Abbott RealTime IDH1

Abbott RealTime IDH1 is an in vitro polymerase chain reaction (PCR) assay for 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.

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).

Intended Use

Abbott RealTime IDH1 is an in vitro polymerase chain reaction (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.

Indications For Use

Abbott RealTime IDH1 is indicated as an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-1 (IDH1) mutation for treatment with TIBSOVO^® (ivosidenib).

ASSAY PROTOCOL

The Abbott RealTime IDH1 assay protocol includes the following steps:

A. Manual preparation (ie, DNA extraction) of samples (specimens and controls) using the Abbott mSample Preparation System_DNA (List No. 06K12 24) reagents to isolate and purify sample DNA.

B. PCR assay setup using the sample eluates and the Abbott RealTime IDH1 Amplification Reagent Kit.

C. Amplification/detection on the Abbott m2000rt instrument.

Specimens for Abbott RealTime IDH1 are processed manually using Abbott mSample Preparation System_DNA (List No. 06K12 24) reagents to isolate and purify sample DNA. 

The Abbott RealTime IDH1 amplification reagents are combined into two amplification master mixes. 

The purified DNA sample is combined with the master mixes in an Abbott 96-Well Optical Reaction Plate, and the plate is transferred to the Abbott m2000rt instrument for amplification and detection of IDH1 mutations. 

Note: Per magnetic rack, a maximum of 12 samples (patient specimens and/or assay controls) can undergo DNA extraction. It is not recommended to perform DNA extraction in batch sizes that exceed 12 samples.

The specimen result is automatically reported on the Abbott m2000rt workstation at run completion. Assay controls are included within each run and are processed through the DNA extraction, amplification, and detection steps of the assay to assess run validity.

Software parameters specific to Abbott RealTime IDH1 are contained in an assay application specification file, which is loaded onto the Abbott m2000rt instrument by using a CD ROM disk.

Refer to the WARNINGS AND PRECAUTIONS section of this package insert for instructions before preparing samples. 

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.
• 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.
• 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, donot use the IDH1 Oligonucleotide Reagents from Amplification kit lot X with the DNA Polymerase from Amplification kit lot Y.