SEBIA HYDRASHIFT 2/4 DARATUMUMAB
MITIGATE DARATUMUMAB INTERFERENCE ON IMMUNOFIXATION FOR DARZALEX® TREATED PATIENTS.HYDRASHIFT 2/4 daratumumab is a reagent used on Sebia’s HYDRAGEL immunofixation test on agarose gel specifically designed to mitigate daratumumab drug interference. It is designed for use on Sebia’s semi-automated gel platform HYDRASYS 2.
TEST PRESENTATION
It is well known that the newer treatments for multiple myeloma that use humanized monoclonal antibodies (mAbs) can interfere with the patient’s native antibodies in immunofixation tests. This can mislead the pathologist in interpreting the patient’s response to treatment. Immunofixation is one of the tests referenced in the IMWG (International Myeloma Working Group) guidelines to establish the diagnosis of complete response in a patient with multiple myeloma.
TEST PRINCIPLE
HYDRASHIFT 2/4 daratumumab kits are to be used in conjunction with the HYDRAGEL IF kit and the semi-automated HYDRASYS 2 electrophoresis instrument.
The HYDRASHIFT daratumumab immunofixation procedure is a direct analysis without the need for sample pre-treatment. It is based on the creation of a daratumumab/anti-daratumumab immune complex to shift daratumumab in the alpha-1 zone. This complex is visible in the IgG and kappa immunofixation tracks.
A negative HYDRASHIFT 2/4 daratumumab result demonstrates the absence of endogenous M-protein.
This IVD test is specific for patients treated by DARZALEX®, to be used only on Sebia’s FDA cleared and CE marked HYDRASYS 2 agarose gel platform. It cannot be used for other patient samples with any other interfering monoclonal antibodies or any other immunofixation test.
PERFORMANCES
- Sensitivity:
- The limit of daratumumab and/or daratumumab/anti-daratumumab immune complex visualized is 200 mg/L.
- According to the mobility of the monoclonal component and polyclonal background, the sensitivity may vary.
- Specificity:
- Concordance study was performed on 54 serum samples analyzed with the HYDRASHIFT daratumumab immunofixation procedure.
- This study, conducted between neat samples and the same samples added with daratumumab, demonstrated a 100 % agreement for displacing daratumumab interference.
- In addition, patients’ monoclonal proteins were detected and characterized with 100 % agreement.
KIT DESCRIPTION
HYDRASHIFT 2/4 daratumumab (PN 4639)
Kit content:
- Anti-daratumumab antiserum
- Sample diluent
- Green applicators
Related products and accessories not provided in the kit:
- HYDRAGEL 2, 4 IF (SM*; Acid Violet stain) (PN 4802, 4804)
- HYDRAGEL 2, 4 IF (DM**; Acid Violet stain) (PN 4302, 4304)
- HYDRAGEL IF related products and accessories
- HYDRASHIFT 2/4 accessories (PN 1251)
- Daratumumab CONTROL (PN 4765)
COMPATIBLE INSTRUMENTS
HYDRASYS 2 SCAN (PN 1200)
HYDRASYS 2 (PN 1201)
HYDRASYS 2 SCAN FOCUSING (PN 1202)
HYDRASYS 2 FOCUSING (PN 1203)
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