Fungitell for antifungal treatment stratification

Level of innovation

One specialist commentator considered the Fungitell test to be highly innovative and to have revolutionised antifungal stewardship in their intensive care units. Two other commentators considered the Fungitell test to have some innovative features, but commented that the concept of lab testing for invasive fungal disease is not novel.

One commentator considered that increasing use of PCR tests is beginning to supersede the Fungitell technology. However, most clinicians perceive that the current approach of having a low threshold for treating with antifungal drugs is safer than relying on laboratory tests that are not 100% accurate and not uniformly available across the NHS, or which may not offer acceptable turnaround times for results.

Potential patient impact

Commentators considered that patients who would particularly benefit from the technology would be patients in intensive care and immunocompromised patients.

One commentator advised that in a low-incidence setting, the test would allow antifungal treatment to be stopped safely. Two added that this would result in less exposure to toxic drugs, and could potentially lead to fewer blood tests, reduced side effects and reduced length of stay in hospital. They also considered that on occasion, the test could identify fungal infection earlier which would result in a better outcome and reduced mortality. However, they indicated that the likely primary use of the test would be to limit the number of patients who are empirically prescribed antifungal treatment.

Potential system impact

Three commentators considered that the main potential system benefit of the Fungitell test is the safe reduction in antifungal treatment. One added that it makes the early start of empiric antifungal treatment based on clinical suspicion more affordable and another added that the potential for reduced antifungal drug use would reduce the opportunity for the development of antifungal drug resistance.

Two of the commentators thought that use of the test would lead to cost savings from the reduced use of antifungal drugs; with another stating that their centre has already generated significant cost savings from using the test. One added that use of the test could make savings by reducing hospital stays. However, 1 commentator highlighted that the test kit is expensive and not cost effective for individual hospitals because of the small number of test samples that would be run on each plate. Instead they thought it would be better suited to use in a reference laboratory, when the throughput of samples would be high enough to allow each plate to be run with the maximum number of samples.

Two commentators highlighted that the test would need additional staff and training costs and 1 commentator considered the test to be more expensive than ELISA tests currently used. Three of the commentators considered the test to be an addition to the current standard of care, however one considered the test would replace empiric antifungal treatment.

One specialist commentator highlighted that the test would have to be run in a glucan-free environment (for example, a molecular laboratory). Another advised that consideration needs to be given to providing space to accommodate the analyser, the turnaround times and how often the test will be done.

One specialist commentator highlighted that in their experience it is better to run the samples in triplicate, to avoid the need to re-run tests when the duplicate results are discordant. In this case one Fungitell kit (2 plates) can provide test results for a maximum of 28 patients, if testing in triplicate. Additional costs could also be incurred in the case of a batch failure because of whole plate contamination, which is not uncommon.

General comments

One specialist commentator considered that the greatest benefit from the Fungitell test would be if it were available on demand, with samples processed individually or in small batches. One commentator highlighted that BDG level is not routinely tested, but considered it would be beneficial if it was offered. Another commentator highlighted that additional evidence would be useful to address uncertainties in special patient groups such as neonates in intensive care, and people having extracorporeal membrane oxygenation or solid organ transplant, but that a lack of clinical expertise and confidence in evaluating test results could prevent Fungitell from being routinely adopted.