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Alinity m SARS-CoV-2 is a real-time in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System for the qualitative detection of nucleic acid from SARS-CoV-2 from patients with signs and symptoms of COVID-19 in nasopharyngeal (NP) swab and anterior nasal swab (ANS) specimens.

Results are for the detection and identification of SARS-CoV-2 RNA. Alinity m SARS-CoV-2 assay is intended for use as an aid in the diagnosis of COVID-19 if used in comunction with other clinical, endemiologic, and laboratory findings. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

Alinity m SARS-CoV-2 is a real-time in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System for the qualitative detection of nucleic acid from SARS-CoV-2 in specimens collected from patients with signs and symptoms of COVID-19.

The steps of the Alinity m SARS-CoV-2 assay consist of sample preparation, RT-PCR assembly, amplification/detection, and result reporting. All stages of the Alinity m SARS-CoV-2 assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random-access analyzer that can perform the Alinity m SARS-CoV-2 assay in parallel with other Alinity m assays on the same instrument.

The Alinity m SARS-CoV-2 assay requires two separate assay specific kits as follows:

• . Alinity m SARS-CoV-2 AMP Kit; 09N78-096 is comprised of 2 types of multi-well trays: Alinity m SARS-CoV-2 AMP TRAY 1 and Alinity m SARS-CoV-2 ACT TRAY 2. The intended storage condition for the Alinity m SARS-CoV-2 AMP Kit is -15°C to -25°C.
• Alinity m SARS-CoV-2 CTRL Kit: 09N78-086 consists of negative controls and . positive controls, each supplied as liguid in single-use tubes. The Alinity m SARS-CoV-2 controls are used for validity determination of the Alinity m SARS-CoV-2 assay on the automated Alinity m System. These controls are intended to be used with the Alinity m SARS-CoV-2 assay. The intended storage condition for the Alinity m SARS-CoV-2 Control Kit is -15°C to -25°C.

The Alinity m SARS-CoV-2 assay may utilize the following for collection and transport of anterior nasal swab specimens:

• Abbott Universal Collection Kit; 09N92-030 consists of one Transport Tube with a solid cap containing 1.65 mL Specimen Transport Buffer and one sterile Specimen Collection Swab. The Abbott Universal Collection Kit is intended for the collection and transport of anterior nasal swabs for testing with the Alinity m SARS-CoV-2 assay. The collected specimens are intended to be tested on the automated Alinity m System. The intended storage condition for the Abbott Universal Collection Kit is 15°C to 30°C.
• Abbott Universal Collection Kit II: 09N92-040 consists of one Transport Tube with . a pierceable cap containing 1.65 mL Specimen Transport Buffer, one sterile Specimen Collection Swab, and one absorbent pad. The Abbott Universal Collection Kit II is intended for the collection and transport of anterior nasal swabs for testing with the Alinity m SARS-CoV-2 assay. The collected specimens are intended to be tested on the automated Alinity m System; The intended storage condition for the Abbott Universal Collection Kit is 15℃ to 30℃.
  SARS-CoV-2 RNA from specimens is extracted automatically on-board 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 the liquid unit-dose activation reagent, liquid unit-dose amplification reagents, and Alinity m Vapor Barrier Solution, and transferred by the instrument to an amplification/detection module for reverse transcription, PCR amplification, and realtime fluorescence detection.

Assay controls are tested to help ensure that instrument and reagent performance remain satisfactory. During each control event, a negative control and a positive control are processed through sample preparation and RT- PCR procedures that are identical to those used for specimens. Assay controls are used to demonstrate proper sample processing and assay validity. Each Alinity m SARS-CoV-2 CTRL kit contains 12 vials (1.3 mL fill volume) of Negative Control and 12 vials (1.3 mL fill volume) of Positive Control.

The Alinity m SARS-CoV-2 amplification reagents include primers and probes that amplify and detect an exogenous internal control (containing an armored RNA sequence). Amplification and detection of the internal control demonstrates proper sample processing. The internal control is used to demonstrate assay validity.

Patient results are automatically reported on the Alinity m instrument. The Alinity m SARS-CoV-2 application parameters will be contained in an assay application specification file.

The Alinity m SARS-CoV-2 assay also utilizes the following:

• . Alinity m SARS-CoV-2 Assay Application Specification File, List No. 09N78-05A
  The Alinity m SARS-CoV-2 application specification file is intended for use with the Alinity m SARS-CoV-2 assay on the automated Alinity m System to allow for processing of assay controls and patient samples.

• Alinity m System and System Software, List No. 08N53-002 •

• Alinity m Sample Prep Kit 2, List No. 09N12-001

• Alinity m Tubes and Caps, List No. 09N49:

  • 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

• 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

The Alinity m SARS-CoV-2 assay is a real-time in vitro reverse transcription polymerase chain reaction (RT-PCR) assay designed for the qualitative detection of SARS-CoV-2 nucleic acid. The study evaluated its performance for in vitro diagnostic use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative assays like this are typically based on positive percent agreement (PPA) and negative percent agreement (NPA) with a composite comparator. While explicit acceptance criteria values (e.g., minimum PPA/NPA) are not directly stated in the provided text, the reported device performance is presented. The study results aim to demonstrate performance comparable to a predicate device, supporting substantial equivalence.

2. Sample Sizes Used for the Test Set and Data Provenance

• Study 1 (Nasopharyngeal Swab):

  • Sample Size: 535 specimens included in the analysis (from an initial 627 UVT NPS specimens tested).
  • Data Provenance: Prospective clinical study, collected at 8 geographically distributed locations in the US from January to February 2021.

• Study 2 (Anterior Nasal Swab):

  • Sample Size (ANS UCK): 766 specimens included in the analysis (from an initial 792 ANS UCK specimens available).
  • Sample Size (ANS UVT): 759 specimens included in the analysis (from an initial 787 ANS UVT specimens available).
  • Data Provenance: Prospective clinical study, collected at 8 geographically distributed locations in the US from September 2021 to January 2022.

The data is explicitly stated as prospective and collected from the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the clinical studies was established using a composite comparator (CC) derived from a minimum of two and up to three highly sensitive EUA SARS-CoV-2 molecular assays. The document does not specify the number or qualifications of experts involved in interpreting the results of these comparator assays or in establishing the final composite result. The ground truth relies on the performance of these other molecular assays.

4. Adjudication Method for the Test Set

The adjudication method for the composite comparator ground truth was:

• CC Positive: If a minimum of 2 comparator positive results were reported.
• CC Negative: If a minimum of 2 comparator negative results were reported.
• CC Indeterminate: If a CC could not be determined due to missing results from the comparator assays.

This method resembles a "2-out-of-X" or "majority vote" approach among the comparator assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This document describes a diagnostic assay (Alinity m SARS-CoV-2) for the detection of nucleic acid, not an AI-assisted diagnostic imaging device or a system involving human "readers." Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on the improvement of human readers with AI assistance is not applicable and was not performed or reported in this context. The Alinity m System is an automated platform, and the assay's output is a "positive," "negative," or "not detected" result based on the instrument's analysis of the PCR reaction.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented evaluate the standalone performance of the Alinity m SARS-CoV-2 assay on the automated Alinity m System. The device is designed to perform all assay steps automatically (sample preparation, RT-PCR assembly, amplification/detection, and result reporting) without intermediate user intervention. The clinical performance data presented in Table 13 directly reflects this standalone, algorithm-only performance against the composite comparator.

7. The Type of Ground Truth Used

The ground truth used for the clinical studies was a composite comparator established using a minimum of two and up to three highly sensitive EUA SARS-CoV-2 molecular assays. This falls under the category of using established, high-performing diagnostic tests as a reference standard.

8. The Sample Size for the Training Set

The document describes performance data for the Alinity m SARS-CoV-2 assay but does not provide details about a specific training set size for the development of the assay's underlying algorithms or parameters. Molecular assays like RT-PCR involve established biochemical principles and reagents rather than general-purpose machine learning algorithms that typically require large, explicit training datasets for model development in the same way an imaging AI algorithm would. The development of such assays often involves extensive analytical verification and validation, including optimization of primer/probe designs and reaction conditions, rather than a "training set" in the common AI sense.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, the concept of a "training set" and its "ground truth" in the context of this specific molecular diagnostic assay is not directly applicable or detailed in the provided summary as it would be for an AI/ML-based device. The assay's analytical characteristics (e.g., Limit of Detection, Inclusivity, Cross-reactivity) are established through controlled laboratory experiments using quantified viral material and known biological samples, which serve to define the assay's performance characteristics rather than "train" an algorithm with a labeled dataset.

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