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Reproducibility of linear array for human papillomavirus genotyping.
Jill Koshiol1, S Terence Dunn, Joan L Walker
1Division of Cancer Epidemiology and Genetics, NCI/NIH/DHHS, Bethesda, Maryland, USA. koshiolj@mail.nih.gov
Journal of Clinical Microbiology
|December 1, 2012
Summary
The Linear Array assay demonstrated high reproducibility for detecting human papillomavirus (HPV) types in women's cytologic specimens. Overall agreement was strong, indicating reliable test performance for HPV detection.
Area of Science:
- Gynecology
- Virology
- Molecular Diagnostics
Background:
- Cervical cancer screening relies on accurate human papillomavirus (HPV) detection.
- Reproducibility of HPV testing methods is crucial for reliable screening results.
Purpose of the Study:
- To evaluate the test-retest reproducibility of the Linear Array assay for HPV detection in cytologic specimens.
- To assess the agreement and reliability of HPV type detection using the Linear Array method.
Main Methods:
- A test-retest analysis was performed on 198 cytologic specimens from women.
- The Linear Array assay was used for human papillomavirus (HPV) typing.
- Statistical analysis included calculation of overall agreement and Kappa values for type-specific detection.
Main Results:
- 67.2% of samples showed consistent HPV type detection between tests.
- Type-specific positive agreement was 83.3% overall (Kappa = 0.9) and 86.8% for carcinogenic types (Kappa = 0.92).
- Discordance was more frequent with low hybridization signal strength.
Conclusions:
- The Linear Array assay exhibits high reproducibility for HPV detection in cytologic samples.
- The assay demonstrates reliable performance, particularly for carcinogenic HPV types.
- Findings support the use of Linear Array as a dependable tool in HPV testing protocols.
