Diagnostic performance of the IMMY cryptococcal antigen lateral flow assay on serum and cerebrospinal fluid for diagnosis of cryptococcosis in HIV-negative patients: a systematic review

Macrae, Catriona; Ellis, Jayne; Keddie, Suzanne H.; Falconer, Jane; Bradley, John; Keogh, Ruth; Baerenbold, Oliver; Hopkins, Heidi; Jarvis, Joseph N.

doi:10.1186/s12879-023-08135-w

Table 1 Summary of characteristics of studies reporting findings of IMMY CrAg^® lateral flow assay on serum and comparator test(s)

From: Diagnostic performance of the IMMY cryptococcal antigen lateral flow assay on serum and cerebrospinal fluid for diagnosis of cryptococcosis in HIV-negative patients: a systematic review

	Author, date of publication	Setting	n	Study population	Immunosuppressed n (%)	Cryptococcal disease phenotype	Samples tested (n)	Comparator test(s)	Reported sensitivity (95% CI)	Reported specificity
1	Dubbels 2017	USA	37	Not reported	15 (40.5%)	Cryptococcal meningitis, pulmonary cryptococcosis, other	36	Culture, histology, LA, composite^c	Not calculated	66%
2	Harrington 2021	USA	96	Asymptomatic inpatients and outpatients	43 (45%)	No disease	35	LA	Not calculated	Not calculated
3	Hevey 2020	USA	34	Symptomatic inpatients	Not reported	Pulmonary cryptococcosis, other^b	34	Composite clinical and laboratory end point^d	Overall 85.3%, localised pulmonary 90.9% (58.7–99.8%), disseminated 82.6% (61.2–95.1%)	Not calculated
4	Jitmuang 2015	USA	31	Symptomatic inpatients	17 (55%)	Cryptococcal antigenemia,^a Cryptococcal meningitis, pulmonary cryptococcosis, other^b	53	LA, EIA	100% (92–100%)	Not calculated
5	Min 2020	China	78	Symptomatic inpatients	17 (22%)	Pulmonary cryptococcosis	78	Lung biopsy (histopathology)	69.2% overall, immunocompetent 80.3%, immunocompromised 29.4%	Not calculated
6	Tintelnot 2015	Germany	8	Not reported^g	0	Cryptococcal antigenemia,^a cryptococcal meningitis	9	LA	Not calculated	Not calculated
7	Wang 2020	China	149	Symptomatic inpatients	55 (37%)	Cryptococcal antigenemia,^a cryptococcal meningitis, pulmonary cryptococcosis	136	Composite clinical and laboratory end point^e	Titre 1:10 39.6% (29.7–50.1%), Titre 1:5 72.9% (62.9–81.5%)	Titre 1:10 100%(69.2–100%), Titre 1:5 70.0% (34.8–93.3%)
8	Wu 2020	China	37	Symptomatic and asymptomatic inpatients	15 (41%)	Pulmonary cryptococcosis	25	Composite clinical and laboratory end point^f	Not calculated	Not calculated

Cryptococcal disease phenotypes
^aCryptococcal antigenaemia: isolated cryptococcal antigenaemia without evidence of disease
^bOther: any other cryptococcal disease including disseminated disease
Definition of composites used as comparators
^c(i) a Cryptococcus species was recovered in culture from any specimen source, (ii) a Cryptococcus species was histopathologically identified in any specimen, or (iii) the patient responded to targeted antifungal therapy with concomitant decreases in serial CrAg LFA titers [28]
^dPositive serum or CSF CrAg, isolation of Cryptococcus neoformans in culture, or identification by the International Classification of Diseases (ICD) 9th (117.5, 321.0) or 10th (B45.1-B45.9) editions [34]
^eCryptococcal infections defined as: either “proven”, “probable”, “possible” or “non-crypto- coccosis”, as described for other invasive fungal diseases, with some modifications in patients with low CrAg LFA titers as per De Pauw et al. [36]
^fProven pulmonary cryptococcosis based on the following criteria: histopathological, cytopathological or direct microscopic examination of a specimen obtained by a needle aspiration or biopsy from a normally sterile site (other than mucous membranes) showing encapsulated budding yeasts; or probable PC if each of the three elements of host factor, clinical features and mycological evidence were present [33]
^gTesting of stored laboratory samples

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ISSN: 1471-2334

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