Cost-effective PCR at the point of care: the SARS-CoV-2/Flu/RSV assay for the Credo VitaSIRO solo™ is now CTDA approved

Una Health is pleased to announce that the SARS-CoV-2 / Flu / RSV assay for the Credo VitaSIRO solo™ – the compact, cartridge-based molecular diagnostics platform we distribute across the UK – has received CTDA approval.

For point-of-care testing (POCT) leads, this is the milestone that matters. With its SARS-CoV-2 performance now independently verified, the respiratory assay can be adopted within live clinical testing pathways – putting cost-effective, lab-grade PCR at the point of care rather than restricting it to research workflows.

Building on our partnership with Credo Diagnostics and our mission to bring cutting-edge molecular diagnostics closer to the patient, this approval strengthens our respiratory and infectious disease portfolio with a true sample-to-result PCR system designed for cost-effective, decentralised testing.

What is the VitaSIRO solo™?

A portable, on-demand real-time PCR system that puts molecular-grade diagnostics at the point of care:

• Genuinely rapid: results in around 40 minutes (timing varies by assay), so clinical decisions and triage don’t wait on a lab courier round.
• True sample-to-answer workflow: a patented cartridge integrates nucleic acid extraction and real-time PCR in one step – three actions (collect, transfer to cartridge, start run) with minimal hands-on time.
• Multiplex capability: detects up to six genetic targets from a single sample, including the SARS-CoV-2 / Flu / RSV respiratory assay with CTDA-approved SARS-CoV-2 detection.
• Sample flexibility: validated across UTM/VTM swabs, saliva, blood, urine and faeces, depending on assay.
• Low training burden: simple, guided procedure on a 7-inch touchscreen – suited to non-laboratory operators under a POCT competency framework.
• Fits where you need it: a 3.6 kg footprint that deploys on a ward, in a clinic, or in a community setting without dedicated lab infrastructure.
• Connectivity built in: POCT1-A support for data transfer into your middleware and LIMS – essential for result traceability, audit and remote QC oversight.

Why this matters for your testing pathway

• Cost-effective molecular testing. On-demand, single-sample testing means you run PCR exactly when clinical need arises – no dedicated lab infrastructure, no waiting to fill a batch, and no reagent wasted on part-filled runs. Lab-grade molecular results become achievable at the point of care without lab-scale overheads.
• Faster clinical decisions at the front door. Actionable respiratory results in under an hour support earlier isolation decisions, better bed management and reduced onward transmission – without adding to central lab turnaround pressure.
• Governance that stands up to scrutiny. CTDA-approved SARS-CoV-2 testing, CE marked, POCT1-A connectivity and point-of-care governance features such as QC lockout.
• Decentralised capacity that complements the lab. Rather than replacing core laboratory PCR, the VitaSIRO solo™ extends molecular capacity to where samples are taken – easing bottlenecks during winter respiratory surges and relieving demand on centralised platforms.
• A platform, not a single test. Beyond the respiratory assay, the menu includes an MT-RNR1 SNP assay for investigating neonatal susceptibility to aminoglycoside-induced hearing loss – signalling a growing menu on a single, familiar device.

Where it fits best

The VitaSIRO solo™ is built for on-demand, time-critical individual testing – emergency departments, acute admissions, urgent care, and community and clinic settings where a rapid, near-patient molecular answer changes what happens next. Running one sample at a time is exactly what makes it cost-effective: you test the moment clinical need arises, with no batching to coordinate and no reagent spent on part-filled runs. For any pathway that needs fast, reliable molecular confirmation for individual patients, it’s well worth a closer look – and we’re happy to talk through how it fits your service.