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External quality assessment for human papillomavirus 16/18 DNA detection and genotyping in Shanghai, China

  • Xueliang Wang EMAIL logo , Fen Liu , Lingli Jiang , Yun Bao , Yanqun Xiao and Hualiang Wang EMAIL logo
Published/Copyright: November 7, 2016
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 55 Issue 2

Abstract

Background:

Human papillomavirus (HPV) DNA detection and genotyping is now being used for cervical screening by a growing number of laboratories in Shanghai, but they may have various levels of proficiency. The objective of this study was to evaluate the performance of clinical laboratories for HPV DNA detection and genotyping by an external quality assessment (EQA) program.

Methods:

The EQA panels were clinically validated by the Cobas 4800 HPV test, and then distributed to the participating laboratories in May 2015 (round 1) and September 2015 (round 2). Each panel consisted of one negative sample and nine positive cell or clinical samples of HPV16 and HPV18 types at different concentrations. In total, 40 laboratories submitted 18 qualitative and 22 genotyping data sets in round 1 and 44 laboratories submitted 18 qualitative and 26 genotyping data sets in round 2. In both rounds, all laboratories used commercial assays.

Results:

The negative samples were detected correctly in both rounds by all participating laboratories. There were no false-positive results in the qualitative data sets and only two false-positive results in the genotyping data sets in each of round 1 and round 2. The false-negative rates were 8.0% for round 1 and 2.7% for round 2. For the qualitative data sets, almost all of the laboratories (100% for round 1 and 97.8% for round 2) obtained a score of acceptable or better. For the genotyping results, acceptable or better scores were obtained in 81.8% (round 1) and 100% (round 2).

Conclusions:

Our results indicate that the majority of laboratories in Shanghai have reliable diagnostic ability for HPV detection and genotyping. Moreover, this study emphasizes the importance of EQA for monitoring the performance of clinical laboratories.

Keywords: external quality assessment; genotyping; HPV DNA testing; human papillomavirus

  1. Author contributions: All authors accept responsibility for the entire content of this manuscript and approve its submission.

  2. Research funding: This study was funded by a grant from the Joint Research Project for Important Diseases by Shanghai Municipal Commission of Health and Family Planning (No. 2013ZYJB0010).

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Supplemental Material:

The online version of this article (DOI: 10.1515/cclm-2016-0293) offers supplementary material, available to authorized users.

Received: 2016-4-11
Accepted: 2016-10-5
Published Online: 2016-11-7
Published in Print: 2017-2-1

©2017 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2016-0293
Keywords for this article
external quality assessment; genotyping; HPV DNA testing; human papillomavirus

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Commutable samples with assigned target concentrations may help us harmonise general chemistry results
  4. Reviews
  5. Performance of point-of-care HbA1c test devices: implications for use in clinical practice – a systematic review and meta-analysis
  6. Cardiac troponins and mortality in type 1 and 2 myocardial infarction
  7. Opinion Paper
  8. Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference
  9. Genetics and Molecular Diagnostics
  10. External quality assessment for human papillomavirus 16/18 DNA detection and genotyping in Shanghai, China
  11. General Clinical Chemistry and Laboratory Medicine
  12. Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain
  13. Commutability of proficiency testing material containing tobramycin: a study within the framework of the Dutch Calibration 2.000 project
  14. Optimization and validation of moving average quality control procedures using bias detection curves and moving average validation charts
  15. Extending laboratory automation to the wards: effect of an innovative pneumatic tube system on diagnostic samples and transport time
  16. Smart management of sample dilution using an artificial neural network to achieve streamlined processes and saving resources: the automated nephelometric testing of serum free light chain as case study
  17. An integrated proteomic and peptidomic assessment of the normal human urinome
  18. An alternative inhibition method for determining cross-reactive allergens
  19. Validation of a new assay for α-synuclein detection in cerebrospinal fluid
  20. Reference Values and Biological Variations
  21. Intra-individual variation of plasma trimethylamine-N-oxide (TMAO), betaine and choline over 1 year
  22. Cancer Diagnostics
  23. Predictive performance of TPA testing for recurrent disease during follow-up after curative intent surgery for colorectal carcinoma
  24. Cardiovascular Diseases
  25. Mid-regional pro-adrenomedullin (MR-proADM) and mid-regional pro-atrial natriuretic peptide (MR-proANP) in severe aortic valve stenosis: association with outcome after transcatheter aortic valve implantation (TAVI)
  26. Association between apolipoprotein E polymorphisms and premature coronary artery disease: a meta-analysis
  27. Urinary orosomucoid: a novel, early biomarker of sepsis with promising diagnostic performance
  28. Letters to the Editor
  29. CT or MRI
  30. Reply to: CT or MRI in the diagnosis of right lower quadrant abdominal pain?
  31. Quantification of daratumumab in the serum protein electrophoresis
  32. Response to: Interference of daratumumab on the serum protein electrophoresis
  33. Glycated albumin: correlation to HbA1c and preliminary reference interval evaluation
  34. Using “big data” to describe the effect of seasonal variation in thyroid-stimulating hormone
  35. IgE multiple myeloma: a new case report
  36. Therapeutic decision-making process in the intensive care unit: role of biological point-of-care testing
  37. How can we evaluate differences between serial measurements on the same sample? A new approach based on within-subject biological variation
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