RESUMEN
Aptima Combo 2 (AC2) Neisseria gonorrhoeae testing of 81,405 patients who were tested by culture and 14,666 who were AC2 tested for Chlamydia trachomatis detected 142 extra infections and confirmed 106 culture-positive samples (the positivity rate increased from 0.13 in testing by culture to 0.26 in testing by AC2). Retrievable AC2 positive samples were confirmed (98.5%) by an alternate AGC test.
Asunto(s)
Gonorrea/diagnóstico , Técnicas de Diagnóstico Molecular/métodos , Neisseria gonorrhoeae/aislamiento & purificación , Infecciones por Chlamydia/diagnóstico , Chlamydia trachomatis/genética , Chlamydia trachomatis/aislamiento & purificación , Femenino , Humanos , Masculino , Neisseria gonorrhoeae/genética , Técnicas de Amplificación de Ácido Nucleico/métodos , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: Persistent cervical infection with high-risk [HR] HPV is a causative factor for cancer. Liquid-based [L-Pap] Pap samples are convenient for HPV testing and SurePath samples have been least studied. Most HPV tests have multiple step protocols and testing laboratories experience large volumes of samples. OBJECTIVES: Using SurePath L-Pap residual samples the objectives were as follows: [1] to test the performance of AMP-HPV and LA-HPV. [2] To perform an agreement study between two laboratories for the AMP-HPV test and [3] to compare agreement of results between AMP-HPV and LA-HPV and HC2. STUDY DESIGN: Samples from 657 women were tested for Pap cytology then assayed for HR-HPV using AMP-HPV and LA-HPV tests. AMP-HPV performance was compared between 2 laboratories and agreement studies were conducted between AMP-HPV, LA-HPV and HC2. RESULTS: HR-HPV genotypes were associated with L-Pap readings as follows: HSIL 92% [23/25], LSIL 73.6% [162/220], ASCUS 70.4% [131/186], normal 31.9% [72/226]. More women less than 30 were infected with HR-HPV and multiple genotypes regardless of the L-Pap reading. AMP-HPV and LA-HPV testing had an overall raw agreement with each other of 84.2% [Kappa 0.66] and each had agreement of 94% with HC2 testing of 133 samples [Kappa 0.86/0.87]. AMP-HPV agreement between two laboratories was better at 93% [Kappa 0.84] compared to 76.1% [Kappa 0.40] when extraction was standardized. CONCLUSION: It is feasible to perform AMP-HPV and LA-HPV on SurePath samples to detect HR-HPV genotypes. HC2, AMP-HPV and LA-HPV showed strong agreement. The extraction component of the AMP-HPV assay needs careful attention to yield consistent results.
Asunto(s)
Técnicas de Diagnóstico Molecular/métodos , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/diagnóstico , Infecciones por Papillomavirus/virología , Virología/métodos , Adulto , ADN Viral/genética , Femenino , Genotipo , Humanos , Persona de Mediana Edad , Hibridación de Ácido Nucleico/métodos , Papillomaviridae/clasificación , Papillomaviridae/genética , Reacción en Cadena de la Polimerasa/métodosRESUMEN
Mocked samples of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) diluted in SurePath liquid-based Pap (L-Pap) fluid were detected by the APTIMA Combo 2 assay to end points 10-fold greater than dilutions in specimen transport media. Pooled L-Pap clinical specimens yielded CT-positive results after storage at room temperature for 10 days. Based on an infected patient standard for comparison, cervical swabs, urine, and SurePath L-Pap test samples collected with a SurePath cervical broom or ThinPrep cytobrush from 520 women then tested by APTIMA Combo 2 assay, detected 25 (4.8%) with CT, 5 (1.0%) with (GC), and 3 (0.6%) with both. Percent sensitivities (80-84), specificities (99.8-100), positive (99.5-100) and negative (99.2-99) predictive values of SurePath L-Pap for CT were validated as similar to those reported in a previously published multicenter trial. All values for GC were 100%. One collection device was not significantly better than the other.
Asunto(s)
Infecciones por Chlamydia/diagnóstico , Chlamydia trachomatis/aislamiento & purificación , Gonorrea/diagnóstico , Neisseria gonorrhoeae/aislamiento & purificación , Técnicas de Amplificación de Ácido Nucleico/métodos , Frotis Vaginal/métodos , Técnicas Bacteriológicas/métodos , Cuello del Útero/microbiología , Infecciones por Chlamydia/microbiología , Chlamydia trachomatis/genética , Medios de Cultivo , Femenino , Gonorrea/microbiología , Humanos , Neisseria gonorrhoeae/genética , Valor Predictivo de las Pruebas , Juego de Reactivos para Diagnóstico , Sensibilidad y Especificidad , Manejo de Especímenes/métodosRESUMEN
The Digene Hybrid Capture 2 (HC2) assay for high-risk human papillomavirus (HPV) identified 92 (28.7%) infected women by testing 320 SurePath liquid-based Pap samples and a hybrid capture 2 (HC2) sampler collection. HPV positivity was predictive for high-grade lesions. A majority of women had normal cervical readings although 15.8% were HPV-positive. Half of the patients with a reading of atypical squamous cells of undetermined significance (ASCUS) (n=16) were HPV-positive.