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  5. 2019 Vol.29 No.1
  6. Basic Evaluation of the automated Gene Amplification Detector RD-200 and LYNOAMP CK19

Sysmex Journal International

2019Vol.29 No.1

Republished

Basic Evaluation of the automated Gene Amplification Detector RD-200 and LYNOAMP CK19

AUTHOR(S)

Akane SEKI*1, Mayuko KOBAYASHI*2, Ayami HIRAKI*2, Mamoru ASHIDA*2, Michiko YOSHIMOTO*1, Tetsuro MORINAGA*2, Mitsue ITO*1, Motonari DAITO*2 and Shuichi NUMATA*1

*1 Scientific Information, Scientific Affairs, Sysmex Corporation
*2 Gene Testing Business, LS Business, Sysmex Corporation

SUMMARY

One-Step Nucleic Acid Amplification (OSNA) is a method that allows the diagnosis of lymph node metastasis and uses a specially designed device and reagents for amplification and detection of cytokeratin (CK) 19 mRNA, which is present only in lymph nodes carrying metastasis. The first OSNA system, developed by Sysmex Corporation (Kobe, Japan), consists of the automated Gene Amplification Detector RD-100i and LYNOAMP BC and it is currently used by several hundred institutions around the world, mainly for breast cancer-related diagnosis.

Now, Sysmex Corporation has developed a new OSNA system, consisting of the automated Gene Amplification Detector RD-200 and LYNOAMP CK19 which allows the analysis of more samples, has shorter turnaround time when compared to the first generation OSNA, and is a multi-application platform. The clinical and analytical performance of this new system was evaluated and results are shown here. Lymph nodes of breast cancer patients were analyzed by using both the conventional and the new system, and concordance rates were calculated; the findings showed that both systems were comparable in clinical performance. Furthermore, the new system has an improved usability which reflects the market needs and leads to facilitated diagnosis with simplified operation and shorter turnaround time in the clinical setting. Due to these elevated improvements, the new system is expected to achieve a broader market acceptance and spread than the first-generation OSNA system.

KEY WORDS

OSNA, RD-200, RD-210, LYNOAMP CK19, LYNOAMP CK19 E, Cytokeratin 19 (CK19)

NOTE(S)

This article is based on current regulatory requirements in Japan. (as of Oct. 2018)
The specifications, performances and functions described here may be different depending on the regions or the countries due to the regulatory affairs, legal matters or local guidelines. For more details, please contact your regional affiliates or distributors.
This article is translated and republished from the Sysmex Journal Web Vol. 19 No. 2, 2018. (Japanese)