QIAcuity Digital PCR System

Para aplicaciones de PCR digital basadas en nanoplaca

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QIAcuity One, 2plex Device

Cat. No. / ID: 911001

Instrumento para PCR digital de una placa que permite detectar hasta 2 colorantes fluorescentes, rodillo, memoria flash USB y QIAcuity Software Suite: incluye 1 visita de mantenimiento preventivo. También incluye garantía de 1 año para mano de obra, gastos de desplazamiento y piezas.

Format

One

Four

Eight

Multi-channel detection

2plex

5plex

Service Options

Device

System

System FUL-2

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El sistema QIAcuity está concebido para su uso en aplicaciones de biología molecular. Este producto no está concebido para el diagnóstico, la prevención ni el tratamiento de enfermedades. Por lo tanto, se desconocen las características del rendimiento del producto para el uso clínico (es decir, diagnóstico, pronóstico, uso terapéutico o en bancos de sangre).

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Features

Sistema completamente integrado
Formato escalable (instrumentos de 1, 4 y 8 placas)
Capacidades avanzadas de multiplexado (hasta 5-plex)
Rendimiento flexible de la muestra
Resultados completos en unas 2 horas

Product Details

El QIAcuity Digital PCR System está diseñado para ofrecer resultados de cuantificación multiplexados y precisos para detección de mutaciones, variación en el número de copias (CNV), estudios de expresión génica, análisis de modificación de genes y mucho más. Este sistema basado en nanoplacas integra a la perfección un flujo de trabajo de dPCR estándar de división en partes, termociclado y obtención de imágenes en una plataforma automatizada que no requiere supervisión con un tiempo de manipulación mínimo.

El sistema se usa junto con las QIAcuity Nanoplates y los accesorios.

Explore la demostración virtual para obtener más información sobre QIAcuity.

Performance

El QIAcuity Digital PCR System permite que la cuantificación absoluta sea accesible y asequible para todos los laboratorios. La automatización sin necesidad de supervisión integra y agiliza todo el flujo de trabajo de PCR digital de división en partes, termociclado y obtención de imágenes en un único instrumento con un tiempo de manipulación mínimo. Adaptar sus ensayos de qPCR actuales al QIAcuity Digital PCR System es también muy fácil. No es necesario realizar cambios en la manipulación de las placas que provienen de qPCR, lo que garantiza una configuración rápida del ensayo y la obtención de resultados en unas 2 horas.

Características y especificaciones de los instrumentos QIAcuity

Característica	QIAcuity One	QIAcuity Four	QIAcuity Eight
Placas procesadas	1	4	8
Canales de detección (multiplexado)	2 o 5	5	5
Termocicladores	1	1	2
Tiempo necesario para obtener el resultado	Unas 2 h	Primera placa en unas 2 h Cada ~60 min una placa siguiente	Primera placa en unas 2 h Cada ~30 min una placa siguiente
Rendimiento (muestras procesadas en una jornada de trabajo)	Hasta 384 (96 pocillos) Hasta 96 (24 pocillos)	Hasta 672 (96 pocillos) Hasta 168 (24 pocillos)	Hasta 1248 (96 pocillos) Hasta 312 (24 pocillos)

Principle

En solo 3 simples pasos, puede obtener el resultado de dPCR que desea en unas 2 horas: pipetee y cargue, realice el experimento y analice los resultados.

El principio de la reacción de dPCR en las nanoplacas se describe aquí.

Procedure

Al igual que en los experimentos de qPCR, la preparación de las muestras incluye la transferencia de mezcla maestra, sondas y cebadores a una nanoplaca de 96 o 24 pocillos, seguida de la adición de las muestras. El sistema integra funciones de división en partes, termociclado y obtención de imágenes en un solo instrumento completamente automatizado que permite a los usuarios obtener los resultados de las muestras en menos de 2 horas. Es posible realizar un análisis en el paquete de software, que proporciona la concentración en copias por microlitro de la secuencia de blancos y también para el control de calidad como muestras positivas o NTC. Este análisis también se puede extender a ordenadores remotos dentro de la misma red de área local (LAN).

Applications

Los instrumentos QIAcuity, junto con las QIAcuity Nanoplates y los QIAcuity PCR kits, posibilitan las aplicaciones de PCR digital, entre las que se incluyen:

Detección de mutaciones poco frecuentes
Análisis de variación en el número de copias
Análisis de expresión génica
Detección de microrganismos patógenos
Genotipado
Investigación sobre miARN

Software

El QIAcuity Software Suite que se incluye con el instrumento y se instala en un ordenador independiente permite controlar uno o varios instrumentos QIAcuity, ya sea que estén conectados directamente a un instrumento o que utilicen una red de área local existente (LAN). Al utilizar el QIAcuity Software Suite, es posible definir los experimentos de PCR digital, las muestras y las mezclas de reacciones, asignarlas a Nanoplates y transferirlas al instrumento QIAcuity. Tras la serie, es posible analizar los datos, crear informes y exportar los datos para el análisis externo. El software proporciona varias funcionalidades de molde que permiten acceder fácilmente a las distribuciones de placas o parámetros de corrida de placas que se repiten, transformando aún más su experiencia de PCR digital.

Si está integrado en una red de área local, el ordenador aloja la función del QIAcuity Software Suite como un servidor al que se puede acceder fácilmente a través de una red LAN a otros ordenadores que funcionan como clientes. De esta manera, varios usuarios pueden acceder al software desde otras salas u oficinas y analizar los datos a través de un navegador estándar sin tener que instalar el software en varios ordenadores o acceder a los datos e intercambiarlos a través de conexiones a Internet.

Services

Proteja su instrumento con una gran variedad de soluciones de servicio de QIAGEN. Obtenga más información sobre un acuerdo de servicio específico que se adapte a sus necesidades.

Supporting data and figures

Flujo de trabajo simple y rápido basado en la placa

Las funciones de división en partes, termociclado y obtención de imágenes están integradas en un solo instrumento completamente automatizado que produce resultados en menos de dos horas. Los formatos de nanoplaca son susceptibles a la automatización inicial para la preparación de las muestras, lo que reduce aún más el tiempo de manipulación.

La exactitud de los datos se demostró con resultados repetibles en dos series independientes en las que se utilizó la QIAcuity Nanoplate dPCR.

Cuantificación similar en configuraciones simples y 5plex.

Se confirmó la viabilidad del multiplexado de blancos de ADNc de abundancia sumamente variable.

Service Plans

QIAcuity One 2plex Full Agreement

Cat. No. / ID: 9245362

Reparación del instrumento QIAcuity One 2plex en el centro, incluidos gastos de desplazamiento, mano de obra y piezas por un periodo de un año. Tiempo de respuesta de dos días laborables. Incluye un mantenimiento preventivo durante el periodo del acuerdo completo.

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QIAcuity One Preventive Subscription

Cat. No. / ID: 9245355

Mantenimiento preventivo (MP) en el centro, incluidos los desplazamientos, la mano de obra y las piezas de MP. Incluye un descuento del 10 % en los servicios de reparación durante el periodo de suscripción preventiva y documentación en un informe de visita que cumple con las normas de correcta fabricación (NCF) y las buenas prácticas de laboratorio (BPL).

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QIAcuity Four Preventive Subscription

Cat. No. / ID: 9245356

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QIAcuity Eight Preventive Subscription

Cat. No. / ID: 9245357

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QIAcuity One 2plex Core Agreement

Cat. No. / ID: 9245358

Servicio de reparación en el centro y mantenimiento preventivo en el centro, incluidos gastos de desplazamiento, mano de obra y piezas de repuesto por un periodo de un año. Tiempo de respuesta de cinco días laborables. Incluye un descuento del 10 % en servicios de reparación adicionales durante el periodo del acuerdo.

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QIAcuity One 5plex Core Agreement

Cat. No. / ID: 9245359

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QIAcuity Four Core Agreement

Cat. No. / ID: 9245360

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QIAcuity Eight Core Agreement

Cat. No. / ID: 9245361

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QIAcuity Four Basic Agreement

Cat. No. / ID: 9245403

Reparación del instrumento QIAcuity Four en el centro, incluidos desplazamientos, mano de obra y piezas por un periodo de un año. Tiempo de respuesta de cinco días laborables. Incluye un mantenimiento preventivo durante el período de Acuerdo básico.

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QIAcuity Eight Basic Agreement

Cat. No. / ID: 9245404

Reparación del instrumento QIAcuity Eight en el centro, incluidos gastos de desplazamiento, mano de obra y piezas por un periodo de un año. Tiempo de respuesta de cinco días laborables. Incluye un mantenimiento preventivo durante el período de Acuerdo básico.

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QIAcuity One 5plex Full Agreement

Cat. No. / ID: 9245363

Reparación del instrumento QIAcuity One 5plex en el centro, incluidos gastos de desplazamiento, mano de obra y piezas por un periodo de un año. Tiempo de respuesta de dos días laborables. Incluye un mantenimiento preventivo durante el periodo del acuerdo completo.

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QIAcuity Four Full Agreement

Cat. No. / ID: 9245364

Reparación del instrumento QIAcuity Four en el centro, incluidos desplazamientos, mano de obra y piezas por un periodo de un año. Tiempo de respuesta de dos días laborables. Incluye un mantenimiento preventivo durante el periodo del acuerdo completo.

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QIAcuity Eight Full Agreement

Cat. No. / ID: 9245365

Reparación del instrumento QIAcuity Eight en el centro, incluidos gastos de desplazamiento, mano de obra y piezas por un periodo de un año. Tiempo de respuesta de dos días laborables. Incluye un mantenimiento preventivo durante el periodo del acuerdo completo.

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QIAcuity One Installation & Training

Cat. No. / ID: 9245352

Instalación del hardware del instrumento y el software del sistema. Incluye formación sobre la aplicación en lo que respecta a la experiencia práctica del uso del instrumento y la cualificación del personal del laboratorio. Incluye mano de obra, gastos de desplazamiento y kit de instalación (si corresponde).

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QIAcuity Four Installation & Training

Cat. No. / ID: 9245353

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QIAcuity Eight Installation & Training

Cat. No. / ID: 9245354

Este servicio combina la instalación con la formación para el manejo de aplicaciones a fin de ayudar a los clientes a obtener experiencia práctica con el hardware, el software y las aplicaciones que usan las plataformas de QIAGEN; además, facilita las cualificaciones profesionales del personal de laboratorio.

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Resources

For Version 2.0

Version 2.1.8

For Version 2

Version 2.1

Version 2.5

Version 2.2

Version 2.5.0.0

Version 2.5.0.1

Version 2.1.8

Version 2.1

For Version 1.2

For Version 1.0

QIAcuity backup and restore scripts for QIAcuity Software Suite versions 2.0, 2.1.7, 2.1.8, and 2.2

Updating QIAcuity Software Suite 1.1.3 and Control Software 0.5.2.18 to QIAcuity Software 2.0

User manual for QIAcuity instruments and QIAcuity Software 2.5

Network connection of QIAcuity instruments

For QIAcuity User Manual – Updated QIAcuity Nanoplate Partition Volumes

User manual for QIAcuity instruments and QIAcuity Software 2.2

User manual for QIAcuity instruments and QIAcuity Software 2.1

User manual for QIAcuity instruments and QIAcuity Software 1.2

For use with QIAcuity systems

July 2021

For QIAcuity Software Suite 1.2: Updating VPF for archived or exported plates

User manual for QIAcuity instruments and QIAcuity Software 2.1.8

QIAcuity backup and restore scripts for QIAcuity Software Suite version 2.5 or higher

User manual for QIAcuity instruments and QIAcuity Software 2.0

The following QIAcuity Software Suite Volume Precision Factor (VPF) patches have been released to enable compatibility with VPF file version 6.0 or higher for QIAcuity Software Suite versions 2.0.20. As the abovementioned QIAcuity Software Suite versions do not allow loading a VPF zip file including more than 20 different individual VPF files, a patch is needed to allow the software for loading VPF zip files version 6.0 or higher. This technical limitation is solved from QIAcuity Software Suite version 2.1.8.23 onwards.

If you are using the QIAcuity Software Suite version 2.0.20, please consider updating your Software Suite and the Instrument Control Software (CSW) to the most recent version. After updating to the latest software version, no patching is needed.

If you are not able to update your QIAcuity Software Suite, please install the QIAcuity Software Suite VPF patch for QIAcuity Software Suite version 2.0.20 before loading VPF file version 6 or higher. Additional information and instructions may be found on the Release Note: QIAcuity Software Suite Volume Precision Factor (VPF) Patches.

Version 9.0

The Volume Precision Factor (VPF) offers a unique feature to secure precision of concentration results obtained from a QIAcuity dPCR run.

In general, Nanoplates provide partitions of fixed sizes that enable a very precise way of sample concentration calculation. Potential variation of partition sizes in Nanoplate batches, caused by different microstructure molding forms, can be addressed by applying the batch specific VPF. Furthermore, the VPF includes well-specific volume information and therefore further increases precision of concentration calculation in each well of the Nanoplates.

Important note:

The Volume Precision Factor file version 9.0 is compatible with QIAcuity Software Suite version 2.1.8.23 or higher. All lower versions, namely 1.2.18, 2.0.20, 2.1.7.182, and 2.1.8.20, require a QIAcuity Software Suite patch to be installed prior the upload of VPF version 9.0. Please read the Release Note for QIAcuity Software Suite Volume Precision Factor (VPF) Patches for more information.

If you are using QIAcuity Software Suite versions older than 2.1.8.23, please consider updating your Software Suite and the Instrument Control Software (CSW) to the most recent version prior the upload of VPF version 9.0. After updating to the latest QIAcuity Software Suite software version, no patching is needed. If you are not able to update your QIAcuity Software Suite, please run the patch for your Software Suite version following the instructions provided in the Release Note for QIAcuity Software Suite Volume Precision Factor (VPF) Patches.

After downloading and updating the VPF file within the QIAcuity Software Suite, the VPF is applied automatically to the analysis of a corresponding Nanoplate batch. The VPF file includes information from all available microstructure molding forms and connected Nanoplate batches. It will be stored on the PC where the QIAcuity Software Suite is installed.

The following QIAcuity Software Suite Volume Precision Factor (VPF) patches have been released to enable compatibility with VPF file version 6.0 or higher for QIAcuity Software Suite version 1.2.18. As the abovementioned QIAcuity Software Suite versions do not allow loading a VPF zip file including more than 20 different individual VPF files, a patch is needed to allow the software for loading VPF zip files version 6.0 or higher. This technical limitation is solved from QIAcuity Software Suite version 2.1.8.23 onwards.

If you are using the QIAcuity Software Suite version 1.2.18, please consider updating your Software Suite and the Instrument Control Software (CSW) to the most recent version. After updating to the latest software version, no patching is needed.

If you are not able to update your QIAcuity Software Suite, please install the QIAcuity Software Suite VPF patch for QIAcuity Software Suite version 1.2.18 before loading VPF file version 6 or higher. Additional information and instructions may be found on the Release Note: QIAcuity Software Suite Volume Precision Factor (VPF) Patches.

Version 2.5

The QIAcuity Control Software is an integral part of the QIAcuity instrument. It offers a GUI (graphical user interface) for basic functionalities such as plate setup, changing the order of plates to be processed, and monitoring the status of runs in real time. After a run is completed, the data are stored on the instrument’s memory and are sent to the connected QIAcuity Software Suite for analysis.

The new version 2.5 of the QIAcuity CSW offers a configurable auto logoff times which enables users to turn off or define logoff times per instrument. In addition the new version supports assay development by providing an essential temperature gradient functionality.

Furthermore improvements were implemented, for example, for the accuracy of time estimation for various software steps.

Detailed information about the QIAcuity Control Software version 2.5 is available in the Release Note, which can also be downloaded under section Software Release Notes.

Note: The latest CSW version 2.5 is only compatible with the Software Suite version 2.5. If only one software component is updated, no connection between the Software Suite and the CSW can be established.

Important: Please follow the instructions provided in the QIAcuity User Manual for software version 2.5 and in the Release Note.

It is strongly recommended to update the QIAcuity Software Suite first before proceeding with the QIAcuity Control Software!

Note: After clicking reboot during CSW upgrade or change of Suite connection, the login screen may appear for short period. Please ignore it and wait for the QIAcuity instrument to shut down and restart itself.

Please contact QIAGEN Technical Services if you are unsure and require technical support.

The QIAcuity backup and restore scripts are a standalone solution to backup all relevant user data of the QIAGEN Software Suite for disaster recovery and restore the data on a new or existing QIAGEN Software Suite installation. The following QIAcuity Software Suite versions are supported: 2.0, 2.1.7, 2.1.8, and 2.2. The backup can be conducted manually or automated by using of the Windows task scheduler.

Note: Windows Admin permission is needed to setup and perform an automated backup and for manual backup and restore.

Please read the QIAcuity Software Suite Backup and Restore Scripts document for more information and instructions how to use the scripts.

Version 2.5.0.1

The QIAcuity Software Suite enables the user to set up plates, analyze results, and monitor the status of runs in real time. This software is also used for the configuration of the system and provides access to the QIAcuity user management. The QIAcuity Software Suite is designed to be installed on a Windows PC that is connected to one or more QIAcuity instruments. For this configuration, the QIAcuity instrument needs to be connected to a network through Ethernet. Alternatively, a direct cable connection between the QIAcuity and the notebook where the QIAcuity Software Suite is running needs to be established. When connected to a network, up to 10 users may access the QIAcuity Software Suite via a browser installed on the client PC (Windows or Mac).

The new version 2.5 of the QIAcuity Software Suite supports assay development by providing an essential temperature gradient functionality. It also offers a new feature that provides calculation of initial concentration of samples by using various dilution factors. In addition, concentration units may be converted into various pre-defined or user-defined units. The new software also offers an integrity value and concentration value per group for up to 5-plex added to the multiple occupancy CSV file export, for example, for the evaluation of AAV (adeno-associated virus) assays and for drop-off assays.

In this new version the initial loading time and the time for recalculation of 1D/2D scatterplot and for signal map image has been reduced, leading to a much faster performance.

Detailed information about the QIAcuity Software Suite version 2.5 is available in the Release Note, which can also be downloaded under section “Software Release Notes”.

Note: The latest Software Suite version 2.5 is only compatible with the latest Control Software (CSW) version 2.5. If only one software component is updated, no connection between the Software Suite and the CSW can be established.

Important: Please follow the instructions provided in the QIAcuity User Manual for software version 2.5 and in the Release Note.

It is strongly recommended to update the QIAcuity Software Suite first before proceeding with the QIAcuity Control Software!

Please contact QIAGEN Technical Services if you are unsure and require technical support.

SHA1 checksum: D1690226299A75E077FA37C420A970FC71D56CBF

The following QIAcuity Software Suite Volume Precision Factor (VPF) patches have been released to enable compatibility with VPF file version 6.0 or higher for QIAcuity Software Suite version 2.1.7.182. As the abovementioned QIAcuity Software Suite versions do not allow loading a VPF zip file including more than 20 different individual VPF files, a patch is needed to allow the software for loading VPF zip files version 6.0 or higher. This technical limitation is solved from QIAcuity Software Suite version 2.1.8.23 onwards.

If you are using the QIAcuity Software Suite version 2.1.7.182, please consider updating your Software Suite and the Instrument Control Software (CSW) to the most recent version. After updating to the latest software version, no patching is needed.

If you are not able to update your QIAcuity Software Suite, please install the QIAcuity Software Suite VPF patch for QIAcuity Software Suite version 2.1.7.182 before loading VPF file version 6 or higher. Additional information and instructions may be found on the Release Note: QIAcuity Software Suite Volume Precision Factor (VPF) Patches.

The following QIAcuity Software Suite Volume Precision Factor (VPF) patches have been released to enable compatibility with VPF file version 6.0 or higher for QIAcuity Software Suite version 2.1.8.20. As the abovementioned QIAcuity Software Suite versions do not allow loading a VPF zip file including more than 20 different individual VPF files, a patch is needed to allow the software for loading VPF zip files version 6.0 or higher. This technical limitation is solved from QIAcuity Software Suite version 2.1.8.23 onwards.

If you are using the QIAcuity Software Suite version 2.1.8.20, please consider updating your Software Suite and the Instrument Control Software (CSW) to the most recent version. After updating to the latest software version, no patching is needed.

If you are not able to update your QIAcuity Software Suite, please install the QIAcuity Software Suite VPF patch for QIAcuity Software Suite version 2.1.8.20 before loading VPF file version 6 or higher. Additional information and instructions may be found on the Release Note: QIAcuity Software Suite Volume Precision Factor (VPF) Patches.

The QIAcuity backup and restore scripts are a standalone solution to backup all relevant user data of the QIAGEN Software Suite for disaster recovery and to restore the data on a new or existing QIAGEN Software Suite installation. The backup supports the QIAcuity Software Suite version 2.5 or higher and can be conducted manually or automatically by using of the Windows Task Scheduler.

Note: Windows Admin permission is needed to setup and perform an automated backup and for manual backup and restore.

For backup and restore of Software versions lower than 2.5, please refer to the QIAcuity Software Suite Backup and Restore Scripts for version 2.0, 2.1.7, 2.1.8 and 2.2.

Note: Windows Admin permission is needed to setup and perform an automated backup and for manual backup and restore.

Please read the QIAcuity Software Suite Backup and Restore Scripts document for more information and instructions how to use the scripts.

The QIAgility instrument is a liquid handler designed for automating PCR setup. For compatibility with the QIAcuity, we developed an adapter to secure up to two nanoplates onto the deck of the QIAgility. Using the QIAgility software, we have optimized a protocol that works for all nanoplate types and QIAcuity applications. Here we report the performance of a front end automated QIAgility dPCR nanoplate setup procedure for use with the QIAcuity dPCR system.

The QIAcuity digital PCR system combined with the QIAcuity One-Step Viral RT-PCR Kit enables precise detection and quantitation of vector-borne viruses in mosquitoes. The results presented in this comparison study showed that digital PCR is a powerful tool for absolute quantitation of low abundant targets and is a more reliable detection method than qPCR. Multiplexing allows detection and quantitation of multiple targets in a single reaction more efficiently by increasing sample throughput at a reduced cost per target.

Here, we present a workflow that combines two technologies, cellenONE and QIAcuity Digital PCR, which accelerate and streamline high-throughput analyses of target copy numbers in cultured cells. The workflow starts with detecting and sorting defined populations of cells as well as individual cells using cellenONE, followed by multiplexing dPCR on the QIAcuity platform. Copy number variations of target regions are then analyzed using the QIAcuity Software Suite, providing an intuitive and fast interpretation of results.

Q-Solution is an innovative and versatile PCR additive that works in part by lowering the melting temperature of DNA. Adjusting template melting properties can be useful when interrogating DNA with high-GC content or with complex secondary structures, such as adeno-associated virus (AAV) genomes. Q-Solution has additional properties that can be used to mitigate the carryover of various PCR inhibitors. This application note will highlight a few examples of how the Q-Solution Kit can be used in QIAcuity workflows.

The goal of this work was to compare performance of quantitative PCR (qPCR) and digital PCR (dPCR) in the quantification of gene expression and Wolbachia abundances in Nasonia parasitoid wasps.

Here, we present a highly efficient, high-throughput workflow that combines two technologies, cellenONE and QIAcuity Digital PCR, to accurately analyze miRNAs in well-defined individual cells and populations of cells.

This study tested a workflow for quantitation and qualification of AAV samples using a duplex assay on the QIAcuity dPCR instrument targeting both an insert (GFP) and the viral backbone (AAV2-ITR). With very low intra-assay and inter-assay CVs <6.5%, we demonstrate one of the main benefits of dPCR: reproducibility.

Here we report the use of saliva samples in combination with dPCR as a suitable alternative to screen for individuals infected with SARS-CoV-2.

Here we demonstrate how to optimize your assays on a microfluidic nanoplate-based digital PCR system, the QIAcuity, and provide recommendations for a seamless transfer. Moreover, the QIAcuity dPCR workflow is very similar to qPCR.

The QIAcuity dPCR System, complemented by the QIAcuity Software Suite version 2.5 and higher, offers a powerful solution for determining DNA integrity and stability. Analyzing up to 5 targets simultaneously enables accurate and precise integrity assessment. The importance of determining genome integrity becomes particularly evident in analyzing viral vectors such as AAVs, which are known for their susceptibility to packaging errors. Moreover, dPCR is a valuable tool for assessing DNA stability, providing valuable insights into storage and processing impacts.

Here we compared the performance of qPCR and the nanoplate dPCR techniques. The digital PCR method on the QIAcuity significantly improved precision when measuring copy number states and sensitivity of mutation detection through absolute quantification and reduced standard error. This is advantageous in various applications, including copy number variation analysis, small fold-change and rare mutation detection.

With the cellenONE-QIAcuity workflow, we achieved high-throughput absolute quantification of low-abundance targets at the single-cell level. cellenONE’s single-cell isolation platform enabled real-time and 100% accurate single-cell isolation without compromising viability and transcript expression. This allowed us to use the exact number of intact cells for RT-dPCR reactions. Moreover, the elimination of the RNA purification step significantly reduced hands-on time, and QIAcuity’s probe-based chemistry allowed the multiplexing of up to five targets in a one-step RT-dPCR format with no or minimal optimization.

Digital PCR (dPCR) is a powerful technique that detects and quantifies ultra-rare mutations in a high background of wild-type cfDNA down to 0.1% variant allele frequency. Here, we describe end-to-end manual and automated workflows that enable accurate detection and absolute quantification of ultra-rare PIK3CA variants in cfDNA using the QIAcuity Digital PCR System.

Here we provide an integrated rAAV genome titer method using the QIAcuity Digital PCR (dPCR) System with detailed parameters for high assay performance. Using this optimized method for pre-PCR handling of in-process rAAV samples, the results demonstrated that QIAcuity dPCR system generates the same level of accuracy and precision as the current gold standard ddPCR system but with much faster sample-to-result times (2 hours vs 7 hours) and higher overall throughput and scalability.

Fast. Scalable. Reliable.

A versatile workflow for the detection of low-abundance microbes

Version 2.1.8

The QIAcuity Control Software (CSW) is an integral part of the QIAcuity instrument. It offers a GUI (graphical user interface) for basic functionalities such as plate setup, changing the order of plates to be processed, and monitoring the status of runs in real time. After a run is completed, the data are stored on the instrument’s memory and are sent to the connected QIAcuity Software Suite for analysis.

The new version 2.1.8 of the QIAcuity software (QIAcuity Software Suite version 2.1.8 and QIAcuity CSW version 2.1.8) offers bug fixes for repeated network connection issues and improved error handling. In addition, it fixes issues seen with latest versions of Microsoft Edge and Google Chrome browsers as well as issues seen with read-only plates after a software update.

Detailed information about the QIAcuity Control Software version 2.1.8 is available in the Release Note, which can also be downloaded under section “Software Release Notes”.

Note: The latest CSW version 2.1.8 is only compatible with the latest Software Suite version 2.1.8. If only one software component is updated, no connection between the Software Suite and the CSW can be established.

Important: Please follow the instructions provided in the QIAcuity User Manual for software version 2.1 and in the Release Note. It is strongly recommended to update the QIAcuity Software Suite first before proceeding with the QIAcuity Control Software!

Please contact QIAGEN Technical Services if you are unsure and require technical support.

SHA1 checksum: D3982B419D7C4CF39FBDDDAA4C0D351B39398278

Version 2.2

The new Version 2.2 of the QIAcuity software (QIAcuity Software Suite v 2.2 and QIAcuity CSW v 2.2.) offers improvements for users working under GMP by adding a user ID validation during the report signing and the addition of timezone offset stamp for audit trail entries and for result report data. Furthermore, the addition of a standard deviation and coefficient of variance calculation in percentage of mean concentration calculation for replicates where implemented. In addition, the instrument camera stability was improved and an internal validation method was implemented.

Detailed information about the QIAcuity Control Software version 2.2 is available in the Release Note, which can also be downloaded under section “Software Release Notes”.

Note: The latest CSW version 2.2 is only compatible with the Software Suite version 2.2. If only one software component is updated, no connection between the Software Suite and the CSW can be established.

Important: Please follow the instructions provided in the QIAcuity User Manual for software version 2.2 and in the Release Note.

It is strongly recommended to update the QIAcuity Software Suite first before proceeding with the QIAcuity Control Software.

Note: After clicking reboot during CSW upgrade or change of Suite connection, login screen may appear for short period. Please ignore it and wait for the QIAcuity instrument to shut down and restart itself.

Please contact QIAGEN Technical Services if you are unsure and require technical support.

SHA1 checksum: 3892D7A434A8F072A15008C76EB088BB78F1C255

Version 2.2

The new version 2.2 of the QIAcuity software (QIAcuity Software Suite v 2.2 and QIAcuity CSW v 2.2.) offers improvements for users working under GMP by adding a user ID validation during the report signing and the addition of timezone offset stamp for audit trail entries and for result report data. Furthermore, the addition of a standard deviation and coefficient of variance calculation in percentage of mean concentration calculation for replicates where implemented. In addition, the instrument camera stability was improved and an internal validation method was implemented.

Detailed information about the QIAcuity Software Suite version 2.2 is available in the Release Note, which can also be downloaded under section “Software Release Notes”.

Note: The latest Software Suite version 2.2 is only compatible with the latest Control Software (CSW) version 2.2. If only one software component is updated, no connection between the Software Suite and the CSW can be established.

Important: Please follow the instructions provided in the QIAcuity User Manual for software version 2.2 and in the Release Note.

It is strongly recommended to update the QIAcuity Software Suite first before proceeding with the QIAcuity Control Software.

Please contact QIAGEN Technical Services if you are unsure and require technical support.

SHA1 checksum: 63A1689F2EB557809F418D159DA438FDC8B327A3

Version 1.2

A newer version of the Software Suite is available. Please use this version for the update of older plates if required.

The QIAcuity Software Suite 1.2 is designed to be installed on a Windows PC that is connected to one or more QIAcuity instruments. The QIAcuity Software Suite enables the user to set up plates, analyze results, and monitor the status of runs in real time. For this configuration, the QIAcuity instrument needs to be connected to a network through Ethernet. Alternatively, a direct cable connection between the QIAcuity and the notebook where the QIAcuity Software Suite is running needs to be established. When connected to a network, up to 10 users may access the QIAcuity Software Suite via a browser installed on the client PC (Windows or Mac).

The following browsers are supported in the QIAcuity Software Suite:

-Mozilla Firefox (version 64.0.2 or higher)
-Microsoft Edge (version 44.17763.1.0 or higher)
-Google Chrome (version 71.0.3578.98 or higher)

The new QIAcuity Software Suite 1.2 offers a functionality that enables users of the QIAcuity Software 1.1.3 to upgrade to the new version while keeping the library of previously stored plate runs.

Note: If you have exported plates from QIAcuity Software Suite 1.1.3 that you would like to import and use in QIAcuity Software Suite 1.2, you will need to import the plates before upgrading from version 1.1.3 to version 1.2. You may then export the plates again. Future software version starting from QIAcuity Software Suite 2.0 will facilitate import of plates from previous QIAcuity Software Suite versions.

The new improvements are as follows:

-Support for the Nanoplate 8.5k 24-well
-Hyperwell functionality to combine several wells to one combined well for analysis
-Automated plate archiving functionality
-Functionality to show the number of single/double positives in 2D scatterplots
-VPF (Volume Precision Factor) to further improve concentration calculation (see related resources)
-Additional improvements for stabilization and troubleshooting

Version 2.1.8

The new version 2.1.8 of the QIAcuity software (QIAcuity Software Suite version 2.1.8 and QIAcuity CSW version 2.1.8.) offers bug fixes for repeated network connection issues and improved error handling. In addition, it fixes issues seen with latest versions of Microsoft Edge and Google Chrome browsers as well as issues seen with read-only plates after a software update.

Detailed information about the QIAcuity Software Suite version 2.1.8 is available in the Release Note, which can also be downloaded under section “Software Release Notes”.

Important: Please ensure that updating to QIAcuity Software Suite version 2.1.8 is performed by the same Windows admin user using the same Windows login name that installed the previous QIAcuity Software Suite version. In case you cannot use the same Windows login name or the software update resulted in the browser error message "Can't reach this page" please contact our Technical Services for additional instructions.

Note: The latest Software Suite version 2.1.8 is only compatible with the latest Control Software (CSW) version 2.1.8. If only one software component is updated, no connection between the Software Suite and the CSW can be established.

Please contact QIAGEN Technical Services if you are unsure and require technical support.

SHA1 checksum: DE2416D926BB98D82A332E7B25EF66728F120DDA

Compliance with 21 CFR Part 11 involves both technical (i.e., hardware and software) and procedural requirements. This document explains how the QIAcuity system contributes to fulfilling those technical requirements.

A new temperature gradient functionality to determine the optimal primer annealing temperature of a digital PCR assay

FAQ

The plate is designed for a single use run. For example, even if only 30 samples are loaded into the 96-well plate, a whole plate will be sealed by the roller. It can't be unsealed and used for another run. The QIAcuity Software won’t allow to set up a separate experiment for the same nanoplate to avoid that previously processed plates being not partitioned a second time.

3781

The QIAcuity Probe PCR Kit should be stored immediately upon receipt at –30 to –15°C in a constant-temperature freezer and protected from light. The QIAcuity Probe PCR master mix can also be stored protected from light at 2–8°C. Components are stable for 12 months, unless otherwise indicated on the label.
The QIAcuity EG PCR Kit should be stored immediately upon receipt at –30 to –15°C in a constant-temperature freezer and protected from light. The QIAcuity EG PCR master mix can also be stored protected from light at 2–8°C. Components are stable for 6 months, unless otherwise indicated on the label.
The QIAcuity Nanoplates does not have expiry date and are stable for at least 1 year when stored at RT.

FAQ ID - 9214

QIAGEN dPCR assays (such as dPCR LNA Mutation Assays) can be found on https://geneglobe.qiagen.com/.

FAQ ID - 9207

A standard PCR plate is required to set up dPCR reaction before transferring it to the nanoplate to ensure a proper mixing of the reaction mix before partitioning.

3774

The up-to-date VPF can be downloaded in the resource section of the QIAcuity product webpage. The VPF is compatible with the QIAcuity Software Suite 1.2 and higher. The latest VPF file contains all factors for all existing nanoplate batches. If a nanoplate from a new nanoplate batch is run and the latest version of the VPF was not installed, the software will recognize this and will give a message to install the latest VPF file. Please note that Applying the VPF file cannot be reversed.

FAQ ID - 9206

The VPF provides a set of well-specific and molding form-specific factors used to specify the exact reaction volume of a nanoplate, thus increasing the concentration calculation of each well.

FAQ ID - 9218

QIAGEN dPCR assays (such as dPCR LNA Mutation Assays) can be found on https://geneglobe.qiagen.com/.

3773

This is not needed. The QIAcuity is equipped with a flexible power supply technology and operates within a range of 100–240V AC, 50/60 Hz, 1500 VA (max).

3761

If you had run a nanoplate for which the installed VPF misses the specific factor, the software will notify you. If you then analyze without the specific VPF, the impact depends on the variation of the partition volume of the new Nanoplate batch compared to the latest. Typically this variation is ±6–7% (approx. 5% CV over the entire plate). The analysis may be repeated after updating the VPF file. After installing the latest VPF and re-analysis of the run, a copy of the plate is generated in the QIAcuity Software Suite including the new results.

3769

QIAGEN master mixes are optimized for nanoplate microfluidics and are recommended to be used with our dPCR system. They also include an optimized reference dye required for proper analysis.

3777

The QIAcuity reads emitted fluorescence from the bottom of the plate, which is covered with a foil. For best results, keep the foil clean and avoid damages such as scratches. Also, keep the barcode on the side of the plate clean and intact. Ensure that you wear gloves when working with a plate and do not apply force to it. For a safe handling of the plate, please place the plate into a nanoplate tray.

FAQ ID - 9202

QIAGEN master mixes are optimized for nanoplate microfluidics and are recommended to be used with our dPCR system. They also include an optimized reference dye required for proper analysis.

FAQ ID - 9211

An essential temperature gradient functionality was introduced with software version 2.5. When updating older software versions to 2.5, each QIAcuity instrument will offer the temperature gradient and may be used to find the best cycling temperature for new dPCR assays. When running a QIAcuity Four or a QIAcuity Eight, all plates may have their own temperature profile, including the option for a temperature gradient.

FAQ ID - 3783

QIAGEN offers a complete range of nucleic acid purification systems. These include QIAprep kits for purification of plasmid DNA, QIAamp and DNeasy kits for purification of genomic DNA, RNeasy kits for purification of total RNA, and the PAXgene Blood RNA System for stabilization and purification of RNA from blood. Phenol and other contaminants can be efficiently removed from crude RNA preps using the RNeasy MinElute Cleanup Kit to clean up and concentrate RNA for sensitive assays. Details about QIAGEN kits for nucleic acid purification can be found at www.qiagen.com.

FAQ ID - 9213

The QIAcuity instrument software does not allow to read and process a plate without seal. If you would like to perform a dry run please use sealed plate and set up this plate in the QIAcuity Software Suite.

FAQ ID - 9201

dPCR master mix can be used in qPCR to optimize sample concentration and/or primer/probe concentration prior to assay transfer from qPCR to dPCR.

FAQ ID - 9209

This is not needed. The QIAcuity is equipped with a flexible power supply technology and operates within a range of 100–240V AC, 50/60 Hz, 1500 VA (max).

FAQ ID - 9195

Results are stored as part of the plates within the QIAcuity Software Suite. In version 1.1.2, plates can be exported to another file location, for example, an external HDD, and imported again if needed. From version 1.2 onwards, plates can also be archived automatically. To do so, an archive destination has to be defined. Additional information can be found in the user manual.

FAQ ID - 9198

QIAGEN offers a complete range of nucleic acid purification systems. These include QIAprep kits for purification of plasmid DNA, QIAamp, and DNeasy kits for purification of genomic DNA, RNeasy kits for purification of total RNA, and the PAXgene Blood RNA System for stabilization and purification of RNA from blood. Phenol and other contaminants can be efficiently removed from crude RNA preps using the RNeasy MinElute Cleanup Kit to clean up and concentrate RNA for sensitive assays. Details about QIAGEN kits for nucleic acid purification can be found at www.qiagen.com.

3779

If you had analyzed your nanoplates without VFP, the impact depends on the variation of the partition volume of the new nanoplate batch compared to the latest. The VPF reduces the CV from approximately 5% to 2%. We recommend to reanalyze results in case the data originated from different wells (e.g., copy number variations or gene expression data sets for which the reference sample was measured in a different well). Results obtained across different plates should also be r-analyzed. A reanalysis is not required for assay data that were analyzed within the same well (e.g., mutation rate determination using two channels within the same well).

3771

In dPCR we measure the absolute concentration of targets at endpoint reaction. Concentrations of unknowns can be determined based on dPCR results observed (number of negatives, number of positives, and partition volume analyzed).

3786

Both software are designed to be upgraded by users. The user manual includes instructions on how to perform the upgrades; instructions for the QIAcuity Suite Software upgrade can be found at page 38 and instructions for the CSW upgrade on page 67 (QIAcuity User Manual, 03/2021).

FAQ ID - 9196

If you had analyzed your nanoplates without VFP, the impact depends on the variation of the partition volume of the new nanoplate batch compared to the latest. The VPF reduces the CV from approximately 5% to 2%. We recommend to re-analyze results in case the data originated from different wells (e.g., copy number variations or gene expression data sets for which the reference sample was measured in a different well). Results obtained across different plates should also be re-analyzed. A re-analysis is not required for assay data that were analyzed within the same well (e.g., mutation rate determination using two channels within the same well).

FAQ ID - 9205

In general, nanoplates provide partitions of fixed sizes that enable a very precise way of sample concentration calculation. If a new molding form is used for nanoplate manufacturing, potential variation of partition sizes can be addressed by applying the molding form-specific VPF. Thus, each time a new molding form is used, a new VPF is created and made available. Currently, the VPF is updated once every 3–6 months.

3785

FAQ ID - 9219

Nanoplate 26K 24-well: 40 μl
Nanoplate 8.5K 24-well:12 μl
Nanoplate 8.5K 96-well: 12 μl

FAQ ID - 9216

The fluorescent signal in the reference channel is measured to determine the number of valid partitions in a well. In addition, differences in the signal intensities between partitions are normalized and the fluorescent signals in the target channels are corrected accordingly.

FAQ ID - 9210

In dPCR, we measure the absolute concentration of targets at endpoint reaction. Concentrations of unknowns can be determined based on dPCR results observed (number of negatives, number of positives, and partition volume analyzed).

FAQ ID - 9220

3776

The VPF provides a set of well-specific and molding form-specific factors used to specify the exact reaction volume of a nanoplate, thus increasing the concentration calculation of each well.

3784

Yes, the report includes a notification if the matching VPF was missing and, therefore, not applied to the analysis. If the matching VPF was applied there is no notification on the report.

3770

3780

Nanoplate 26K 24-well: 40 μl
Nanoplate 8.5K 24-well:12 μl
Nanoplate 8.5K 96-well: 12 μl

3782

All DNA samples used in reaction mixes should show similar quality and quantity, which can easily be assessed using UV spectrophotometry. DNA samples with an average length of ≥20 kb (e.g., genomic DNA purified via spin column with silica membrane) should be fragmented by restriction digestion before partitioning. Enzymatic fragmentation of larger DNA ensures an even distribution of template throughout the QIAcuity Nanoplate, which in turn leads to an accurate and precise quantification.

3778

The instrument software GUI shows error codes including a description and information how to resolve the error. The instrument touchscreen shows an alarm icon in the upper right corner that turns red in case of an instrument failure. Accessing the System Status in the Tool tab allows users to clear errors. Rebooting of the instrument is required to complete the removal of the error. Please do not skip this step. You may always contact QIAGEN Technical Services in case of any question.

3763

FAQ ID - 9215

FAQ ID - 9203

Yes, the report includes a notification if the matching VPF was missing and, therefore, not applied to the analysis. If the matching VPF was applied there is no notification on the report.

FAQ ID - 9204

All DNA samples used in reaction mixes should show similar quality and quantity, which can easily be assessed using UV spectrophotometry. DNA samples with an average length of ≥20 kb (e.g., genomic DNA purified via spin column with silica membrane) should be fragmented by restriction digestion before partitioning. Enzymatic fragmentation of larger DNA ensures an even distribution of template throughout the QIAcuity nanoplate, which in turn leads to an accurate and precise quantification.

FAQ ID - 9212

3767

dPCR master mix can be used in qPCR to optimize sample concentration and/or primer/probe concentration prior to assay transfer from qPCR to dPCR.

3775

The user manual contains instructions on how to perform a regular cleaning and decontamination, and how to replace air filters on the QIAcuity instruments. A regular maintenance reduces the dust in the instrument and therefore minimizes the presence of dust particles on the nanoplate, which might interfere with the plate analysis.

3765

3772

3768

FAQ ID - 9197

No. The QIAcuity platform introduces four variations: QIAcuity One 2plex, QIAcuity One 5plex, QIAcuity Four (5plex), and QIAcuity Eight (5plex). All of them have fix channel combination.

FAQ ID - 9200

No. The QIAcuity platform introduces four variations: QIAcuity One 2plex, QIAcuity One 5plex, QIAcuity Four (5plex), and QIAcuity Eight (5plex). All of them have fix channel combination.

3766

A standard PCR plate is required to set up dPCR reaction before transferring it to the nanoplate to ensure a proper mixing of the reaction mix before partitioning.

FAQ ID - 9208

QIAcuity does not support temperature gradient in PCR cycling profile. However, optimization of a dPCR assay can be done by qPCR on a gradient cycler using the dPCR master mix and then transferred from qPCR to dPCR.

FAQ ID - 9217

3764

3762

The user manual contains instructions on how to perform a regular cleaning, decontamination, and how to replace air filters on the QIAcuity instruments. A regular maintenance reduces the dust in the instrument and therefore minimizes the presence of dust particles on the nanoplate, which might interfere with the plate analysis.

FAQ ID - 9199