Clinical Performance of SurePath™ Preservative Compared to PreservCyt® with Cobas® and Hybrid Capture® 2 HPV Tests in a Colposcopy Population
| Autor: | Margit M. Janát-Amsbury, Marisa R. Adelman, Keith D. Tardif, Michael T. Pyne, Robert Schlaberg, Laurie Lesher, Corinne Sexsmith, Alexys Allen |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
030213 general clinical medicine Preservative medicine.medical_specialty Population Urology General Biochemistry Genetics and Molecular Biology Human Papillomavirus DNA Tests Specimen Handling Linear array Young Adult 03 medical and health sciences 0302 clinical medicine medicine Humans education Human Papillomavirus DNA Test Aged Colposcopy education.field_of_study medicine.diagnostic_test business.industry Hybrid capture Clinical performance Middle Aged Hpv testing Female business |
| Zdroj: | Clinical Laboratory. 65 |
| ISSN: | 1433-6510 |
| Popis: | Background Until recently, no HPV test had been US FDA-approved for SurePath preservative. Clinical performance remains incompletely understood. The clinical performances of the Cobas HPV Test (Cobas) and Hybrid Capture 2 High-Risk HPV DNA Test (HC2) with PreservCyt and SurePath preservatives were compared. Methods Cervical cytology samples were collected in both preservatives in random order from women age 21+ (n = 244) referred for colposcopy. Before cytology processing and pelleting, SurePath samples were tested by the Cobas test with and without buffered SDS heat pretreatment. SurePath pellets were tested by the HC2 test and by the Cobas test (with pretreatment). Performance characteristics were calculated in relation to cases of cervical in-traepithelial neoplasia grade 2 or higher (CIN2+) as the clinical target outcome. All HPV-positive samples were also genotyped with the Linear Array test. Results CIN2+ was detected in 42 patients (17.2%). For both HPV tests, there was a trend towards higher positivity and sensitivity for SurePath compared to PreservCyt preservative. The Cobas test had higher sensitivity than HC2 and the HC2 test had higher specificity than Cobas. Pretreated SurePath samples produced results similar to untreated ones, despite a two-fold dilution during pretreatment [sensitivity %: 95.1 (82.2 - 99.2) vs. 94.3 (79.5 - 99.0); specificity %: 33.0 (26.6 - 40.1) vs. 33.0 (26.4 - 40.3)]. Conclusions There was good agreement between the preservatives and HPV tests in detecting HPV and between the Cobas and Linear Array tests for genotyping HR-HPV. These trends were not statistically significant due to the limited number of CIN2+ cases. However, these data may help in evaluations of preservative selection for colposcopy samples. Pre-treatment for Cobas testing eliminated invalid results due to clots. The Cobas test has been FDA-approved for use with heat pretreated SurePath samples. |
| Databáze: | OpenAIRE |
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