Currently, international and national clinical guidelines recommend HPV testing on the screening of cervical cancer(1). This screening in Spain is adviced for individuals between 21 and 65 years old(1). Such screenings are based on the triage of high-risk HPV and propose genotyping for HPV16 and HPV18, and cytology for women positive for any of the other 12 High-Risk (HR) genotypes(2).
Clinical laboratories have a wide range of HPV based tests to decide the best option according to their necessities. The Xpert® HPV (GX-HPV) from Cepheid, and Anyplex ™ II HPV28 Detection (SG-HPV) from Seegene methods have proved excellent concordance (k 0.85, 95% CI 0.75 to 0.96) and a high agreement percentage; i.e., 92.93% (3).
The aim of this work is to present a testing algorithm, that is performed at the Clínica Rotger (CR) of Palma de Mallorca (Spain) as a routine protocol, for the diagnostic of HPV. The algorithm consists of a first-line-test with GX-HPV for information screening, and a second-line-test for genotyping with SG-HPV. Furthermore, they were compared for effectiveness and required time with a value stream mapping for the SG-HPV.
A total of 225 endocervical samples were collected and processed at the CR during 2015. The isolation and purification of nucleic acids for the SG-HPV method in DX Real-Time System (BioRad) was performed with the Virus minikit v2.0 (Qiagen). Moreover, the Cepheid based design does not require prior isolation and purification, since both steps are automatically included in the supplied GeneXpert cartridges system.
The mean age of the patients included in the survey was 39.3 years old (95% CI 38.1 to 40.5); the 99.09% of the samples were included into the recommended age for the screening. The 61.36% of the results were negative (135/220); the samples positive for HPV16 reached 5.91% (13/220); meaning while the 32.73% (72/220) were positive for at least one of other HR HPV, and consequently genotyped with the SG-HPV test; positive results for HPV18/45 were also tested with SG-HPV for individual typing. Remarkably, the first-line-test reduces a 57% hands-on time and it is 67% quicker than the second one.
The first-line-test (GX-HPV) provides results in less than 2 hours for “HPV16 positive” or “no detectable”. A second-line-test (SG-HPV) provides additional information about other HR and LR types.
The first-line test provides faster laboratory turnaround time, avoiding unnecessary genotyping of samples.
The second-line-test is bassically useful for confirmation of doubtful results obtained along the first-line-test, gathering epidemiological information and for the analysis of samples where other HPV types have influence.
1. Aureli Torne Blade, Marta del Pino Saladrigues, Maite Cusido Gimferrer, Francesc Alameda Quitllet,Daniel Andia Ortiz, Xavier Castellsague Pique, Javier Cortes Bordoy, Rosario Granados Carreno, Rosa Maria Guarch Troyas, Belen LLoveras Rubio, Amina Lubrano Rosales, Juan Carlos Martinez-Escoriza, Jaume Ordi Maja, Luis M. Puig-Tintore, Mar Ramirez Mena, Silvia de Sanjose Llongueras, Rafael Torrejon Cardoso, Xavier Bosch Jose, Miguel Angel Piris Pinilla, Julio Rodriguez Costa, Rafael Comino Delgado, Josep M. Lailla Vicens y Jordi Ponce Sebastia, 2014. Guía de cribado del cáncer de cuello de útero en España, 2014. Rev Esp Patol. 2014;47(1):1-43. ISSN: 0031-3106.
2. Huh WK et al., 2015. Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance. Gynecol Oncol. Jan 6. pii: S0090-8258(14)01577-7. doi: 10.1016/j.ygyno.2014.12.022.
3. Aliaga-Lozano, F; Jaén-Luchoro, D; Bennasar-Figueras, A; Ruiz-Veramendi, M. Comparison of Xpert® HPV (Cepheid) with Anyplex™ II HPV28 Detection (Seegene) for the detection of High Risk Human Papillomavirus in clinical samples. Int J STD AIDS October 2015 26: 1-121, DOI: 10.1177/0956462415601768.