Firma:                Nuclisens

Modell:              PCR

Kommentar:      Dokumente engl.

Introduction

The NucliSens System consists of the Nucleic Acid Sequenced Base Amplification (NASBA) technology combined with a simple nucleic acid extraction procedure, NucliSens Extractor, and a user-friendly detection method, NucliSens Reader. The NucliSens Extractor automates the Isolation process for the nucleic acids. This instrument relieves the user of the mang centrifugation, Suspension, and aspiration steps. lt allows the processing of multiple samples during a single Run, minimizes the labor and reduces the time required for the processing steps.

Intended use

For in vitro diagnostic use.

The NucliSens Extractor is an instrument for the extraction of nucleic acids from lysed biological samples; the nucleic acids are concentrated by adsorbing to Silica, filtering, washing, and eluting into a closed vial for further processing.

The extraction and concentration of the nucleic acids are performed in a 'closed" Container, referred to as the nucleic acid extractor Cartridge. The Cartridge is designed to hold the lysed biological sample, Silica, and internal control nucleic acid (if used), during the extraction process. A ready source of filtered, dry air provided to the Cartridge allows fluid manipulation for the filtration, washing and elution steps, and for drying of the Silica following the wash steps. This minimizes contamination of the nucleic acids and exposure of the operator to hazardous biological samples.

General Theory of Operation

The technology employed in the NucliSens Extractor is based on the manual method by R. Boom et al. (1990, J. Clin. Micro. 28, 495-503), which has been successfully used to isolate nucleic acids from a variety of biological samples. The 'Boom" method utilizes the lysing properties of a chaotropic agent and the nucleic acid binding properties of a solid phase, Silica, in the presence of this agent.

The extraction procedure is initiated by adding the biological sample to Lysis Buffer. The Lysis Buffer disrupts (dissociates) the cells and/or viral particles, releasing the nucleic acids and inactivating the nucleases present in the mixture. Silica is added to the lysed mixture for adsorption of the nucleic acids prior to processing by the Extractor. (When calibrator or control nucleic acids are used, these materials are added prior to the addition of Silica.) This mixture, containing sample (nucleic acids), Lysis Buffer, and Silica, is added to the Cartridge which is subsequently placed on the Extractor for processing. The Silica (solid phase) containing the adsorbed nucleic acids is filtered from the mixture, washed to remove extraneous materials, and dried. The adsorbed nucleic acids are eluted from the Silica into a closed Eluate Cup for further processing.

Extractor applications

A pure beginning for endless possibilities

The NucliSens Extractor can be used to prepare nucleic acids from many sample types for a wide range of applications. The unique features of the Extractor make it extremely well suited for applications in the fields of clinical, in vitro diagnostic testing and blood safety testing. The Extractor is the instrument of choice as front-end for:

HucliSens HIV-1 OT

The NASBA based assay for HIV-1 RNA quantification. Automated extraction ensures a high degree of standardization and labor-efficiency.

HIV-1 RIIA Genotyping

One eluate from the Extractor/HIV-1 QT assay can not only be used for HIV-1 RNA quantification but also very effectively for HIV-1 RNA sequencing. to determinate antiviral drug resistancy.

The Extractor allows excellent sensitivity of genotyping in clinical samples with low RNA concenfrations.

HucliSens HIV-1 OL

The quantitative NASBA assay for detection of HIV-1 RNA.

HucliSens CMV pp67

The NASBA-based assay for CMV mRNA detection.

HucliSens Basic Kit

The standardized platform for customized RNA amplification testing. Please ask for available applications.

Plasma Pool testing (HAT)

The Extractor features very effective isolation of vital targets for plasma pools in blood safety testing. Extraction from 2 ml of the pool allows very sensitive down-stream testing for HCV-RNA, HIV-1 RNA, HBV-DNA, and Parvo B19-DNA. As of July 1999, the Extractor has been approved by the German Paul-Ehrlich Institute for minipool screening of blood donations for HCV-RNA, for a maximum: ppol size of 96 donations. (6)

The superior sensitivity of the Extractor in combination with pool testing results in cost­effective nucleic acid testino: the costs per blood donation are strongly reduced as compared to single donation testing.

Technical Specifications

Physical

*           Height: 79 cm

*           Diameter 66 cm

*           Weight 90 kg:

Electrical

*           Voltage: 100, 120, 220, 240 V ± 10%

*           Current 7.0, 5.0, 2.5, 2.5 A

*           Frequency 50 - 60 Hz

*           Power 700W Maximum

*           Fuses: 10 A Time Detay (100/120 V)

  6,3 A Time Delay (220/240 V)

Environmental conditions

*           Operating temperature 15-30 °C

*           Storage temperature 10-50 °C

*           Humidity 80% maximum

Noise generated

*           Typical            Less than 55 dB(A)

*           Maximum:       Less than 61 dB(A) (duration < 10%)

EMC Compliance

*           CE 89/336/EEC, Class A (essential req.)

*           Emissions: EN 50081- 1 : 1992 (class radiated emissions)

*           Immunity: EN 50082-1 : 1997

Electrical safety complicance

*           International Standards:>

UL 3101 -1 (Harmonized UL 1262-1 and IEC 1010-1),

CSA C22.2 No. 1010.1-92

CB Certified and Construction File