michel ; Ziermann, Rainer</creatorcontrib><description>Plasma human immunodeficiency virus type 1 (HIV-1) RNA level is an important parameter for patient management, yet viral load assays from different manufacturers are not standardized.
In this study, we evaluated the concordance between test results obtained for 1,000 plasma specimens collected from HIV-1-infected individuals measured with the VERSANT HIV-1 RNA 3.0 assay (bDNA) and the COBAS AMPLICOR HIV-1 MONITOR 1.5 test (PCR). We compared viral load values obtained by each of these assays throughout their dynamic ranges, with particular focus on samples with low viral load (i.e. 50-250 copies/mL), and calculated the estimated distribution of distinct plasma viral load levels for the entire study population modeled from the data observed in the study.
We found that these two assays show excellent agreement, with a correlation (R(2)) of 0.957 and a slope of 1.004. The mean difference in viral load values between the two assays was less than 0.10-log(10) throughout the dynamic range and 98.2% of all samples had bDNA and PCR results within 0.5-log(10) of each other, a difference that is within the range considered to be a minimal change in plasma viremia. Moreover, the two assays show very similar results across all assay ranges tested. The estimated prevalence of samples with results <50 copies/mL, 50-250 copies/mL, and 250-500,000 copies/mL were 41.6%, 7.7%, and 49.7%, respectively, by the bDNA assay, and 42.4%, 6.9%, and 50.7%, respectively, by the PCR assay.
Based on our findings from 1,000 clinical specimens, we do not see the need to re-establish a baseline value or apply a conversion factor when switching from one assay to the other. Since the majority of our patient population likely is infected with subtype B virus, it is unclear if our findings will apply to other patient populations with a greater incidence of infection with non-B subtypes.</description><identifier>ISSN: 1386-6532</identifier><identifier>PMID: 16286047</identifier><language>eng</language><publisher>Netherlands</publisher><subject>Branched DNA Signal Amplification Assay ; HIV Infections - diagnosis ; HIV Infections - therapy ; HIV Infections - virology ; HIV-1 - genetics ; HIV-1 - isolation & purification ; Humans ; Polymerase Chain Reaction ; Reagent Kits, Diagnostic ; RNA, Viral - blood ; Sensitivity and Specificity ; Viral Load</subject><ispartof>Journal of clinical virology, 2005-12, Vol.34 (4), p.245-252</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16286047$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Galli, Rick</creatorcontrib><creatorcontrib>Merrick, Linda</creatorcontrib><creatorcontrib>Friesenhahn, Michel</creatorcontrib><creatorcontrib>Ziermann, Rainer</creatorcontrib><title>Comprehensive comparison of the VERSANT HIV-1 RNA 3.0 (bDNA) and COBAS AMPLICOR HIV-1 MONITOR 1.5 assays on 1,000 clinical specimens</title><title>Journal of clinical virology</title><addtitle>J Clin Virol</addtitle><description>Plasma human immunodeficiency virus type 1 (HIV-1) RNA level is an important parameter for patient management, yet viral load assays from different manufacturers are not standardized.
In this study, we evaluated the concordance between test results obtained for 1,000 plasma specimens collected from HIV-1-infected individuals measured with the VERSANT HIV-1 RNA 3.0 assay (bDNA) and the COBAS AMPLICOR HIV-1 MONITOR 1.5 test (PCR). We compared viral load values obtained by each of these assays throughout their dynamic ranges, with particular focus on samples with low viral load (i.e. 50-250 copies/mL), and calculated the estimated distribution of distinct plasma viral load levels for the entire study population modeled from the data observed in the study.
We found that these two assays show excellent agreement, with a correlation (R(2)) of 0.957 and a slope of 1.004. The mean difference in viral load values between the two assays was less than 0.10-log(10) throughout the dynamic range and 98.2% of all samples had bDNA and PCR results within 0.5-log(10) of each other, a difference that is within the range considered to be a minimal change in plasma viremia. Moreover, the two assays show very similar results across all assay ranges tested. The estimated prevalence of samples with results <50 copies/mL, 50-250 copies/mL, and 250-500,000 copies/mL were 41.6%, 7.7%, and 49.7%, respectively, by the bDNA assay, and 42.4%, 6.9%, and 50.7%, respectively, by the PCR assay.
Based on our findings from 1,000 clinical specimens, we do not see the need to re-establish a baseline value or apply a conversion factor when switching from one assay to the other. Since the majority of our patient population likely is infected with subtype B virus, it is unclear if our findings will apply to other patient populations with a greater incidence of infection with non-B subtypes.</description><subject>Branched DNA Signal Amplification Assay</subject><subject>HIV Infections - diagnosis</subject><subject>HIV Infections - therapy</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - genetics</subject><subject>HIV-1 - isolation & purification</subject><subject>Humans</subject><subject>Polymerase Chain Reaction</subject><subject>Reagent Kits, Diagnostic</subject><subject>RNA, Viral - blood</subject><subject>Sensitivity and Specificity</subject><subject>Viral Load</subject><issn>1386-6532</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kEtLw0AYRbNQbK3-BflWomDKTOaR6TKm1QbaRNrQbZhOZuhIXmZaoXt_uAHr6nLhcC7cK2-MieA-ZyQYebfOfSKEGaHhjTfCPBAc0XDs_cRt3fX6oBtnvzWoocneuraB1sDxoGG32GyjNIdlsvMxbNIIyBTB036eRs8gmxLi7DXaQrT-WCVxtrlw6yxN8qHhKQPpnDw7GJT4BSEEqrKNVbIC12ll62H5zrs2snL6_pITL39b5PHSX2XvSRyt_I7R0DcBxeGMhyJQTDGqmJHGUIQ1YZxhxrhhTIlA0lLwUnKpzX5mqMZ8FhitkCQT7_FP2_Xt10m7Y1Fbp3RVyUa3J1dwIRASlAzgwwU87WtdFl1va9mfi__byC-TcGJY</recordid><startdate>200512</startdate><enddate>200512</enddate><creator>Galli, Rick</creator><creator>Merrick, Linda</creator><creator>Friesenhahn, Michel</creator><creator>Ziermann, Rainer</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>200512</creationdate><title>Comprehensive comparison of the VERSANT HIV-1 RNA 3.0 (bDNA) and COBAS AMPLICOR HIV-1 MONITOR 1.5 assays on 1,000 clinical specimens</title><author>Galli, Rick ; Merrick, Linda ; Friesenhahn, Michel ; Ziermann, Rainer</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p547-f241796782c5c54c5faff401e35651556f55c82a4d86da6aefb9f4e1692fec0a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Branched DNA Signal Amplification Assay</topic><topic>HIV Infections - diagnosis</topic><topic>HIV Infections - therapy</topic><topic>HIV Infections - virology</topic><topic>HIV-1 - genetics</topic><topic>HIV-1 - isolation & purification</topic><topic>Humans</topic><topic>Polymerase Chain Reaction</topic><topic>Reagent Kits, Diagnostic</topic><topic>RNA, Viral - blood</topic><topic>Sensitivity and Specificity</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Galli, Rick</creatorcontrib><creatorcontrib>Merrick, Linda</creatorcontrib><creatorcontrib>Friesenhahn, Michel</creatorcontrib><creatorcontrib>Ziermann, Rainer</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical virology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Galli, Rick</au><au>Merrick, Linda</au><au>Friesenhahn, Michel</au><au>Ziermann, Rainer</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comprehensive comparison of the VERSANT HIV-1 RNA 3.0 (bDNA) and COBAS AMPLICOR HIV-1 MONITOR 1.5 assays on 1,000 clinical specimens</atitle><jtitle>Journal of clinical virology</jtitle><addtitle>J Clin Virol</addtitle><date>2005-12</date><risdate>2005</risdate><volume>34</volume><issue>4</issue><spage>245</spage><epage>252</epage><pages>245-252</pages><issn>1386-6532</issn><abstract>Plasma human immunodeficiency virus type 1 (HIV-1) RNA level is an important parameter for patient management, yet viral load assays from different manufacturers are not standardized.
In this study, we evaluated the concordance between test results obtained for 1,000 plasma specimens collected from HIV-1-infected individuals measured with the VERSANT HIV-1 RNA 3.0 assay (bDNA) and the COBAS AMPLICOR HIV-1 MONITOR 1.5 test (PCR). We compared viral load values obtained by each of these assays throughout their dynamic ranges, with particular focus on samples with low viral load (i.e. 50-250 copies/mL), and calculated the estimated distribution of distinct plasma viral load levels for the entire study population modeled from the data observed in the study.
We found that these two assays show excellent agreement, with a correlation (R(2)) of 0.957 and a slope of 1.004. The mean difference in viral load values between the two assays was less than 0.10-log(10) throughout the dynamic range and 98.2% of all samples had bDNA and PCR results within 0.5-log(10) of each other, a difference that is within the range considered to be a minimal change in plasma viremia. Moreover, the two assays show very similar results across all assay ranges tested. The estimated prevalence of samples with results <50 copies/mL, 50-250 copies/mL, and 250-500,000 copies/mL were 41.6%, 7.7%, and 49.7%, respectively, by the bDNA assay, and 42.4%, 6.9%, and 50.7%, respectively, by the PCR assay.
Based on our findings from 1,000 clinical specimens, we do not see the need to re-establish a baseline value or apply a conversion factor when switching from one assay to the other. Since the majority of our patient population likely is infected with subtype B virus, it is unclear if our findings will apply to other patient populations with a greater incidence of infection with non-B subtypes.</abstract><cop>Netherlands</cop><pmid>16286047</pmid><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1386-6532 |
| ispartof | Journal of clinical virology, 2005-12, Vol.34 (4), p.245-252 |
| issn | 1386-6532 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_68800843 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Branched DNA Signal Amplification Assay HIV Infections - diagnosis HIV Infections - therapy HIV Infections - virology HIV-1 - genetics HIV-1 - isolation & purification Humans Polymerase Chain Reaction Reagent Kits, Diagnostic RNA, Viral - blood Sensitivity and Specificity Viral Load |
| title | Comprehensive comparison of the VERSANT HIV-1 RNA 3.0 (bDNA) and COBAS AMPLICOR HIV-1 MONITOR 1.5 assays on 1,000 clinical specimens |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-05T11%3A57%3A12IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Comprehensive%20comparison%20of%20the%20VERSANT%20HIV-1%20RNA%203.0%20(bDNA)%20and%20COBAS%20AMPLICOR%20HIV-1%20MONITOR%201.5%20assays%20on%201,000%20clinical%20specimens&rft.jtitle=Journal%20of%20clinical%20virology&rft.au=Galli,%20Rick&rft.date=2005-12&rft.volume=34&rft.issue=4&rft.spage=245&rft.epage=252&rft.pages=245-252&rft.issn=1386-6532&rft_id=info:doi/&rft_dat=%3Cproquest_pubme%3E68800843%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=68800843&rft_id=info:pmid/16286047&rfr_iscdi=true |