Carina Eklund1, Laila Sara Arroyo Mühr1, Camilla Lagheden1, Ola Forslund2, Karin Dahlin Robertsson3, Joakim Dillner4. 1. Department of Laboratory Medicine, Karolinska Institutet, 141 86 Stockholm, Sweden. 2. Department of Laboratory Medicine, Division of Medical Microbiology, Lund University, 221 85 Lund, Sweden. 3. EQUALIS AB, 751 09 Uppsala, Sweden. 4. Department of Laboratory Medicine, Karolinska Institutet, 141 86 Stockholm, Sweden; Center for Cervical Cancer Prevention, Karolinska University Hospital, 141 86 Stockholm, Sweden. Electronic address: joakim.dillner@ki.se.
Abstract
BACKGROUND: Accurate and internationally comparable human papillomavirus (HPV) testing services are essential for cervical cancer elimination programs. The WHO HPV Laboratory Network started issuing international HPV testing proficiency panels in 2008. OBJECTIVES: We report the results of the 2019 global proficiency study and evaluate the proficiency over time. STUDY DESIGN: The proficiency panel contained 40 coded samples containing mixes of purified HPV types (HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/68a/68b) and 4 controls. Proficiency required detection of both single and multiple infections of 50 International Units of HPV 16/18, of 500 genome equivalents (10x higher concentration) for other HPV types, and no false positives (stricter requirement compared to previous panels). RESULTS: Seventy-eight laboratories submitted 110 datasets with 38 different assays. Most samples (38/44) were reported with 100% proficiency in most datasets. Mostly commercial assays were used (88/110 datasets). Overall, 47.3% of the datasets were 100% proficient. False positivity was detected in at least one sample in 30.1% of datasets. When analysing all datasets ever since 2008 using exactly the same proficiency criteria, there was a steady improvement up to 2017 (the proportion of datasets being completely proficient increased from 25% to 73%). However, in the 2019 proficiency testing the proportion of fully proficient datasets dropped to 50%. CONCLUSIONS: Although we initially documented a worldwide improvement in comparability and reliability of HPV testing services, the trend now appears to be reversed. In response, the International HPV Reference Center will provide support for improved quality of laboratory services, including issuing of global proficiency panels every year.
BACKGROUND: Accurate and internationally comparable human papillomavirus (HPV) testing services are essential for cervical cancer elimination programs. The WHO HPV Laboratory Network started issuing international HPV testing proficiency panels in 2008. OBJECTIVES: We report the results of the 2019 global proficiency study and evaluate the proficiency over time. STUDY DESIGN: The proficiency panel contained 40 coded samples containing mixes of purified HPV types (HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/68a/68b) and 4 controls. Proficiency required detection of both single and multiple infections of 50 International Units of HPV 16/18, of 500 genome equivalents (10x higher concentration) for other HPV types, and no false positives (stricter requirement compared to previous panels). RESULTS: Seventy-eight laboratories submitted 110 datasets with 38 different assays. Most samples (38/44) were reported with 100% proficiency in most datasets. Mostly commercial assays were used (88/110 datasets). Overall, 47.3% of the datasets were 100% proficient. False positivity was detected in at least one sample in 30.1% of datasets. When analysing all datasets ever since 2008 using exactly the same proficiency criteria, there was a steady improvement up to 2017 (the proportion of datasets being completely proficient increased from 25% to 73%). However, in the 2019 proficiency testing the proportion of fully proficient datasets dropped to 50%. CONCLUSIONS: Although we initially documented a worldwide improvement in comparability and reliability of HPV testing services, the trend now appears to be reversed. In response, the International HPV Reference Center will provide support for improved quality of laboratory services, including issuing of global proficiency panels every year.
Authors: François Coutlée; Alexandra de Pokomandy; Ann N Burchell; Mariam El-Zein; Marie-Hélène Mayrand; Sophie Rodrigues-Coutlée; Deborah Money; Émilie Comète; Elisabeth McClymont; Danielle Rouleau; Eduardo L Franco Journal: J Med Virol Date: 2022-01-28 Impact factor: 20.693
Authors: Sophie Pils; Jana Mlakar; Mario Poljak; Grega Gimpelj Domjanič; Ulrike Kaufmann; Stephanie Springer; Andreas Salat; Eva Langthaler; Elmar A Joura Journal: EClinicalMedicine Date: 2022-10-12