P20-01RETROSPECTIVE STUDY OF SENSITIVITY, SPECIFICITY, POSITIVE PREDICTIVE VALUE AND NEGATIVE PREDICTIVE VALUE OF CYTOLOGY IN LIQUID MEDIUM, HPV DNA TEST AND GENOTYPING FOR HPV16, IN DIFFERENT CERVICAL CANCER SCREENING SCENES

20. Diagnostic procedures / management
F.J. Queipo Gutierrez 1, J.M. Ramon Y Cajal 2, M. Hernandez Aragon 2, L. Ruiz Campo 2, C. Abad Rubio 2, M. Vicente Iturbe 2, R. Moreno Perez 2, A.M. Vela Lete 2.
1Department of Pathological Anatomy. General Hospital San Jorge. Huesca (Spain), 2Department of Obstetrics and Gynecology. General Hospital San Jorge. Huesca (Spain)

Background / Objectives

Estimation of sensitivity (SE), specificity (SP), positive and negative predictive value (PPV/NPV) of cytology in liquid medium, HPV DNA test and partial genotyping for HPV16 in women older and younger than 30 years old in 3 screening periods: 2010-13, 2014-5 and 2016 (Huesca General Hospital, Spain).


Methods

Our target population is 54.372 women. Cytologies are performed in liquid medium. HPV determination is performed by COBAS 4800 Roche platform. From 2010 to 2013, screening was based on triennial cytology and HPV DNA test in ASC-US; during 2014-2015 period on co-testing in > 30 years-old women, and from 2016 on HPV DNA test with reflex cytology and partial genotyping for HPV16-18. The burden of disease is based on colposcopy biopsies.


Results

Table 1. Cytology in liquid medium.
  2010-13 (n=197) 2014-15 (n=267) 2016 (n=176)
SE<30 years-old 88,9% 73,7% 72,4%
SE>30 68,1% 54,2% 64,1%
SP<30 42% 36,8% 21,4%
SP>30 45,6% 67,7% 52,6%
PPV<30 21,6% 36,8% 42,1%
PPV>30 39,5% 52,3% 53,2%
NPV<30 95,5% 73,7% 50%
NPV>30 73,2% 69,4% 63,5%

 

Table 2. HPV DNA test

  2010-13 (n=62) 2014-15 (n=248) 2016 (n=187)
SE<30 years-old 100% 100% 100%
SE>30 100% 98,8% 98,5%
SP<30 0% 2,7% 21,4%
SP>30 3,5% 7,9% 14%
PPV<30 18,8% 32,1% 47,6%
PPV>30 37,8% 42,9% 46,8%
NPV<30 100% 100% 100%
NPV>30 100% 90% 92,3%

 

Table 3. HPV DNA type 16

  2010-13 (n=29) 2014-15 (n=127) 2016 (n=73)
SE<30 years-old 66,7% 64,7% 90%
SE>30 52,9% 60% 47%
SP<30 61,5% 64,9% 57,1%
SP>30 55,2% 51,8% 75,6%
PPV<30 28,6% 28,6% 60%
PPV>30 40,9% 46,6% 59,6%
NPV<30 88,9% 80% 88,9%
NPV>30 66,7% 64,8% 65%

 


Conclusion

Cytology shows a progressive reduction of sensitivity and specificity in < 30 years-old women. There are also marked variations in specificity and NPV in women > 30. These changes may be due to new screening paradigms and to the incorporation of younger pathologists. On the other hand, PPV increases with the incorporation of HPV to screening.

Sensitivity for HPV DNA test is around 100%, regardless of age and analyzed period. Its specificity has increased with the systematic HPV DNA test (following a standard protocol) and with patient selection following consensus guidelines.

Positivity for HPV16 is associated with a decrease in sensitivity, specially in women > 30 years-old, coupled with a spectacular increase in specificity, mostly in women > 30. Likewise, a moderate increase in PPV is corroborated, with no relevant age differences. In addition, there is a slight to moderate decrease in NPV, regardless of age and screening periods.

The explanation to low specificity of HPV DNA test may be that 2/3 are positive to some of the types NO16-18.

The high sensitivity and low specificity of the HPV DNA test make us incorporate more specific techniques that reduce unnecessary colposcopies. Perhaps dual staining help us to refine derivation scheme.


References

- Evidence Regarding Human Papillomavirus Testing in Secondary Preventión of Cervical cancer.Marc Arbyn.Guglielmo Ronco.Athi Antttila Vaccine 305 ( 2012) F88-F99.