Table 3 Criteria for assessing applicability in the systematic review of studies evaluating the diagnostic accuracy of MAT, PCR, and IgM ELISA, published global and between 1950–2022
Domain | Grade | Criteria |
|---|---|---|
A. Criteria for assessing applicability in studies selected for MAT accuracy evaluation | ||
 Patient selection | Low risk | Patients with a febrile illness, symptoms of leptospirosis or fever of unspecified duration |
High risk | Patients without febrile illness or without clinical suspicious of leptospirosis | |
 Index test (MAT) | Low risk | Panel of local known circulating serovars; where local serovars are unknown, a globally representative serovar panel is used; MAT performed according to described methodology |
High risk | Panel without local circulating serovars; MAT not performed according to described methodology | |
 Comparator test (Culture and/or PCR) | Low risk | PCR and/or culture performed according to standard methodology |
High risk | PCR and/or culture not performed according to standard methodology | |
B. Criteria for assessing applicability in studies selected for PCR accuracy evaluation | ||
 Patient selection | Low risk | Patients with febrile illness, symptoms of leptospirosis or fever of unspecified duration |
High risk | Patients without febrile illness or without clinical suspicious of leptospirosis | |
 Index test (PCR) | Low risk | PCR performed according to standard methodology |
High risk | PCR not performed according to standard methodology | |
 Comparator test (MAT and/or culture and/or PCR) | Low risk | Panel of local known circulating serovars; where local serovars are unknown, a globally representative serovar panel is used; tests performed according to standard methodology |
High risk | Panel without local circulating serovars; tests not performed according to standard methodology | |
C. Criteria for assessing applicability in studies selected for IgM ELISA accuracy evaluation | ||
 Patient selection | Low risk | Patients with febrile illness, symptoms of leptospirosis or fever of unspecified duration |
High risk | Patients without febrile illness or without clinical suspicious of leptospirosis | |
 Index test (IgM ELISA) | Low risk | IgM ELISA performed according to standard methodology |
High risk | IgM ELISA not performed according to standard methodology | |
 Comparator test (MAT, culture and/or PCR) | Low risk | Panel of local known circulating serovars; where local serovars are unknown, a globally representative serovar panel is used; MAT, PCR and/or culture performed according to standard methodology |
High risk | Panel without local circulating serovars; MAT, PCR and/or culture not performed according to standard methodology | |