Alere Afinion CRP for C-reactive protein testing in primary care

NICE has developed a medtech innovation briefing (MIB) on the Alere Afinion CRP for C-reactive protein testing in primary care.

• The technology described in this briefing is the Alere Afinion C-reactive protein (CRP) point-of-care test. It is used to quantify CRP in blood, serum or plasma using the Afinion AS100 analyser.
• The innovative aspects are that the Alere Afinion CRP test has the potential to provide rapid results by point-of-care testing of a 1.5 microlitre blood sample, with a reading time of 4 minutes.
• The intended place in therapy would be in primary care, where it would be used by GPs or nurse practitioners to help guide appropriate prescribing of antibiotics to people with lower respiratory tract infection.
• The key points from the evidence summarised in this briefing are from 6 studies (n=1,615). One randomised controlled trial reported that Alere Afinion CRP testing resulted in a lower antibiotic prescribing rate and fewer referrals for chest X-ray compared with non-CRP-guided treatment. A diagnostic case-control study reported sensitivity as 55% and 20% for low (20 mg/litre) and high (100 mg/litre) thresholds respectively for the detection of radiographic pneumonia, and specificity as 73% and 99%. CRP testing improved simulated clinical management of pneumonia compared with a basic model without CRP testing. One study in a paediatric population, incorporating a randomised controlled trial component, reported an increase in antibiotic prescribing rate during 10 day follow-up.
• Key uncertainties around the evidence are that neither of the included randomised controlled trials provided diagnostic accuracy data on the system and clinical follow-up was limited. A diagnostic case-control study did provide diagnostic accuracy information, but had important methodological weaknesses in its design.
• The cost of the Afinion AS100 analyser is £1,200 and Alere Afinion CRP test cartridges are £3.50 per test (excluding VAT). These would represent an additional acquisition cost to standard care, along with costs associated with maintenance and quality assurance. Using this technology could contribute to fulfilling antibiotic stewardship programmes.
• NICE has also published a medtech innovation briefing on the QuikRead go for CRP testing in primary care.

MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.

Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.

MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.

MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.