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The Sentosa® SA201 HSV-1/2 PCR Test is a real-time PCR-based qualitative in vitro diagnostic test for detection and differentiation of Herpes Simplex Virus (HSV-1 and HSV-2) DNA from male and female skin lesions from anogenital or oral sites. The test is intended for use as an aid in diagnosis of herpes infection in symptomatic patients.

Warning: The Sentosa® SA201 HSV-1/2 PCR Test is not FDA cleared for use with cerebrospinal fluid (CSF). The test is not intended to be used for prenatal screening.

The Sentosa® SA201 HSV-1/2 PCR Test is a (4x24) configuration contains reagents and enzymes for specific amplification of a 104 bp (base-pair) fragment of the UL30 gene common to both HSV1 and HSV2, and specific probes for the direct detection and differentiation of HSV1 and HSV2 amplicons, respectively. Pathogen detection by PCR is based on the amplification of specific regions of the pathogen genome. In real-time PCR, the amplified product is detected via fluorescent dyes, which are usually linked to oligonucleotide probes that bind specifically to the target sequences. Real-time monitoring of the fluorescence intensities during a PCR run allows the detection of the accumulating product. Amplification of the targets occurs in three channels: green, orange and red on the Sentosa® SA201. Output is recorded as the increase of fluorescence over time in comparison to background signal. Monitoring the fluorescence intensities during the PCR run allows the detection of the accumulating product without having to re-open the reaction tubes after the PCR run.

The Sentosa® SA201 HSV-1/2 PCR Test workflow starts with extraction of nucleic acids from samples (anogenital or oral swabs) using the Sentosa® SX Virus Total Nucleic Acid Kit on the Sentosa SX101 instrument. Following extraction, the instrument will automatically set up the PCR with the extracted nucleic acids in a 96-well PCR plate. Subsequently, the 96-well PCR plate is sealed and transferred to the Sentosa® SA201 for PCR amplification, followed by data analysis.

The Sentosa® Link facilitates data transfer between the Sentosa® SX101, the Sentosa® SA201 Reporter and existing LIS/LIMS (laboratory information systems) in the clinical lab. The Sentosa SX101 instrument communicates with Sentosa® SA201 thermocycler. This creates a user environment that links the SX101 and the Sentosa® SA201 to facilitate automated workflow to export results in a LIS/LIMS-compatible format.

The provided document describes the analytical and clinical performance of the Sentosa SA201 HSV-1/2 PCR Test, a qualitative in vitro diagnostic test for the detection and differentiation of Herpes Simplex Virus (HSV-1 and HSV-2) DNA. It is not an AI/ML-based device. Therefore, the questions related to AI/ML specific aspects (e.g., number of experts, adjudication, MRMC study, training set, ground truth for training set) are not applicable. The information focuses on the device's ability to accurately detect and differentiate HSV-1 and HSV-2 DNA in patient samples.

Here's an analysis of the provided information, focusing on the device's acceptance criteria and the studies proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a single table, but the performance studies demonstrate implied criteria. For diagnostic devices like this, the key performance metrics are sensitivity, specificity, limit of detection (LoD), precision, and freedom from interference.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Study):

  • Total Samples Enrolled: 2684
  • Samples in Final Analysis: 2295 (389 excluded due to unspecified reasons)
  • Oral Lesions: 317
  • Anogenital Lesions: 1978
  • Data Provenance: Residual anogenital lesion or oral lesion samples from male and female patients with signs and symptoms of HSV infections. Collected from 8 sites in the USA. Samples were tested either at the same facility they were obtained or shipped to a different testing site.
  • Retrospective/Prospective: The text does not explicitly state retrospective or prospective. However, "residual samples" suggest a retrospective collection. "Samples were either tested at the same facility at which they were obtained, or were shipped to a different testing site" could imply some forward-looking testing strategy, but it's not clearly defined as a prospective study. Given the clinical study results are compared against a "reference test," it most likely involves previously collected and banked samples.

• Test Set (Analytical Studies):

  • Limit of Detection: Determined by Probit analysis; specific sample numbers not explicitly given beyond "multiple replicates" across concentrations.
  • Precision: 60 replicates per sample type (NC, PC, 3xLoD HSV-1, 1.5xLoD HSV-1, 3xLoD HSV-2, 1.5xLoD HSV-2).
  • Reproducibility: 90 replicates per sample type (same as precision).
  • Analytical Reactivity / Cross-reactivity: 55 organisms tested, plus high and low concentration HSV-1/2 samples with competing organisms. Specific replicate numbers not given for all reactivity tests.
  • Interfering Substances: Each of 31 substances assayed in triplicate. Competitive interference study used 20 replicates for each combination.
  • Carry-over and Cross-contamination: 12 runs; 96 positive samples, 183 negative samples.

• Training Set: Not applicable for this type of PCR diagnostic device. This device is based on a well-defined molecular biology assay (real-time PCR) and does not involve AI/ML models that require dedicated training data sets in the typical sense. Performance is assessed through analytical validation (LoD, precision, specificity) and clinical concordance with a reference method.

3. Number of Experts and Qualifications to Establish Ground Truth

Not applicable. This is a molecular diagnostic test, not an image-based AI/ML device relying on expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. Ground truth for the clinical study was established by a "reference test" (ELVIS® HSV ID and D3 Typing Test System) and supplemented by "bi-directional sequencing analysis" for discordant samples. This is a confirmatory molecular method, not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a diagnostic test; it is not described as providing AI assistance to human readers.

6. Standalone (Algorithm Only) Performance

The entire performance evaluation of the Sentosa SA201 HSV-1/2 PCR Test represents its "standalone" performance, as it is a fully automated system from nucleic acid extraction to result reporting. There is no human interpretative step described for the final result.

7. Type of Ground Truth Used

• Clinical Study: The primary ground truth for the clinical study was the ELVIS® HSV ID and D3 Typing Test System. For samples with discordant results between the Sentosa test and the ELVIS system, bi-directional sequencing analysis was used as a confirmatory method to resolve the discrepancy. This is a molecular gold standard.
• Analytical Studies: Ground truth for analytical studies was established by known concentrations of well-characterized viral strains (TCID50/mL) for LoD, precision, and reproducibility. For analytical specificity and interference studies, known panels of organisms and substances were used.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device requiring a training set in that context.

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

Not applicable.

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