RESUMO
BACKGROUND: The Aptima Herpes Simplex Virus (HSV) 1&2 Assay recently received Health Canada approved for detection and differentiation of HSV-1 and HSV-2 from anogenital sites. This assay uses target capture, transcription mediated amplification, and real-time detection of messenger RNA (mRNA) produced in host cells during active HSV infection. To evaluate its performance, the Aptima assay was compared to another Health Canada approved assay, the BD ProbeTec Herpes Simplex Viruses HSV 1&2 Qx Amplified DNA Assay, which uses strand displacement amplification technology. METHODS: As recommended by the manufacturers, the Aptima and ProbeTec assays were performed on the Panther and Viper instruments, respectively. Analytical sensitivity and specificity were assessed using 10-fold serial dilution of viruses in viral universal transport media (UTM), and nucleic acids extracted and concentrated from other viruses including all members of the Herpesviridae family. The clinical sensitivity and specificity were assessed retrospectively using 60 archived specimens, and prospectively using 158 swabs in UTM. Discrepant results were resolved with real-time PCR using the Altona Diagnostics RealStar alpha Herpes assay. RESULTS: Both the Aptima and ProbeTec assays showed excellent analytical and clinical specificity. However, the Aptima HSV assay failed to detect HSV in specimens with low viral loads, resulting in reduced sensitivity for HSV-2 during the retrospective evaluation at 85.0%, and for HSV-1 at 85.0% during the prospective evaluation. CONCLUSIONS: This study compared the Aptima and ProbeTec HSV assays and demonstrated that detection of HSV mRNA using the Aptima HSV assay was less sensitive in both retrospective and prospective analyses.
Assuntos
Herpes Simples/diagnóstico , Herpesvirus Humano 1/genética , Herpesvirus Humano 2/genética , Técnicas de Diagnóstico Molecular/métodos , Automação , Estudos de Casos e Controles , DNA Viral/genética , Diagnóstico Diferencial , Herpes Simples/virologia , Herpesvirus Humano 1/fisiologia , Herpesvirus Humano 2/fisiologia , Humanos , Técnicas de Diagnóstico Molecular/instrumentação , Estudos Prospectivos , Reação em Cadeia da Polimerase em Tempo Real , Estudos Retrospectivos , Sensibilidade e Especificidade , Carga ViralRESUMO
In an effort to determine whether residence in a foreign country increases the risk of hepatitis B and C and cytomegalovirus (CMV) infection in United States (US) Armed Forces blood donors, 5719 volunteer donors at four US Navy blood banks were evaluated. Most participants were repeat donors (68%) and were young (mean age, 25 years), male (88%), and white (80%), black (10%), or Hispanic (7%). Birth outside of the United States was reported by 6 percent of subjects, and 34 percent had lived in a foreign country for more than 3 months. Twenty (0.3%) subjects had hepatitis B surface antigen (HBsAg), and 100 (1.7%) had antibody to hepatitis B core antigen (anti-HBc). Thirty-four (0.6%) were repeatably reactive in enzyme-linked immunosorbent assay for antibody to hepatitis C virus (anti-HCV); 11 (0.2%) had anti-HCV in immumoblot assay. Of the 3484 donors tested for anti-CMV, 1117 (32.1%) were positive. When demographic characteristics were controlled for both anti-HBc and anti-CMV seropositivies were independently associated in male blood donors with residence in the Philippines. Geographic factors were not associated with HBsAg and anti-HCV positivity. These findings indicate that the prevalence of serologic markers for viral hepatitis is low in military blood donors, but that residence in the Western Pacific is a risk factor for hepatitis B and CMV infection.
