Table 1.

The diagnostic criteria and classifications for Bacillus Calmette-Guérin (BCG) disease.

DIAGNOSTIC CRITERIA

1. A history of BCG vaccination: vaccination record showing BCG vaccination. 2. Evidence of dissemination: evidence of BCG infection at the presentation that involved ≥1 anatomical site in addition to that of the vaccination site and its regional lymph nodes. 3. Pathology/etiology: clinical specimen that was positive for Mycobacterium tuberculosis complex based on culturing, acid-fast staining, and histological detection of caseating granuloma. 4. BCG identification: real-time PCR (careTB PCR ASSAY kit, Qiagen) was performed to identify the M. tuberculosis complex according to the manufacturer's instructions. Positive specimens were subsequently testing using a BCG assay based upon genomic deletions at RD1, 9, and 10, which was established by Parsons et al. (21).

DIAGNOSTIC CLASSIFICATIONS

Definite (all of the following criteria)

History of BCG vaccination

Evidence of dissemination

Evidence regarding the pathology/etiology

BCG identification

Highly probable (all of the following criteria)

History of BCG vaccination

Evidence of dissemination

Evidence regarding the pathology/etiology

Probable (all of the following criteria)

History of BCG vaccination

Evidence of dissemination