Oudshoom P, Simons F, Cronin M, Vella S, de Wolf F, Cuypers T; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 5th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 5th 1998 Chic Ill. 1998 Feb 1-5; 5th: 138 (abstract no. 312).
Organon Teknika, Boxlel, The Netherlands.
Drug therapy of HIV infected patients is guided by the number of CD4(+) T-cells and the plasma viral load. Multidrug treatment is initiated when the viral load rises above 10,000 copies/ml and is effective when the load drops 2-logs or more. Molecular diagnostics to assess the HIV-1 RNA load should therefore have a high performance in both quantitation and sensitivity. The NucliSens HIV-1 QT assay, which is based on isothermal transcription based nucleic acid amplification (NASBA), meets these requirements. Performance of the NucliSens HIV-1 QT assay has been assessed in a multicentre study using masked samples. The quantitative region ranges from 250 to 10(7) plasma or serum copies/ml with respectively an accuracy and a precision of less than or equal to 0.15 and less than or equal to 0.2 logs. Viral loads obtained by the new assay are very similar to quantitations with the first generation NASBA HIV-1 RNA QT assay, illustrating consistent standardization. The detection limit of 10 to 20 copies/ml plasma can be obtained by applying an improved eluted nucleic acids from silica particles and a color controlled precipitation of eluted nucleic acids. The indicated assay performance can be obtained by using either the manual- or the automatic -extractor- mode for nucleic acid isolation. The extractor is able to process moderately ten samples mixed with a chaotropic lysis buffer and silica particles in less than one hour. Each sample mixture is loaded in a disposable cartridge containing a filter to achieve bound-free separation. Each cartridge is connected to a dedicated fluid displacement circuit for washing and eluting the nucleic acids.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Antigens, CD4
- Biological Assay
- Evaluation Studies
- HIV Infections
- HIV Seropositivity
- HIV-1
- Humans
- Plasma
- RNA
- RNA, Viral
- Self-Sustained Sequence Replication
- Sensitivity and Specificity
- Viral Load
- analysis
- immunology
Other ID:
UI: 102235892
From Meeting Abstracts