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The Sample Preservative Fluid is intended for the stabilization, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.

Sample Preservative Fluid is a medium for stabilization of Influenza A RNA during sample transport/storage. The fluid is composed of quanidine thiocyanate, Triton X-100, and nuclease-free water. Sample Preservative Fluid is provided in a labeled screw-cap tube.
Sample Preservative Fluid configuration:

• BSC82X1-A1: a screw-cap tube filled with 2 mL of Sample Preservative Fluid liquid ● and a prepackaged nasopharyngeal swab for sample collection
• Nasopharyngeal swab: regular size, sterile disposable sample swab (80mm . breakpoint)

Here's a summary of the acceptance criteria and study details for the Sample Preservative Fluid, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Shelf-life: 3 lots of Sample Preservative Fluid. Data provenance is not explicitly stated but is implicitly from an in-house study conducted by the applicant (Hangzhou Bioer Technology Co., Ltd). The study appears to be proprietary/internal rather than retrospective or prospective clinical data.
   • Detection Limit (LoD):
     • Preliminary LoD: 5 replicates for each of 5 concentrations (0.32, 0.16, 0.08, 0.04, 0.02, 0.01 TCID50/mL) for a total of 30 replicates (though actual testing for 0.02 and 0.01 TCID50/mL ceased if a certain number of negative results were observed).
     • Confirmatory LoD: 20 replicates at 0.08 TCID50/mL (initially attempted at 0.04 TCID50/mL).
     • Data provenance is from an in-house laboratory study.
   • Specimen Stability: Replicates of four for each of three reagent lots, tested at 6 timepoints (Day 0, 1, 8, 15, 22, 35) at two different temperatures (2-4°C and 20-25°C). Total number of Ct values reported is 144 for each temperature condition (3 lots * 4 reps * 6 timepoints). Data provenance is from an in-house laboratory study.
   • Cytotoxicity Study: Not explicitly stated, but multiple dilutions (from 1:10 up to 1:8000 for preliminary, and from 1:1000 for confirmatory) were tested against a cell monolayer. This is an in-house laboratory study.
   • Viral Inactivation Study: Influenza A H3N2 virus combined with Sample Preservative Fluid and negative nasal matrix, incubated for 30 and 60 seconds. Each mixture diluted 3500x and plated into 8 wells in triplicate (total of 24 wells per condition). Positive and negative controls were also used. This is an in-house laboratory study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are laboratory-based performance studies (shelf-life, LoD, stability, inactivation) using controlled experimental conditions and quantitative measurements (e.g., bacterial/fungal growth, leakage, density, PCR Ct values, viral titers, cell morphology), not expert interpretation of clinical data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as expert adjudication is not used for these types of laboratory performance studies.

4. 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: Not applicable. This device is a sample preservative fluid, not an AI-powered diagnostic or imaging system involving human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device (fluid) and does not involve an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Shelf-life: Physical and chemical property evaluations (e.g., visual inspection, pressure tests, density measurements) and microbial growth assays.
   • Detection Limit (LoD): Defined concentration of target virus (Influenza A H3N2) in negative nasal matrix, assayed by a cleared molecular diagnostic device (Cepheid Xpert Xpress Flu/RSV Assay).
   • Specimen Stability: Defined concentration of target virus (Influenza A H3N2) in negative nasal matrix, assayed by a cleared molecular diagnostic device (Cepheid Xpert Xpress Flu/RSV Assay). Comparison of Ct values over time to a baseline (Day 0).
   • Cytotoxicity Study: Observation of cell morphology and growth status on a cell monolayer (MDCK cells).
   • Viral Inactivation Study: Measurement of viral titers (TCID50/mL) and observation of cytopathic effects on MDCK cells. Reduction in culturable virus compared to controls.

7. The sample size for the training set: Not applicable. This device does not use machine learning or AI, and therefore does not have a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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