Search Results

The Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test intended for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens and anterior nasal (AN) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. This assay is intended to aid in the differential diagnosis of SARS-CoV-2, Flu A, Flu B, and RSV infections in humans and is not intended to detect influenza C virus infections.

Nucleic acids from the viral organisms identified by this test are generally detectable in NP and AN swab specimens during the acute phase of infection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infective of the presence of the identified virus and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Positive results do not rule out coinfection with other organism(s) detected by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. This assay is designed for use on the Panther Fusion system.

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is classified as a Class II in vitro diagnostic device per 21 CFR 866.3981 and has product code QOF. The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is designed for use on the fully automated Panther Fusion System.

The Panther Fusion system is a class II exempt device under 21CFR 862.2570 that has product code OOI.

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a multiplex real-time reverse transcriptase PCR (RT-PCR) in vitro diagnostic test developed for use on the fully automated Panther Fusion system to detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) directly from nasopharyngeal and anterior nasal swab specimens, from individuals exhibiting signs and symptoms of a respiratory tract infection.

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay involves the following steps: sample lysis, nucleic acid capture and elution transfer, and multiplex RT-PCR where analytes (when present) are simultaneously amplified, detected and differentiated. Nucleic acid capture and elution takes place in a single tube on the Panther Fusion system. The eluate is transferred to the Panther Fusion system reaction tube containing the assay reagents. Multiplex RT-PCR is then performed for the eluted nucleic acid on the Panther Fusion system.

Sample lysis, nucleic acid capture, and elution: Prior to processing and testing on the Panther Fusion system, specimens are transferred to a Specimen Lysis Tube containing specimen transport media (STM). Alternatively, samples can be collected with the RespDirect Collection kit which contains enhanced specimen transport media (eSTM). STM and eSTM lyse the cells, release target nucleic acid and protect them from degradation during storage. The Internal Control-S (IC-S) is added to each test specimen and controls via the working Panther Fusion Capture Reagent-S (wFCR-S). The IC-S is the reagent used to monitor specimen processing, amplification and detection. Magnetic particles with covalently bound oligonucleotides mediate the nucleic acid capture. Capture oligonucleotides hybridize to nucleic acid in the test specimen. Hybridized nucleic acid is then separated from the lysed specimen in a magnetic field. Wash steps remove extraneous components from the reaction tube. The elution step elutes purified nucleic acid. During the nucleic acid capture and elution step, total nucleic acid is isolated from specimens.

Elution transfer and RT-PCR: During the elution transfer step, eluted nucleic acid is transferred to a Panther Fusion tube already containing oil and reconstituted mastermix. Target amplification occurs via RT-PCR. A reverse transcriptase generates a DNA copy of the target sequence. Target specific forward and reverse primers and probes then amplify targets while simultaneously detecting and discriminating multiple target types via multiplex RT-PCR. The Panther Fusion system compares the fluorescence signal to a predetermined cut-off to produce a qualitative result for the presence or absence of the analyte. The positive result for each analyte will be accompanied by the cycle threshold (Ct value).

Here's a breakdown of the acceptance criteria and the study details for the Hologic Panther Fusion SARS-CoV-2/Flu A/B/RSV assay, based on the provided document:

Acceptance Criteria and Device Performance

The document describes the performance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in detecting SARS-CoV-2, Flu A, Flu B, and RSV in prospectively collected Anterior Nasal (AN) swab specimens in RespDirect eSTM.

Table of Acceptance Criteria (Implicit) and Reported Device Performance

While explicit acceptance criteria (e.g., minimum PPA/NPA values) are not stated, the document presents the observed Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) with their 95% Confidence Intervals. These values are implicitly the performance targets for the assay.

Study Information

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

• Prospective Study:
  • Sample Size: 1021 evaluable anterior nasal (AN) swab specimens.
  • Data Provenance: Prospective, multicenter study conducted in the US between January 2023 and May 2023 at nine participating medical facilities.
• Enrichment Study (Supplemental Clinical Data for Low Prevalence Analytes):
  • Sample Size: 205 evaluable anterior nasal (AN) swab specimens.
  • Data Provenance: Enrichment phase of the study, conducted in the US between October 2023 and February 2024 at six participating medical facilities. The specimens were from individuals with a positive standard of care (SOC) test result for Flu A, Flu B, and/or RSV. All were frozen prior to testing.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. Instead, it refers to:

• For SARS-CoV-2: A composite comparator algorithm (CCA) consisting of up to three highly sensitive US FDA EUA SARS-CoV-2 molecular tests.
• For Flu A, Flu B, and RSV: A US FDA-cleared molecular Flu A/B/RSV assay (in the prospective study) and a U.S. FDA-cleared molecular Flu A/B/RSV assay (in the enrichment study).
• For the enrichment study, initial selection was based on a positive standard of care (SOC) test result for Flu A, Flu B, and/or RSV.

4. Adjudication Method for the Test Set

• For SARS-CoV-2 in the prospective study: A Composite Comparator Algorithm (CCA) was used. A final CCA result was assigned when two of the three composite comparator assays were in concordance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This study is for an in vitro diagnostic (IVD) assay (a molecular test), not an AI-powered diagnostic imaging device.

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

Yes, this study represents a standalone performance evaluation of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The assay itself is an automated molecular diagnostic test on the Panther Fusion system, and its performance was evaluated against comparator methods (other molecular tests or algorithms), not against human interpretation of its outputs in a clinical setting for diagnostic aid.

7. The Type of Ground Truth Used

• SARS-CoV-2: Composite comparator algorithm (CCA) based on multiple FDA EUA molecular tests.
• Flu A/B/RSV: US FDA-cleared molecular Flu A/B/RSV assay.
• Enrichment Study (Flu A/B/RSV): US FDA-cleared molecular Flu A/B/RSV assay, and initial selection based on positive Standard of Care (SOC) test results.

This represents a reference standard method ground truth, where another established diagnostic test is used as the benchmark.

8. The Sample Size for the Training Set

The document does not provide information on a specific "training set" sample size for algorithm development. The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a real-time RT-PCR in vitro diagnostic test, not a machine learning or AI algorithm in the context of typical training/validation splits. Its development would involve analytical studies and design verification, but not typically a "training set" in the same sense as an AI model. The provided clinical data are for performance evaluation.

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

As noted in point 8, the concept of a "training set" with established ground truth in the context of AI models is not directly applicable here. The assay's performance characteristics (e.g., limit of detection, analytical reactivity) are established through various analytical studies (bench studies), not through a "training set" with a clinical ground truth. The clinical studies described are for validation and performance assessment, not for training an algorithm.

Ask a specific question about this device