National Institute for Health and Clinical Excellence (NICE)
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Four innovative tests for diagnosing UTIs could help in the fight against antimicrobial resistance

Innovative tests with the potential to help people with a urinary tract infection (UTI) receive the correct course of antibiotics more quickly could soon be considered for use in the NHS.

A NICE committee has seen promise in four tests which produce results in under an hour and can be carried out by a healthcare professional outside of a conventional laboratory in a primary or community care setting.

The technologies’ developers claim they can identify the presence of bacteria in a urine sample in less than 40 minutes. One can identify within minutes the strain of bacterial infection present. Another goes on to test which antibiotics are most appropriate to treat the infection.

Prescribing antibiotics to people without a bacterial infection adds to the risk of antibiotic resistance. Misdiagnosing a UTI or prescribing an ineffective antibiotic can also have a severe impact on a person’s physical and mental health and may result in a chronic UTI or in some cases, sepsis.

In draft guidance NICE is calling for further research to establish how accurately the tests detect and identify bacteria and test for which antibiotic is most effective, and how much the tests affect decisions about antibiotic prescribing.

If further research is done and suggests the tests could be beneficial if used in practice, they could help to improve antimicrobial prescribing, and be considered for conditional roll out for use in the NHS while further evidence on their clinical and cost-effectiveness is generated.

UTIs are one of the most common conditions found in primary care and are defined as an infection of the urethra, bladder, ureters or kidneys. The most commonly identified bacteria in samples is E. coli.

One fifth of antibiotics prescribed in 2019/20 in England were for lower urinary tract infections, 7m prescriptions out of a total of 31.4m, according to the NHS Business Services Authority’s RightCare UTI Focus Pack from 2021.

Mark Chapman, interim director of medical technology and digital evaluation, at NICE, said:

“There is a need for new tests that can accurately identify whether an infection is present. Our Early Value Assessment project has identified that these four tests could help meet that need.

“Soon we expect to have a fuller and more detailed picture of the tests’ accuracy and potential benefits and will be able to make a further recommendation on their use in the NHS.

“One of the most exciting aspects of these technologies could be their ability to maximise the use of antibiotics where most effective. We know that reducing antimicrobial resistance is a top priority for healthcare systems around the globe and NICE has a part to play in this mission.”

Currently UTIs are diagnosed using a combination of clinical symptoms, dipstick tests and laboratory-based tests.

Dipstick tests are sometimes used as an initial test at the point of care, but they may not be accurate. They involve dipping a specially treated paper or plastic strip into a urine sample to identify the likelihood of a UTI. Results are available within a few minutes.

Follow up laboratory tests are sometimes used to confirm a UTI diagnosis. Laboratory-based tests, such as microbiological culture and antibiotic susceptibility testing (AST), are typically done to find out which, if any, bacteria are present and which antibiotic is most likely to kill them.

This process can take 24 to 72 hours depending on geographical location, local available facilities, and day of sample collection. In some cases, antibiotics may be delayed until culture and susceptibility results are available.

But a suspected UTI is often initially treated with empiric antibiotics (which are typically broad spectrum) before the lab results are back. These may have side effects, can be less effective than targeted antibiotics, and can increase the risk of antibiotic resistance developing.

In draft guidance, the NICE committee has said that more data on the tests’ accuracy would allow better assessment of the potential risks and benefits of using them in the NHS. Ongoing studies may provide this for at least some groups (for example the TOUCAN study). Once further data is available, the committee will meet to decide if the recommendations can be reconsidered and if the technologies can be recommended for early access in the NHS.

A consultation on the recommendations has begun and feedback can be made via until Tuesday 30 March 2023.

About the technologies

  • Astrego PA-100 analyser with the PA AST panel U-0501 (Sysmex Astrego)

The Astrego system detects the presence of bacteria in a urine sample in 10 to 15 minutes. If the urine sample is positive, it assesses the susceptibility of the bacteria to 5 antibiotics (amoxicillin-clavulanic acid, ciprofloxacin, fosfomycin, nitrofurantoin, trimethoprim). Full results take 30 to 45 minutes. The company says that it is CE-IVD marked but is not currently available in the UK.

  • Lodestar DX (Llusern Scientific)

The Lodestar DX test detects 6 common UTI-causing bacteria (E. coli, Klebsiella spp, Proteus mirabilis, Staphylococcus saprophyticus, Enterococcus spp, Pseudomonas aeruginosa). Results take approximately 40 minutes. The company says that the technology does not yet have regulatory approval, but that this is expected within 12 months.

  • Uriscreen (Savyon Diagnostics)

The Uriscreen test is an enzyme-based test that detects the presence of bacterial catalase in a urine sample. Results take approximately 2 minutes. The company says that the technology is CE-IVD marked.

  • UTRiPLEX (Global Access Diagnostics)

The UTRiPLEX test detects the presence of matrix metalloproteinase-8 (MMP8) and human neutrophil elastase (HNE) in a urine sample. Results take approximately 6 minutes. The company says that the technology does not yet have regulatory approval, but that this is expected within 12 months.


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