RD-100i OSNA – the new generation of sentinel lymph node analysis in breast cancer

RD-100i OSNA – the new generation of sentinel lymph node analysis in breast cancer Sentinel node biopsy has rapidly emerged as the surgical procedure of choice for early stage, clinically node-negative breast cancer patients. Conventional intra-operative analysis of the sentinel lymph node (SLN) has, until now, been performed by frozen section or touch imprint with a rapid H & E (haematoxylin and eosin) staining. The sensitivity of these histopathological methods is low because only a small proportion of the lymph node tissue can be investigated in an intra-operative setting. As a result, there...

Advanced technology OSNA is an automated molecular diagnostic assay using a rapid nucleic acid amplification technology (RT-LAMP*) for the detection of Cytokeratin 19 (CK19) mRNA expression. CK19 is an epithelial cell marker and normally not present in lymph node tissue. The amount of CK19 mRNA expression correlates with the size of metastatic foci: The system indicates the extent of the metas- tatic tumour burden. The basis for the evaluation of the patient result is by comparison to a standard curve with three different In a second step the seven most promising candidate markers with high mRNA...

RT-LAMP technology The innovative amplification technology RT-LAMP is a rapid isothermal procedure offering several advantages in comparison to conventional PCR methods. The amplification reaction takes place within i6 min and no prior RNA purification is necessary. Conditions for sample preparation and the special primer design are tailored to ensure high specificity and to avoid false positive Six different primers are used in RT-LAMP specifically designed to avoid the amplification of CK19 pseudogenes or their transcripts, and furthermore to speed up the reaction of the assay. LAMP Primer...

Clinical validation studies and results The OSNA method has been evaluated in multiple multicentric studies in different countries [1–5]. In all these studies OSNA was compared to an extensive histopathological examination. The lymph nodes were cut with a special cutter device into 4 slices of 1 or 2 mm width. Alternate slices were applied either to the OSNA assay or used for multilevel histology on permanent sections. Sections were taken from 5 levels with skip ribbons of 100, 200 or 250 µm. In summary, 2313 lymph nodes have been analysed and generated the following performance data: Concordance...

Displayed parameters Tissue range per sample Sample volume Data storage Quality control Gene Amplification Detector System RD-100/ OSNA (One Step Nucleic Acid Amplification) RT-LAMP (Reverse transcriptase loop-mediated isothermal amplification) change of transmitted light caused by the precipitation of magnesium pyrophosphate depending on the grade of the reaction homogenising reagent LYNORHAG amplification reagent LYNOAMP BC positive and negative control 180 data points per file host computer connection (RS232, LAN) wxhxd [mm]/[kg] SNCS optional with Sysmex Service Agent and remote access Design...