Basic Evaluation of Lynoamp BC Used for Intra-Operative Detection of Lymph Node Metastasis in Breast Cancer Patients

• Basic Evaluation of Lynoamp BC Used for Intra-Operative Detection of Lymph Node Metastasis in Breast Cancer Patients

AUTHOR(S)

Masatoshi YAMASAKI, Akane SEKI, Michiko YOSHIMOTO, and Toru SUGIYAMA

Scientific Research Division, Scientific Affairs, Sysmex Corporation

SUMMARY

In 2008, OSNA ( One Step Nucleic acid Amplification ) was approved by the Ministry of Health in Japan. Following the approval, OSNA has been applied as a routine diagnostic tool for rapid detection of metastases in sentinel lymph node samples from breast cancer patients.

We performed the basic evaluation of Lynoamp BC on the basis of the following criteria :
1) Reproducibility, 2) Linearity, 3) Inter-vial variability test, 4) Positive and negative accuracy, 5) Long-term stability, and 6) Interference materials.

As a result, it turned out that the result of the basic evaluation of Lynoamp BC was excellent. We expect that OSNA can contribute to standardizing breast cancer treatment by minimizing the known variability in the methodology and accuracy of conventional SLN diagnosis.

KEY WORDS

OSNA, RD-100i , Lynoamp BC, Cytokeratin 19 (CK19)

NOTE(S)

This article is translated and republished from the Sysmex Journal Web Vol. 12 No. 1, 2011. (Japanese)