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ID NOW COVID-19 2.0 performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection. ID NOW COVID-19 2.0 performed on the ID NOW Instrument is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection.

Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not preclude co-infection with bacteria or other viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

A negative test result is presumptive, and it is recommended these results be confirmed by another molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. This test is intended for prescription use only and can be used in Pointof-Care settings.

ID NOW COVID-19 2.0 is a rapid, instrument-based isothermal test for the qualitative detection of nucleic acid from SARS-CoV-2 viral RNA in direct nasal or nasopharyngeal swabs. The ID NOW COVID-19 2.0 System utilizes isothermal nucleic acid amplification technology and is comprised of:

• Sample Receiver single use, disposable containing the elution buffer.
• Test Base single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet.
• Transfer Cartridge - single use, disposable for transfer of the eluted sample to the Test Base
• Patient Swabs sterile anterior nasal swabs (foam) for anterior nasal swab collection and for use as a Negative Control Swab
• Positive Control Swab - single use, to ensure that test reagents are working properly and that the test is correctly performed, and
• ID NOW Instrument

The reaction tubes in the Test Base contain lyophilized reagents required for amplification of the target nucleic acid and an internal control. ID NOW COVID-19 2.outilizes a pair of templates (similar to primers) for the specific amplification of RNA from SARS-CoV-2 and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid targets. ID NOW COVID-19 2.0 is performed within the confinement of the Test Base, and no other part of the ID NOW Instrument has contact with the sample during the amplification process. This minimizes the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument. The sample is added to the Sample Receiver and transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating viral lysis and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the ID NOW Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the ID NOW Instrument by the operator either manually or using barcode scanner. Data can be retrieved and downloaded by the operator at any time after testing. An external Universal Printer can be attached via USB to the ID NOW Instrument to print test results.

The provided text describes the performance of the ID NOW COVID-19 2.0 device, which is an in vitro diagnostic test for SARS-CoV-2.

Here's an analysis addressing your questions, keeping in mind that this is a diagnostic test and not an AI-assisted imaging device, so some questions (like MRMC studies) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For diagnostic tests, "acceptance criteria" are typically defined by performance targets for sensitivity (Positive Agreement) and specificity (Negative Agreement). These are assessed against a highly accurate comparator method (Ground Truth).

Acceptance Criteria (Implied by High Performance and Clinical Utility for a Molecular Test) and Reported Device Performance:

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

• Sample Size for Clinical Test Set: 914 specimens (460 anterior nasal swabs and 454 nasopharyngeal swabs).
• Data Provenance:
  • Country of Origin: United States (US). The study was conducted at twenty-one (21) US sites.
  • Retrospective or Prospective: Prospective clinical study. Specimens were collected from individuals showing signs and symptoms of upper respiratory infection at the time of enrollment.

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

This is a diagnostic test based on molecular detection, not an imaging device requiring expert reader interpretation for ground truth.

• Number of "Experts": Not applicable in the context of human readers for establishing ground truth for individual cases. The ground truth was established by a composite comparator method using three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays. This method is considered the "gold standard" for SARS-CoV-2 detection.
• Qualifications of Experts: N/A for individual case ground truth. The RT-PCR assays are performed by laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

The ground truth was established by a composite comparator method using three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays. This implies that the consensus or outcome of these highly sensitive and specific molecular tests served as the ground truth. The document does not describe a human adjudication process, as the ground truth is derived from objective molecular testing results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Was it done?: No, an MRMC study was not conducted for this device.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: This question is not applicable as the ID NOW COVID-19 2.0 is a standalone molecular diagnostic test, not an AI-assisted diagnostic tool for human readers.

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

• Was it done?: Yes, the clinical performance study evaluated the standalone performance of the ID NOW COVID-19 2.0 device. The results are automatically reported by the ID NOW Instrument (see Device Description), meaning there is no human interpretation of the raw signal or algorithm output before a result is given. Results are "Positive," "Negative," or "Invalid."

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical study was established using a composite comparator method consisting of three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays for the detection of SARS-CoV-2. This is considered a molecular gold standard or definitive diagnostic method.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set" in the context of machine learning model development. This is a traditional IVD device, not an AI/ML diagnostic. The analytical studies (LoD, Inclusivity, Cross-Reactivity, Interference) and clinical study are part of the validation process, not "training" of an AI model.

• Training Set Size: Not applicable/not explicitly stated as this is not an AI/ML device that undergoes a discrete training phase with labeled data in the same way. The development and optimization of the assay itself would involve iterative testing, but this is different from an AI "training set."

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

• How Ground Truth for Training was Established: Not applicable as this is a molecular diagnostic test, not an AI/ML device requiring a distinct training set with established ground truth labels in the typical AI sense. The assay's analytical characteristics and performance are established through experiments and clinical trials.

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