Table 2.
Study | Regions screened | No. donors tested | Serologic assay | No. seropositive | No. PCR positive | No. PCR and seropositive | Specificity (95% CI)* | ||
---|---|---|---|---|---|---|---|---|---|
Endemic | Non-endemic | Endemic | Non-endemic | Endemic | Endemic | ||||
Young, 2012 [23] | RI | N/A | 2,113 | IFA (AFIA) | 26/2,113 (1.23%) | N/A | 0 | 0/26 (0%) | N/A |
Moritz, 2014 [34] | CT, MA | AZ, OK | 13,269 | IFA (AFIA) | 38/5,080 (0.75%) | 3/4,022 (0.075%) | 5/5,080 (0.1%) | 5/38 (13%) | 99.95% (99.82–99.99) |
Levin, 2014 [45] | NY | AZ | 15,000 | ELISA | 46/5,000 (0.92%) | 8/5,000 (0.16%) | 1/5,000 (0.02%) | 1/46 (2.2%) | NA |
Levin, 2016 [35] | NY | NM | 26,703 | ELISA | 38/13,757 (0.28%) | 11/8,363 (0.13%) | 8/13,757 (0.06%) | 8/38 (21%) | 99.93% (99.84–99.97) |
after exclusion of confirmed positives
Note: The sensitivity of the IFA (AFIA) assay for detection of PCR-positive patients with symptoms of babesiosis was reported as 81.6%, with non-detected cases presumed to be in the window period[34]. The sensitivity of the ELISA assay for PCR or blood smear positive patients with symptoms of babesiosis was 78.3%[35]. The two methods were statistically equivalent in sensitivity.