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(249 days)
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in viro 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) 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 specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative 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 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 Hologic RespDirect Collection Kit can be used to collect NP specimens for testing with the Panther Fusion
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 (NP) swab specimens collected into UTM/VTM or with the Hologic RespDirect Collection Kit, from individuals exhibiting signs and symptoms of a respiratory tract infection.
The Hologic RespDirect Collection Kit is intended for the collection of NP swab specimens. Each individual collection kit is comprised of a single flocked NP swab and an enhanced Direct Load Tube (eDLT) containing 2.9mL of enhanced Specimen Transport Media (eSTM) which are flow wrapped together for customer convenience.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay involves the following steps: a) Sample lysis; b) Nucleic acid capture and elution; c) Elution transfer and multiplex RT-PCR.
The Panther Fusion system integrates Hologic's commercialized Panther instrument system with an add-on sidecar, the Panther Fusion module, which extends the functionality of the Panther system by increasing the assay processing capabilities to include real-time PCR (RT-PCR). The Panther Fusion module includes instrument hardware and can be installed on existing Panther instruments or ordered with new Panther instruments.
The Panther Fusion system employs non-specific target capture (NSTC) for the purification of RNA and DNA from the sample, followed by nucleic acid amplification and real-time fluorescent detection. The process involves sample loading and preparation (i.e. nucleic acid extraction) on the Panther instrument using similar workflow and processing steps as for other commercialized Hologic Aptima TMA assays. The extracted nucleic acid for each sample is transferred to the Panther Fusion module where PCR amplification and detection occurs.
The information provided in the document refers to a Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, which is an in vitro diagnostic test for the qualitative detection and differentiation of SARS-CoV-2, influenza A virus (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV). This is a laboratory diagnostic device, not an AI/ML-enabled device for medical imaging analysis. Therefore, much of the requested information (e.g., number of experts, adjudication method, MRMC study, standalone performance for an algorithm, training set details) is not applicable to this type of device submission.
However, I can extract and structure the relevant acceptance criteria and performance data as presented for this diagnostic assay.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance:
Since specific "acceptance criteria" for each performance metric are not explicitly stated in a single table, I will synthesize them from the descriptions of the studies. Performance is generally demonstrated by achieving high Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) with comparator methods, or by demonstrating acceptable analytical performance (LoD, cross-reactivity, precision, etc.).
| Criterion (Implicit from Study Design) | Reported Device Performance |
|---|---|
| Clinical Performance (Prospective Study): | |
| - SARS-CoV-2 PPA | Overall: 96.9% (95% CI: 94.7-98.2) |
| - SARS-CoV-2 NPA | Overall: 98.5% (95% CI: 97.7-99.0) |
| - Flu A PPA | Overall: 98.4% (95% CI: 94.3-99.6) |
| - Flu A NPA | Overall: 99.7% (95% CI: 99.3-99.9) |
| - Flu B PPA | Overall: Not calculable (0/0 positive cases) |
| - Flu B NPA | Overall: 99.8% (95% CI: 99.4-99.9) |
| - RSV PPA | Overall: 84.6% (95% CI: 57.8-95.7) |
| - RSV NPA | Overall: 100% (95% CI: 99.8-100) |
| Clinical Performance (Retrospective Study): | |
| - Flu A PPA | 93.1% (95% CI: 78.0-98.1) |
| - Flu B PPA | 95.5% (95% CI: 78.2-99.2) |
| - RSV PPA | 100% (95% CI: 92.4-100) |
| - Flu A NPA (Confirmed Negative) | 100% (95% CI: 94.5-100) |
| - Flu B NPA (Confirmed Negative) | 100% (95% CI: 95.0-100) |
| - RSV NPA (Confirmed Negative) | 100% (95% CI: 92.6-100) |
| Analytical Sensitivity (LoD): | Defined as lowest concentration at which >95% of all replicates tested positive. Specific LoD values per viral strain are provided in Table 3. For example, SARS-CoV-2 USA-WA1/2020: 0.03 TCID50/mL; Flu A/Brisbane/02/18 (H1N1): 0.06 TCID50/mL. |
| Reproducibility: | Agreement values were 100% for all panel member components, except: True negative (Flu B): 98.9% (one false positive). Flu A low positive: 98.9% (one false negative), indicating robustness. Total signal variability overall <2.04% in the precision study for panel members. |
| Interfering Substances: | No cross-reactivity observed in analyte negative pools (0% positive results). No interference to analyte positive pools at 3xLoD (100% positive results). |
| Cross-Reactivity (Wet Testing): | All pools had expected results of no interference or cross-reactivity. For example, Adenovirus 1 at 1x10^5 TCID50/mL did not cross-react. |
| Analytical Reactivity (Strain Testing): | The assay demonstrates SARS-CoV-2, Flu A, Flu B, and RSV strain wet testing inclusivity for the strains tested at the illustrated concentrations (e.g., SARS-CoV-2 strains detected at 0.09-0.30 TCID50/mL, Flu A strains at 0.18-183 TCID50/mL, Flu B strains at 0.006-33 TCID50/mL, RSV strains at 0.06-0.30 TCID50/mL). |
| Analytical Reactivity (In Silico): | Predicted to detect all 934,493 SARS-CoV-2 sequences evaluated (10% random sampling up to 6/25/2022), including VOCs like Delta and Omicron. Predicted to detect ≥99.998% of 88,128 Flu A, ≥99.94% of 31,801 Flu B, ≥98.12% of 1,599 RSV A, and ≥98.23% of 1,240 RSV B sequences (Jan 2015 - Feb 2022). |
| Cross-Reactivity (In Silico): | No predicted cross-reactivity or interference with genetically closely related or commonly encountered respiratory microorganisms, with the exception of S. marcescens (which wet testing confirmed caused no interference). |
| Analytical Exclusivity: | The assay did not detect non-indicated influenza types C and D. |
| Specimen Stability: | VTM/UTM: Primary specimens stable refrigerated for up to 96 hours, or frozen. Processed specimens stable at room temp for up to 6 days, refrigerated for 3 months, or frozen (-20°C or -70°C) for 3 months. Supports minimization of freeze/thaw cycles.RespDirect: Stable at 15°C-30°C for up to 6 days. Stable refrigerated (2-8°C) or frozen (-20°C or -70°C) for up to 3 months. May undergo up to 3 freeze-thaw cycles when stored at -20°C or -70°C. |
| Carry-over/Cross-contamination: | No carry-over or cross-contamination observed (100% Flu A positivity for positive panels, 0% for negative panels in checkerboard runs). |
| Transport Media Equivalency: | Demonstrated equivalency between various VTM/UTM vendor types and between clinical NP matrix and simulated NP matrix based on comparable positivity observed at 1xLoD and 5xLoD for all targets. |
| Collection Device/Swab Equivalency: | Comparable positivity observed between RespDirect Collection Kit and control collection device for all concentrations and targets. Swab equivalency study demonstrated equivalency between RespDirect swab and control NP swab for absorption and elution of targets (100% positivity for all targets with both swab types at 4x LoD). |
| Competitive Interference/Co-Infection: | Most targets at 3xLoD maintained positivity when paired with other assay targets at 1x10^4 TCID50/mL (with specific exceptions noted for high concentrations of RSV B affecting SARS-CoV-2 and Flu A, and RSV B affecting Flu B, and SARS-CoV-2 affecting Flu A at specific concentrations). Five co-infections detected by the Panther Fusion assay were largely confirmed by comparator testing in the prospective study. Two co-infections in the retrospective study were also confirmed by comparator testing. |
Study Details (Applicable Sections)
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Clinical Performance Study:
- Prospective Study:
- Total specimens enrolled: 1949 NP swab specimens.
- Evaluable specimens: 1900 (after withdrawals and removals).
- SARS-CoV-2 evaluation: 1887 samples (790 fresh, 1097 frozen).
- Flu A, Flu B, RSV evaluation: 1837 samples (798 fresh, 1039 frozen).
- Data Provenance: Multicenter study in the US (five participating US pediatric/adolescent, private and/or university hospitals). Data collected between January 2022-March 2022 and November 2020-March 2021. Remnant NP swab specimens.
- Retrospective Study:
- Evaluable specimens: 95 preselected archived NP swab specimens.
- Data Provenance: Collected between December 2019 and March 2020. Preselected based on historic qualitative positive result.
- Prospective Study:
- Analytical Studies:
- LoD: Minimum of 24 replicates per concentration, per reagent lot (3 lots total = 72 replicates per strain) for initial determination, confirmed with additional 24 replicates. For RespDirect, 30 replicates per concentration.
- Interfering Substances: Not specified as a total number, but pools tested with and without assay analytes.
- Cross-Reactivity (Wet Testing): Minimum of three replicates per microorganism panel.
- Analytical Reactivity (Strain Wet Testing): Not specified by exact number of replicates, but sufficient to demonstrate detection at ~3x LoD.
- Within Laboratory Precision and Repeatability: 96 measurements performed for each panel member (total from 2 operators, 2 runs/day, 3 reagent lots, 3 Panther Fusion systems, 12 days).
- Competitive Interference: 3 replicates per panel.
- Hologic RespDirect Collection Device Equivalency/Swab Equivalency: Paired NP swabs from 25 symptomatic donors for collection device equivalency. 20 swabs per swab type for swab equivalency.
- Carry-over/Cross-contamination: 100 replicates of negative panel per baseline run; 30 positive and 30 negative panels in alternating "checkerboard" runs.
- Reproducibility Study: 150 samples tested at each of 3 sites (total ~450 samples). Each panel member had 90 results across all sites.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the ground truth was established by molecular diagnostic comparator assays, not human experts in medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Prospective Clinical Study (for SARS-CoV-2): A composite comparator algorithm (CCA) was used. It consisted of two highly sensitive US FDA EUA SARS-CoV-2 molecular tests and a validated PCR followed by bi-directional sequencing (PCR/BDS) assay. A final CCA result was assigned when two of the three composite comparator assays were in concordance.
- Prospective Clinical Study (for Flu A, Flu B, and RSV): A US FDA-cleared molecular Flu A/B/RSV assay was the comparator method.
- Retrospective Clinical Study: Confirmatory testing using a US FDA-cleared molecular Flu A/B/RSV assay.
- Discordant Testing: For discordant results in both clinical studies, additional testing with a US FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test was performed (volume permitting).
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 is not applicable as the device is an in vitro diagnostic assay and does not involve human readers for interpretation, nor does it incorporate AI/ML in a way that would be assessed through an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an AI/ML algorithm. The device, an automated RT-PCR assay, inherently performs without human intervention beyond sample loading and results interpretation; its performance is thus "standalone" in that sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Clinical Performance Studies:
- SARS-CoV-2: Composite Comparator Algorithm (CCA) consisting of two highly sensitive US FDA EUA SARS-CoV-2 molecular tests and a validated PCR followed by bi-directional sequencing (PCR/BDS) assay.
- Flu A, Flu B, RSV: US FDA-cleared molecular Flu A/B/RSV assays (for both prospective and retrospective studies), and confirmatory testing with US FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test for discordant results.
- Analytical Studies: Ground truth was established by spiked samples with known concentrations of viral strains, or by known negative matrices.
8. The sample size for the training set
This is not applicable as the device is an in vitro diagnostic assay and does not use a training set in the AI/ML sense. Analytical and clinical validation studies are performed to characterize its performance.
9. How the ground truth for the training set was established
This is not applicable as there is no training set in the AI/ML sense.
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