In the anatomy and cytopathology laboratory of Coteaux, we perform 40 000 Pap smears per year. We were using an in situ hybridization semi manual technique from Greiner to run HPV tests. This method was hogging two days of a full-time technician work. Technical difficulties to set up the assay were stress inducer for the team.
In 2014, Cepheid launched a new molecular assay (Xpert® HPV), which is a fully integrated assay (extraction, PCR and detection) with rapid and on-demand result. The issue with the first method was the necessary samples consolidation to run the batch, what was delaying responses compared with the Pap smear results, and prompted the change to the Xpert HVP assay.
Our purpose is to communicate about a two years’ experience of Xpert HPV use.
The use of the Xpert HPV assay on the GeneXpert® system changed radically our routine habits and lab organization. The three PCR reactions are done inside the test cartridge; thereby the three rooms dedicated to PCR were not required anymore, simplifying the space management in the lab. By its easy-of-use, all technicians were trained and able to do the HPV test. The minimal hand of time (< 1 minute per sample) and the limited risk of errors and contamination reduced dramatically the technician stress. Xpert HPV is an on-demand test, with a time to result of 60 minutes, which allows us to provide the HPV testing result at the same time as Pap smear to gynecologists. This improved significantly the quality of our service for a better patient management and follow-up.
Xpert HPV report results are expressed as following: “Detected” or “Not detected” for the 14 HR HPVs. HPV types have been pooled in 5 channels, more one for the cellular control (HBMS gene).
P1: HPV 16
P2: HPV 18, 45
P3: HPV 31, 33, 35, 52, 58
P4: HPV 51, 59
P5: HPV 39, 56, 66, 68
SPC (HBMS).
In 2015, we ran 1500 HPV tests (3.75 % of Pap smears), of which 1266 are performed after ASC-US (84.4%). Other tests are requested as part of post conisation surveillance and send-out demands from pathologists who are not able to do HPV testing in their lab.
Among the 1266 HPV tests, 412 were negatives (32.5%) and 854 were positives (67.5%).
The types distribution of the HPV positives was 29,9% (255), 14,4% (123), 41,5% (354), 26,7% (228) and 40,5% (346) for HPV 16, HPV 18/45, P3, P4 and P5 respectively.
Co-infections with 2 to 5 HPV types are frequent (additional data will be provide).
The new Xpert HPV assay has changed our HPV routine, with the benefits of simplicity, fast and on demand result, allowing us to develop our activity and get satisfaction from gynecologists, providing them a unique report for cytology and HPV testing.