QIAcuityデジタルPCRシステム

ナノプレートを使用するデジタルPCRアプリケーション向け

バーチャルデモ

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QIAcuity One, 2plex Device

Cat. No. / ID: 911001

最大2色の蛍光色素を検出する1プレートタイプのデジタルPCR装置、ローラー、USBフラッシュメモリー、およびQIAcuity Software Suite。予防保守点検訪問1回分を含みます。人件費、交通費、部品費について1年間保証。

Format

One

Four

Eight

Multi-channel detection

2plex

5plex

Service Options

Device

System

System FUL-2

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QIAcuityは、分子生物学アプリケーション向けに設計されています。本製品を疾病の診断、予防、治療に使用することはできません。そのため、臨床用途（診断、予後、治療、または血液バンク）としてご使用できません。デジタルPCRの診断アプリケーションについては、QIAcuityDx Digital PCR Systemをご利用ください。

バーチャルデモ

バーチャルツアーに参加し、この製品が実際に作動している様子をご覧ください。

ツアーを開始する

特徴

完全統合型のシステム
スケーラブルなフォーマット（装置プレート1枚、4枚、8枚）
一歩進んだマルチプレックス性能（最大5プレックス）
柔軟性に富んだサンプルスループット
わずか2時間ですべての結果を提供

製品詳細

QIAcuityデジタルPCRシステムは、突然変異検出、コピー数多型（Copy Number Variation, CNV）、遺伝子発現研究、遺伝子編集解析、その他多くの用途で正確なマルチプレックス定量を行えるように設計されています。ナノプレートを使用する本システムは、パーティショニング、ヒートサイクル、およびイメージングの標準的なデジタル PCRワークフローを最小限の労力で実施できる、シームレスに統合された完全自動化プラットフォームです。

本システムは、QIAcuityナノプレート、試薬、アッセイと組み合わせて使用します。

QIAcuityについての詳しい情報は、バーチャルデモをご覧ください。

パフォーマンス

QIAcuityデジタルPCRシステムは、すべての研究室に絶対定量をお手頃な価格で提供します。パーティショニング、ヒートサイクル、イメージングの全デジタルPCRワークフローを1つの装置に統合し、最小限の労力で実施できる自動化装置です。また、現行のリアルタイム PCRアッセイをQIAcuity デジタルPCR システムに適用することも簡単です。リアルタイムPCR からデジタル PCRで解析を行う場合、プレート操作を変える必要はなく、簡便なアッセイのセットアップと約2時間での迅速な解析を行うことができます。

QIAcuity装置：機能と仕様

特徴	QIAcuity One	QIAcuity Four	QIAcuity Eight
プレート処理数	1	4	8
検出チャンネル（マルチプレックス）	2または5	5	5
サーモサイクラー	1	1	2
結果までの時間	約2時間	最初のプレートは約2時間 80分ごとに次のプレート	最初のプレートは約2時間 40分ごとに次のプレート
スループット（1日のサンプル処理数）	最大384（96ウェル）最大96（24ウェル）	最大672（96ウェル）最大168（24ウェル）	最大1,248（96ウェル）最大312（24ウェル）

原理

分注およびロード、実験、結果解析というわずか3つのステップで、約2時間でdPCRの結果が得られます。

ナノプレートでのdPCR反応の原理はこちらで説明しています。

操作手順

リアルタイム PCR実験と同様に、サンプル調製では、マスターミックス、プローブ、プライマーを96または24ウェルナノプレートに加え、その後サンプルを加えます。このシステムは、パーティショニング、ヒートサイクル、イメージングを1つに統合した完全自動化装置です。サンプルから結果まで2時間未満で完了します。専用ソフトウェア Software Suiteは、ターゲット配列のマイクロリットルあたりのコピー数（濃度）を示すことに加え、陽性サンプルやNTCなどの品質コントロールも解析できます。この解析は、同じローカルエリアネットワーク（LAN）内の離れた場所にあるコンピューターでも行うことができます。

アプリケーション

QIAcuity装置は、QIAcuity NanoplateｓおよびQIAcuity PCR Kitと組み合わせて、次のデジタルPCRアプリケーションに利用できます。

希少突然変異の検出
コピー数多型解析
遺伝子発現解析
病原体検出
ジェノタイピング
miRNA研究
細胞および遺伝子治療

ソフトウェア

QIAcuity Software Suiteは装置に同梱されており、個々のコンピューターにインストールできます。これは、装置に直接接続、または既存のローカルエリアネットワーク（LAN）を使用して、1台または複数のQIAcuity装置を制御します。QIAcuity Software Suiteを用いて、デジタルPCR 実験、サンプル、反応ミックス情報を入力し、ナノプレートに割り当て、QIAcuity装置に転送できます。測定終了後は、データ解析とレポート作成が可能になります。解析のため、データを外部へエクスポートすることができます。本ソフトウェアには、繰り返し使えるプレートレイアウトや簡単にアクセスできるプレートランパラメーターの設定などのテンプレート機能があり、デジタルPCR実験をさらに使いやすく、より身近な解析方法となり得ます。

ローカルエリアネットワークに組み込むことで、QIAcuity コンピューターはクライアントとして機能する他のコンピューターにLAN経由でアクセスできるサーバーとなります。このようにして QIAcuity Software Suiteと通信できるようになります。これにより、複数のユーザーが他の部屋やオフィスからソフトウェアにアクセスしたり、複数のコンピューターにソフトウェアをインストールしなくても標準的なブラウザを介してデータを解析したり、インターネット接続を経由してデータのやり取りができるようになります。

サービス

QIAGENの多様なサービスソリューションなら機器を安心してご利用いただけます。ニーズに合ったサービス契約の詳細をご覧ください。

裏付けデータと数値

プレート方式のシンプルで迅速なワークフロー

パーティショニング、熱サイクル、イメージングを1台で処理して2時間以内に結果を提供する完全自動システムです。ナノプレート方式はサンプル調製のためのフロントエンド自動化に適しており、ハンズオン時間のさらなる削減をもたらします。

QIAcuity Nanoplateを使ったdPCRにおける独立した2つのランで得られた結果の再現性から、データの正確性を実証

存在比が大きく変動するcDNAターゲットのマルチプレックス解析の実現可能性を確証

サービスプラン

QIAcuity One 2plex Full Agreement

Cat. No. / ID: 9245362

QIAcuity One 2Plex の派遣費、技術料および交換部品代を含む1年間の修理費用をカバー。契約期間内に1回の定期点検が付帯。対応時間2日以内

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QIAcuity One Preventive Subscription

Cat. No. / ID: 9245355

1回の予防保守（Preventive Maintenance, PM）点検訪問に対応します。交通費、人件費、予防保守部品費が含まれています。サブスクリプション期間における出張修理費、およびGMP/GLPに準拠した訪問報告書の作成費については10%減額します。

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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

年1回の出張修理と予防保守点検訪問に対応します。交通費、人件費、補修部品費が含まれています。受付から5営業日以内に対応します。契約期間における追加の出張修理費については10%減額します。

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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 One 2plex Basic Agreement

Cat. No. / ID: 9245401

QIAcuity One 2Plex の派遣費、技術料および交換部品代を含む1年間の修理費用をカバー。契約期間内に1回の定期点検が付帯。対応時間5日以内

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QIAcuity One 5plex Basic Agreement

Cat. No. / ID: 9245402

QIAcuity One 5Plex の派遣費、技術料および交換部品代を含む1年間の修理費用をカバー。契約期間内に1回の定期点検が付帯。対応時間5日以内

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QIAcuity One 5plex Full Agreement

Cat. No. / ID: 9245363

QIAcuity One 5Plex の派遣費、技術料および交換部品代を含む1年間の修理費用をカバー。契約期間内に1回の定期点検が付帯。対応時間2日以内

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QIAcuity Four Full Agreement

Cat. No. / ID: 9245364

QIAcuity Four の派遣費、技術料および交換部品代を含む1年間の修理費用をカバー。契約期間内に1回の定期点検が付帯。対応時間2日以内

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QIAcuity Eight Full Agreement

Cat. No. / ID: 9245365

QIAcuity Eight の派遣費、技術料および交換部品代を含む1年間の修理費用をカバー。契約期間内に1回の定期点検が付帯。対応時間2日以内

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QIAcuity One Installation & Training

Cat. No. / ID: 9245352

装置ハードウェアの設置とシステムソフトウェアのインストールを実施します。装置の操作の実践体験と研究室スタッフの資格認定に役立つアプリケーショントレーニングを兼ね備えています。人件費、交通費、設置キット（該当する場合）が含まれています。

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QIAcuity Four Installation & Training

Cat. No. / ID: 9245353

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QIAcuity Eight Installation & Training

Cat. No. / ID: 9245354

このサービスはインストールや設置、ならびにお客様がQIAGENプラットフォームを使用したハードウェア、ソフトウェア、アプリケーションの実践体験を得るお手伝いをし、研究室スタッフが専門的な資格認定を取得する際に役立つアプリケーショントレーニングを兼ね備えています。

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リソース

For Version 2.0

Version 2.1.8

For Version 2

Version 3.0

Version 2.1

Version 2.5

Version 2.2

Version 3.0

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

User manual for QIAcuity instruments and QIAcuity Software 3.0

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

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 3.0

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 3.0 supports dPCR assays up to a 8-plex by using six optical channels for six standard dyes and the additional use of two channel combinations for LSS (Long Stoke Shift) dyes, which can be selected from five different dye channel combinations. It also offers a new feature to create a custom cross talk matrix to address cross talk between neighboring channels for all multiplex assays.

In this new version, an overview presenting individual 2D scatterplots of all selected wells is introduced. In addition, a sample-based 2D scatterplot analysis of individual replicates is provided. The new software also provides a reaction mix template functionality for the creation of a master mix including a custom cross talk matrix.

Detailed information about the QIAcuity Software Suite version 3.0 is available in the Release Note, which can also be downloaded under section Software Release Notes.

Note: The latest Software Suite version 3.0 is only compatible with the latest Control Software (CSW) version 3.0. 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 3.0 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: C01F7BEA7D20DA3E22D95916A7046D06F03C523A

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.

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

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.

Version 3.0

The new version 3.0 of the QIAcuity CSW supports dPCR assays up to a 8-plex by using six optical channels for six standard dyes and the additional use of two channel combinations for LSS (Long Stoke Shift) dyes, which can be selected from five different dye channel combinations. In addition, the new version has optimized the run time for all instrument types (QIAcuity One, Four, and Eight) with introducing a new auto focus algorithm.

Detailed information about the QIAcuity Control Software 3.0 is available in the Release Note, which can also be downloaded under section Software Release Notes.

Note: The latest CSW version 3.0 is only compatible with the Software Suite version 3.0. 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 3.0 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: E58C84A95E892EF2F3DAFF4C6927279645A17FBF

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 2.2

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 2.5.0.1

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.

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

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 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

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

For QIAcuity Software Suite version 3.0

Version 10.1

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

Important note:

The Volume Precision Factor file version 10.1 is compatible with the 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 10.1. 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 10.1. 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.

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 3.0 and can be conducted manually or automatically by using of the Windows Task Scheduler.

For backup and restore of Software version 2.5, please refer to the QIAcuity Software Suite Backup and Restore Scripts for QIAcuity Software Suite 2.5 version 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.

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.

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

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

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

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

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

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

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

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.

3780

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 - 9203

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

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