6
Views
4
CrossRef citations to date
0
Altmetric
Miscellaneous

Health care industries’ perspective of viral load assays: the VERSANT HIV-1 RNA 3.0 assay

, &
Pages 275-285 | Published online: 09 Jan 2014

References

  • Piatak M, Jr., Saag MS, Yang LC et al High levels of HIV-1 in plasma during all stages of infection determined by competitive PCR Science 259, 1749–1754 (1993).
  • •Historical account of the natural history of HIV4 infection.
  • Mellors JW, Rinaldo CR, Jr., Gupta P et al Quantitation of HIV-1 RNA in plasma predicts outcome after seroconversion. Ann. Intern. Med. 122, 573–579 (1995).
  • ••First report that correlates high viral loadto poor prognosis.
  • Mellors JW, Rinaldo CR, Jr., Gupta P, White RM, Todd JA, Kingsley LA. Prognosis of HIV-1 infection predicted by the quantity of virus in plasma. Science 272, 1167–1170 (1996).
  • •• First significant study that correlates viral load with clinical course.
  • Jurriaans S, van Gemen B, Goudsmit J et al. The natural history of HIV-I infection: viral load and virus phenotype independent determinants of clinical course. Virology 204, 223–233 (1994).
  • Palumbo PE, Raskino C, Fiscus S et al. Predictive value of quantitative plasma HIV RNA and CD4+ lymphocyte count in HIV-infected infants and children. JAMA 279, 756–761 (1998).
  • Schnittman SM, Greenhouse JJ, Psallidopoulos MC et al. Increasing viral burden in CD4+ T-cells from patients with human immunodeficiency virus (HIV) infection reflects rapidly progressive immunosuppression and clinical disease. Ann. Intern. Med 113, 438 443 (1990).
  • Hammer S, Crumpacker C, D'Aquila R et al Use of virologic assays for detection of human immunodeficiency virus in clinical trials: recommendations of the AIDS Clinical Trials Group Virology Committee. Clin. Microbial 31, 2557–2564 (1993).
  • Bart PA, Rizzardi GP, Tambussi G et al Immunological and virological responses in HIV-1-infected adults at early stage of established infection treated with highly active antiretroviral therapy. AIDS 14, 1887–1897 (2000).
  • Carpenter CC, Cooper DA, Fischl MA et al. Antiretroviral therapy in adults: updated recommendations of the International AIDS Society-USA Panel. JANIA 283, 381–390 (2000).
  • ••Recommended guidelines for thetreatment of HIV-1-infected individuals.
  • Katzenstein DA, Hammer SM, Hughes MD et al. The relationship of virologic and immunologic markers to clinical outcome after nucleoside therpay in adults with human immunodeficiency virus and 200 to 500 cells per cubic millimeter. N Engl Med. 335, 1091–1096 (1996).
  • Welles SL, Jackson JB, Yen-Lieberman B et al. Prognostic value of plasma human immunodeficiency virus Type 1 (HIV1) RNA levels with advanced HIV1 disease and with little or no zidovudine therapy. J Infect Dis. 174, 696–703 (1996).
  • Coombs RW, Welles SL, Hooper C et al Association of plasma human immunodeficiency virus Type 1 RNA level with risk of clinical progression in patients with advanced infection. AIDS Clinical Trials Group (ACTG) 116B/117 Study Team. ACTG Virology Committee Resistance and HIV4 RNA Working Groups." Infect. Dis. 174, 704-712(1996).
  • O'Brien WA, Hartigan PM, Martin D et al. Changes in plasma HIV1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. Veterans Affairs Co-operative Study Group on AIDS. N Engl J Med. 334, 426–431 (1996).
  • Dewar RL, Highbarger HC, Sarmiento MD et al Application of branched DNA signal amplification to monitor human immunodeficiency virus Type 1 burden in human plasma." Infect. Dis. 170, 1172–1179 (1994).
  • ••First report comparing viral load withHIV-1 p24 measurements. Significantly higher sensitivity with viral load.
  • Michael ML, Herman SA, Kwok S et al Development of calibrated viral load standards for group M subtypes of human immunodeficiency virus Type 1 and performance of an improved AMPLICOR HIV1 MONITOR test with isolates of diverse subtypes. J Clin. Microbial 37, 2557–2563 (1999).
  • ••The first subtype panel to be developedand utilized to determine the subtype performance characteristics of Arnplicor HIV-1 Monitor versions 1.0 and 1.5.
  • Elbeik T, Alvord WG, Trichavaroj R et al Comparative analysis of HIV-1 viral load assays on subtype quantification: Bayer VERSANT HIV1 RNA 3.0 versus Roche AMPLICOR HIV1 MONITOR version 1.5. J. AIDS 29, 330–339 (2002).
  • •A comprehensive statistical analysis defining the level of reliability of bDNA and Amplicor 1.5 viral load results from different subtypes.
  • Triques K, Coste J, Perret JL et al Efficiencies of four versions of the AMPLICOR HIV-1 MONITOR test for quantification of different subtypes of human immunodeficiency virus Type 1." Clin. Microbial 37, 110–116 (1999).
  • •A report providing an in-depth comparison of the performance of various Atnplicor assays. Provides a useful list of references.
  • Jagodzinski LL, Wiggins DL, McManis JL et al. Use of calibrated viral load standards for group M subtypes of human immunodeficiency virus Type 1 to assess the performance of viral RNA quantitation tests." Clin. Microbial 38, 1247–1249 (2000).
  • •The first paper to compare different viral load assays on subtype quantification (Arnplicor, bDNA, NASBA).
  • Giinthard HF, Wong JK, Ignacio CC et al Human immunodeficiency virus replication and genotypic resistance in blood and lymph nodes after a year of potent antiretroviral therapy. J Viral 72, 2422–2428 (1998).
  • Volberding PA. Advances in the medical management of patients with HIV1 infection: an overview. AIDS 13, S1—S9 (1999).
  • Friedland GH, Williams A. Attaining higher goals in HIV treatment: the central importance of adherence. AIDS 13, S61—S72 (1999).
  • Gallant JE. Strategies for long-term success in the treatment of HIV infection. JANIA 283, 1329–1334 (2000).
  • Mouroux M, Yvon-Groussin A, Peytavin G et al. Early virological failure in naive human immunodeficiency virus patients receiving saquinavir (soft gel capsule)-stavudine-zalcitabine (MIKADO trial) is not associated with mutations conferring viral resistance. J Clin. Microbial 38, 2726–2730 (2000).
  • de Maat MM, Hoetelmans RM, Mathot RA et al. Drug interaction between St John's wort and nevirapine. AIDS 15, 420–421 (2001).
  • Piscitelli SC, Burstein AH, Chaitt D, Alfaro RM, Falloon J. Indinavir concentrations and St John's wort. Lancet 355, 547–548 (2000).
  • Boden D, Hurley A, Zhang L et al HIV-1 drug resistance in newly infected individuals. JAMA 282, 1135–1141 (1999).
  • Brenner B, Wainberg MA, Salomon H et al. Resistance to antiretroviral drugs in patients with primary HIV-1 infection. Investigators of the Quebec Primary Infection Study. Int. J Antimicrob. Agents 16, 429–434 (2000).
  • Briones C, Perez-Olmeda M, Rodriguez C, del Romero J, Hertogs, K, Soriano V. Primary genotypic and phenotypic HIV-1 drug resistance in recent seroconverters in Madrid." Acquir. Immune. Defic. Syndr. 26, 145–150 (2001).
  • Cesaire R, Dos Santos G, Abel S, Bera 0, Sobesky G, Cabie A. Drug resistance mutations among HIV-1 strains from antiretroviral-naive patients in Martinique, French West Indies. J Acquir. Immune Defic. Syndr. 22, 401–405 (1999).
  • Little SJ, Daar ES, D'Aquila RT et al. Reduced antiretroviral drug susceptibility among patients with primary HIV infection. JANIA 282,1142–1149 (1999).
  • Yerly S, Kaiser L, Race E, Bru JP, Gavel F, Perrin L Transmission of antiretroviral-drug-resistant HIV-1 variants. Lancet 354, 729–733 (1999).
  • Elbeik T, Hoo B, Campodonico et al. The In vivo emergence of drug resistance mutations at less than 50 HIV1 RNA copies/ml that are maintained at viral rebound in longitudinal plasma samples from HIV1 infected patients on highly active antiretroviral therapy. J. Hum. Viral. (2002) (In Press).
  • •First paper to show the in vivo emergence of new primary HIV-1 genotypic mutations during successful HAART therapy.
  • Martinez-Picado J, DePasquale MP, Kartsonis N et al. Antiretroviral resistance during successful therapy of HIV Type 1 infection. Proc. Natl Acari Sci. USA 97, 10948–10953 (2000).
  • •Using an in vitro model, the first paper to show the emergence of new primary HIV-1 genotypic mutations during successful HAART therapy.
  • Todd J, Pachl C, White R et al. Performance characteristics for the quantitation of plasma HIV-1 RNA using branched DNA signal amplification technology j Acquir. Immune DOc. Syndr. Hum. Retrovirol 10, S35-44 (1995).
  • •The origins of the bDNA assay.
  • Kern D, Collins M, Fultz T et id An enhanced-sensitivity branched-DNA assay for quantification of human immunodeficiency virus Type 1 RNA in plasma." Clin. Microbial 34, 3196–3202 (1996).
  • Collins ML, Irvine B, Tyner D et al. A branched DNA signal amplification assay for quantification of nucleic acid targets below 100 molecules/ml. Nucleic Acids Res. 25, 2979–2984 (1997).
  • •The first paper to report on the 'progenitor' bDNA 3.0 assay and describes the use of iso C and Gin probes.
  • Kwok S, Sninsky JJ. PCR detection of human immunodeficiency virus Type 1 proviral DNA sequences. In: Diagnostic Molecular Microbiology: Principles and Applications. Persing DH, Smith TF, Tenover FC, White TJ (Ed.) American Society for Microbiology, Washington, DC, USA 309–315 (1993).
  • •Background information for the HIV-1 Arnplicor assay.
  • Christopherson C, Sninsky J, Kwok S. The effects of internal primer-template mismatches on RT-PCR: HIV-1 model studies. Nucleic Acids Res. 25, 654–658 (1997).
  • •Background information for the HIV-1 Arnplicor assay.
  • Sun R, Ku J, Jayakar H et al UltraSensitive reverse transcription-PCR assay for quantitation of human immunodeficiency virus Type 1 RNA in plasma. J. Clin. Microbial 36, 2964–2969 (1988).
  • •Background information for the HIV-1 Arnplicor assay.
  • Swanson P, Soriano V, Devare SG, Hackett J, Jr. Comparative performance of three viral load assays on human immunodeficiency virus Type 1 (HIV1) isolates representing group M (subtypes A to G) and group o: LCx HIV RNA quantitative, AMPLICOR HIV1 MONITOR version 1.5 and Quantiplex HIV-1 RNA version 3.0." Clin. Microbial 39, 862–870 (2001).
  • ••First report on subtype quantificationusing the Abbott LCx HIV RNA quantitative assay.
  • Guatelli JC, Whitfield KM, Kwoh DY, Barringer KJ, Richman DD, Gingeras TR. Isothermal, in vitro amplification of nucleic acids by a multienzyme reaction modeled after retroviral replication. Proc. Natl Acari Sci. USA 87, 1874–1878 (1990).
  • ••First paper to describe NASBAtechnology.
  • Guatelli JC, Whitfield KM, Kwoh DY, Barringer KJ, Richman DD, Gingeras TR. Isothermal, in vitro amplification of nucleic acids by a multienzyme reaction modeled after retroviral replication. Proc. Natl. Acad. Sci. USA 87, 7797 (1990).
  • ••A correction for [41].
  • van Gemen B, van Beuningen R, Nabbe A et al A one-tube quantitative HIV-1 RNA NAS BA nudeic acid amplification assay using electrochemiluminescent (ECL) labelled probes.' Viral Meth. 49, 157–167(1994).
  • •Information on the NASBA assay.
  • de Baar MP, van Dooren MW de Rooij E et al. Single rapid real-time monitored isothermal RNA amplification assay for quantification of human immunodeficiency virus Type 1 isolates from groups M, N and 0.1 Clin. Microbial 39, 1378–1384 (2001).
  • ••Subtype quantification using the NASBA assay.
  • Elbeik T, Charlebois E, Nassos et al. Quantitative and cost comparison of UltraSensitive HIV-1 RNA viral load assays: Bayer bDNA Quantiplex versions 3.0 and 2.0 and Roche PCR Amplicor Monitor version 1.5.j Clin. Micro. 38, 1113–1120 (2000).
  • ••The first in-depth cost analysis (labor anddisposables) of viral load assays.
  • Havlir DV, Bassett R, Levitan D et al Prevalence and predictive value of intermittent viremia with combination HIV therapy. JANIA 286, 171–179 (2001).
  • Stephens JC, Rogers J, Ruano G. Theoretical underpinning of the single-molecule-dilution (SMD) method of direct haplotype resolution. Am. J. Hum. Genet. 46, 1149–1155 (1990).
  • Freeman WM, Walker SJ, Vrana KE. Quantitative RT-PCR: pitfalls and potential. BiaTechniques 26, 112–122 (1999).
  • ••A comprehensive review covering technicalaspects of quantitative RT-PCR.
  • Ferre F, Marchese A, Pezzoli P, Griffin S, Buxton E, Boyer V. Quantitative PCR: an overview. In: The Polymerase Chain Reaction. Mullis KB, Ferre F, Gibbs RA, (Ed.), Birkhäuser, Boston, MA, USA, 67–88 (1994).
  • •A review of the HIV-1 PCR assay.
  • Rich JD, Merriman NA, Mylonakis E et al. Misdiagnosis of HIV infection by HIV-1 plasma viral load testing: a case series. Ann. Intern. Med. 130, 37–39 (1999).
  • ••A report on the risks of using viral loadassays for HIV-1 diagnosis.
  • www.hivatis.org/trtgdlns.html Department of Health and Human Services (Dhhs) and The Henry J Kaiser Family Foundation: Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents.
  • ••A critical up-to-date resource for thetreatment of HIV-1 infected individuals and includes use of viral load testing.
  • Nesheim SR The diagnosis, and management of perinatal HIV and diagnosis of HIV infection in infants:a review. Clin. Obstet. Gyn. 39, 396–410 (1996).
  • Nielsen K, Bryson YJ. Diagnosis of HIV infection in children. Ped. Clin. NA 47, 39–63 (2000).
  • ••Use of viral load in the diagnosis for diagnosis of pediatric cases.
  • Schneider K. The diagnosis of HIV infection at-risk infants: a critical review. hup://pangloss.ucsfmedicalcenter.org/ Education/CritRev/pedHIVSchneider.html (2000).
  • ••A review of various studies evaluatingthe specificity and sensitivity of different tests for the diagnosis of pediatric cases.
  • Elbeik T, Markowitz N, Nassos P, Kumar U, Haller B, Ng V. Simultaneous run of the Bayer VERSANT HIV-1 version 3.0 and HCV bDNA version 3.0 quantitative assays on the semi-automated System 340: reliable quantitation with cost savings from labor and reagents. XIV International AIDS Conference, Barcelona, Spain. 7–12 (2002).
  • •A report on the adaptation of system 340 to allow for the simultaneous run of HIV and HCV bDNA assays: provides cost savings, benefits low- and high-throughput labs and improves staff scheduling.
  • http://www.unaids.org/ Unaids: the Joint UN Programme on HIV/AIDS: Aids epidemic update.
  • ••Global data on HIV-1 infection.
  • Christopherson C, Lu SD, Kwok S. Laboratory markers of antiviral activity. Antivir. Then 3, 247–250 (1998).
  • •Reviews various tests.
  • Damond F, Descamps D, Farfara I et al. Quantification of proviral load of human immunodeficiency virus Type 2 subtypes a and B using real-time PCR j Clin. Microbial 39, 4264 4268 (2001).
  • •Description of the HIV-1 proviral assay and use in quantifying HIV–2.
  • Desire N, Dehee A, Schneider Vet al Quantification of human immunodeficiency virus Type 1 proviral load by a TaqMan real-time PCR assay. J. Clin. Microbial 39, 1303–1310 (2001).
  • ••The most current technology used toquantify proviral DNA. Real-time PCR is the next generation technology.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.