Serious adverse events associated with bacille Calmette-Guérin vaccine in Canada.

BACKGROUND: Targeted Bacille Calmette-Guérin (BCG) vaccination is offered to neonates in some First Nations and Inuit (FNI) communities in Canada. Serious adverse events associated with BCG vaccine prompted a review to assess causality. METHODS: The Immunization Monitoring Program Active (IMPACT), a pediatric hospital-based active surveillance network, reported admissions for BCG-related adverse events between 1993 and April 2002. The Canadian Advisory Committee on Causality Assessment (ACCA) reviewed the reports to assess causality. Data between 1987 and September 2002 from the Vaccine-Associated Adverse Event Surveillance (VAAES) Program, a passive national reporting system, were also reviewed. RESULTS: IMPACT identified 21 pediatric cases; 19 were Canadian-born, and 18 were FNI. Six disseminated BCG cases were identified; 5 were FNI infants who subsequently died. All had immunodeficiencies and concurrent infections. Other adverse events included 2 cases of osteomyelitis, BCG abscesses and lymphadenitis. ACCA reviewed the 21 cases and determined that 14 were very likely associated with the vaccine, including the 6 disseminated BCGs; 5 were probably associated and 1 was possibly associated with the vaccine; 1 was unclassifiable. The VAAES program identified 157 adverse events. No additional serious systemic adverse events (disseminated BCG or osteomyelitis) were identified. CONCLUSIONS: Serious BCG vaccine-associated complications continue to occur in Canada. The numbers of FNI children with disseminated disease was greater than expected from reported rates in the literature.

Field evaluation of the Merlin immediate HIV-1 and -2 test for point-of-care detection of human immunodeficiency virus antibodies.

The Merlin Immediate HIV-1 and -2 Test (Merlin point-of-care [POC] test; Merlin Biomedical & Pharmaceutical) is a nitrocellulose membrane flow immunoassay performed at the POC with the use of blood obtained from a fingerprick. The results of this test were compared with those of enzyme immunoassay (EIA) performed on venous blood samples in the laboratory. Positive results of both tests were confirmed by a Western blot (WB). The study included 553 adults with known HIV (human immunodeficiency virus) seropositivity (all of whom had positive Merlin POC test results) and 2659 adults with unknown HIV serostatus (20 of whom had positive EIA/WB results; 19 of the 20 also had positive Merlin-POC test results). The sensitivity of the Merlin POC test was 95.0% for patients with an unknown HIV serostatus and 99.83% for those with a positive serostatus. For previously untested subjects, the test's specificity and positive predictive value were 100%, its negative predictive value was 99.96%, and its overall accuracy was 99.96%. The Merlin POC test is highly accurate for the detection of HIV antibodies.