Laboratory Evaluation Checklist for Molecular Diagnostics Platforms
A structured checklist for Indian laboratories evaluating a cartridge-based molecular diagnostics platform such as iFIND: regulatory status, technical specs, validation, service, training, cost, and conflict documentation.
Laboratory Evaluation Checklist for Molecular Diagnostics Platforms
This structured checklist helps Indian laboratories evaluate a cartridge-based molecular diagnostics platform such as iFIND before clinical deployment. All iFIND technical parameters are manufacturer-provided and not independently verified.
1. Regulatory status
- [ ] CDSCO registration confirmed for the instrument
- [ ] CDSCO registration confirmed for each reagent kit (TBR, IFQ)
- [ ] Registration certificate numbers obtained and verified in the official registry
- [ ] Registration validity periods checked
- [ ] Registered specifications match marketing claims
2. Technical specifications
- [ ] IFU obtained for TBR and IFQ
- [ ] Technical specification sheet obtained
- [ ] Amplification targets confirmed (TBR: IS6110, IS1081/IS1087, rpoB; IFQ: katG, inhA, gyrA)
- [ ] IS1081 / IS1087 discrepancy resolved with manufacturer in writing
- [ ] LoD values confirmed (TBR: 10 CFU/mL TB, 100 CFU/mL rifampicin; IFQ: 100 CFU/mL)
- [ ] Turnaround time confirmed and 85-minute / 120-minute discrepancy resolved
- [ ] Specimen types confirmed (sputum, BAL, others)
- [ ] System configuration selected (S2 / S4 / S8)
3. Local validation plan
- [ ] Validation protocol drafted with acceptance criteria
- [ ] Reference method selected (culture, CBNAAT, LPA)
- [ ] Accuracy assessment planned
- [ ] Precision (repeatability, reproducibility) assessment planned
- [ ] LoD verification planned (serial dilutions)
- [ ] Cross-reactivity with non-tuberculous mycobacteria planned
- [ ] Inhibition assessment planned
- [ ] Sample size determined per laboratory procedures and Indian regulations
4. Service and support
- [ ] Authorised service centre in India confirmed
- [ ] Service response time confirmed
- [ ] Spare-parts availability confirmed
- [ ] Warranty terms confirmed
- [ ] Post-warranty service terms confirmed
- [ ] Consumables (cartridge) supply chain confirmed
- [ ] Consumables lead times and storage conditions confirmed
5. Training and documentation
- [ ] Training availability for Indian staff confirmed
- [ ] Training language confirmed (English; Hindi where needed)
- [ ] IFU available in English
- [ ] Software localisation confirmed
- [ ] LIS compatibility confirmed
- [ ] SOP drafted for the platform
- [ ] Result-interpretation guide drafted
6. Cost
- [ ] Cost per test calculated (reagents + consumables)
- [ ] Instrument cost calculated (purchase or lease)
- [ ] Annual service and maintenance cost calculated
- [ ] Training cost calculated
- [ ] Validation cost calculated
- [ ] Comparison with alternatives available in India completed
7. Conflicts and gaps
- [ ] IS1081 / IS1087 conflict documented and communicated to staff
- [ ] 85-minute / 120-minute turnaround-time conflict documented
- [ ] IFQ / MDR naming conflict documented
- [ ] Injectable-drug resistance gap (IFQ does not detect) documented
- [ ] All "not verified" statuses documented
Outcome
Critical blockers (prevent clinical deployment)
- No confirmed CDSCO registration
- No local service network
- No reliable consumables supply chain
Significant risks (require assessment)
- Unresolved documentation conflicts (IS1081/IS1087, 85/120 min, IFQ/MDR)
- No independent clinical study
- No Indian-market evaluation data
Recommendations
- Do not deploy the platform clinically until CDSCO registration is confirmed.
- Complete local validation before clinical use.
- Obtain written manufacturer clarification for every unresolved conflict.
- Document every stage of the evaluation.
Note: This checklist is an orientation document. Specific requirements depend on the laboratory type, its accreditation, and applicable Indian regulations. All iFIND technical parameters are manufacturer-provided and require independent verification.