DnaNudge, developers of the rapid, lab-free CovidNudge test that delivers results in just over an hour, has appointed healthcare manufacturing solutions provider Jabil Healthcare, to manufacture the cartridges used in the company’s COVID-19 testing solution.
The Jabil Healthcare cleanroom manufacturing facility in Bray, Ireland is ramping up to produce 1.4 million test cartridges per month by early 2021. This effort will support DnaNudge’s ongoing commercial delivery programme, including the fulfilment of the recently announced order for 5.8 million rapid CovidNudge test kits from the UK government’s Department of Health and Social Care (DHSC).
The CovidNudge test is a portable, out-of-laboratory RT-PCR (reverse transcription polymerase chain reaction) test that delivers results on the spot, at the point of need, and in just over an hour.
A paper published last month by peer-reviewed journal The Lancet Microbe demonstrates that the test delivers highly accurate results, with an average sensitivity – the ability to correctly identify those with COVID-19 – of 94.4% compared against standard NHS lab-based tests, and a specificity – correctly identifying those without the disease – of 100%, meaning no false positives. The test kits are intended to accelerate the shift from centralised testing to point-of-need analysis in both clinical and non-clinical settings. The CovidNudge solution is currently being deployed UK-wide in NHS urgent patient care and elective surgery settings, plus out-of-hospital locations. DnaNudge’s NudgeBox analyser – which has successfully miniaturised the gold-standard lab-based PCR test – is about the size of a shoebox, and the test cartridge itself fits into the palm of your hand.
DnaNudge CEO and co-founder Regius Professor Chris Toumazou, said: “The value of our CovidNudge technology in helping to meet the needs of the pandemic is being recognised around the world, and we knew we needed a trusted partner to enable us to scale delivery and achieve speed to market. In addition to its deep bench of expertise in mass production of complex technologies, Jabil’s footprint in Ireland and around the world will be vital in helping us accelerate availability of the CovidNudge test globally, and in enabling DnaNudge to offer to the mass market a rapid, accurate near-patient testing solution that has the potential to transform the pandemic response worldwide.”
The CovidNudge test uses the gold-standard RT-PCR technique to test for the presence of the genetic material of the COVID-19 virus. The cartridge – manufactured by Jabil – can extract RNA from a naso-pharyngeal, nasal or buccal swab (inner cheek swab) sample, which is then inserted into the NudgeBox for analysis and reverse transcribing to DNA. The cartridge has 72 tiny wells in its assay, known as a multiplex. This means that the technology can detect the presence of human RNA as well as viral RNA, to eliminate ‘false negatives’ by control testing for inadequate swab specimen collection technique. The test detects the presence of a number of the COVID-19 genes – including both the World Health Organization (WHO) and Centers for Disease Controls (CDC) assays – for optimal accuracy, and also offers the capability to test for FluA, FluB and respiratory syncytial virus (RSV).
David Panneton, VP global business units, Jabil, said: “The availability of rapid, high-accuracy testing performed at the point of patient specimen collection is a vital tool amid this COVID-19 pandemic that continues to spread. We are thrilled to support DnaNudge’s efforts in the UK and globally and to apply our full healthcare manufacturing and supply chain solution set to meet this critical market demand.”
