RESUMO
Labor, supply and waste were evaluated for HIV-1 and HCV bDNA on the semi-automated System 340 bDNA Analyzer and the automated VERSANT 440 Molecular System (V440). HIV-1 sample processing was evaluated using a 24- and 48-position centrifuge rotor. Vigilance time (hands-on manipulations plus incubation time except initial target hybridization) and disposables were approximately 37 and 12% lower for HIV-1, and 64 and 31% lower for HCV bDNA, respectively, with V440. Biohazardous solid waste was approximately twofold lower for both assays and other waste types were the same for either assay on both platforms. HIV-1 sample processing vigilance time for the 48-position rotor was reduced by 2 h. V440 provides cost savings and improved workflow.
Assuntos
Ensaio de Amplificação de Sinal de DNA Ramificado , Custos e Análise de Custo , DNA Viral/análise , Infecções por HIV , HIV-1 , Ensaio de Amplificação de Sinal de DNA Ramificado/economia , Ensaio de Amplificação de Sinal de DNA Ramificado/instrumentação , Ensaio de Amplificação de Sinal de DNA Ramificado/métodos , Ensaio de Amplificação de Sinal de DNA Ramificado/normas , Infecções por HIV/diagnóstico , Infecções por HIV/economia , HIV-1/genética , HIV-1/metabolismo , Humanos , Carga ViralRESUMO
Comparative cost models were developed to assess cost-per-reportable result and annual costs for HIV-1 and HCV bDNA and AmpliPrep/TaqMan Test (PCR). Model cost components included kit, disposables, platform and related equipment, equipment service plan, equipment maintenance, equipment footprint, waste and labor. Model assessment was most cost-effective when run by bDNA with 36 or more clinical samples and PCR with 30 or fewer clinical samples. Lower costs are attained with maximum samples (84-168) run daily. Highest cost contributors include kit, platform and PCR proprietary disposables. Understanding component costs and the most economic use of HIV-1 and HCV viral load will aid in attaining lowest costs through selection of the appropriate assay and effective negotiations.
Assuntos
Ensaio de Amplificação de Sinal de DNA Ramificado , DNA Viral/análise , HIV-1/genética , Hepacivirus/genética , RNA Viral/análise , Carga Viral , Ensaio de Amplificação de Sinal de DNA Ramificado/economia , Ensaio de Amplificação de Sinal de DNA Ramificado/instrumentação , Ensaio de Amplificação de Sinal de DNA Ramificado/métodos , Custos e Análise de Custo , Infecções por HIV/genética , Infecções por HIV/metabolismo , Hepatite C/genética , Hepatite C/metabolismo , Humanos , Reprodutibilidade dos Testes , Reação em Cadeia da Polimerase Via Transcriptase Reversa/economia , Reação em Cadeia da Polimerase Via Transcriptase Reversa/instrumentação , Reação em Cadeia da Polimerase Via Transcriptase Reversa/métodos , Sensibilidade e EspecificidadeRESUMO
This review addresses hidden costs associated with the Bayer VERSANT assay, Roche AMPLICOR MONITOR test and COBAS AMPLICOR MONITOR test and how these influence the final per reportable cost to a testing laboratory in resource-rich and -poor countries. An in-depth evaluation and recommendation of the most cost-effective approach for these tests is presented. The analyses demonstrate the need for manufacturers to consider labor and supply costs when marketing a kit in resource-poor countries, noting that marketing strategies need to change. In the absence of any proven monitoring alternative, emphasis is placed on increasing market share to promote significant reduction in kit prices to suit the demands of markets in resource-poor countries. Finally, recommendations are made to improve the overall cost structure of viral load testing. This review is intended as a tool to optimize assay usage in attaining the lowest performance costs by assay and is not to endorse any test, as will become apparent.
RESUMO
This article will compare the VERSANT HIV-1 RNA 3.0 (bDNA 3.0) assay with other HIV-1 viral load assays, particularly the AMPLICOR HIV-1 MONITOR (Amplicor 1.5), the industry standard. The discussion will cover the history of viral load assay development and challenges to the field. It will finish with a description of the evolving markets for viral load assays in the developing world and the impact of variations in the different assays on their ability to reach those markets and patient populations.
