The effects of the Roche AMPLICOR HIV-1 MONITOR ® UltraSensitive Test versions 1.0 and 1.5 viral load assays and plasma collection tube type on determination of response to antiretroviral therapy and the inappropriateness of cross-study comparisons
Because there are limited head-to-head data comparing antiretroviral combinations, physicians are tempted to rely on cross-trial comparisons to evaluate the relative efficacy of HIV drugs. However, a variety of factors can confound these comparisons, resulting in misleading or invalid conclusions. T...
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| Veröffentlicht in: | Journal of clinical virology 2006-04, Vol.35 (4), p.420-425 |
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| creator | Giordano, Michael Kelleher, Thomas Colonno, Richard J. Lazzarin, Adriano Squires, Kathleen |
| description | Because there are limited head-to-head data comparing antiretroviral combinations, physicians are tempted to rely on cross-trial comparisons to evaluate the relative efficacy of HIV drugs. However, a variety of factors can confound these comparisons, resulting in misleading or invalid conclusions.
To compare and evaluate the use of: (i) versions 1.0 and 1.5 of the Roche AMPLICOR HIV-1 MONITOR
® UltraSensitive assay, and (ii) ethylenediaminetetraacetic acid (EDTA) and plasma preparation (PPT) tubes on the proportion of HIV-infected patients who would be classified as virological responders in a multinational clinical trial.
The study utilized was a randomized, double-blind trial comparing the efficacy and safety of atazanavir with efavirenz, each in combination with fixed-dose zidovudine/lamivudine, in antiretroviral-naïve patients. To evaluate the effect of monitor kit version, paired plasma samples from 634 patients at week 48 were analyzed using both versions 1.0 and 1.5 of the monitor kit. To evaluate the effect of collection tube type, paired plasma samples collected from 584 patients at week 52 using both EDTA and PPT tubes were assayed. Patients were classified as responders if HIV-1 RNA levels were below a pre-determined level of quantification (LOQ), both 400 and 50
copies/ml.
Substantially higher HIV-1 RNA levels were observed with monitor kit version 1.5, resulting in lower response rates. The version 1.0 monitor kit resulted in a 7% increase in patients classified as responders at the LOQ of 400
copies/ml and a 13% increase at the LOQ of 50
copies/ml. Consistently higher response rates (11% higher at the LOQ of 400
copies/ml and 34% higher at the LOQ of 50
copies/ml) were also observed when samples were collected in EDTA tubes compared with PPT tubes. Differences in monitor kit sensitivity and plasma collection procedures are key factors in study results and suggest caution when performing cross-study comparisons. |
| doi_str_mv | 10.1016/j.jcv.2005.10.011 |
| format | Article |
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To compare and evaluate the use of: (i) versions 1.0 and 1.5 of the Roche AMPLICOR HIV-1 MONITOR
® UltraSensitive assay, and (ii) ethylenediaminetetraacetic acid (EDTA) and plasma preparation (PPT) tubes on the proportion of HIV-infected patients who would be classified as virological responders in a multinational clinical trial.
The study utilized was a randomized, double-blind trial comparing the efficacy and safety of atazanavir with efavirenz, each in combination with fixed-dose zidovudine/lamivudine, in antiretroviral-naïve patients. To evaluate the effect of monitor kit version, paired plasma samples from 634 patients at week 48 were analyzed using both versions 1.0 and 1.5 of the monitor kit. To evaluate the effect of collection tube type, paired plasma samples collected from 584 patients at week 52 using both EDTA and PPT tubes were assayed. Patients were classified as responders if HIV-1 RNA levels were below a pre-determined level of quantification (LOQ), both 400 and 50
copies/ml.
Substantially higher HIV-1 RNA levels were observed with monitor kit version 1.5, resulting in lower response rates. The version 1.0 monitor kit resulted in a 7% increase in patients classified as responders at the LOQ of 400
copies/ml and a 13% increase at the LOQ of 50
copies/ml. Consistently higher response rates (11% higher at the LOQ of 400
copies/ml and 34% higher at the LOQ of 50
copies/ml) were also observed when samples were collected in EDTA tubes compared with PPT tubes. Differences in monitor kit sensitivity and plasma collection procedures are key factors in study results and suggest caution when performing cross-study comparisons.</description><identifier>ISSN: 1386-6532</identifier><identifier>EISSN: 1873-5967</identifier><identifier>DOI: 10.1016/j.jcv.2005.10.011</identifier><identifier>PMID: 16604577</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Anti-HIV Agents - therapeutic use ; Antiretroviral therapy ; Atazanavir Sulfate ; Benzoxazines ; Biological and medical sciences ; Blood Specimen Collection - instrumentation ; Blood Specimen Collection - methods ; Clinical trials ; Cross-study comparisons ; DNA Primers ; Drug Therapy, Combination ; Edetic Acid ; Fundamental and applied biological sciences. Psychology ; HIV Infections - drug therapy ; HIV Infections - virology ; HIV Protease Inhibitors - therapeutic use ; HIV sequence variability/subtypes ; HIV-1 - classification ; HIV-1 - drug effects ; HIV-1 - genetics ; HIV-1 - isolation & purification ; Human viral diseases ; Humans ; Infectious diseases ; Internationality ; Medical sciences ; Microbiology ; Miscellaneous ; Nucleic Acid Amplification Techniques - methods ; Oligopeptides - therapeutic use ; Oxazines - therapeutic use ; Plasma collection procedures ; Polymerase chain reaction ; Pyridines - therapeutic use ; Randomized Controlled Trials as Topic ; Reagent Kits, Diagnostic ; Reverse Transcriptase Inhibitors - therapeutic use ; RNA, Viral - blood ; RNA, Viral - isolation & purification ; Treatment Outcome ; Viral diseases ; Viral Load ; Virology</subject><ispartof>Journal of clinical virology, 2006-04, Vol.35 (4), p.420-425</ispartof><rights>2005</rights><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c381t-ca73169ab6b1f7824a7fc89a8c7828968d0ddbb1f7e201a892e24efecc8be3d13</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1386653205003082$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,65309</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17897086$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16604577$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Giordano, Michael</creatorcontrib><creatorcontrib>Kelleher, Thomas</creatorcontrib><creatorcontrib>Colonno, Richard J.</creatorcontrib><creatorcontrib>Lazzarin, Adriano</creatorcontrib><creatorcontrib>Squires, Kathleen</creatorcontrib><title>The effects of the Roche AMPLICOR HIV-1 MONITOR ® UltraSensitive Test versions 1.0 and 1.5 viral load assays and plasma collection tube type on determination of response to antiretroviral therapy and the inappropriateness of cross-study comparisons</title><title>Journal of clinical virology</title><addtitle>J Clin Virol</addtitle><description>Because there are limited head-to-head data comparing antiretroviral combinations, physicians are tempted to rely on cross-trial comparisons to evaluate the relative efficacy of HIV drugs. However, a variety of factors can confound these comparisons, resulting in misleading or invalid conclusions.
To compare and evaluate the use of: (i) versions 1.0 and 1.5 of the Roche AMPLICOR HIV-1 MONITOR
® UltraSensitive assay, and (ii) ethylenediaminetetraacetic acid (EDTA) and plasma preparation (PPT) tubes on the proportion of HIV-infected patients who would be classified as virological responders in a multinational clinical trial.
The study utilized was a randomized, double-blind trial comparing the efficacy and safety of atazanavir with efavirenz, each in combination with fixed-dose zidovudine/lamivudine, in antiretroviral-naïve patients. To evaluate the effect of monitor kit version, paired plasma samples from 634 patients at week 48 were analyzed using both versions 1.0 and 1.5 of the monitor kit. To evaluate the effect of collection tube type, paired plasma samples collected from 584 patients at week 52 using both EDTA and PPT tubes were assayed. Patients were classified as responders if HIV-1 RNA levels were below a pre-determined level of quantification (LOQ), both 400 and 50
copies/ml.
Substantially higher HIV-1 RNA levels were observed with monitor kit version 1.5, resulting in lower response rates. The version 1.0 monitor kit resulted in a 7% increase in patients classified as responders at the LOQ of 400
copies/ml and a 13% increase at the LOQ of 50
copies/ml. Consistently higher response rates (11% higher at the LOQ of 400
copies/ml and 34% higher at the LOQ of 50
copies/ml) were also observed when samples were collected in EDTA tubes compared with PPT tubes. Differences in monitor kit sensitivity and plasma collection procedures are key factors in study results and suggest caution when performing cross-study comparisons.</description><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral therapy</subject><subject>Atazanavir Sulfate</subject><subject>Benzoxazines</subject><subject>Biological and medical sciences</subject><subject>Blood Specimen Collection - instrumentation</subject><subject>Blood Specimen Collection - methods</subject><subject>Clinical trials</subject><subject>Cross-study comparisons</subject><subject>DNA Primers</subject><subject>Drug Therapy, Combination</subject><subject>Edetic Acid</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - virology</subject><subject>HIV Protease Inhibitors - therapeutic use</subject><subject>HIV sequence variability/subtypes</subject><subject>HIV-1 - classification</subject><subject>HIV-1 - drug effects</subject><subject>HIV-1 - genetics</subject><subject>HIV-1 - isolation & purification</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Internationality</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Nucleic Acid Amplification Techniques - methods</subject><subject>Oligopeptides - therapeutic use</subject><subject>Oxazines - therapeutic use</subject><subject>Plasma collection procedures</subject><subject>Polymerase chain reaction</subject><subject>Pyridines - therapeutic use</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Reagent Kits, Diagnostic</subject><subject>Reverse Transcriptase Inhibitors - therapeutic use</subject><subject>RNA, Viral - blood</subject><subject>RNA, Viral - isolation & purification</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral Load</subject><subject>Virology</subject><issn>1386-6532</issn><issn>1873-5967</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UcuO1DAQjBCIXRY-gAvyBW4Z7GRiO-K0Gi3sSLMsWma5Rh2nIzzKC7dnpPkpPoK_4kbPQ9obF9vlriqXu5PkrZIzJZX-uJlt3G6WSVkwnkmlniWXypo8LUptnvM5tzrVRZ5dJK-INlKqIp-bl8mF0lrOC2Muk7_rnyiwbdFFEmMrIsOH0fF6ffdttVzcP4jb5Y9Uibv7r8s1oz-_xWMXA3zHgXz0OxRrpCh2GMiPAwk1kwKGhvdC7HyATnQjNAKIYE_HytQB9SDc2HX8KotE3NYo4n5CwaDBiKH3AxxLHCkgTezMjJH10QeMYTxZc9oA0_5oe0jOqmkK4xQ8RByQjl9yYSRKKW6bPT_aTxA8sd_r5EULHeGb836VPH6-WS9u09X9l-XiepW63KqYOjC50iXUulatsdkcTOtsCdYxsKW2jWya-lDDTCqwZYbZHLmfztaYNyq_Sj6cfDnYry33quo9Oew6GHDcUqWNzbMiK5ioTsRj4IBtxf_oIewrJavDvKtNxfOuDvM-XPG8WfPubL6te2yeFOcBM-H9mQDkoGsDDM7TE8_Y0kirmffpxENuxc5jqMh5HBw23G8Xq2b0_4nxD4ktzeI</recordid><startdate>20060401</startdate><enddate>20060401</enddate><creator>Giordano, Michael</creator><creator>Kelleher, Thomas</creator><creator>Colonno, Richard J.</creator><creator>Lazzarin, Adriano</creator><creator>Squires, Kathleen</creator><general>Elsevier B.V</general><general>Elsevier Science</general><scope>IQODW</scope><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></search><sort><creationdate>20060401</creationdate><title>The effects of the Roche AMPLICOR HIV-1 MONITOR ® UltraSensitive Test versions 1.0 and 1.5 viral load assays and plasma collection tube type on determination of response to antiretroviral therapy and the inappropriateness of cross-study comparisons</title><author>Giordano, Michael ; Kelleher, Thomas ; Colonno, Richard J. ; Lazzarin, Adriano ; Squires, Kathleen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c381t-ca73169ab6b1f7824a7fc89a8c7828968d0ddbb1f7e201a892e24efecc8be3d13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antiretroviral therapy</topic><topic>Atazanavir Sulfate</topic><topic>Benzoxazines</topic><topic>Biological and medical sciences</topic><topic>Blood Specimen Collection - instrumentation</topic><topic>Blood Specimen Collection - methods</topic><topic>Clinical trials</topic><topic>Cross-study comparisons</topic><topic>DNA Primers</topic><topic>Drug Therapy, Combination</topic><topic>Edetic Acid</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - virology</topic><topic>HIV Protease Inhibitors - therapeutic use</topic><topic>HIV sequence variability/subtypes</topic><topic>HIV-1 - classification</topic><topic>HIV-1 - drug effects</topic><topic>HIV-1 - genetics</topic><topic>HIV-1 - isolation & purification</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Internationality</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Miscellaneous</topic><topic>Nucleic Acid Amplification Techniques - methods</topic><topic>Oligopeptides - therapeutic use</topic><topic>Oxazines - therapeutic use</topic><topic>Plasma collection procedures</topic><topic>Polymerase chain reaction</topic><topic>Pyridines - therapeutic use</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Reagent Kits, Diagnostic</topic><topic>Reverse Transcriptase Inhibitors - therapeutic use</topic><topic>RNA, Viral - blood</topic><topic>RNA, Viral - isolation & purification</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Viral Load</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Giordano, Michael</creatorcontrib><creatorcontrib>Kelleher, Thomas</creatorcontrib><creatorcontrib>Colonno, Richard J.</creatorcontrib><creatorcontrib>Lazzarin, Adriano</creatorcontrib><creatorcontrib>Squires, Kathleen</creatorcontrib><collection>Pascal-Francis</collection><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>Giordano, Michael</au><au>Kelleher, Thomas</au><au>Colonno, Richard J.</au><au>Lazzarin, Adriano</au><au>Squires, Kathleen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effects of the Roche AMPLICOR HIV-1 MONITOR ® UltraSensitive Test versions 1.0 and 1.5 viral load assays and plasma collection tube type on determination of response to antiretroviral therapy and the inappropriateness of cross-study comparisons</atitle><jtitle>Journal of clinical virology</jtitle><addtitle>J Clin Virol</addtitle><date>2006-04-01</date><risdate>2006</risdate><volume>35</volume><issue>4</issue><spage>420</spage><epage>425</epage><pages>420-425</pages><issn>1386-6532</issn><eissn>1873-5967</eissn><abstract>Because there are limited head-to-head data comparing antiretroviral combinations, physicians are tempted to rely on cross-trial comparisons to evaluate the relative efficacy of HIV drugs. However, a variety of factors can confound these comparisons, resulting in misleading or invalid conclusions.
To compare and evaluate the use of: (i) versions 1.0 and 1.5 of the Roche AMPLICOR HIV-1 MONITOR
® UltraSensitive assay, and (ii) ethylenediaminetetraacetic acid (EDTA) and plasma preparation (PPT) tubes on the proportion of HIV-infected patients who would be classified as virological responders in a multinational clinical trial.
The study utilized was a randomized, double-blind trial comparing the efficacy and safety of atazanavir with efavirenz, each in combination with fixed-dose zidovudine/lamivudine, in antiretroviral-naïve patients. To evaluate the effect of monitor kit version, paired plasma samples from 634 patients at week 48 were analyzed using both versions 1.0 and 1.5 of the monitor kit. To evaluate the effect of collection tube type, paired plasma samples collected from 584 patients at week 52 using both EDTA and PPT tubes were assayed. Patients were classified as responders if HIV-1 RNA levels were below a pre-determined level of quantification (LOQ), both 400 and 50
copies/ml.
Substantially higher HIV-1 RNA levels were observed with monitor kit version 1.5, resulting in lower response rates. The version 1.0 monitor kit resulted in a 7% increase in patients classified as responders at the LOQ of 400
copies/ml and a 13% increase at the LOQ of 50
copies/ml. Consistently higher response rates (11% higher at the LOQ of 400
copies/ml and 34% higher at the LOQ of 50
copies/ml) were also observed when samples were collected in EDTA tubes compared with PPT tubes. Differences in monitor kit sensitivity and plasma collection procedures are key factors in study results and suggest caution when performing cross-study comparisons.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>16604577</pmid><doi>10.1016/j.jcv.2005.10.011</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Journal of clinical virology, 2006-04, Vol.35 (4), p.420-425 |
| issn | 1386-6532 1873-5967 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Anti-HIV Agents - therapeutic use Antiretroviral therapy Atazanavir Sulfate Benzoxazines Biological and medical sciences Blood Specimen Collection - instrumentation Blood Specimen Collection - methods Clinical trials Cross-study comparisons DNA Primers Drug Therapy, Combination Edetic Acid Fundamental and applied biological sciences. Psychology HIV Infections - drug therapy HIV Infections - virology HIV Protease Inhibitors - therapeutic use HIV sequence variability/subtypes HIV-1 - classification HIV-1 - drug effects HIV-1 - genetics HIV-1 - isolation & purification Human viral diseases Humans Infectious diseases Internationality Medical sciences Microbiology Miscellaneous Nucleic Acid Amplification Techniques - methods Oligopeptides - therapeutic use Oxazines - therapeutic use Plasma collection procedures Polymerase chain reaction Pyridines - therapeutic use Randomized Controlled Trials as Topic Reagent Kits, Diagnostic Reverse Transcriptase Inhibitors - therapeutic use RNA, Viral - blood RNA, Viral - isolation & purification Treatment Outcome Viral diseases Viral Load Virology |
| title | The effects of the Roche AMPLICOR HIV-1 MONITOR ® UltraSensitive Test versions 1.0 and 1.5 viral load assays and plasma collection tube type on determination of response to antiretroviral therapy and the inappropriateness of cross-study comparisons |
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