Evidence-centred evaluation for India

Evaluating Chinese biomedical technology for Indian professional users.

SinoBio Access helps Indian professional users evaluate Chinese biomedical technology through laboratory evaluation data, workflow and throughput information, TB and drug-resistance evidence, and regulatory and import guidance. Manufacturer-provided information is clearly labelled.

100% Sourced

Every parameter tagged to manufacturer IFU or study

Grade A~U

Multi-tiered evidence grading system

CDSCO & NTEP

Import and local evaluation pathways for India

Zero Bias

Transparent disclosure of evidence limits & gaps

Laboratory evaluation for India

How throughput, turnaround time and concordance data are organised for Indian labs.

Workflow and throughput

Manufacturer-stated throughput is labelled as manufacturer-provided. Independent lab evaluation is tracked where available.

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TB & drug resistance

The iFIND TBR + IFQ workflow for tuberculosis molecular diagnostics, including detection of MDR/FQ markers.

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Room-temp logistics

For Indian settings without continuous cold chain, room-temperature lyophilized stability claims are verified.

Featured: TB molecular diagnostics — iFIND TBR + IFQ

Automated qPCR closed-cartridge workflow for high-burden diagnostic settings.

🧪 Step 1: Prep Sputum / BAL Sample Lysis • Sputum / BAL • DNA Extraction • Buffer Ingestion ~15 mins 🔬 iFIND TBR Cartridge 1: Screen MTB + RIF Screen IS6110 (M. tuberculosis) IS1081 / IS1087 ⚠ rpoB (Рифампицин / RIF) Primary Screen 🧬 iFIND IFQ Cartridge 2: MDR MDR Resistance katG (Изониазид / INH) inhA (Изониазид Low) gyrA (Фторхинолоны / FQ) MDR Profiling 📋 Report Clinical • MTB Pos/Neg • RIF Sens/Res • INH Sens/Res • FQ Sens/Res Validated

iFIND TBR + IFQ Molecular Workflow

  1. 1 Specimen
    Sample Collection & Lysis Sputum or alternative respiratory specimen. Automated or manual lysis per protocol.
  2. 2 Cartridge 1
    iFIND TBR (Primary Screen) Detection of M. tuberculosis complex DNA and rifampicin-resistance markers.
    IS6110 IS1081 / IS1087 rpoB
  3. 3 Cartridge 2
    iFIND IFQ (MDR Profiling) Expanded resistance detection for isoniazid and fluoroquinolones.
    katG inhA gyrA
  4. 4 Report
    Clinical Interpretation Integrated fluorescent quantification evaluated together with clinical context.
Evidence Boundary Note: All parameters are manufacturer-provided (iFIND). IS1081/IS1087 target conflict and detection time discrepancy (85 min vs ≤120 min) are unresolved. Local regulatory status is not verified. This diagram is for educational purposes.

Indian Clinical Context

Early evidence cluster for molecular tuberculosis detection, including detection of drug resistance markers (RIF, INH, FQ). All technical parameters are provided by the manufacturer and are clearly labelled. Local CDSCO registration status is not verified.

  • Target Genes: IS6110, IS1081/IS1087, rpoB, katG, inhA, gyrA
  • Turnaround Time: 85 mins (Claimed) vs ≤120 mins (Doc discrepancy)
  • Cartridge Format: Lyophilized reagents stable at 2-30°C

Solution areas

Technologies organised by clinical area, open for evaluation in India.

Regulatory and import questions for India

CDSCO registration

Is the product registered with the Central Drugs Standard Control Organisation (CDSCO)? Default status is "not checked" until verified.

Local regulatory status not verified

Import permissions

Import may be permitted for evaluation even before full registration. Import status is tracked per product and defaults to "not checked".

Evaluation checklist

Use the laboratory evaluation checklist when assessing Chinese technology in an Indian lab setting.

Open evaluation checklist

Technical documentation

Technical documents are available on request through a signed, time-limited link. No public download.

Request documentation

Evidence updates

Receive notifications when new evidence or verification status changes are published. Double opt-in.

Submit an unmet need

Tell us about a clinical or laboratory need that current options do not meet for the Indian context.

Submit a requirement