P76 Four Year History of APTIMA GC/CT Nucleic Acid Amplification Testing (NAAT) in Children Seen for Sexual Abuse

Wednesday, March 10, 2010
Pre-Function Lobby & Grand Ballroom D2/E (M4) (Omni Hotel)
Kimberle C. Chapin, MD1, Carole Jenny, MD, MBA2, Christine E. Barron, MD3 and Sarah B. Andrea, BS1, 1Department of Pathology, Rhode Island Hospital, Providence, RI, 2Pediatrics, Brown Medical School, Providence, RI, 3Pediatrics, Hasbro Children's Hospital, Providence, RI

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.

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