iFIND TBR and IFQ: Evidence and Regulatory Questions for India

Purpose

This article sets out what evidence currently exists for the iFIND TBR and IFQ kits, and what regulatory questions Indian laboratories should ask before considering the platform. All parameters are manufacturer-provided.

What Evidence Exists

The available evidence for the iFIND TBR and IFQ kits is limited to manufacturer brochures and instructions for use — evidence level B. Specifically:

• Manufacturer product brochures.
• Manufacturer technical specification sheets.
• Manufacturer instructions for use (IFU), some in draft form.

What is not available:

• No independent peer-reviewed clinical study has been confirmed.
• No multicentre trial data is available.
• No systematic review or meta-analysis is available.
• No Indian-market evaluation data is available.

iFIND TBR — manufacturer-provided parameters

• Detects: M. tuberculosis complex + rifampicin resistance.
• Targets: IS6110, IS1081 / IS1087 (conflict), rpoB.
• LoD: 10 CFU/mL (TB), 100 CFU/mL (rifampicin).
• Turnaround time: 85 min in one source, 120 min in another — unresolved.

iFIND IFQ — manufacturer-provided parameters

• Detects: isoniazid + fluoroquinolone resistance.
• Targets: katG, inhA, gyrA.
• LoD: 100 CFU/mL.
• Turnaround time: 120 min.
• Does not detect injectable-drug resistance.

Documented Conflicts

Two conflicts in the manufacturer documentation are documented and unresolved:

• IS1081 vs IS1087 (EVC-002) — manufacturer documents disagree on which insertion sequence the TBR kit targets. IS1081 and IS1087 may be distinct genetic elements with different characteristics.
• 85 min vs 120 min (EVC-001) — one manufacturer source states an 85-minute turnaround time while another states 120 minutes. The relationship between the two figures has not been clarified.

A third conflict concerns product naming (IFQ vs MDR, EVC-003) and is also unresolved.

CDSCO Registration Status

The CDSCO registration status of the iFIND instrument, the TBR kit, and the IFQ kit is not verified. This means SinoBio Access has not independently confirmed any CDSCO registration. It does not mean the products are unregistered, and it does not mean they are registered. Until an official CDSCO registration document is independently confirmed, the status remains "not verified", and the platform should not be deployed clinically in India.

Regulatory Questions Indian Labs Should Ask

Registration

1. Is the iFIND instrument registered with the CDSCO? Request the registration certificate and verify it in the official registry.
2. Is the TBR reagent kit registered with the CDSCO? Request the certificate.
3. Is the IFQ reagent kit registered with the CDSCO? Request the certificate.
4. What is the validity period of each registration?
5. Do the registered specifications match the manufacturer's marketing claims?

Technical

1. Which insertion sequence does the TBR kit actually target — IS1081 or IS1087? Request written clarification.
2. What is the definitive turnaround time for TBR — 85 minutes or 120 minutes? Request written clarification.
3. What is the registered name of the IFQ kit — IFQ or MDR?
4. What are the registered specimen types?
5. Has any Indian clinical evaluation been performed?

Service and documentation

1. Is there an authorised service centre in India?
2. Are consumables (cartridges) available through a reliable local supply chain?
3. Is the IFU and software available in English and, where needed, in Hindi?
4. What training is available for Indian laboratory staff?

Validation

1. What reference method will your laboratory use for local validation?
2. What sample size does your laboratory's procedures require?
3. How will your laboratory handle the IS1081 / IS1087 and turnaround-time conflicts in its validation report?

Evidence Boundary

All parameters in this article are manufacturer-provided (evidence level B). No independent clinical study has been confirmed. CDSCO registration is not verified. The documented conflicts remain unresolved.

Important Note

This article does not claim CDSCO registration, FDA approval, or WHO approval for any iFIND product. SinoBio Access is not a distributor and does not sell medical devices. Indian laboratories should not deploy the platform clinically until CDSCO registration is confirmed and local validation is complete.