Dr Rob Hicks, MB BS
Four tests for diagnosing UTIs that produce results in “under an hour” and can be carried out by a healthcare professional outside a conventional laboratory in a primary or community care setting show “promise”, but cannot be used in the NHS while further evidence is generated, says NICE.
The National Institute for Health and Care Excellence (NICE) highlighted that according to the NHS Business Services Authority’s RightCare UTI Focus Pack from 2021, “one fifth” of antibiotics prescribed in 2019/20 in England were for lower urinary tract infections, which equated to 7 million prescriptions in a total of 31.4 million.
“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 spokesperson said.
The regulator also hailed that the potential of the tests for diagnosing UTIs could “help in the fight against antimicrobial resistance”.
In its early value guidance public consultation document, NICE assessed early evidence on these technologies to determine if earlier patient and system access in the NHS was appropriate while further evidence was generated.
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.”
However, in its recommendations the regulator stated that the four point of care tests identified:
- Astrego PA-100 analyser with the PA AST panel U-0501 (Sysmex Astrego)
- Lodestar DX (Llusern Scientific; this technology is awaiting regulatory approval)
- Uriscreen (Savyon Diagnostics)
- UTRiPLEX (Global Access Diagnostics; this technology is awaiting regulatory approval) should not be used for early routine use for suspected urinary tract infections (UTIs) in primary or community care settings in the NHS while further evidence is generated.
“They show promise,” NICE said, but further research would “allow the risks and benefits of early routine use in the NHS to be understood”.
NICE added that the following culture-based tests were not recommended for early routine use in primary or community care settings for suspected UTIs, as they were “not expected to give results quickly enough” to affect antimicrobial prescribing in these settings:
- Diaslide, DipStreak and ChromoStreak (Novamed)
- Flexicult Human (SSI Diagnostica)
- Uricult, Uricult trio and Uricult plus (Aidian)
Faster Results Claimed
The new technologies’ developers claimed the tests could identify the presence of bacteria in a urine sample in less than 40 minutes. One claimed to be able to identify the strain of bacterial infection present within minutes, and another said it could test which antibiotics were most appropriate to treat the infection.
Despite these impressive claims, NICE called for further research to establish how accurately the tests detected and identified bacteria, and tested for which antibiotic was most effective, and how much the tests affected decisions about antibiotic prescribing.
In the draft guidance, the NICE committee said that more data was needed on the tests’ accuracy, whether the tests give results quickly enough to improve antibiotic prescribing, what the risks and benefits were of using these tests in the NHS, and the potential cost to the NHS. NICE also pointed out that some of the tests were “still awaiting regulatory approval”.
NICE emphasised that there was a need for more appropriate, accurate, and speedier testing methods, having acknowledged that current processes involving dipstick testing, laboratory-based tests, and empirical prescribing of antibiotics for UTIs, may be, respectively, inaccurate, treatment-delaying, and risk side effects for the patient along with increasing the risk of antibiotic resistance.
Roll-out Dependent on Further Research
If further research were done and suggested the tests could be “beneficial” if used in practice, and that they could help to “improve antimicrobial prescribing”, they may be considered for conditional roll out for use in the NHS while further evidence on their clinical and cost-effectiveness was generated, a NICE spokesperson explained.
Mr Chapman pointed out that NICE soon expected to have a “fuller and more detailed picture” of the tests’ accuracy and potential benefits, which would put the regulator in a stronger position with regards recommendations for 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,” said Mr Chapman.