Immulite2000 2500 Xpi Assayts2

IMMULITE 2000/2500 and IMMULITE 2000 XPi
Assay Troubleshooting
ForProtection
internal use
notice
only// © 2008 Siemens Healthcare Diagnostics Inc.
Objective
 Identify and define the problem
 Use control and adjustment data as a troubleshooting tool
 Isolate the issue and use information to develop an appropriate Plan of

Action
ForProtection
internal use
notice
only// © 2008 Siemens Healthcare Diagnostics Inc.
Define the problem: Important questions to ask
 Is the assay a Sandwich or Competitive assay?
 What is the pattern of the CPS for the assay in question?
 Which assay failed-Single or multiple assays?
 When was the assay(s) last adjusted?
 Is the adjustment valid?
 How are adjustments for other assays?
 When was the QC last acceptable?
 When did the problem begin and what happened in between?

Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.
Page 3 Date Author Siemens Healthcare Diagnostics / Region / Department
Reviewing data to determine cause
 Review Adjustment and control data around the time the incorrect result
occurred.
 Review data for at least a two week period or longer
 Verify instrument precision by reviewing adjustment data for

various assays
 Verify instrument accuracy by reviewing QC data for various

assays
 QC results can be used as a tool to detect changes in the
pattern of the results by comparing QC data from previous
days
 Evaluating dose and cps of failed results compared to
acceptable results can provide information on why the
change in results occurred
Using data to evaluate result issues
CPS differs but Dose remains consistent
Normal occurrence of reagent activity
 Over time the reagent activity of an open wedge will decrease, which is
indicative in the CPS. This is expected behavior for an open wedge.
 Recommended adjustment schedule compensates for this change
Master curve CPS=CPS(unkown) x slope+Intercept
 Maintaining the recommended adjustment interval is essential for optimal

assay performance.
 Factors such as, Instrument maintenance and onboard consumables will

effect results if not properly maintained, as recommended in the Operator’s
Manual. Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.
EXAMPLE
CPS changes, dose remains consistent-normal occurrence of decreased

activity for a reagent wedge over time.
Date Cps Dose

11/5/2009 1,500,500 50 pg/ml
11/25/2009 1,200,250 49 pg/ml
12/1/2009 1,115,000 50 pg/ml

CPS remains consistent but dose changes, when compared to previous

results
 Adjustment issue: The adjustment is not doing its job…why?
 Improper Adjustor reconstitution, handling or storage
 Slope and intercept will affect the dose
 Readjust with fresh adjustors

Example
CPS consistent, dose changes-due to slope and intercept.
Date Cps Dose

11/5/2009 1,550,550 50 pg/ml
11/25/2009 1,550,000 80 pg/ml

CPS differs and Dose differs, when compared to previous results
 Issue with control material
 Review handling of control material and storage
 Reconstitute fresh controls

Example
CPS differs, dose differs for control material; incorrectly reconstituted

on different days.
Date Cps Dose
11/5/2009 1,550,200 50 pg/ml
11/25/2009 1,750,500 75 pg/ml
12/1/2009 1,450,000 45 pg/ml

Control Dose values go in the same direction for both Sandwich and
Competitive assays
 If Sandwich and Competitive assays exhibit the same low dose or

high dose response this indicates an issue with control reconstitution:
 Example
 Concentrated control material results in high dose
 High cps for sandwich assays and low cps for competitive assays
can be caused by increased binding of sample to the bead. Both
will result in High Dose.

QC failures due to contamination of instrument or reagent
 Adjustments will compensate for contamination
 This can mask an underlying problem

 Seen with a pattern of QC within expected range after a readjustment
 QC starts to drift out of range a couple of days after the adjustment
 A bad slope with controls in range may be indicative of reagent

contamination
 If issue is isolated to the wedge, try a new wedge
 DECON instrument and substrate pumps

 Use 0.1M NaOH
 Investigate water source

Causes of Imprecision or Erratic CPS
 Probe occlusion/bent probe (evident in a dispense angle)
 Intermittent, Improper dispense of water or substrate volume from

pumps
 Loose fittings or air leak in system components such as DRD’s
 Splashing on Incubator cover
 Shaker bars need adjustment
 Improperly primed instrument
 Improper handling and storage of adjustor or control material

Affected results for a single assay
 Events that may contribute to a single assay with failing results
 Reagent Lot changes
 Reagent storage issues (improper storage or handling)
 Adjustment that is significantly different than previous adjustment

(high or low slope)
 Assay related issue

Affected results for multiple assays
 If multiple assays are affected possibly indicative of an instrument

problem
 Review error log for possible instrument related issues
 Onset after monthly maintenance-
 Water source changed
Probe wash residue left in lines, if decontamination diagnostic was

prematurely stopped
 Common control used for multiple assays
 Improper reconstitution/storage of material

Reviewing dose and cps
Sandwich assay
 High cps = High dose -Caused by added CPS
 Low cps = Low dose - Caused by lack of sample or reagent
Competitive assay
 High cps= Low dose - Caused by lack of sample
 Low cps = High dose - Caused by lack of reagent

High CPS for Sandwich assays only
 Common cause of added counts in Sandwich assays:

 Improper water dispense (from water pump)
 Improper wash
 KNF pump, clogged sump/waste tube, tube lifter
 Air in lines
 Spinner errors
 Contamination
 Probe, water, substrate, instrument
 Sample related issue
*Diagnostic files are not useful for investigating causes of high cps in
Sandwich assays.

High CPS for Competitive assays only
 Common causes of added counts with Competitive assays
 Insufficient aspiration of sample (Level sensing or pipettor)
 Sample manifold (valve)
 Sample DRD
 Sample Probe dispense (occlusion or bent)
 Sample related: bubble or foam in sample
*Diagnostic files very useful for investigating high cps in Competitive assay

High CPS for Sandwich and Competitive Assays
 Highcps occurring with both Sandwich and Competitive

assays may be indicative of an instrument related issue:
 Insufficient water dispense from pump
 Improper spin
 Improper wash
 KNF pump, clogged sump/waste tube, tube lifter
 Contamination
 Probe, water, substrate, instrument
 Air in the DRD’s or tubing

Low CPS in Sandwich Assay Only
 Common causes of low CPS with Sandwich assays :
 Insufficient aspiration of Sample or Reagent (level sensing or pipettor)

 Sample or Reagent Manifolds (valves)
 Sample or Reagent DRD’s
 Improper Substrate dispense from pump
 Inactive substrate
 Clogged / old CO2 scrubber
 Occluded / bent Sample or Reagent Probes
 Bubbles / foam in sample tube or reagent wedge
 Issues with the water source or contamination may sometimes affect
assays by causing low CPS values.

Low CPS in Competitive Assay Only
 Common causes of low CPS with Competitive assays:

 Insufficient aspiration of reagent (level Sensing or pipettor)
 Reagent Manifold (valve)
 Reagent DRD
 Insufficient substrate dispense

 Inactive substrate
 Reagent Probe occluded/bent
 Bubbles/foam in reagent wedge
*Diagnostic files are useful for result failure with low CPS for both Sandwich and
competitive assays Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.
Guide for Conditions and Expected Results
Sandwich Assays
Condition Expected Result
No Bead Error or < lower assay limit
No Sample < lower assay limit
No Reagent Error; < lower assay limit; Extremely low results
No Substrate Error and CPS will be <100 CPS

Competitive Assays

No Bead Error
No Sample < Lower assay limit
No Reagent Error; > Upper assay limit;
No Substrate Error; CPS will be < 100 CPS

Pre-Treated Assays
No Bead Error
No Sample <Lower assay limit
No Reagent(1); <Lower assay limit

Pretreatment
No reagent (2) Error;>upper assay limit
No Substrate Error; CPS will be <100 CPS

Files Needed for Investigation
In order for Global Product Support Instrument Support to thoroughly

investigate causes of incorrect results, control or adjustment issues the
following files are needed:
 Main database.mdb
 Error log.mdb
 diagnostic files for the days that had the issue
 Accession number(s) of test(s) in question (very important)

Conclusion
 Review data to rule out if instrument or operator related
 When investigating assay issues such as control results, discordant

results or adjustment issues:
 Adjustment and QC data are useful and readily available

 Export data provides easy review of this information
 Review of detailed error log for mechanical issues

 Review errors during time range when the incorrect result(s) was
reported
 By defining the problem you can narrow down the possible causes
and develop an appropriate plan of action

The End


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IMMULITE 2000/2500 and IMMULITE 2000 XPi

 Identify and define the problem

 Use control and adjustment data as a troubleshooting tool

 Isolate the issue and use information to develop an appropriate Plan of

 Is the assay a Sandwich or Competitive assay?

 What is the pattern of the CPS for the assay in question?

 Which assay failed-Single or multiple assays?

 When was the assay(s) last adjusted?

 Is the adjustment valid?

 How are adjustments for other assays?

 When was the QC last acceptable?

 When did the problem begin and what happened in between?

 Verify instrument precision by reviewing adjustment data for

 Verify instrument accuracy by reviewing QC data for various

CPS differs but Dose remains consistent

Normal occurrence of reagent activity

 Recommended adjustment schedule compensates for this change

Master curve CPS=CPS(unkown) x slope+Intercept

 Maintaining the recommended adjustment interval is essential for optimal

 Factors such as, Instrument maintenance and onboard consumables will

CPS changes, dose remains consistent-normal occurrence of decreased

Date Cps Dose

11/25/2009 1,200,250 49 pg/ml

12/1/2009 1,115,000 50 pg/ml

Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.

CPS remains consistent but dose changes, when compared to previous

 Adjustment issue: The adjustment is not doing its job…why?

 Improper Adjustor reconstitution, handling or storage

 Slope and intercept will affect the dose

 Readjust with fresh adjustors

Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.

CPS consistent, dose changes-due to slope and intercept.

Date Cps Dose

11/25/2009 1,550,000 80 pg/ml

Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.

CPS differs and Dose differs, when compared to previous results

 Issue with control material

 Review handling of control material and storage

 Reconstitute fresh controls

Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.

CPS differs, dose differs for control material; incorrectly reconstituted

Date Cps Dose

11/5/2009 1,550,200 50 pg/ml

11/25/2009 1,750,500 75 pg/ml

12/1/2009 1,450,000 45 pg/ml

Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.

 If Sandwich and Competitive assays exhibit the same low dose or

 Concentrated control material results in high dose

Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.

 Adjustments will compensate for contamination

 This can mask an underlying problem

 QC starts to drift out of range a couple of days after the adjustment

 A bad slope with controls in range may be indicative of reagent

 DECON instrument and substrate pumps

Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.

 Probe occlusion/bent probe (evident in a dispense angle)

 Intermittent, Improper dispense of water or substrate volume from

 Loose fittings or air leak in system components such as DRD’s

 Splashing on Incubator cover

 Shaker bars need adjustment

 Improperly primed instrument

 Improper handling and storage of adjustor or control material

Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.

 Events that may contribute to a single assay with failing results