5-Channel Qualification Kit Result Review Table

Error Acceptable Criteria Initial Field Service Action Follow-Up Run Final Field Service Action
Quad Point Melt (Required to Run before EBP)

[cartridge row][channel] EVALUATE

 

Description: PCR heater exceeded set tolerances [±2] (530nm/565nm OR 585nm/630nm OR 630nm/665nm) OR [±3] (475nm/520nm)

*Note optic 680/715nm data is not

evaluated as a part of the QPM

 0 Evaluate results
  • Check for no fills, partials, and bubbles in cartridge.
  • If no other errors present, clean the MUX glass wafer where the cartridge sits then conduct Heater MUX Self-Test and PCR.script.
  • Complete a reader health check. Renormalize or replace reader as needed.
  • Complete follow up run.
Only rerun specific bank of suspect lane Replace heater/MUX board ONLY if same lane triggers error
EBP Qualification

No Amp on > 2 Lanes WITHIN Rack and Row; on Color [color] [cartridge row]

Description: Error triggered only if >2 lanes on the same reader and channel

 

 0 Evaluate results
  • Check Strip for magnet beads
  • Check cartridge for no fills, partial fills, and bubbles
  • Perform general health check in Service Guide Troubleshooting Section.

In addition, perform the following:

  1. Check magnet position and alignment
  2. Review/Adjust Pressure Settings. Confirm values in the instrument match with the calrack table. If not, adjust the values by editing the calrack table.
  3. Check Cartridge for Debris
  4. Perform reader tray alignment.
  5. Check the PCR tray drive assembly screws.
Only rerun specific bank of suspect reader Replace reader ONLY if same reader triggers error

IC No Amp [cartridge row]

 

Description: Error triggered only if in channel Cy5.5 (680nm/715nm)

If "No Amp on >2 Lanes" error also raised, overlook error

 0 Evaluate results
  • Check Strip for magnet beads
  • Check cartridge for no fills, partial fills, and bubbles
  • Perform general health check in Service Guide Troubleshooting Section.

In addition, perform the following:

  1. Check magnet position and alignment
  2. Review/Adjust Pressure Settings. Confirm values in the instrument match with the calrack table. If not, adjust the values by editing the calrack table.
  3. Check Cartridge for Debris
  4. Perform reader tray alignment.
  5. Check the PCR tray drive assembly screws.
Only rerun specific bank of suspect lane Escalate through your Regional Escalation Process.

Target NO Amp on Color [color][cartridge row]

 

Description: Error triggered only if in channels

530nm/565nm OR 585nm/630nm OR

630nm/665nm OR 475nm/520nm

 

If "No Amp on >2 Lanes" error also

raised, overlook error

 0 Evaluate Results
  • Check Strip for magnet beads
  • Check cartridge for no fills, partial fills, and bubbles
  • Perform general health check in Service Guide Troubleshooting Section.

In addition, perform the following:

  1. Check magnet position and alignment
  2. Review/Adjust Pressure Settings. Confirm values in the instrument match with the calrack table. If not, adjust the values by editing the calrack table.
  3. Check Cartridge for Debris
  4. Perform reader tray alignment.
  5. Check the PCR tray drive assembly screws.
Only rerun specific bank of suspect lane Escalate through your Regional Escalation Process
Liquid Level Sense Error 1 Evaluate Result with septum Caps
  • Examine consumables for abnormalities such as low sample buffer fill volumes
  • Check to see if errors correspond to a specific pump
  • Check pump cables/flag/connectors and liquid level sensors
  • Run Pump check from MAX PowerOn.script
  • Clean and test the Photo and Receiver sensors

Only rerun specific bank of suspect lane without septum caps

  • An acceptable

result for the

follow up run is

0 Evaluate

Results without

septum caps

 Escalate through your Regional Escalation process.

Error in Full Fill Check

 

Description: Full fill check without amplification

 1 Evaluate Results
  • Check cartridge for no fills, partial fills, and bubbles
  • Check consumables for consistent fluid level across all strips
  • Inspect pump cables/flags/connectors and sensors
  • Run calrack.script to check alignment
  • Perform tray alignment as per Service Guide. Check the four drive train screws which holds the belt drive and z-bracket.
  • Run load cartridge script to verify
  • Gantry maintenance: clean the grease, and keep clean without re-greasing.
 Only rerun specific bank of suspect lane Escalate through your Regional Escalation process.

Normalizer on Color [color] Too Noisy

 

Description: Normalization noise error

0 Evaluate Results
  • On affected side, Perform Reader Health check and if required, perform reader normalization
On affected side, perform Full Qualification run to include QPM and EBP Replace reader

PCR Heater Warning

 

Description :

PCR heater exceeded set tolerances

 0 Evaluate Results
  • Run MUX self-test (also known as PCR self-test.)
  • Run PCR.script.
Only rerun specific bank of suspect lane Replace heater/MUX board ONLY if same lane triggers error

Step Loss on Axis Z; [how many] Steps

 

Description :

Lost more than 15 steps on the Z axis

 0 Evaluate Results
  • Refer to Motor Issues section and run Motor Script as per the troubleshooting section.
  • Be sure to check Z for motor step loss and get encoder values. o If motor script fails, refer to the Motor Issues section to determine whether to replace the motor (encoder included) and/or cables. o If motor script passes, then run Z-Gantry binding test as per the Service Guide Troubleshooting section. As part of the Z-gantry binding test, run strip positions 1, 6, and 11 only to verify the Z-movement.
  • Perform Z-gantry maintenance: clean the grease, and keep clean without re-greasing.
 Rerun an EBP qualification run on both sides Replace Gantry if test fails.

Step Loss on Axis [X|Y]; [how many] Steps

 

Description :

Lost more than 3 steps on the X/Y axis

 0 Evaluate Results
  • Check belt tensions and set screw
  • Verify gantry components are tight
  • Check if encoder cable is plugged in.
  • Check tip sensors.
  • Refer to Motor Issues section and run Motor Script as per the troubleshooting section
  • Be sure to check X and Y for motor step loss and get encoder values. If motor script fails, refer to the Motor Issues section to determine whether to replace the motor (encoder included), and/or the cables.
Rerun an EBP qualification run on both sides Escalate through your Regional Escalation process.

Ct %CV > 5%; [percent]% ACROSS RUN

 

Description :

Ct variation higher than expected

across banks / readers

 0 Evaluate Results
  • Check Strip for magnet beads
  • Check cartridge for no fills, partial fills, and bubbles
  • Perform general health check in Service Guide Troubleshooting Section.

In addition, perform the following:

  1. Check magnet position and alignment
  2. Review/Adjust Pressure Settings. Confirm values in the instrument match with the calrack table. If not, adjust the values by editing the calrack table.
  3. Check Cartridge for Debris
  4. Perform reader tray alignment.
  5. Check the PCR tray drive assembly screws.

Evaluate resulting curves

 Rerun an EBP qualification run on both sides Escalate through your Regional Escalation process.

Ct %CV > 5% on Color [color]; [percent]% WITHIN Rack and Row [cartridge row]

 

Description : Ct variation higher than expected within same bank / reader

 0 Evaluate Results
  • Check Strip for magnet beads
  • Check cartridge for no fills, partial fills, and bubbles
  • Perform general health check in Service Guide Troubleshooting Section.

In addition, perform the following:

  1. Check magnet position and alignment
  2. Review/Adjust Pressure Settings. Confirm values in the instrument match with the calrack table. If not, adjust the values by editing the calrack table.
  3. Check Cartridge for Debris
  4. Perform reader tray alignment.
  5. Check the PCR tray drive assembly screws.

Evaluate resulting curves

Only rerun specific rack Escalate through your Regional Escalation process.

Could not Pickup Tip

 

Description : Tip pickup failure on rack A/B

 0 Evaluate Results
  • Check alignment by running Calrack script
  • Inspect tips for deformities
  • Check Nozzles alignment, tightness, position
  • Clean and test the Photo and Receiver sensors
Rerun an EBP qualification run on both sides Escalate through your Regional Escalation process.

Heater Timeout Warning

 

Description : Lysis heater hardware issue

0 Evaluate Results
  • Check cables
  • Perform Lysis Heater test
  • If possible, reconfigure GORT Board by flashing Refer to Software/Firmware Update section in Service Guide.
On affected side, perform an EBP qualification run Replace GORT board and perform Full qualification run to include QPM and EBP

PCR Detector Motor Failure

Description : Reader detector motor issue

0 Evaluate Results
  • Check all connections to the reader.
  • If loose connections, then secure.
  • Run EFC to confirm motor failure. If EFC fails, replace reader. If EFC passes, re-run Quad Point Melt to see if motor loses steps.
  • If error persists, then replace Reader on affected side.
  • Perform Reader Health check and if needed, perform reader normalization.
On affected side, perform Full Qualification run to include QPM and EBP Escalate through your Regional Escalation process.
Errors Not Generated in Run Report
Barcode Issues
Cataloging Issue with Sample Tube Description: This condition is not generated in the run report and will occur during catalog [0] Error/Run
  • Run CatalogWin script.
  • Clean the mirror according to the cleaning procedures.
  • Realign barcode and allow instrument to re-catalog.
  • Replace all consumables if not readable.
  • Record lot number, and ensure complaint is opened against consumable.
Run Catalog Script Escalate through your Regional Escalation Process.
Cataloging issue with Snap ins Description: This condition is not generated in the run report and will occur during catalog [0] Error/Run
  • Run CatalogWin script.
  • Realign barcode and allow instrument to re-catalog.
  • Replace all consumables if not readable.
  • Record lot number, and ensure complaint is opened against consumable.
Run Catalog Script Escalate through your Regional Escalation process.
Additional Issues
Reader Saturation N/A
  • Disregard error
 N/A N/A

Instrument Connection Loss During Run

 

Description: This condition is not generated in the run report and will generate an Alert

0 Evaluate Results Perform Full Qualification run to include QPM and EBP Escalate through your Regional Escalation process.

Error in Empty Fill Check

 

Description: Empty fill check without amplification. This condition is not generated in the run report and will occur during catalog

0 Evaluate Results
  • Perform reader health check and reader normalization as needed
  • Check cartridge for debris
  • Clean glass heater cover
  • Clean reader Aperture Plate
  • Perform tray alignment as per Service Guide.
  • Check the four drive train screws which holds the belt drive and Z-bracket.
On affected side, perform Full Qualification run to include QPM and EBP Escalate through your Regional Escalation process.
Error in Results Processing 0 Evaluate Results
  • Check physical connections (especially on readers and heater mux assemblies).
  • Check/replace AIO USB cable.
Repeat the qualification run Escalate through your Regional Escalation process.