Comparative evaluation of AMPLICOR HPV PCR and Linear Array assays on SurePath liquid-based Pap samples for the detection of high-risk HPV genotypes.
J Clin Virol
; 50(3): 201-4, 2011 Mar.
Article
em En
| MEDLINE
| ID: mdl-21195020
ABSTRACT
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. STUDYDESIGN:
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Papillomaviridae
/
Virologia
/
Infecções por Papillomavirus
/
Técnicas de Diagnóstico Molecular
Tipo de estudo:
Diagnostic_studies
/
Etiology_studies
/
Evaluation_studies
/
Risk_factors_studies
Limite:
Adult
/
Female
/
Humans
/
Middle aged
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article