For In Vitro Diagnostic Use

INTENDED USE

Abbott RealTime IDH1 is an in vitro PCR assay for the qualitative detection of single nucleotide variants (SNVs) coding five IDH1 R132 mutations (R132C, R132H, R132G, R132S, and R132L) in DNA extracted from human blood (EDTA) or bone marrow (EDTA). Abbott RealTime IDH1 is for use with the Abbott m2000rt System.

INDICATION FOR USE

Abbott RealTime IDH1 is indicated as an aid in identifying acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients with an IDH1 mutation for treatment with TIBSOVO® (ivosidenib) or in identifying AML patients for treatment with REZLIDHIA^TM (olutasidenib).

This test is for prescription use only.

Description

Abbott RealTime IDH1 consists of two kits:

• Abbott RealTime IDH1 Amplification Reagent Kit (List No. 08N90‑090)
  That includes 5 vials sufficient for 24 tests:
  • Oligonucleotide Regent 1 and 2 (each vial 0.905 mL)
  • DNA Polymerase (2 vials – 0.051 mL/vial)
  • Activation Reagent (1 vial – 0.930 mL/vial)
• Abbott RealTime IDH1 Control Kit (List No. 08N90‑080)
  That includes 10 vials sufficient for 5 runs:
  • Negative Control (5 vials – 0.210 mL / vial)
  • Positive Control (5 vials – 0210 mL / vial).

Warnings and Precautions

Abbott RealTime IDH1 is for use with EDTA preserved human blood and EDTA preserved bone marrow aspirate.

Use only USP grade 190 to 200 proof ethanol (95% to 100% ethanol) to prepare the mWash 2 DNA sample preparation reagent. Do not use ethanol that contains denaturants.

Limitations Of The Assay

• For In Vitro Diagnostic Use
• Abbott RealTime IDH1 is for use with human blood (EDTA) and bone marrow aspirate (EDTA) specimens only.
• Optimal performance of this test requires appropriate specimen collection, handling, preparation, and storage (refer to the SPECIMEN COLLECTION, STORAGE, And Transport To The Test Site section of the package insert).
  
• Use of the Abbott RealTime IDH1 assay is limited to personnel who have been trained in the procedures of molecular diagnostic assays, the Abbott m2000rt instrument, and the manual sample preparation method for Abbott RealTime IDH1.
• A “Not Detected” result does not preclude the presence of IDH1 mutations in the specimen. Assay results may be affected by inadequate specimen integrity, mutation content in the sample, and amount of amplifiable DNA.
• The instrument and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the positive control or specimens must be controlled by good laboratory practices and careful adherence to the procedures specified in this package insert.
• Abbott RealTime IDH1 is designed to detect IDH1 R132C, R132H, R132G, R132S, and R132L mutations. Specimens with results reported as “Not Detected” may contain mutations that are not targeted by the assay.
• Components contained within a kit are intended to be used together. Do not mix components from different kit lots. For example, do not use the IDH1 Oligonucleotide Reagents from Amplification kit lot X with the DNA Polymerase from Amplification kit lot Y.
  

Rx Only

To learn more about RealTime IDH1 please visit: https://www.molecular.abbott/us/en/products/oncology/realtime-idh1