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The MultiCode®-RTx HSV 1&2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV1&2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.

Warning: The device is not FDA cleared for the use with cerebral spinal fluid (CSF) or any lesions other than vaginal. This assay is not intended to be used for male penile specimens, for prenatal screening, or for females under the age of 18 years.

The EraGen MultiCode® -RTx Herpes Simplex Virus 1 & 2 kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV) DNA using vaginal swab specimens.

Patient vaginal swab specimens are collected in Copan Universal Transport Medium, or identical Copan manufactured media formulations (Becton Dickinson Universal Viral Transport Media, Copan branded Universal Transport Medium for LabCorp, and the Quest Viral Culture Media) and transported to the laboratory. An extractable sample processing control (SPC) target is added to the specimen prior to lysis. The SPC controls for specimen lysis, for recovery of extracted nucleic acid, for inhibitory substances and for PCR reagent and instrument integrity. The specimen is lysed and nucleic acid is extracted using the Roche MagNA Pure LC instrument using the Roche MagNA Pure LC Total Nucleic Acid Isolation Kit.

A sample of the extracted nucleic acid is added to the MultiCode® RTx Herpes Simplex Virus 1 & 2 Kit reagents that contain a primer pair specific to HSV-1 and HSV-2 and a second primer pair specific to the SPC sequence. The two specific primer pairs are labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored using the Roche LightCycler 1,2 real-time PCR instrument. Incorporation of the quencher-labeled nucleotide causes a decrease in assay fluorescence. Following amplification, the reaction is slowly heated and fluorescence is monitored. The strands of the amplification products will separate at a specific melting temperature (Tm) that is determined by an increase in fluorescence as the strands are separated. The instrument fluorescence output is analyzed and test results are determined using the MultiCode -RTx Herpes Simplex Virus 1 & 2 Kit Analysis Software. A printed results report is generated.

The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a qualitative in vitro diagnostic test for the detection and typing of HSV-1 and HSV-2 DNA in vaginal swab specimens from symptomatic female patients.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance studies, specifically the sensitivity and specificity values against a reference method.

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

• Sample Size for Clinical Performance Test Set: 1041 vaginal swab specimens.
• Data Provenance: Prospective study performed at three U.S. clinical laboratories during 2008-2009.

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

The ground truth for the clinical performance study was established using a "cell culture based ELVIS® Herpes Simplex Virus identification and typing test" as the reference method. For discordant samples, "Sequence analysis" was performed. While this refers to laboratory techniques, the document does not specify the number of experts (e.g., microbiologists, virologists) who interpreted the cell culture results or the sequence analysis, nor their specific qualifications.

4. Adjudication Method for the Test Set

The document describes an adjudication process for discordant results in the clinical performance study:

• When the MultiCode®-RTx Kit and the reference method yielded discordant results (i.e., one positive, one negative), "Sequence analysis" was used to further investigate these samples. The results of the sequence analysis were then used to determine the true status of the discordant samples for the calculation of final sensitivity and specificity. This indicates a "third-party resolution" or "tie-breaker" adjudication method.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a diagnostic kit that provides qualitative results, not an AI-assisted interpretation tool for human readers. Therefore, the effect size of human readers improving with AI vs without AI assistance is not applicable.

6. Standalone Performance Study

Yes, a standalone study (algorithm only performance, without human-in-the-loop) was performed. The clinical performance study directly tested the MultiCode®-RTx HSV 1&2 Kit against a reference method, reporting its sensitivity and specificity. The analytical performance studies (precision, LoD, LoB, specificity, interference, inhibition, carry-over) also represent standalone performance.

7. Type of Ground Truth Used

• For the Clinical Performance Study (test set): The primary ground truth was established by a cell culture-based ELVIS® Herpes Simplex Virus identification and typing test. For discordant samples between the investigational device and the ELVIS® system, DNA sequencing analysis was used as an adjudicator to resolve discrepancies.
• For Analytical Performance Studies (e.g., LoD, LoB, Analytical Specificity/Cross Reactivity, Interfering Substances, Competitive Inhibition, Carry-over/Contamination): Ground truth was established using quantified viral cultures (TCID50/mL), known concentrations of organisms, or precisely formulated simulated samples.

8. Sample Size for the Training Set

The document does not explicitly state a sample size for a "training set" in the context of machine learning. As this is a PCR-based diagnostic kit, it wouldn't typically undergo a "training" phase in the same way an AI/ML algorithm does. The development process would involve extensive analytical testing and optimization (e.g., primer design, reaction conditions, software algorithm for calling results) using various known samples and clinical specimens during the R&D phase, but these are not referred to as a "training set" in the provided text.

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

Given that this is a PCR-based diagnostic kit rather than an AI/ML algorithm, the concept of a "training set" with ground truth in the machine learning sense doesn't directly apply. The device's operational parameters and interpretation rules (e.g., melting temperatures, deflection percentages) were established through extensive analytical and developmental studies using characterized samples, likely with ground truth based on:

• Known concentrations and types of HSV-1 and HSV-2 viruses.
• Defined negative controls and interfering substances.
• These experimental setups would have been used to define thresholds and algorithms for result interpretation (e.g., the software analysis described in section 4.0), which acts similarly to how an AI model learns from a training set.

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