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Vysis EGR1 FISH Probe Kit

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Intended Use

The Vysis EGR1 FISH Probe Kit is intended to detect deletion of the LSI EGR1 probe target on chromosome 5q in bone marrow specimens and to be used, in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of acute myeloid leukemia (AML) diagnosis as an aid in determining prognosis. Deletion of chromosome 5q has been associated with an unfavorable prognosis in AML patients.

Limitations of the Procedures

  • FOR IN VITRO DIAGNOSTIC USE ONLY.
  • The Vysis EGR1 FISH Probe Kit is intended to be used in combination with additional biomarkers, morphology, and other clinical information.
  • If a specimen has a low level abnormal FISH pattern, use of the appropriate single-pass filter to confirm the pattern is recommended. Failure to follow this recommendation may result in inaccurate identification of signals.
  • Other abnormal signal patterns may occur, and metaphase analysis may be helpful in characterization of such patterns.

Rx Only

To learn more about Vysis EGR1 FISH Probe Kit - SC please visit: https://www.molecular.abbott/us/en/products/oncology/vysis-egr1-fish-probe-kit-specimen-characterization

Normal Hybridization: Vysis LSI EGR1 SpectrumOrange/D5S23, D5S721 SpectrumGreen Probes hybridized to cells showing the two orange, two green (2R2G) signal pattern.

ASR Analyte Specific Reagent (Analytical and performance characteristics are not established)
GPR General Purpose Reagent
IVD In Vitro Diagnostics (Rx Only)
RUO Research Use Only (Not for Diagnostic Use)
All products manufactured and/or distributed by Abbott should be used in accordance with the products' labeled intended use.

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