schliessen

Filtern

 

Bibliotheken

Concordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials

The COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1... Full description

Journal Title: Clinical Infectious Diseases Apr 1, 2016, Vol.62(7), p.929
Main Author: Garner, Will
Other Authors: White, Kirsten , Szwarcberg, Javier , Mccallister, Scott , Zhong, Lijie , Wulfsohn, Mike
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: ISSN: 10584838
Link: http://search.proquest.com/docview/1777988572/?pq-origsite=primo
Zum Text:
SendSend as email Add to Book BagAdd to Book Bag
Staff View
recordid: proquest1777988572
title: Concordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials
format: Article
creator:
  • Garner, Will
  • White, Kirsten
  • Szwarcberg, Javier
  • Mccallister, Scott
  • Zhong, Lijie
  • Wulfsohn, Mike
subjects:
  • Polymerase Chain Reaction
  • Human Immunodeficiency Virus–HIV
  • Ribonucleic Acid–RNA
  • Clinical Trials
ispartof: Clinical Infectious Diseases, Apr 1, 2016, Vol.62(7), p.929
description: The COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes. A total of 2217 samples were collected from 1922 HIV-1-infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA
language: eng
source:
identifier: ISSN: 10584838
fulltext: fulltext
issn:
  • 10584838
  • 1058-4838
url: Link


@attributes
ID489771035
RANK0.07
NO1
SEARCH_ENGINEprimo_central_multiple_fe
SEARCH_ENGINE_TYPEPrimo Central Search Engine
LOCALfalse
PrimoNMBib
record
control
sourcerecordid1777988572
sourceidproquest
recordidTN_proquest1777988572
sourcesystemOther
pqid1777988572
galeid455178849
display
typearticle
titleConcordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials
creatorGarner, Will ; White, Kirsten ; Szwarcberg, Javier ; Mccallister, Scott ; Zhong, Lijie ; Wulfsohn, Mike
ispartofClinical Infectious Diseases, Apr 1, 2016, Vol.62(7), p.929
identifierISSN: 10584838
subjectPolymerase Chain Reaction ; Human Immunodeficiency Virus–HIV ; Ribonucleic Acid–RNA ; Clinical Trials
descriptionThe COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes. A total of 2217 samples were collected from 1922 HIV-1-infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA <50 copies/mL by Amplicor from 7 recent clinical trials. HIV-1 RNA results were obtained from the Amplicor and TaqMan 2.0 assays in parallel by a reference laboratory. The overall concordance between assay results was 96% at the cutoff of 50 copies/mL. However, statistically significant discordance at the 50 copies/mL cutoff was found between the assays for 3.9% of samples (n = 87). By TaqMan 2.0, virologic failure defined as HIV-1 RNA ≥50 copies/mL was reported for 2.8% more samples than Amplicor. Of these 87 samples, 68 samples fell within the predicted range of assay variability. Retesting of HIV-1 RNA by TaqMan 2.0 confirmed the discordance in only 28 of the 87 samples. The TaqMan 2.0 assay reports fewer subjects below the clinical endpoint of HIV-1 RNA <50 copies/mL in HIV clinical trials than the Amplicor assay. This difference must be considered when assessing disease progression, designing clinical trials, and comparisons with historical trials that used the Amplicor assay.
languageeng
source
version4
lds50peer_reviewed
links
openurl$$Topenurl_article
openurlfulltext$$Topenurlfull_article
backlink$$Uhttp://search.proquest.com/docview/1777988572/?pq-origsite=primo$$EView_record_in_ProQuest_(subscribers_only)
search
creatorcontrib
0Garner, Will
1White, Kirsten
2Szwarcberg, Javier
3Mccallister, Scott
4Zhong, Lijie
5Wulfsohn, Mike
titleConcordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials
descriptionThe COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes. A total of 2217 samples were collected from 1922 HIV-1-infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA <50 copies/mL by Amplicor from 7 recent clinical trials. HIV-1 RNA results were obtained from the Amplicor and TaqMan 2.0 assays in parallel by a reference laboratory. The overall concordance between assay results was 96% at the cutoff of 50 copies/mL. However, statistically significant discordance at the 50 copies/mL cutoff was found between the assays for 3.9% of samples (n = 87). By TaqMan 2.0, virologic failure defined as HIV-1 RNA ≥50 copies/mL was reported for 2.8% more samples than Amplicor. Of these 87 samples, 68 samples fell within the predicted range of assay variability. Retesting of HIV-1 RNA by TaqMan 2.0 confirmed the discordance in only 28 of the 87 samples. The TaqMan 2.0 assay reports fewer subjects below the clinical endpoint of HIV-1 RNA <50 copies/mL in HIV clinical trials than the Amplicor assay. This difference must be considered when assessing disease progression, designing clinical trials, and comparisons with historical trials that used the Amplicor assay.
subject
0Polymerase Chain Reaction
1Human Immunodeficiency Virus–HIV
2Ribonucleic Acid–RNA
3Clinical Trials
general
0English
1Oxford University Press, UK
2Medical Database
3Health & Medical Collection (Alumni edition)
4Medical Database (Alumni edition)
5ProQuest Pharma Collection
6Health & Medical Collection
7ProQuest Public Health
8Research Library China
9Engineering Research Database
10Technology Research Database
11ProQuest Research Library
12ProQuest Discovery
13ProQuest Biological Science Collection
14ProQuest Central
15ProQuest Engineering Collection
16ProQuest Environmental Science Collection
17ProQuest Hospital Collection
18ProQuest Natural Science Collection
19ProQuest Technology Collection
20Research Library (Alumni edition)
21Hospital Premium Collection (Alumni edition)
22ProQuest SciTech Collection
23ProQuest Health & Medical Complete
24ProQuest Medical Library
25Agricultural & Environmental Science Database
26Biological Science Database
27Natural Science Collection
28ProQuest Central (new)
29ProQuest Central K-12
30ProQuest Central Korea
31Research Library Prep
32SciTech Premium Collection
33Health Research Premium Collection
34Health Research Premium Collection (Alumni edition)
35ProQuest Central Essentials
36ProQuest Central China
sourceidproquest
recordidproquest1777988572
issn
010584838
11058-4838
rsrctypearticle
creationdate2016
addtitleClinical Infectious Diseases
searchscope
01000273
11006759
21006761
31006762
41006815
51006993
61007015
71007067
81007404
91007431
101007488
111007490
121007530
131007531
141007617
151007899
161007906
171007945
181008005
191008886
201009127
211009384
2210000002
2310000004
2410000005
2510000006
2610000013
2710000015
2810000022
2910000025
3010000027
3110000034
3210000038
3310000039
3410000041
3510000043
3610000047
3710000050
3810000053
3910000064
4010000118
4110000119
4210000120
4310000155
4410000156
4510000157
4610000158
4710000164
4810000198
4910000200
5010000209
5110000217
5210000234
5310000238
5410000253
5510000255
5610000256
5710000257
5810000258
5910000259
6010000260
6110000270
6210000271
6310000281
6410000300
65proquest
scope
01000273
11006759
21006761
31006762
41006815
51006993
61007015
71007067
81007404
91007431
101007488
111007490
121007530
131007531
141007617
151007899
161007906
171007945
181008005
191008886
201009127
211009384
2210000002
2310000004
2410000005
2510000006
2610000013
2710000015
2810000022
2910000025
3010000027
3110000034
3210000038
3310000039
3410000041
3510000043
3610000047
3710000050
3810000053
3910000064
4010000118
4110000119
4210000120
4310000155
4410000156
4510000157
4610000158
4710000164
4810000198
4910000200
5010000209
5110000217
5210000234
5310000238
5410000253
5510000255
5610000256
5710000257
5810000258
5910000259
6010000260
6110000270
6210000271
6310000281
6410000300
65proquest
lsr43
01000273false
11006759false
21006761false
31006762false
41006815false
51006993false
61007015false
71007067false
81007404false
91007431false
101007488false
111007490false
121007530false
131007531false
141007617false
151007899false
161007906false
171007945false
181008005false
191008886false
201009127false
211009384false
2210000002false
2310000004false
2410000005false
2510000006false
2610000013false
2710000015false
2810000022false
2910000025false
3010000027false
3110000034false
3210000038false
3310000039false
3410000041false
3510000043false
3610000047false
3710000050false
3810000053false
3910000064false
4010000118false
4110000119false
4210000120false
4310000155false
4410000156false
4510000157false
4610000158false
4710000164false
4810000198false
4910000200false
5010000209false
5110000217false
5210000234false
5310000238false
5410000253false
5510000255false
5610000256false
5710000257false
5810000258false
5910000259false
6010000260false
6110000270false
6210000271false
6310000281false
6410000300false
startdate20160401
enddate20160401
citationpf 929 vol 62 issue 7
lsr30VSR-Enriched:[galeid, pages, pqid]
sort
titleConcordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials
authorGarner, Will ; White, Kirsten ; Szwarcberg, Javier ; Mccallister, Scott ; Zhong, Lijie ; Wulfsohn, Mike
creationdate20160401
lso0120160401
facets
frbrgroupid5140875568480672954
frbrtype5
languageeng
creationdate2016
topic
0Polymerase Chain Reaction
1Human Immunodeficiency Virus–HIV
2Ribonucleic Acid–RNA
3Clinical Trials
collection
0Medical Database
1Health & Medical Collection (Alumni edition)
2Medical Database (Alumni edition)
3ProQuest Pharma Collection
4Health & Medical Collection
5ProQuest Public Health
6Research Library China
7Engineering Research Database
8Technology Research Database
9ProQuest Research Library
10ProQuest Discovery
11ProQuest Biological Science Collection
12ProQuest Central
13ProQuest Engineering Collection
14ProQuest Environmental Science Collection
15ProQuest Hospital Collection
16ProQuest Natural Science Collection
17ProQuest Technology Collection
18Research Library (Alumni edition)
19Hospital Premium Collection (Alumni edition)
20ProQuest SciTech Collection
21ProQuest Health & Medical Complete
22ProQuest Medical Library
23Agricultural & Environmental Science Database
24Biological Science Database
25Natural Science Collection
26ProQuest Central (new)
27ProQuest Central K-12
28ProQuest Central Korea
29Research Library Prep
30SciTech Premium Collection
31Health Research Premium Collection
32Health Research Premium Collection (Alumni edition)
33ProQuest Central Essentials
34ProQuest Central China
prefilterarticles
rsrctypearticles
creatorcontrib
0Garner, Will
1White, Kirsten
2Szwarcberg, Javier
3Mccallister, Scott
4Zhong, Lijie
5Wulfsohn, Mike
jtitleClinical Infectious Diseases
toplevelpeer_reviewed
delivery
delcategoryRemote Search Resource
fulltextfulltext
addata
aulast
0Garner
1White
2Szwarcberg
3McCallister
4Zhong
5Wulfsohn
aufirst
0Will
1Kirsten
2Javier
3Scott
4Lijie
5Mike
auinit1
0W.
1K.
2J.
3S.
4L.
5M.
au
0Garner, Will
1White, Kirsten
2Szwarcberg, Javier
3Mccallister, Scott
4Zhong, Lijie
5Wulfsohn, Mike
atitleConcordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials
jtitleClinical Infectious Diseases
risdate20160401
volume62
issue7
spage929
issn10584838
formatjournal
genrearticle
ristypeJOUR
abstractThe COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes. A total of 2217 samples were collected from 1922 HIV-1-infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA <50 copies/mL by Amplicor from 7 recent clinical trials. HIV-1 RNA results were obtained from the Amplicor and TaqMan 2.0 assays in parallel by a reference laboratory. The overall concordance between assay results was 96% at the cutoff of 50 copies/mL. However, statistically significant discordance at the 50 copies/mL cutoff was found between the assays for 3.9% of samples (n = 87). By TaqMan 2.0, virologic failure defined as HIV-1 RNA ≥50 copies/mL was reported for 2.8% more samples than Amplicor. Of these 87 samples, 68 samples fell within the predicted range of assay variability. Retesting of HIV-1 RNA by TaqMan 2.0 confirmed the discordance in only 28 of the 87 samples. The TaqMan 2.0 assay reports fewer subjects below the clinical endpoint of HIV-1 RNA <50 copies/mL in HIV clinical trials than the Amplicor assay. This difference must be considered when assessing disease progression, designing clinical trials, and comparisons with historical trials that used the Amplicor assay.
copOxford
pubOxford University Press, UK
urlhttp://search.proquest.com/docview/1777988572/
pages929
date2016-04-01