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Background: This study describes the 4 year history of STI evaluation with NAAT, specifically the APTIMA GC/CT assays (Gen-Probe, Inc.) in children evaluated for possible sexual assault. All children in RI are referred to this one Child Safe Clinic.
Objectives: To report on the performance of the APTIMA Combo 2 assay in combination with the individual FDA-cleared APTIMA GC and CT assays in identifying these STIs in children of possible sexual abuse.
Methods: 426 children presenting at Hasbro hospital’s ChildSafe clinic from October 2004 to February 2009 were tested. Urine samples were collected from each patient; genital, pharyngeal, and rectal swabs were collected when deemed clinically appropriate. Specimens were submitted for the APTIMA COMBO 2® GC/CT amplification assay. Positive samples were run in duplicate and subsequently tested with probe sets for alternate sequences (APTIMA GC and CT assays).
Results: Children were 62.3% white and 54.5% pubertal with a mean age of 11.3 yr. Normal/non-specific findings were noted in the majority of patients (79.4%). Of 334 patients with confirmed or probable history of sexual abuse, 19 patients had STIs identified (5.6 %). All positive NAAT urine results confirmed with the alternate probe NAAT as well as other specimen sites submitted for a sensitivity and specificity of 100%.
Conclusions: APTIMA exhibited both excellent sensitivity and specificity in children being evaluated for possible sexual abuse. Urine in females showed 100% correlation with other invasive specimens. No false positive results were noted from any site. 100% correlation with original positive results was seen with the secondary APTIMA probe set.
Implications for Programs, Policy, and/or Research: APTIMA is an acceptable method for diagnosing GC/CT in child sexual abuse. Non-invasive urine specimens are preferred when genital infection is possible. Rectal/pharyngeal specimens should be considered when history suggests mucosal contact at these sites. Secondary probe assays differ in confirmatory specificity.