LYNOAMP CK19 E
OSNA amplification reagent
- Cytokeratin 19 (CK19) carcinoma marker
- Simple reagent management and consumption traceability by QR code
- IVDR CE-marked for application in breast, colorectal and gastric cancer.
- IVD CE-marked for application in endometrial, cervical, prostate and non-small cell lung cancer.
OSNA – One Step Nucleic Acid Amplification – is an automated rapid molecular diagnostic test for the detection of lymph node (LN) metastases. It analyses the entire LN tissue using a reverse transcriptase loop-mediated isothermal amplification reaction (RT-LAMP*) to quantify tumour-specific cytokeratin 19 (CK19) mRNA expression in LNs.
LYNOAMP CK19 E is an in vitro diagnostic reagent kit (IVDR class C) for the detection and quantification of CK19 mRNA in surgically removed lymph node(s) lysate of breast, colorectal, gastric, non-small cell lung, cervical, endometrial, and prostate cancer patients as an aid to diagnosing the size of metastasis and metastatic burden in the lymph node(s). LYNOAMP CK19 E is intended for use exclusively on the Sysmex Gene Amplification Detector, RD-210.
| Article number | BX207480 |
| Capacity | 120 tests |
| Operative temperature | Measurement: 64 °C |
| Dimensions box | W105 mm x D85 mm x H50 mm |
| Weight box | total 88 g; vials only 6.4 g |
| Storage conditions | -15 to -25° C |
| Shelf life | 12 months after production |
| In-use expiry | 3 months after enzyme opening |
Sysmex Europe SE
Bornbarch 1
22848 Norderstedt
Germany
+49 (40) 527 26 0
+49 (40) 527 26 100
Product documents
Regulatory documents
Regulatory documents, such as Instructions for Use, can be accessed with a valid My Sysmex login:
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