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The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals. The assay is intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV infection, and to aid in the management of patients with known active HCV infection, including Sustained Virologic Response (SVR) determination.

The results from the Alinity m HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.

The Alinity m HCV assay is not intended to be used in screening blood, plasma, serum, tissue or tissue donors for HCV.

Alinity m HCV is an in vitro polymerase chain reaction (PCR) assay for both the detection and quantitation of HCV RNA in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals.

This device is similar to the predicate device originally approved (PMA P190025) with the exception that the subject device may use a new DNA Polymerase as an alternative to the original DNA Polymerase and a new Reverse Transcriptase as an alternative to the original Reverse Transcriptase in the reagent formulation of the assay. This formulation difference does not introduce any changes to sample processing, assay procedure, or data reduction.

Additional studies were initiated to support the formulation of the assay with alternative DNA Polymerase and Reverse Transcriptase. Supplemental data from these studies were used with data previously obtained from the analytical and clinical testing studies submitted in P190025.

The steps of the Alinity m HCV assay consist of sample preparation, real-time PCR assembly, amplification/detection, result calculation, and reporting. All steps of the Alinity m HCV assay procedure are executed automatically by the Alinity m System. Manual dilutions may be performed for low-volume specimens to meet the minimum volume requirement and for high-titer specimens above the upper limit of quantitation (ULoQ). The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m HCV assay in parallel with other Alinity m assays on the same instrument.

Alinity m HCV requires three separate assay specific kits as follows:

• Alinity m HCV AMP Kit (List No. 08N50-095), consisting of 2 types of multi-well assay trays. The amplification trays (AMP Trays) contain lyophilized, unit-dose RT-PCR amplification/detection reagents and lyophilized, unit-dose IC in separate wells, and the activation trays (ACT Trays) contain liquid activation reagent. The intended storage condition for the Alinity m HCV AMP Kit is 2°C to 8°C.

• Alinity m HCV CTRL Kit (List No. 08N50-085), consisting of negative controls, low positive controls, and high positive controls, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m HCV CTRL Kit is –25°C to –15°C.

• Alinity m HCV CAL Kit (List No. 08N50-075), consisting of 2 calibrator levels, each supplied as liquid in single-use tubes. The intended storage condition for the Alinity m HCV CAL Kit is –25°C to –15°C.

HCV RNA from human plasma or serum is extracted automatically on-board in the Alinity m System using the Alinity m Sample Prep Kit 2, Alinity m Lysis Solution, and Alinity m Diluent Solution. The Alinity m System employs magnetic microparticle technology to facilitate nucleic acid capture, wash, and elution. The resulting purified nucleic acids are then combined with liquid unit-dose Alinity m HCV activation reagent and lyophilized unit-dose Alinity m HCV amplification/detection reagents and transferred into a reaction vessel. Alinity m Vapor Barrier Solution is then added to the reaction vessel which is then transferred to an amplification/detection unit for PCR amplification, and real-time fluorescence detection of HCV targets.

At the beginning of the Alinity m HCV sample preparation process, a lyophilized unit-dose IC on the AMP Tray is rehydrated by the Alinity m System and delivered into each sample preparation reaction. The IC is then processed through the entire sample preparation and real-time PCR procedure along with the specimens, calibrators, and controls to demonstrate proper sample processing and validity.

The Alinity m HCV amplification/detection reagents consist of enzymes, primers, probes, and activation reagents that enable reverse transcription, polymerization, and detection.

An HCV calibration curve is required for determination of HCV RNA concentration. Two levels of calibrators are processed through sample preparation and RT-PCR to generate the calibration curve. The concentration of HCV RNA in specimens and controls is then calculated from the stored calibration curve.

Assay controls are tested at or above an established minimum frequency to help ensure that instrument and reagent performance remains satisfactory. During each control event, a negative control, a low-positive control, and a high-positive control are processed through sample preparation and RT-PCR procedures that are identical to those used for specimens.

The Alinity m HCV assay also utilizes the following:

• Alinity m HCV Application Specification File, (List No. 08N50-03B)
• Alinity m System and System Software (List No. 08N53)
• Alinity m Sample Prep Kit 2 (List No. 09N12-001)
• Alinity m Specimen Dilution Kit I (List No. 09N50-001)
• Alinity m System Solutions, (List No. 09N20):
  • Alinity m Lysis Solution (List No. 09N20-001)
  • Alinity m Diluent Solution (List No. 09N20-003)
  • Alinity m Vapor Barrier Solution, (List No. 09N20-004)
• Alinity m Tubes and Caps (List No. 09N49):
  • Alinity m LRV Tube (List No. 09N49-001)
  • Alinity m Transport Tubes Pierceable Capped (List No. 09N49-010)
  • Alinity m Transport Tube (List No. 09N49-011)
  • Alinity m Pierceable Cap (List No. 09N49-012)
  • Alinity m Aliquot Tube (List No. 09N49-013)

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