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What does Alteration Detected mean, and how is it confirmed?

An alteration triggers a repeat within 30 minutes; the second result classifies the pair.

An Alteration Detected result means that OPTOVERA detected a significant alteration in the User’s pupillary response when compared with the User’s individual baseline.

The Device displays Alteration Detected and instructs the User to wait before repeating the test. The result is a safety signal that requires review according to the organization’s internal procedure. It does not identify the cause of the alteration and does not, by itself, determine whether the User is fit or unfit for work.

An Alteration Detected result triggers a repeat measurement for the same User within 30 minutes. If the repeat is completed within this window, its result determines the pair’s final classification and the first result is labeled Retested.

There are three possible outcomes:

  1. Alteration Confirmed. If a second Alteration Detected result is recorded for the same User within 30 minutes of the first, the pair is classified as Alteration Confirmed, assigned to the second result, and counts as one confirmed alteration. The first result is labeled Retested and is no longer valid as a standalone result and is not counted separately.
  2. Within Baseline Range. If the repeat measurement for the same User returns Within Baseline Range within 30 minutes of the first, the pair is classified as Within Baseline Range, assigned to the second result. The first result is labeled Retested and is no longer valid as a standalone result and is not counted separately.
  3. Alteration Not Verified. If no repeat measurement is completed for the same User within 30 minutes of the first result, the first result is classified as Alteration Not Verified. This indicates that the required verification step was not completed; there is no final classification of a completed pair.

These confirmation statuses are shown in the dashboard. The Device shows the individual measurement result: Within Baseline Range or Alteration Detected.

Retested is the status of the first result after a repeat measurement is completed for the same User within 30 minutes, regardless of the repeat outcome. The first alteration is a trigger for the repeat test; the second result determines the pair’s final classification. The first result is no longer valid as a standalone result and is not counted separately.

None of these classifications identifies the cause of the result. OPTOVERA does not diagnose impairment, intoxication, fatigue, a medical condition, or any specific cause.

Supervisors or qualified personnel should follow the organization’s internal safety procedure for review and follow-up. OPTOVERA provides the objective measurement result; the organization remains responsible for any operational decision.