Table 1.
Sera from clinically ill patients with a confirmed parasitic, bacterial or viral infection tested by the Serion IgM ELISA (REF EST125M) for anti-leptospiral antibodies and partially confirmed by the Microscopic Agglutination Test (MAT).
Table 2.
Overview of origin of serum samples, diagnostic tests and laboratories involved in the evaluation of the Serion IgM ELISA (REF EST125M), which was performed at the Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland.
Table 3.
Strains, serogroups and serovars of Leptospira spp. used as live antigens in the Microscopic Agglutination Test (MAT) for the populations in the Netherlands (N = 14), and Colombia (N = 156).
Fig 1.
The 321 sera of the Colombian study population were screened by the Serion ELISA classic Leptospira IgM (Institut Virion\Serion GmbH, REF EST125M).
All ELISA-positive (n = 124) and a random sample of the ELISA-negative samples (n = 32) were tested for confirmation by the Microscopic Agglutination Test (MAT = imperfect reference test) to assess the performance of the ELISA (in rose). Only one of the ELISA-positive serum samples tested Leptospira seropositive by the MAT, while 123 ELISA positive samples were negative in the MAT. All ELISA negative results, tested by MAT were confirmed by the MAT as negative.
Table 4.
Performance of the Serion IgM ELISA (REF EST125M) tested with sera from persons from the Netherlands, Switzerland, and Colombia with different disease/exposure status compared to the results of the MAT, calculated by the MedCalc online tool (https://www.medcalc.org/calc/diagnostic_test.php).
Table 5.
Distribution of Microscopic Agglutination Test (MAT) antibody titer of 156 serum samples originating from the Colombian Wiwa tribe against the Leptospira serovar panel listed below (strains and serogroups are listed in Table 3).
A MAT titer cut-off of ≥1:100 was classified as seropositive. Given the large serovar panel, the quantity of serum was not always sufficient to test all samples against all serovars. The number and percentage of samples not tested for a given serovar are visible in the last column.