About QuBAS

What is QuBAS?

QuBAS is a statistical analysis software package for bioassays. It is designed for relative potency and ELISA-type assays, and includes all standard models and suitability criteria.

Who is QuBAS for?

QuBAS is designed for anyone analysing bioassay data. Its Development mode gives you the flexibility to experiment with your assay data to find an optimised analysis method, while Routine mode allows for rapid analysis of large quantities of data under strict GxP conditions.

How do I cite QuBAS?

QuBAS can be cited as : Quantics Consulting Ltd, “QuBAS v3.1.2.” Edinburgh, UK. 2023

Does anyone I know use QuBAS?

QuBAS is used by a wide range of organisations ranging from start-ups to multinational corporations, including CROs, CMOs and beyond. Check out our testimonials page for more from some of our clients!

How can I access QuBAS?

QuBAS is a browser-based app which can be used in either Google Chrome or Mozilla Firefox. It can be installed on your company’s internal intranet servers, where it acts as any other internal webpage and can be accessed remotely via a VPN. Or, alternatively, QuBAS can be used in the cloud, where it can be accessed as any other cloud-based service.

Is QuBAS cloud-based?

QuBAS is the only bioassay statistics platform which is available as a cloud-based option, giving access to everything QuBAS has to offer with minimal IT burden. We recognise, however, that cloud is not for everyone, which is why we continue to offer local installation options.

How do I buy QuBAS?

There are a range of ways to license QuBAS, which are outlined on our Pricing page. QuBAS is licensed on a concurrent user basis, meaning your team’s access to QuBAS is not limited to a single computer.

Can I try QuBAS before purchasing?

Yes! QuBAS Now offers you the ultimate try-before-you-buy experience. Discover all of QuBAS’ powerful development features using your own data, or learn the ropes using the pre-prepared demo method. QuBAS Now is available to use for free with no download required. Simply sign up!

Integrations

What file formats can be imported into QuBAS?

QuBAS can natively import any delimited file such as .txt and .csv. Other file formats can be pre-processed for import using a plugin – get in touch for more information!

Will QuBAS integrate with my plate reader?

QuBAS is built to integrate natively with most commonly used plate readers. Exports from Gen5 readers can be imported directly, while results from readers running SoftMax Pro can be imported using a free plugin.

In what file formats does QuBAS export its results?

QuBAS exports results in an easy-to-read .pdf format. .XML and .xlsx exports are also available.

Analysis Options

What kinds of data is QuBAS designed to analyse?

QuBAS is built to analyse data from relative potency (both quantitative and quantal) and ELISA-type bioassays.

What model types does QuBAS offer?

QuBAS provides model fitting for linear, 4-parameter logistic (4PL), and 5-parameter logistic (5PL) models.

Which suitability criteria are available in QuBAS?

QuBAS provides all standard system and suitability criteria, adhering closely to USP and EP guidelines. Both equivalence and significance testing are available for both system and sample suitability testing.

Does QuBAS support outlier management?

QuBAS includes a comprehensive outlier management process which follows current guidance closely. Outlier identification can be performed using either Grubbs’ test or Studentised Residuals. QuBAS also offers the choice of whether any detected outliers are to be automatically removed or flagged for further investigation.

Can I programme my own analysis in QuBAS?

All analysis options in QuBAS are pre-programmed and available to select using simple click-and-drag tools, meaning there is no need for any further coding and the associated QA/QC nightmares!

What if my analysis is not supported by QuBAS?

Not to worry! QuBAS is developed by Quantics Biostatistics with more than 20 years of experience helping clients with their bioassays. If your analysis is not suitable for QuBAS, we will help you find a solution which is right for you, whether that’s a bespoke plugin or via our consultancy services. Just get in touch!

Validation & CrtV

Which regulations is QuBAS compliant with?

Analyses performed in QuBAS’ Routine mode are fully GMP and 21 CFR pt11 compliant.

How does Continuous real-time Validation (CrtV) work?

Continuous real-time Validation is a QA/QC solution based on n-version programming, which is frequently used in the aerospace industry.

Every analysis in QuBAS is performed simultaneously in two parallel analysis engines, each written by a different programmer in a different programming language, and each using different mathematical techniques. Once the analysis is complete, the results are cross-checked, and only if all results match are the results reported.

Since the two branches differ completely in their design and implementation, it is vanishingly unlikely that any incorrect results . That means that provided that the results do match, we can be absolutely confident that the analysis has proceeded as expected and the results are valid.

You can find out more about the CrtV process on our explainer page.

Does QuBAS require validation on installation?

QuBAS provides all standard system and suitability criteria, adhering closely to USP and EP guidelines. Both equivalence and significance testing are available for both system and sample suitability testing.

Does QuBAS support outlier management?

Thanks to CrtV, every QuBAS analysis is validated in real time. This means that traditional IQ, OQ, PQ validation is not required. This has been verified by the MHRA, who described CrtV as “innovative and elegant”.

We recognise, however, that traditional validation might be baked into your SOPs, so we are happy to assist in any validation process which is required. For QuBAS Cloud installs, we can provide a full GMP validation and certification as a service.

Does QuBAS require re-validation when a new update comes out?

When updated, QuBAS performs a check to ensure continuing validity using CrtV. This is done by returning to data already uploaded to the QuBAS database and comparing results calculated in the updated analysis engine to those returned by the previous version. If the results match, then the update has proceeded as expected.

What if my IT department insist on validating QuBAS?

Although traditional IQ, OQ, PQ validation is not required, we understand that some IT departments may need to follow their SOPs, which may insist on traditional validation processes. To accommodate this, we have created a simple step-by-step guide for traditional validation. You can download the guide from [here].

Support

What support is available when using QuBAS?

We provide extensive online resources to help you get up and running in QuBAS. Should this not be sufficient, our expert team are on hand to help you get back on track.

For an additional fee, our premium support package gives you access to one-on-one live support calls with a member of our team.

See our Support page for more information.

I need help setting up my analysis. Can you help?

We can absolutely provide assistance with setting up your analysis. Don’t hesitate to get in touch with our support team so we can find the best solution for your situation.

Can you help install QuBAS?

Yes! Our support team are happy to assist with installation for all local instances.

For cloud instances, Quantics will perform the installation on your behalf, so there’s nothing for you to worry about!

How can I get in touch with technical support?

Email: support@quantics.co.uk or call +44 (0) 131 440 2781

Availability: Mon-Fri 08:30 – 17:30 (UK)