Validation of L-shape Endo/Esocervical Flocked Swab and CyMol Transport Medium with NucliSENS® EasyQ® HPV v1.1 Assay

Abstract

Objective: NucliSENS® EasyQ® HPV v1.1 (bioMérieux) is a qualitative nucleic acid assay for the detection of E6/E7 HPV oncogene mRNA (HPV16, 18, 31, 33 and 45). The L-shape endo/esocervical flocked swab (LEC) is a device for Pap collection and CyMol is a cell and nucleic acid preservation medium (COPAN). Study objectives were:

1) validate the performance of LEC and CyMol medium compared to the Cervex Brush (CB) (Rovers) and PreservCyt solution (Hologic) for collection and preservation of specimens for HPV detection with the NucliSENS EasyQ® HPV 1.1 assay.

2) Evaluate stability of specimens in CyMol medium after 3 weeks at room temperature (RT) and 6 weeks at -20°C.

Methods: Six hundred clinical specimens were collected from voluntary women during a routine visit for Pap testing at 5 Fleming Lab sites in Brescia. Two clinical specimens (300 with CB in PreservCyt and 300 with LEC in CyMol) were collected from each patient in a randomized order and classified for PAP cytology status. Aliquots of all positive specimens in CyMol medium and the same number of negative specimens were used for 3 weeks RT and 6 weeks -20°C stability study. All specimens were extracted and tested with the NucliSENS® easyMAG® and EasyQ® HPV v1.1 assay.

Conclusions: No statistical difference was found between the specimens collected with cervex brush in PreservCyt solution and specimens collected with L-shape endo/esocervical flocked swab in CyMol medium when tested with NucliSENS® EasyQ® HPV v1.1.