Evidence Policy

Purpose

This policy explains how manufacturer claims are labelled on SinoBio Access, what verification levels exist, how conflicts between sources are handled, and what "not verified" means in practice.

How Manufacturer Claims Are Labelled

Every claim published on this platform carries a claim status badge so that a reader can immediately see how much trust the platform places in it. The claim statuses are:

• Manufacturer-provided information — the information was provided directly by the manufacturer and has not been independently verified by SinoBio Access.
• Supported by an external source — the claim is backed by at least one external source, such as a peer-reviewed study, an official regulator, or an international guideline.
• Document discrepancy identified — two or more sources disagree about the same claim. The discrepancy is documented and published openly.
• Pending verification — verification is in progress and a definitive statement is not yet available.
• Local regulatory status not verified — the local regulatory status for this market has not been checked.
• Verified for the specified market — an official regulatory document for this market has been independently confirmed.
• Source may be outdated — the supporting source may no longer be current and requires re-checking.

Evidence Levels

In addition to the claim status, each supporting source is assigned an evidence level that describes the reliability hierarchy of that source:

A higher level does not make a claim true, and a lower level does not make it false. The level only describes how much independent corroboration currently exists. Most parameters on this platform are currently level B (manufacturer official documents) because independent evaluation is still in planning.

Verification Levels

Verification on this platform is layered:

1. Manufacturer documentation received — the manufacturer has supplied documents, but their contents have not been independently confirmed.
2. Externally supported — at least one external source corroborates the manufacturer claim.
3. Verified for market — an official regulatory document for the specific market (for example a Roszdravnadzor registration in Russia or a CDSCO registration in India) has been independently confirmed.

A claim can move up or down these levels as new evidence arrives or as sources become outdated.

How Conflicts Are Handled

When two sources disagree about the same claim, the conflict is not hidden. Instead:

1. The conflict is recorded with both sources, their evidence levels, and the exact wording of each.
2. The affected content is set to a "document discrepancy identified" status.
3. The conflict is published openly so that professional users can see it.
4. A clarification is requested from the manufacturer.
5. Only when a definitive source is obtained is the conflict resolved and the content updated.

Documented Conflicts

For the iFIND molecular diagnostics platform, two conflicts are currently documented and unresolved:

• IS1081 vs IS1087 — manufacturer documents disagree on which insertion sequence the TBR kit targets. This is recorded as conflict EVC-002 and remains open.
• 85 min vs 120 min — one manufacturer source states a turnaround time of 85 minutes while another states 120 minutes. This is recorded as conflict EVC-001 and remains open.

Both conflicts are published with their full source attribution. No definitive turnaround time or target sequence is stated until the conflicts are resolved.

What "not verified" Means

The phrase "not verified" appears frequently on this platform. It has a specific meaning:

• Local regulatory status not verified means that SinoBio Access has not independently confirmed the regulatory registration in the relevant market. It does not mean the product is unregistered, and it does not mean the product is registered. It means the status is unknown to this platform.

This default is deliberate. Claiming a registration exists when it has not been confirmed would be as misleading as claiming it does not exist. Until an official regulatory document is independently confirmed, the status remains "not verified".

Source Visibility

Evidence sources have a visibility setting:

• Public — the source is publicly available and may be linked directly.
• Request-only — the source is listed by title but its file is never exposed publicly; access is handled through a verified professional-user request.
• Private — the source is held internally and is not publicly listed.

No Promotional Claims

This platform does not make statements such as "FDA Approved", "WHO Approved", "CE certified", or "Available for purchase" unless an independently confirmed source supports them. Availability and approval are expressed only through the per-market status fields, which default to "not checked".

Professional Use

Medical device information on this platform is intended for healthcare professionals only. It is not a substitute for professional clinical judgement, local regulatory compliance, or independent local validation.

For the methodology behind these rules, see How We Work.