TY - JOUR
T1 - Quality assurance of human papillomavirus (HPV) testing in the implementation of HPV primary screening in Norway
T2 - An inter-laboratory reproducibility study
AU - Engesæter, Birgit
AU - van Diermen Hidle, Bianca
AU - Hansen, Mona
AU - Moltu, Pia
AU - Staby, Kjersti Mangseth
AU - Borchgrevink-Persen, Siri
AU - Vintermyr, Olav K.
AU - Lönnberg, Stefan
AU - Nygård, Mari
AU - Janssen, Emiel A.M.
AU - Castle, Philip E.
AU - Christiansen, Irene Kraus
N1 - Publisher Copyright:
© 2016 The Author(s).
PY - 2016/11/24
Y1 - 2016/11/24
N2 - Background: Human papillomavirus (HPV) testing as primary screening for cervical cancer is currently being implemented in Norway in a randomized controlled fashion, involving three laboratories. As part of the quality assurance programme of the implementation, an evaluation of the inter-laboratory reproducibility of the HPV test was initiated, to ensure satisfactory HPV test reliability in all three laboratories. Methods: The HPV test used is the cobas 4800 HPV Test, detecting 14 high-risk types with individual HPV genotype results for HPV16 and HPV18. In addition to the three laboratories involved in the implementation, the Norwegian HPV reference laboratory was included as a fourth comparative laboratory. A stratified sample of 500 cervical liquid based cytology (LBC) samples was used in the evaluation, with an aim towards a high-risk HPV positivity of ~25%. Samples were collected at one laboratory, anonymized, aliquoted, and distributed to the other laboratories. Results: Comparison of the test results of all four laboratories revealed a 95.6% agreement, an 86.3% positive agreement and a kappa value of 0.94 (95% CI 0.92-0.97). For negative cytology specimens, there was a 95.8% overall agreement, a 67.4% positive agreement, and a kappa value of 0.88 (95% CI 0.80-0.93). For abnormal cytology specimens, there was a 95.8% overall agreement, a 95.5% positive agreement, and a kappa value of 0.86 (95% CI 0.71-0.97). Conclusions: The study showed a high inter-laboratory reproducibility of HPV testing, implying satisfactory user performance and reliability in the laboratories involved in the implementation project. This is important knowledge and we recommend similar studies always to be performed prior to the introduction of new screening routines.
AB - Background: Human papillomavirus (HPV) testing as primary screening for cervical cancer is currently being implemented in Norway in a randomized controlled fashion, involving three laboratories. As part of the quality assurance programme of the implementation, an evaluation of the inter-laboratory reproducibility of the HPV test was initiated, to ensure satisfactory HPV test reliability in all three laboratories. Methods: The HPV test used is the cobas 4800 HPV Test, detecting 14 high-risk types with individual HPV genotype results for HPV16 and HPV18. In addition to the three laboratories involved in the implementation, the Norwegian HPV reference laboratory was included as a fourth comparative laboratory. A stratified sample of 500 cervical liquid based cytology (LBC) samples was used in the evaluation, with an aim towards a high-risk HPV positivity of ~25%. Samples were collected at one laboratory, anonymized, aliquoted, and distributed to the other laboratories. Results: Comparison of the test results of all four laboratories revealed a 95.6% agreement, an 86.3% positive agreement and a kappa value of 0.94 (95% CI 0.92-0.97). For negative cytology specimens, there was a 95.8% overall agreement, a 67.4% positive agreement, and a kappa value of 0.88 (95% CI 0.80-0.93). For abnormal cytology specimens, there was a 95.8% overall agreement, a 95.5% positive agreement, and a kappa value of 0.86 (95% CI 0.71-0.97). Conclusions: The study showed a high inter-laboratory reproducibility of HPV testing, implying satisfactory user performance and reliability in the laboratories involved in the implementation project. This is important knowledge and we recommend similar studies always to be performed prior to the introduction of new screening routines.
KW - Cervical cancer screening
KW - Cobas 4800 HPV Test
KW - HPV
KW - HPV primary screening
KW - HPV testing
KW - Human papillomavirus
KW - Inter-laboratory reproducibility
KW - Quality assurance
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U2 - 10.1186/s12879-016-2028-7
DO - 10.1186/s12879-016-2028-7
M3 - Article
C2 - 27881082
AN - SCOPUS:84997254278
SN - 1471-2334
VL - 16
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
IS - 1
M1 - 698
ER -