Expert comments

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.

The technology is not yet available in the NHS. Three out of 4 experts had not used this technology before. One of the experts was familiar with the technology and had been provided with a prototype.

Level of innovation

Most of the experts agreed that the technology was a novel concept for detecting direct oral anticoagulants (DOACs), with 2 experts adding that it is a first-in-class procedure. Experts noted that the technology was innovative compared with standard care because it does not need venepuncture or laboratory-based analyses. One expert also noted that, if urine samples were easy to collect, the DOASENSE test would be faster than standard care. One expert thought it would replace standard care. None of the experts were aware of any competing technologies in the NHS that have a similar mode of action. However, 1 expert said that other point-of-care tests are available (such as thromboelastography and rotational thromboelastometry) but that these need blood samples.

Potential patient impact

The main benefits for patients identified by the experts include earlier detection of DOACs, leading to more timely clinical decision making and appropriate emergency treatment. One expert said that in elective cases a negative test result would assure surgeons and when a positive test result is given the procedure could be delayed. This would help to reduce the risk of bleeding complications during surgery. One expert noted that more patients could have access to testing with the technology compared with standard laboratory-based DOAC testing, which has limited availability in most hospitals.

People at risk of haemorrhagic stroke or bleeding during surgery, people with head injuries, and people presenting to emergency departments with acute bleeding or haemorrhagic stroke who are confused were identified as people who would particularly benefit from the technology. One expert felt the technology could be used in the hyperacute phase of management for people with ischaemic stroke on DOACs. They stated that if a reliable point-of-care test was available it could help stroke specialists decide whether to offer these people alteplase, which is currently contraindicated in people who have taken DOACs in the previous 48 hours.

Potential system impact

Potential system benefits identified by the experts include a reduced number of phlebotomy blood samples taken, reduced hospital or GP visits for blood sampling, and helping relieve some pressure on laboratory technicians. However, 1 expert stated that a blood test may still be needed to test for residual warfarin. Other benefits were more appropriate management for patients who present with an acute bleed or need emergency surgery and safer management for people having elective surgery.

One expert said that the test would initially be used alongside standard testing but may replace standard care once there is confidence in the test results. Another expert noted that it would be an addition to standard care because DOACs are not routinely tested for. One of the experts noted that because it is a screening tool, positive test results may need further testing to assess the quantity and type of DOAC in the blood.

One expert believed the technology would lead to cost savings overall, while another felt the technology would cost the same as standard care because positive tests would need further testing. Overall, the experts did not think adopting the technology would have a negative impact on resource use, and minimal training would be needed. One of the experts said that the technology could be taken up quickly by emergency departments, as well as outpatient and inpatient services. This is because it is simple to do and not labour intensive.

General comments

The experts were not aware of any NHS centres currently using the technology.

The accuracy and reliability of the test were key uncertainties identified by 2 of the experts. Experts highlighted potential harm for people with an inaccurate test result. This includes planned procedures that carry a bleeding risk being done in people with a false positive result and people not having appropriate or timely treatment because of a false negative result. One expert stated that if the test were shown to be reliable and reproducible, with a low false negative rate, it could be a cost-effective way to screen for DOACs. However, another expert felt that the test would only be useful in people presenting to emergency departments in whom a medical history is uncertain and who are unable to provide further clarity (that is, they are confused or cognitively impaired), and very occasionally in people who had been involved in a traffic accident who are unable to communicate about their medication history. This expert did not see a place for the technology in people having elective surgery.

One expert highlighted that the current evidence base is limited, relies on insufficient patient numbers and has not been done in the intended population. They stated that for the test to be routinely adopted, a prospective randomised controlled trial is needed that shows efficacy compared with standard care by evaluating the effect of using the test on clinical outcomes.