Performance Qualification (PQ) Procedure

Purpose

This procedure verifies that Panther System operation is in compliance with Validity and Acceptance Criteria for the currently approved assays.

Panther has two methods of PQs, TMATranscription-mediated amplification—Hologic's patented nucleic acid amplification technology. and Real-Time processing.
The Fusion, if added, has a 3rd - PCR.
Please familiarize yourself with Automated System Performance Qualification (PQPerformance Qualification) Procedure, Diagnostic [19-03-01-004-WI] on what assay PQ is required for any and all assay types.

Reference Documents

• Current Panther System Operator's Manual
• Current AssayProcedures required to prepare and perform a specific test. In the context of this document, assay refers exclusively to a Hologic test, such as Aptima Combo or Ultrio. Package Insert
• 19-01-23-SOP Service Request Procedure for Field Service
• Automated System Performance Qualification (PQ) Procedure, Diagnostic [19-03-01-004-WI]

  Ensure that the most current document revisions are referenced.

Parts and Materials Required

Reference the current version of Automated System Performance Qualification (PQ) Procedure, Diagnostic [19-03-01-004-WI]

Procedure

1. Perform the Panther Luminometer Flashcheck Reagent Verification procedure if applicable.
2. Start up the Panther System main software.

   Refer to the Panther System Operator's Manual for system start-up and basic operations.

3. Disable LIS Communication.
4. If necessary, Set Sample Handling Configuration to Read Repeat Barcodes.
5. If reflex testing is enabled, disable reflex testing until the performance qualification run is complete, then re-enable reflex testing.
6. Assay Reagents Preparation.
   1. Prepare the specific Assay Reagents for use with the assay according to directions in the appropriate package insert.
   2. Load Assay Reagents according to instructions outlined in the Panther System Operator's Manual.

      It is recommended not to use previously reconstituted assay reagents.

   If not previously registered, the Master Lot number for the Assay Reagent kit will have to be entered using the hand-held barcode scanner.

7. Sample Rack Configuration
   1. Prepare the assay panels and controls and/or calibrators in the Sample Racks as outlined in 19-03-1-004-WI.

      Each APTIMA Assay Control or Calibrator may only be used once.

8. Sample Processing
   1. Load and process samples according to instructions outlined in the Panther System Operator's Manual.
   2. Monitor the run and add consumables as required.
9. When the run completes, perform the following activities.
   1. Enable LIS Communication.
   2. If necessary, Set Sample Handling Configuration to Not Read repeat Barcodes.
   3. Enable reflex testing.
   4. Discard all used Assay Reagent kits, panels, calibrators, and/or controls according to local laboratory guidelines.
   5. Clean Sample Racks and laboratory work surfaces.
   6. Document activities as outlined in 19-01-23-SOP Service Request Procedure for Field Service.
   7. Pass/Fail Analysis.
   8. Determine for each panel if the RLURelative light unit result was in accordance to the acceptance criteria outlined below.

Performance Qualification Analysis

The Performance Qualification results can be analyzed and reported with the Panther Dashboard software

Note— Not all assays will have a PQ analysis tab within the Dashboard. If not, then the PQ results will need to be manually verified. Refer to Automated System Performance Qualification (PQ) Procedure, Diagnostic [19-03-01-004-WI] for acceptance and validity criteria for all assays that have a PQ.

APTIMA COMBO 2 Assay PQ Analysis

1. Launch the Panther Dashboard software.
   1. Navigate to the Tasks screen.
      
   2. Select the Perform Maintenance button.
      
   3. Select the Service button.
      
   4. Select the Dashboard button.
      

2. The Panther Dashboard software screen appears.

   

3. Select the AC2Aptima Combo 2 Assay for Chlamydia trachomatis and Neisseria gonorrhoeae PQ tab.

   

4. Select the AC2 dataset to be calculated.

   

5. Enter the Operator's Name and Notes in the appropriate fields.

   The Instrument ID and Today's Date fields are auto-populated.

   

6. Select Perform Calculation.

   

   The Dashboard software displays the AC2 PQ Report.

   

APTIMA HPV Assay PQ Analysis

1. In the Panther FSE Shield software screen, select Dashboard.

   The Panther Dashboard software screen appears.

   

2. Select the HPV PQ tab.

   

3. Select the HPV dataset to be calculated.

   

4. Enter the Operator's Name and Notes in the appropriate fields.

   The Instrument ID and Today's Date fields are auto-populated.

   

5. Select Perform Calculation.

   

   The Dashboard software displays the HPV PQ Report.

   

Validity and Acceptance Criteria

Reference the current Automated System Performance Qualification (PQ) Procedure, Diagnostic [19-03-01-004-WI].

All PQs required (passing and any failed PQs with mediation notes) should be attached to the applicable service record.

Nonconforming Results

• Nonconforming results will be recorded and reported to the test lead for disposition whether to repeat the failed run or reject the system.
• Root cause analysis, corrective/preventative action identification, and verification testing, as applicable, will be completed prior to disposition and attached per 19-01-23-SOP Service Request Procedure for Field Service
• Run failures due to operator errors will be documented and a protocol retest will follow.
• System hardware failures require module verification testing followed by a protocol retest.

• All PQs required (passing and any failed PQs with mediation notes) should be attached to the applicable service record.