Aims-To assess the clinical usefulness of a commercial aspergillus antigen
enzyme linked immunosorbent assay (ELISA) in the diagnosis of invasive aspe
rgillosis (IA) in bone marrow transplant recipients, and to compare it with
a commercial latex agglutination (LA) test.
Methods-In total, 2026 serum samples from 104 bone marrow transplant recipi
ents were tested. These comprised 67 sera from seven patients who had died
with confirmed IA, 268 sera from nine patients who had died with suspected
IA, and 1691 sera from 88 patients with no clinical, radiological, or micro
biological signs of IA.
Results-The ELISA was more sensitive than the LA test. All patients who wer
e ELISA positive were also LA positive, and a positive LA result never prec
eded a positive ELISA. Twelve of 16 patients with confirmed or suspected IA
were ELISA positive on two or more occasions, compared with 10 of 15 who w
ere LA positive. ELISA was positive before LA in five patients (range, 2-14
days), and became positive on the same day in the remainder. Aspergillus a
ntigen was detected by ELISA a median of 15 days before death (range, 4-233
). Clinical and/or radiological evidence of IA was noted in all patients, a
nd a positive ELISA was never the sole criterion for introduction of antifu
ngal treatment. Two samples (one from each of two patients without IA) gave
false positive results.
Conclusions-The aspergillus ELISA is a specific indicator of invasive asper
gillosis if the criterion of two positive samples is required to confirm th
e diagnosis. However, the test is insufficiently sensitive to diagnose aspe
rgillosis before other symptoms or signs are apparent, and hence is unlikel
y to lead to earlier initiation of antifungal treatment. It is therefore un
suitable for screening of asymptomatic patients at risk of invasive aspergi
llosis, but does have a useful role in confirming the diagnosis in symptoma
tic patients.