Laboratory Evaluation Checklist for Chinese Molecular Diagnostics Platforms
A structured checklist for laboratories evaluating Chinese molecular diagnostics platforms, covering regulatory, technical, and operational dimensions.
Purpose
This checklist is designed for laboratory directors and technical specialists evaluating Chinese molecular diagnostics platforms such as the iFIND system. It covers regulatory, technical, operational, and evidence dimensions.
1. Regulatory Verification
- [ ] Manufacturer business licence verified
- [ ] Manufacturer ISO 13485 certification verified
- [ ] Product CE-IVD certificate verified (if claimed)
- [ ] Product CFDA/NMPA registration verified (if claimed)
- [ ] Local regulatory registration status confirmed (e.g., ROSZDRAVNADZOR for Russia, CDSCO for India)
- [ ] Import/export permits confirmed for your jurisdiction
2. Technical Specification Verification
- [ ] Limit of detection (LoD) claims documented
- [ ] Sensitivity and specificity claims documented with evidence level
- [ ] Sample types specified by manufacturer listed
- [ ] Amplification method documented
- [ ] Detection targets documented
- [ ] Turnaround time documented (note any discrepancies between IFU and brochure)
- [ ] Storage and transport conditions documented
- [ ] Shelf life documented
3. Evidence Level Assessment
For each manufacturer claim, assign an evidence level:
- Level A: Independently verified by peer-reviewed clinical study
- Level B: Manufacturer-provided (IFU, brochure, technical specification)
- Level C: Manufacturer-claimed (marketing material, verbal communication)
- Level D: Unverified or contradictory information
Document any:
- Discrepancies between different manufacturer documents
- Discrepancies between manufacturer claims and independent literature
- Missing evidence for critical claims
4. Operational Assessment
- [ ] Local service and support availability confirmed
- [ ] Spare parts availability and lead time documented
- [ ] Training program available (language compatibility checked)
- [ ] Consumables supply chain reliability assessed
- [ ] Consumables cost per test calculated
- [ ] Instrument maintenance requirements documented
- [ ] Waste disposal requirements documented
5. Local Validation Plan
- [ ] Validation protocol written
- [ ] Reference strains selected
- [ ] Sample panel designed (covering expected prevalence range)
- [ ] Comparison method selected (e.g., vs Xpert MTB/RIF or culture)
- [ ] Statistical analysis plan defined
- [ ] Local regulatory requirements for validation confirmed
6. Documentation Requirements
- [ ] IFU available in local language or English
- [ ] Technical specification sheets obtained
- [ ] Quality certificates obtained
- [ ] Risk assessment documented
- [ ] Standard operating procedures drafted
Important Note
This checklist is a general framework. It does not constitute regulatory advice. Each laboratory must comply with its local regulatory requirements. Manufacturer-provided information should be verified independently wherever possible.