RESUMO
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.
Assuntos
Gonorreia/diagnóstico , Técnicas de Diagnóstico Molecular/métodos , Neisseria gonorrhoeae/isolamento & purificação , Infecções por Chlamydia/diagnóstico , Chlamydia trachomatis/genética , Chlamydia trachomatis/isolamento & purificação , Feminino , Humanos , Masculino , Neisseria gonorrhoeae/genética , Técnicas de Amplificação de Ácido Nucleico/métodos , Sensibilidade e EspecificidadeRESUMO
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.