QXDx BCR-ABL %IS Kit (IVD/CE-IVD)

The QXDx BCR-ABL %IS Kit is a digital PCR test that monitors the p210 BCR-ABL major translocation in the peripheral blood of patients with Chronic Myeloid Leukemia (CML). The test is designed and run on Bio-Rad's QXDx Droplet Digital PCR System, enabling precise, highly sensitive quantification of nucleic acids.

Features and Benefits

• Absolute quantification — eliminates the need for standard curves
• High precision and accuracy — increased sensitivity with 2-well test per patient sample
• High precision and accuracy — increased sensitivity with 2- or 4-well test per patient sample
• Simplified and scalable workflow — flexibility to evaluate 8 to 48 samples per run in a workflow as simple as qPCR
• Direct reporting on International Scale (%IS) and Molecular Response (MR) values — provides standardized interpreted output
• QXDx BCR-ABL CE-IVD Reporter Tool — download the reporter tool to automate your report generation with MR binning and MR power calculations

The QXDx BCR-ABL %IS Kit (12005660)(12006134) can be used with either one of Bio-Rad’s digital PCR systems FDA-cleared for use in regulatory/in vitro diagnostics (IVD)* environments:

• QXDx ddPCR System, requires QXDx Consumable Pack (12001921) and QXDx Droplet Reader Oil Pack (12002526)
• QXDx AutoDG ddPCR System, requires QXDx AutoDG Consumable Pack (12001922) and QXDx Droplet Reader Oil Pack (12002526)

Related Categories

• Digital PCR
• QXDx Product Family

Supporting Documents

• Approved Importers