General tab

Status

Assay plugins can be activated or inactivated (or disabled (Customer Support only)). This latter is useful when an assay is no longer used or a new version becomes available.

1. Navigate to Lab Configuration > Assays
2. Select the Assay Plugin that you would like to (in)activate.
3. In the General tab, the status is indicated. Toggle the button to change the status.

It is always possible to re-activate an inactivated Assay Plugin.

For more information, see Lab configuration - Assays.

Instrument reference

Visible for users using FastFinder Workflow. Prefilled with the information available in the Assay Plugin. This is an open text field. Information that is shown here is only visible in this field.

Remarks

Additional assay information can be added in the remarks section, e.g. lot number information or remarks on the content or changes made to the Assay Plugin. This information is only visible in this field. 

Target information

Mix name

Mix name as defined in the Assay Plugin.

Targets (dye)

Targets and dyes as defined in the Assay Plugin.

External mix information

When your Assay Plugin requires information from another assay (APEC - Assay Plugin that requires external context), you can define the link with the other assay by using the (Mix- and) Target tags.

Mix name

Mix name as defined in the Assay Plugin.

Mix tags

• This is an optional field.
• If no external mix tag is filled in here, the APEC can use any mix name as long as the external target tag is found.
• Multiple tags can be added for one external mix. Tags don't need to be unique within the same APEC.

Target

Target name as defined in the Assay Plugin.

Target tags

• This is a required field and a minimum of one tag is required
• Multiple tags can be added for one external target, but each tag has to be unique within an external mix in its assay.

Sample types

Sample type name

All sample type names as defined by the Assay Plugin.

Type

Possible sample types: Regular, Negative control, Positive control, Quantification standard, User-defined quantification standard, Reference sample.

The given concentration for Quantification standards with a known concentration can be visualised by opening the details (clicking on the triangle in front of the row). Same for the corrected concentration unit.

Mix names (amount)

Mix names as defined by the Assay Plugin.

The amount indicates the default number of replicates defined within the assay. eg below screenshot from an assay requiring 3 replicates for the regular samples.

Nametags

To assign the relevant wells as a negative/positive control or quantification standard, the sample names need to begin with a set of characters (prefix) that will function as an identifier. One or more prefixes can be added and/or removed to a specific sample type.

External mix names

When your Assay Plugin requires information from another assay (APEC - Assay Plugin that requires external context), the external mix name is indicated.

PCR setup

PCR setup information is used by FastFinder Workflow.

Versions

All assay versions from the same assay card (different cycler, or product identifier with the same Assay definition GUID) will be shown in this table:

Cycler

Each cycler type needs its own Assay Plugin. The cycler for which the Assay Plugin is developed is shown in this column. Please check the IFU in the support tab of FastFinder to find a list of all cycler types compatible with FastFinder.

Intended use

Optional field that states the regulatory intended use as defined in the Assay Plugin: RUO, IUO, IVD, AFNOR, AOAC.

Device Identifier

The unique device identification (UDI) as defined in the Assay Plugin is displayed here. A UDI is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability.

Production Identifier

Each AP that is made available to the customer, via upload to the FastFinder platform, has a specific version. When an update is made to the AP, the versioning will increase accordingly.

During development by UgenTec, a draft AP is created. Draft APs always are versioned as 0.x. Upon each new iteration, the version will be increased (e.g., from 0.3 to 0.4).  Note that not every draft version is made available to the customer.

Once the customer approves the AP, i.e., provides design freeze, the final draft of the AP will be validated, thereby generating a ‘1.x’ version. In case of a minor update to a validated AP, e.g., minor correction during the validation procedure, the versioning will increase accordingly from 1.0 to 1.1. In case of a major change, e.g., a change request, the AP version will increase from 1.x to 2.x.

When an AP is created with FastFinder Studio, a v1.0 is created directly.

(In)activate a specific assay version within the same assay card

Click on the small triangle in front of the row to open all available Assay Plugin versions and to inactivate an individual assay from the same assay card.

By default, the highest plugin version will be selected for the automatic plate setup (in case no other assay card is active). Select the 'Make default' button to use a previous plugin version in the automatic plate assignment (from within the same assay card).

Relevant articles

Lab configuration - Assays