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QUANTA Flash LKM-1 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-liver/ kidney microsome type 1 antibodies in human serum. The presence of anti-liver/kidney microsome type 1 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of autoimmune hepatitis type 2.

QUANTA Flash LKM-1 Calibrators are intended for use with the QUANTA Flash LKM-1 Reagents for the determination of IgG anti-LKM-1 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.

QUANTA Flash LKM-1 Controls are intended for use with the QUANTA Flash LKM-1 Reagents for quality control in the determination of IgG anti-LKM-1 autoantibodies in human serum.

The QUANTA Flash LKM-1 assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash LKM-1 assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument.

Recombinant cytochrome P450 2D6 (LKM-1) antigen is coated onto paramagnetic beads. The bead suspension is lyophilized and stored in the bead tube. Prior to use in the BIO-FLASH system, the sealed reagent tubes are pierced with the reagent cartridge lid and the beads are rehydrated and resuspended using resuspension buffer by pipetting up and down with a transfer pipette. The reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in sample racks. Serum samples are diluted by the BIO-FLASH with system rinse in a small disposable plastic cuvette. Small amounts of the diluted patient serum, the beads, and assay buffer are combined into a second cuvette, and mixed. This cuvette is then incubated at 37°C. The beads are magnetized and washed several times. Isoluminol conjugated anti-human IgG antibodies are then added to the cuvette, and again incubated at 37°C. The beads are magnetized and washed repeatedly. The isoluminol conjugate is oxidized when Trigger 1 (Fe(II)coproporphyrin in sodium hydroxide solution) and Trigger 2 (urea-hydrogen peroxide in sodium chloride solution) are added to the cuvette, and the flash of light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of isoluminol conjugate that is bound to the human IgG, which is in turn proportional to the amount of anti-LKM-1 antibodies bound to the corresponding beads.

For quantitation, the QUANTA Flash LKM-1 assay utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use, with the QUANTA Flash LKM-1 Calibrators. Based on the results obtained with the three Calibrators included in the Calibrator Set (sold separately), an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU) from the instrument signal (RLU) obtained for each sample.

The QUANTA Flash LKM-1 Reagents kit contains the following materials:

One (1) QUANTA Flash LKM-1 Reagent Cartridge One (1) vial of Resuspension buffer One (1) Transfer pipette

The QUANTA Flash LKM-1 reagent cartridge contains the following reagents for 50 determinations:

• a. LKM-1 coated paramagnetic beads, lyophilized.
• b. Assay buffer - colored pink, containing Tris-buffered saline, Tween 20, protein stabilizers and preservatives.
• C. Tracer IgG - Isoluminol labeled anti-human IgG antibodies in buffer, containing protein stabilizers and preservative.

The QUANTA Flash LKM-1 Calibrators kit contains two vials each of Calibrator 2, and Calibrator 3:

QUANTA Flash LKM-1 Calibrators:

• । QUANTA Flash LKM-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.
• -QUANTA Flash LKM-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.
• -QUANTA Flash LKM-1 Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.

The QUANTA Flash LKM-1 Controls kit contains two vials of Negative Control and two vials of Positive Control:

QUANTA Flash LKM-1 Controls:

• । QUANTA Flash LKM-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers and preservatives.
• । QUANTA Flash LKM-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers, and preservatives.

This document describes the regulatory submission for the QUANTA Flash® LKM-1 Reagents, Calibrators, and Controls, a chemiluminescent immunoassay used for the semi-quantitative determination of IgG anti-liver/kidney microsome type 1 antibodies in human serum. This product aids in the diagnosis of autoimmune hepatitis type 2 (AIH-2) when used with clinical findings and other laboratory tests.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally implied within the performance studies described in the document, rather than explicitly stated in a single summarized table. The document provides detailed performance data for analytical and clinical characteristics. Here's a partial summary based on the provided information, focusing on quantifiable metrics:

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