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

Table 2 Summary of characteristics of studies reporting findings of IMMY CrAg^® lateral flow assay on cerebrospinal fluid (CSF) and comparator test(s)

	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	Chen 2016	China	58	Symptomatic inpatients	7 (12%)	Cryptococcal meningitis	85	India ink, culture, LAMP, qPCR	97.6%, (91.8–99.7%)	Not calculated
2	Dubbels 2017	USA	37	Not reported	15 (40.5%)	Cryptococcal meningitis, pulmonary cryptococcosis, other	12	Culture, histology, LA, composite^c	Not calculated	66%
3	Harrington 2021	USA	96	Asymptomatic inpatients and outpatients	43 (45%)	No disease	79	LA	Not calculated	Not calculated
4	Jitmuang 2015	USA	31	Symptomatic inpatients	17 (55%)	Cryptococcal antigenemia,^a Cryptococcal meningitis, pulmonary cryptococcosis, other^b	11	LA, EIA	100% (66–100%)	Not calculated
5	Tintelnot 2015	Germany	8	Not reported^e	0	Cryptococcal antigenemia,^a cryptococcal meningitis	2	LA	Not calculated	Not calculated
6	Wang 2020	China	149	Symptomatic inpatients	55 (37%)	Cryptococcal antigenemia,^a cryptococcal meningitis, pulmonary cryptococcosis	22	Composite clinical and laboratory end point^d	CSF titre 1:10 50.0% (21.1–78.9%), CSF titre 1:5 66.7% (34.9–90.1%)	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]
^dCryptococcal infections defined as: either “proven”, “probable”, “possible” or “non-cryptococcosis”, as described for other invasive fungal diseases, with some modifications in patients with low CrAg LFA titers as per De Pauw et al. [42]
^eTesting of stored laboratory samples

ISSN: 1471-2334