Search Results

The miDiagnostics HSV-1&2 CSF Test is an in vitro polymerase chain reaction (PCR) assay intended for use with the miDiagnostics PCR Platform for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of Herpes Simplex Virus (HSV) infection of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infection in the CNS.

Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.

The test is not intended for use as a donor screening test. The test is for professional use only.

The miDiagnostics HSV-1&2 CSF Test is a real-time polymerase chain reaction (PCR) assay that enables the direct amplification, detection, and differentiation of Herpes Simplex Virus 1 (HSV-1) and Herpes Simplex Virus 2 (HSV-2) DNA from cerebrospinal fluid (CSF) specimens, obtained via lumbar puncture, from individuals with signs and/or symptoms of HSV-1 or HSV-2 infection in the central nervous system (CNS).

The test consists of three major steps: (1) manual sample preparation, (2) manual PCR reaction preparation and (3) automated PCR run which includes targets amplification and detection by fluorescent probes for 1 target specific to HSV-1, 1 target specific to HSV-2 and a human DNA control target.

After manual sample and PCR reaction preparation, the miDiagnostics HSV-1&2 CSF test consists of three major steps: (1) manual sample preparation, (2) manual PCR reaction preparation and (3) automated PCR run on the miDiagnostics PCR Platform which is an automated in vitro diagnostic system for the amplification and detection of the target nucleic acid(s) using real-time polymerase chain reaction (PCR).

Description of the different components of miDiagnostics HSV-1&2 CSF Test:

1. miDiagnostics HSV-1&2 CSF Detection Mix: contains a freeze-dried cake, stored in a tube, containing all the PCR components for amplification and fluorescent detection of HSV-1, HSV-2 and the Sample Processing Control (SPC). Each tube is individually packed in a pouch. The device consists of 24 pouches in a box.

2. miDiagnostics HSV-1&2 CSF Dilution Buffer: contains 300 µL HSV CSF Dilution Buffer for diluting the CSF specimen. It also contains a SPC (RPP30, a human housekeeping gene). The device consists of 24 tubes packed in one box.

3. miDiagnostics Concentration Device: consists of a combination of the miDiagnostics Concentration Column and 2 miDiagnostics Collection Tubes, to concentrate the viral material. The device consists of one bag with 24 miDiagnostics Concentration Columns and 48 miDiagnostics Collection Tubes.

4. miDiagnostics HSV-1&2 CSF Algorithm: The software system that interprets fluorescence signals and reports test results. The miDiagnostics HSV-1&2 CSF Algorithm is embedded in the miDiagnostics Software.

The miDiagnostics PCR Platform is an automated in vitro diagnostics medical device intended to be used in combination with a selected miDiagnostics test for the amplification and detection of the target nucleic acid(s) using real-time polymerase chain reaction (PCR). The miDiagnostics PCR Platform is intended to be used by healthcare professionals (trained laboratory personnel) in laboratory environment.

Description of the different components of miDiagnostics PCR Platform:

1. miDiagnostics PCR Reader 2.0 receives the miDiagnostics PCR Card 2.0 and is responsible for performing consecutive PCR cycles through thermocycling. The miDiagnostics PCR Reader 2.0 monitors the consequent polymerase chain reaction's progress with a four-channel camera system. It also contains a 2D barcode reader to identify the loaded miDiagnostics PCR Card 2.0 and is connected to the miDiagnostics Computer, from which it receives test-specific parameters for the PCR and to which it sends the camera images that contain the raw data of the PCR.

The firmware is an embedded software system running on the miDiagnostics PCR Reader 2.0 microprocessor with as main functionalities the thermocycling and the triggering of the camera.

2. miDiagnostics PCR Card 2.0 is a single-use, disposable test accessory. The miDiagnostics PCR Card 2.0 is manually loaded with a small volume of sample mixed with PCR components of the selected miDiagnostics test (so called reaction mixture). Once loaded, the miDiagnostics PCR Card 2.0 is manually inserted in the miDiagnostics PCR Reader 2.0. The miDiagnostics PCR Card 2.0 includes a fluidic chip with the reaction chamber that enables a very fast polymerase chain reaction driven by the miDiagnostics PCR Reader 2.0. Each miDiagnostics PCR Card 2.0 is individually packed in a pouch. The device consists of 24 pouches in a box.

3. miDiagnostics Computer connects to the miDiagnostics PCR Reader 2.0 via two USB-cables and can connect to the customer's network via ethernet or WiFi. It interacts with a user via a touchscreen, has an integrated barcode scanner that allows the user to scan the sample consumable identifiers, and it runs the miDiagnostics Software.

The miDiagnostics Software is the software of the miDiagnostics PCR Platform, that is installed on the miDiagnostics Computer. It controls the miDiagnostics PCR Reader 2.0, retrieves the camera captures, hosts the test specific algorithm that interprets the fluorescence signals, reports the test results, and provides a user interface for the operator to interact with the miDiagnostics PCR Platform.

N/A

Ask a specific question about this device