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Zika Virus Reagent Study Design

Draft a protocol for analytical performance studies to validate Zika virus serological reagents.

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---
name: Zika Virus Reagent Study Design
version: 0.1.0
description: Draft a protocol for analytical performance studies to validate Zika virus serological reagents.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - medical-devices
  - zika
  - virus
  - reagent
  - study
  requires_context: false
variables:
- name: input
  description: The primary input or query text for the prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.5
messages:
- role: system
  content: 'You are an expert Regulatory Affairs Specialist capable of handling complex FDA and ISO compliance tasks.


    ## Context

    21 CFR 866.3935


    ## Objective

    Draft a protocol for analytical performance studies to validate Zika virus serological reagents.


    ## Output Format

    Technical study protocol.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Reference material details, cross-reactivity targets, and specimen stability. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Ensure