Quality of Sample in theMolecular Determination of Human Papillomavirus in Breast Tissue: Pre-Analytical and Analytical Error-Based Approach

Introduction: High-risk Human Papillomavirus (HR-HPV) can play an important role in the development of breast cancer. The investigations that attempt to clarify this purpose require quality in their results, which constitute the success of each study and the assurance of each result in both clinical practice and scientific research. Objective: to evaluate the quality of breast tissue during the analysis of HR-HPV in samples of patients with breast cancer, in order to establish a quality control of pre-analytical and analytical processes in the laboratory of molecular biology useful for clinical diagnosis and for scientific research. Materials and methods: Twenty-five samples of mammary carcinoma (12 surgical specimens and 13 biopsies) were included with prior informed consent at INEN in Peru, which had a diagnostic pathologic report with breast receptors (RE, RP and HER2) and were analyzed for HR-HPV with the My09/My11 system. The quality evaluation was performed during extraction and amplification (β-globin, positive control (HPV 16) and negative), and the sample quality analysis under CLSI guidelines MM13-A and CLSI MM06-A2. Results: All samples were negative for HR-HPV and one had no β-globin amplification. An overall DNA concentration of ≤ 45 ng/μL was determined. Biopsies performed better than surgical specimens did (p=0.001). No association was found between samples with ≥ 1 positive breast marker with sample quality (p=0.588), or with molecular result (p=0.778). Conclusion: Verification of breast tissue quality during the determination of HR-HPV in breast cancer showed poor quality, with low levels of DNA concentration and significant differences between sample types.