Roche COBAS TaqMan 48 User manual

AMPLILINK Software

Flags and Troubleshooting Guide

Version 3.0

Software Version 3.3 and 3.4 Series

AMPLILINK Software

Software Version 3.3 and 3.4 Series

Roche Diagnostics

2 Flags and Troubleshooting Guide · Version 3.0

Publication information

Edition notice This publication is intended for operators of the AMPLILINK Software Version 3.3

and 3.4 Series.

Some of the tests identified for use with the AMPLILINK Software Version 3.3 and

3.4 Series, may not be approved for use in all countries. Contact a Roche

representative for tests that are commercially available in your country.

Every effort has been made to ensure that all the information contained in this

manual is correct at the time of publishing. However, Roche Molecular Systems, Inc.

may need to update the manual information as output of product surveillance

activities, leading to a new version of this manual.

CAUTION

General attention

To avoid incorrect results, ensure that you are familiar with the instructions and safety

information.

r Pay particular attention to all safety notices.

r Always follow the instructions in this publication.

r Do not use the software in a way that is not described in this publication.

r Store all publications in a safe and easily retrievable place.

Trademarks The following trademarks are acknowledged:

AMPLILINK, COBAS, COBAS P, AMPLIPREP, and TAQMAN are trademarks of

Roche.

All other trademarks are the property of their respective owners.

Intended use

As a component of the COBAS

®

AmpliPrep Instrument/COBAS

®

TaqMan

®

Analyzer

2

nd

generation system, the AMPLILINK Software is used to integrate all instruments

and analyzers offering a single user interface for PCR testing. AMPLILINK Software

supports various instrument configurations, data management, and analysis of test

results from clinical specimens using PCR technology.

Test results can be automatically transferred to an external host.

Publication

version

Software version Revision date Change description

1.0 n/a December 2009 First publication

2.0 n/a April 2011 New flags added

3.0 3.3 and 3.4 Series June 2015 Information for Software Version 3.4 Series added

Table 1 Revision history

Roche Diagnostics

Flags and Troubleshooting Guide · Version 3.0 3

AMPLILINK Software

Software Version 3.3 and 3.4 Series

The AMPLILINK Software is setup as a client/server architecture. This allows the use

of several decentralized AMPLILINK control units each controlling individual

instruments and/or analyzers.

The AMPLILINK Software also handles the test definition file (TDF) for each assay it

supports, captures sample identification, absorbance results, and interpretations and

comments from the data output for the instruments it supports and presents the data

in the user interface.

Symbols and abbreviations

Symbols used in the publication

Abbreviations The following abbreviations are used:

Symbol Explanation

p Start of procedure

s End of procedure

o List item

u Cross-reference

q Tip

Danger alert symbol

Warning alert symbol

Caution and general safety alert symbol

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

The symbol denotes that the equipment must not be disposed of in

the municipal waste system.

Table 2 Symbols used in the publication

Abbreviation Definition

AFI Absolute Fluorescence Increase

BLS Baseline Subtraction Elbow (algorithm)

cm Centimeters

C/mL

cp/mL

Copies per milliliter

DSLM Double Sigmoid Levenberg Marquardt (flag group)

IC Internal Control

in Inches (2.54 cm)

IU/mL International Units per milliliter

mL milliliters (10-3 liters)

QS Quantitation Standard

RFI Relative Fluorescence Increase

Table 3 Abbreviations

AMPLILINK Software

Software Version 3.3 and 3.4 Series

Roche Diagnostics

4 Flags and Troubleshooting Guide · Version 3.0

SPU Sample Processing Unit

TDF Test Definition File

TNAI Total Nucleic Acid Isolation

Abbreviation Definition

Table 3 Abbreviations

Roche Diagnostics

Flags and Troubleshooting Guide · Version 3.0 5

AMPLILINK Software

Software Version 3.3 and 3.4 Series

Table of contents

General flag description ........................................................................................................8

Flags ...................................................................................................................................8

Where the flags are displayed ..................................................................................9

Flag code ...................................................................................................................11

Flag text.....................................................................................................................11

Flag remarks ...................................................................................................................11

Sample status in Systems window ...............................................................................12

Result display..................................................................................................................12

Curve display / normalization......................................................................................14

List of all AMPLILINK Software flags...............................................................................16

cobas p 630 instrument flags ..............................................................................................20

TADM flag remark ........................................................................................................20

Liquid flag remark .........................................................................................................20

Clot flag remark .............................................................................................................21

Mixing flag remark ........................................................................................................21

Manual barcode entry flag............................................................................................22

COBAS

®

AmpliPrep Instrument flag remarks .................................................................23

DISP_ERROR flag remark............................................................................................23

Error AP00060157...................................................................................................24

KIT_EXPIRY flag remark (COBAS

®

AmpliPrep Instrument) ................................25

NO_SAMPLE flag remark............................................................................................26

PREP_ABORT flag remark ..........................................................................................27

REAG_ERROR flag remark..........................................................................................28

SAMPLECLOT flag remark .........................................................................................29

TEMP_RANGE flag remark.........................................................................................30

COBAS

®

TaqMan

®

Analyzer and COBAS

®

TaqMan

®

48 Analyzer flags with flag

remark....................................................................................................................................32

A/D_ABORT flag remark.............................................................................................32

DATA_ERROR flag remark.........................................................................................32

EVAL_ERROR flag..................................................................................................32

NO_DATA flag........................................................................................................33

DSLM flag remark .........................................................................................................33

INTERCEPT_RANGE-n flag.................................................................................34

CURVEFIT_FAIL_DSLM-n flag...........................................................................35

REGR_FAILURE_DSLM-n flag............................................................................36

CURVE_ABOVE_AFL-n flag................................................................................36

HPCINVALID flag remark ..........................................................................................37

KIT_EXPIRY flag remark.............................................................................................38

LPCINVALID flag remark ...........................................................................................38

MATH_ERROR flag remark........................................................................................39

NC_INVALID flag remark...........................................................................................40

PRECHECK flag remark...............................................................................................41

SPK_INFL-n flag......................................................................................................41

AMPLILINK Software

Software Version 3.3 and 3.4 Series

Roche Diagnostics

6 Flags and Troubleshooting Guide · Version 3.0

DRIFT_HIGH-n flag...............................................................................................42

CURVENOISE-n flag..............................................................................................43

BLTOOLOW-n flag.................................................................................................45

BLTOOHIGH-n flag ...............................................................................................46

POSTCHECK flag remark............................................................................................47

BLSLOPEHIGH-n flag............................................................................................47

NRMRFILOW-n......................................................................................................48

CTDETERR-n..........................................................................................................49

RFITOOHIGH-n.....................................................................................................49

QS_INVALID flag remark............................................................................................51

RUN_EXPIRY flag remark...........................................................................................52

STEPMOM flag remark ................................................................................................52

REGR_FAILURE_STEPMOM-n flag...................................................................53

LIN_EST_FAILURE-n flag ....................................................................................53

SYS_ERROR flag remark..............................................................................................53

PC_INVALID flag remark ...........................................................................................54

S_INVALID flag remark...............................................................................................54

BLS flag remark..............................................................................................................55

INVALIDOFFSET-n flag........................................................................................55

INTERPOLATION-n flag ......................................................................................56

BLSLOPEMINCHK-n flag .....................................................................................56

OVERROTATION-n flag.......................................................................................57

YINORMMAXCHK-n flag ....................................................................................57

AFITOOLOW-n flag...............................................................................................58

COBAS

®

TaqMan

®

Analyzer and COBAS

®

TaqMan

®

48 Analyzer flags without flag

remark....................................................................................................................................59

Diluted flag .....................................................................................................................59

ABOVE_RANGE flag....................................................................................................60

BELOW_RANGE flag ...................................................................................................60

DSLM flags......................................................................................................................61

DELTAB_MIN_FAILURE-n flag..........................................................................61

RFI_MIN_FAILURE-n flag ...................................................................................62

AFI_MIN_FAILURE-n flag ...................................................................................62

DATA_RANGE_FAILURE-n flag ........................................................................63

DECLINE_CORRECTED-n flag...........................................................................64

ROOT_NOT_FOUND-n flag................................................................................65

LINEAR_MODEL_DSLM-n flag ..........................................................................66

LMOM flags....................................................................................................................67

GAUSSJORDAN-n flag ..........................................................................................67

NONLINREGR-n flag.............................................................................................67

INVALIDFIRSTCYC-n flag...................................................................................68

RFITOOLOW-n flag .....................................................................................................68

SPK_DETECT-n / SPK_CORRECT-n / SPKREMOVED-n flag............................70

STEPMOM flags ............................................................................................................72

CURVEFIT_FAIL_STEPMOM-n flag .................................................................73

CONFIDENCE_INTERVAL-n flag......................................................................73

LINEAR_MODEL_STEPMOM-n flag.................................................................73

STEP_CORR-n flag .......................................................................................................74

AMPLILINK Software flag remarks..................................................................................75

CNTRL_FAIL flag remark............................................................................................75

Roche Diagnostics

Flags and Troubleshooting Guide · Version 3.0 7

AMPLILINK Software

Software Version 3.3 and 3.4 Series

CNTRL_MSNG flag remark ........................................................................................76

Result calculation algorithms .............................................................................................77

ELTH and Threshold algorithm ..................................................................................78

DSLM algorithm ............................................................................................................79

BLS algorithm.................................................................................................................80

Roche Diagnostics

8 Flags and Troubleshooting Guide · Version 3.0

General flag description AMPLILINK Software

Flags Software Version 3.3 and 3.4 Series

General flag description

The AMPLILINK Software and the connected analyzers and instruments generate

flags to indicate particular events during a run. An event that triggers a flag could be

for example a control failure, an aborted run, the occurrence of a hardware error, or

the fact that a diluted sample has been used.

Certain flags generate a flag remark in the Results window. The flag remark indicates

the cause of the flag.

Understanding the flag concept is a prerequisite for effective flag interpretation and

decisions about corrective measures and preventive actions for results with flag

remarks.

Flags

Flags are part of the result details and can have different impacts on results and result

interpretations (e.g. certain flags with a flag remark might set the result to Invalid or

Failed). Not all flags require a user action but each flag that generates a flag remark

must be interpreted. A result can have more than one flag.

There are two major flag categories:

Flags without a flag remark These flags provide additional information. The final result is valid and can be

reported.

Flags with a flag remark These flags can have an impact on the final result and must be interpreted.

A flag is built in the following way:

o The first four positions are reserved for the flag code. It consists of a system code

and two numerical digits.

o To the right of the flag code the flag text is displayed. It informs you about the

cause of the flag (e.g. high drift or high temperature).

o At the end of the flag the channel number is displayed (only used for channel-

specific flags generated by COBAS

®

TaqMan

®

Analyzer and COBAS

®

TaqMan

®

48

Analyzer).

Figure 1 Flag building blocks

A Flag code. Indicates the source of the flag

(e.g. TM) and the two digit code number

(e.g. 50).

C Channel number. Indicates the channel

number for channel specific flags

(COBAS

®

TaqMan

®

Analyzer and

COBAS

®

TaqMan

®

48 Analyzer only)

B Flag text. Indicates the cause of the flag.

TM50: QS_INVALID-2

A B C

Roche Diagnostics

Flags and Troubleshooting Guide · Version 3.0 9

AMPLILINK Software General flag description

Software Version 3.3 and 3.4 Series Flags

Where the flags are displayed

All flags (with or without flag remark) are displayed in the Detail Flags tab in the

Result Detail dialog box and in the Flag popup in the Results window.

q

The flag with the highest priority is always displayed first, if more than one flag is

generated for a result.

Figure 2 Flags in Control Result Detail dialog box

Figure 3 Flags popup in Results window

A Flags. The highest priority is always displayed first.

A Flags popup. Right-click a result to display the flags popup. The flag with the highest priority is

always displayed first.

A

Roche Diagnostics

10 Flags and Troubleshooting Guide · Version 3.0

General flag description AMPLILINK Software

Flags Software Version 3.3 and 3.4 Series

Flags with flag remark

Figure 4 Flags with flag remarks

Flags without flag remark

Figure 5 Flags without flag remarks

The following table shows all components of a flag with and without flag remark:

A Flag remark displayed in the Flag Remark

column

C Flag code

B Flag remark D Flag text

C D

A

B

A No flag remark displayed in the Flag

Remark column.

C Flag text

B Flag code

Flags Flag Remark Flag Code Flag Text

With flag remark 

Example: REAG_ERROR AP03 Lysis level missing

Without flag remark <no Flag Remark> 

Example: <no Flag Remark> TM40 STEP_CORR-n

Table 4 Flag information with and without flag results

B C

A

Roche Diagnostics

Flags and Troubleshooting Guide · Version 3.0 11

AMPLILINK Software General flag description

Software Version 3.3 and 3.4 Series Flag remarks

Flag code

The flag code consists of four characters. The first two characters indicate the system

which has generated the flag. The last two characters represent the code number.

Together they build a unique flag identifier.

The display of the flag code can be enabled or disabled in the Configuration window

Processing Configuration dialog box by the administrator. It is recommended to

enable the flag codes.

The following table shows the system codes used in the flag code.

Flag text

The flag text informs about the cause of the flag.

Channel-specific flags

Some flags generated by COBAS

®

TaqMan

®

Analyzer and COBAS

®

TaqMan

®

48

Analyzer are channel specific. The number at the end of the flag (e.g. SPK_DETECT-

2) indicates the channel for which the flag was generated.

Flag remarks

Certain flags generate a flag remark. The flag remark is displayed in the Results

window and indicates the cause of the flag. Only the flag remark of the flag with the

highest priority is displayed in the Results window if a result has more than one flag.

Related flags are grouped to the same flag remark (e.g. flags that are generated during

the pre-check calculation like DRIFT_HIGH-n or BLTOOHIGH-n all generate the

same flag remark PRECHECK).

u

For details about flag priorities and a list of flag remarks, see List of all AMPLILINK

Software flags (p. 16)

q

There are flags that have no flag remarks associated with it. In this case no flag remark is

displayed in the Results window.

Code System Example

AL AMPLILINK Software AL00

AP

COBAS

®

AmpliPrep Instrument

AP25

TM

COBAS

®

TaqMan

®

Analyzer

COBAS

®

TaqMan

®

48 Analyzer

TM23

HS cobas p 630 instrument HS05

Table 5 System codes in the flag code

Flag text Description

S-tube Input missing Input S-tube is missing

KIT_EXPIRY Reagent expired

SPK_DETECT-n A spike has been detected in the growth curve of the

indicated channel (n).

Table 6 Examples of flag texts

Roche Diagnostics

12 Flags and Troubleshooting Guide · Version 3.0

General flag description AMPLILINK Software

Sample status in Systems window Software Version 3.3 and 3.4 Series

Figure 6 Display of results with a flag remark in Results window

Sample status in Systems window

The color of finished samples in the Systems window indicates if a result is valid or

not and if the sample has a flag remark or not.

u

For details about status mapping of flags, see List of all AMPLILINK Software flags (p. 16)

Figure 7 Sample with a flag remark in Systems window

Result display

Result calculations are performed based on parameters defined in the test definition

file.

Possible result display elements:

A Flag remark in Results window

A

Color Sample status Comment

Green Sample finished Result is valid. No flag remark is displayed in the

Results window.

Orange Sample warning Result titer is displayed. In addition, there is a flag

remark displayed in the Results window.

Red Sample failed Result is invalid. A flag remark is displayed in the

Results window.

Table 7 Sample color in Systems window

A Sample with a flag remark on K-carrier

A

Result display Comment

Target Not Detected Result is below the detectable limit

<[TiterMin] Elbow in range, but calculated titer below the range defined

for the test.

[Titer] Elbow in range and calculated titer within range.

Table 8 Result display

Roche Diagnostics

Flags and Troubleshooting Guide · Version 3.0 13

AMPLILINK Software General flag description

Software Version 3.3 and 3.4 Series Result display

In some cases a flag remark is displayed in the Flag Remark column of the Results

window, and a titer result is still available. (A flag remark indicates the cause of the

flag.) These exceptions are listed below. Note that in these cases only results with a

Barcode flag may be reported.

Figure 8 Example of Failed results

Figure 9 Example of Invalid results

Figure 10 Example of Aborted results

Figure 11 Example of high titer results

>[TiterMax] Elbow in range, but calculated titer is above the range defined

for the test.

[Test dependent display] A qualitative test displays the result as defined in the test

definition file. This might vary from test to test.

Failed

Problem encountered during the COBAS

®

AmpliPrep

Instrument sample preparation.

Corresponding flag remark will be displayed.

Invalid Problem encountered during cobas p 630 instrument

primary tube pipetting or COBAS

®

TaqMan

®

Analyzer /

COBAS

®

TaqMan

®

48 Analyzer run.

Corresponding flag remark will be displayed.

Aborted Aborted order after processing has started.

NO flag remark will be displayed.

Flag remark Explanation Interpretation

CONTRL_FAIL Depending on AMPLILINK

Software settings.

Specimen invalid. Repeat

extraction, amplification, and

detection.

RUN_EXPIRY

KIT_EXPIRY

CNTRL_MSNG

TEMP_RANGE

COBAS

®

AmpliPrep Instrument

environment: Reagent loading

area or incubator temperature out

of specified operating range

REAG_ERROR Reagent level detection problem

Barcode Manual entry of barcode on

cobas p 630 instrument

Result is reportable.

Table 9 Flag remarks with titer results

Result display Comment

Table 8 Result display

Roche Diagnostics

14 Flags and Troubleshooting Guide · Version 3.0

General flag description AMPLILINK Software

Curve display / normalization Software Version 3.3 and 3.4 Series

Curve display / normalization

Flags can be evaluated in more detail using the growth curve in the Result Detail

dialog box.

Figure 12 Growth curve in Measurement Details tab

As default the growth curves will be displayed normalized. If the result is Invalid, the

growth curves will not be displayed under the normalized display. In order to view

the growth curves the normalization can be disabled.

Figure 13 Growth curves of a valid result

Normalization Normalization is used to compare different growth curves that have different

baselines. Different baseline levels occur due to usage of different fluorescence dyes.

After normalization, the baseline for each growth curve will be adjusted to a common

baseline. Depending on the algorithm used, the baseline is set to 1 or to 0 after

normalization.

The elbow value, also called threshold cycle (Ct) value, will be calculated using the

respective normalized growth curves.

A Normalized view B Un-normalized view

A

B

Roche Diagnostics

Flags and Troubleshooting Guide · Version 3.0 15

AMPLILINK Software General flag description

Software Version 3.3 and 3.4 Series

p To show the un-normalized growth curve

1

Click the Results button.

2

Double-click a result entry.

The Result Detail dialog box is displayed.

3

Select the Measurement Details tab to display the growth curves.

4

Clear the normalized check box to show the un-normalized growth curves.

s

Roche Diagnostics

16 Flags and Troubleshooting Guide · Version 3.0

List of all AMPLILINK Software flags AMPLILINK Software

Software Version 3.3 and 3.4 Series

List of all AMPLILINK Software flags

Code Flag text Description Priority Reportable

result

Status

mapping

(a)

Flag remark

AL00 Control failed Control(s) failed in batch 1

No

(b)

W CNTRL_FAIL

AL01 Control missing Control(s) missing in batch 2

No

(c)

W CNTRL_MSNG

TM03 BRIGHTRNG Sample bright value out of range 7 No A SYS_ERROR

TM04 TEMPCOVER TCCover under limit 8 No A SYS_ERROR

TM05 DARKDRIFT Dark drift greater than maximum

dark drift

9No A SYS_ERROR

TM06 SYS_CALC Calculation error (Div by 0) 4 No A SYS_ERROR

TM07 SYS_ABORT Hardware error occurred 3 No A SYS_ERROR

TM09 REFRNG Reference channel bright

measurement out of range

10 No A SYS_ERROR

TM17 A/D_ABORT Amplification/detection aborted 11 No A A/D_ABORT

TM18 KIT_EXPIRY Test kit expired 504 No W KIT_EXPIRY

TM19 RUN_EXPIRY Test-specific check for run expiry

failed

503 No W RUN_EXPIRY

TM20 EVAL_ERROR DB-Error while getting data 13 No A DATA_ERROR

TM21 NO_DATA Too few data points 12 No A DATA_ERROR

TM22 BELOW_RANGE Assay range check 612 Yes

TM23 ABOVE_RANGE Assay range check 613 Yes

TM24 NC_INVALID Negative controls (NC) invalid 31 No A NC_INVALID

TM25 LPCINVALID Low positive controls (LPC)

invalid

32 No A LPCINVALID

TM26 MPCINVALID Medium positive controls (MPC)

invalid

33 No A MPCINVALID

TM27 HPCINVALID High positive controls (HPC)

invalid

34 No A HPCINVALID

TM28 PC_INVALID Positive control (PC) in tests using

qualitative algorithm is invalid

35 No A PC_INVALID

TM29 S_INVALID Sample for qualitative test is invalid 36 No A S_INVALID

TM30 DILUTED Sample diluted 614 Yes

TM31 MATH_ERROR General calculation error 20 No A MATH_ERROR

TM40 STEP_CORR-n

BLStepCorr: step corrected 600 Yes

TM41 SPK_DETECT-n SpikeDet: spike(s) detected 601 Yes

TM42 SPK_CORR-n SpikeDet: spike(s) corrected 602 Yes

TM43 SPKREMOVED-n SpikeDet: spike(s) removed 603 Yes

TM44 SPK_INFL-n Pre-checks: spike influence 44 No A PRECHECK

TM45 DRIFT_HIGH-n Pre-checks: drift of baseline too

high

43 No A PRECHECK

TM46 CURVENOISE-n Pre-checks: curve noise >

MaxBLnoise

42 No A PRECHECK

TM47 BLTOOLOW-n Pre-checks: baseline range check

too low

41 No A PRECHECK

Table 10 AMPLILINK Software flags

Roche Diagnostics

Flags and Troubleshooting Guide · Version 3.0 17

AMPLILINK Software List of all AMPLILINK Software flags

Software Version 3.3 and 3.4 Series

TM48 BLTOOHIGH-n Pre-checks: baseline range check

too high

40 No A PRECHECK

TM49 RFITOOLOW-n Pre-checks: RFI < RFImin 604 Yes

TM50 QS_INVALID-n Plausibility checks QS: plausibility

QS failed

30 No A QS_INVALID

TM51 BLSLOPEHIGH-n Normalized baseline slope of curve

too high

60 No A POSTCHECK

TM52 NRMRFILOW-n Normalized RFI too low 61 No A POSTCHECK

TM53 CTDETERR-n Not enough subsequent data point

above AFL

62 No A POSTCHECK

TM54 RFITOOHIGH-n RFI of a negative curve too high 63 No A POSTCHECK

TM55 AFITOOLOW-n BLS elbow calculation: AFI too low 605 Yes

TM56 INVALIDOFFSET-n BLS elbow calculation: invalid

offset

50 No A BLS

TM57 INTERPOLATION-n BLS elbow calculation:

interpolation point not positive

51 No A BLS

TM58 BLSLOPEMINCHK-n BLS elbow calculation: baseline

slope out of range

52 No A BLS

TM59 OVERROTATION-n BLS elbow calculation: CT value

below AFI level

53 No A BLS

TM60 YINORMMAXCHK-n BLS elbow calculation: last cycle

below zero

54 No A BLS

TM61 GAUSSJORDAN-n LMOM: Singular matrix

encountered during the model

estimation

606 Yes -

TM62 NONLINREGR-n LMOM: Maximum number of

iterations reached during the

model estimation

607 Yes -

TM63 INVALIDFIRSTCYC-n LMOM: Estimated fluorescence

value at cycle 1 is below -0.1

608 Yes -

TM69 REGR_FAILURE_STEPMO

M-n

StepMOM: Calculation error in the

double-sigmoid estimation,

selection of the model, or in the

computation of the confidence

interval

57 No A STEPMOM

TM70 LIN_EST_FAILURE-n StepMOM: Calculation error in the

linear model estimation

58 No A STEPMOM

TM71 CURVEFIT_FAIL_STEPMO

M-n

StepMOM: The quality of the

estimated double-sigmoid model is

lower than 0.8. No step identified

that needs correction

615 Yes -

TM72 CONFIDENCE_INTERVAL-

n

StepMOM: Estimated model that

includes a step is overdetermined.

No step correction needed

616 Yes -

TM73 LINEAR_MODEL_STEPMO

M-n

StepMOM: A linear model is used

in the estimation of the raw curve

617 Yes -

TM74 DELTAB_MIN_FAILURE-n DSLM: The computed DeltaB of

the raw curve is below the

DeltaBMin

618 Yes -

Code Flag text Description Priority Reportable

result

Status

mapping

(a)

Flag remark

Table 10 AMPLILINK Software flags

Roche Diagnostics

18 Flags and Troubleshooting Guide · Version 3.0

List of all AMPLILINK Software flags AMPLILINK Software

Software Version 3.3 and 3.4 Series

TM75 INTERCEPT_RANGE-n DSLM: The median of the first five

fluorescence values is less than the

InterceptMin or greater than the

InterceptMax

71 No A DSLM

TM76 RFI_MIN_FAILURE-n DSLM: The computed RFI of the

raw curve is below RFIMin

619 Yes -

TM77 CURVE_FIT_FAIL_DSLM-n DSLM: The quality of the double-

sigmoid estimation of a positive

curve is less than 0.8

72 No A DSLM

TM78 AFI_MIN_FAILURE-n DSLM: The computed AFI of the

raw curve is below AFIMin

620 Yes -

TM79 DATA_RANGE_FAILURE-n DSLM: The median of the last five

fluorescence values is less than the

median of the first five

fluorescence values (evaluated for

the raw curve, the estimated model,

and the normalized curve)

621 Yes -

TM80 DECLINE_CORRECTED-n DSLM: A decline in the

fluorescence values is detected and

the raw curve is truncated at the

beginning of this decline

622 Yes -

TM81 REGR_FAILURE_DSLM-n DSLM: Calculation error in the

double-sigmoid estimation

73 No A DSLM

TM82 ROOT_NOT_FOUND-n DSLM: The normalized curve does

not intersect the AFL

623 Yes -

TM83 CURVE_ABOVE_AFL-n DSLM: All fluorescence values of

the normalized curve are above the

AFL

74 No A DSLM

TM84 LINEAR_MODEL_DSLM-n DSLM: Raw curve estimated using

a linear model

624 Yes -

TM95 MATH_ERROR_STEP-n Calculation error in step correction 25 No A MATH_ERROR

TM96 MATH_ERROR_SPIKE-n Calculation error in spike detection 24 No A MATH_ERROR

TM97 MATH_ERROR_PRECHK-n Calculation error in prechecks 23 No A MATH_ERROR

TM98 MATH_ERROR_ELBOW-n Calculation error in elbow

calculation

22 No A MATH_ERROR

TM99 MATH_ERROR_POSTCHK-

n

Calculation error in post-checks 21 No A MATH_ERROR

AP00 Test Kit expired Test kit expired 348 No W KIT_EXPIRY

AP02 ICIQS level missing ICIQS reagent missing 359 No A REAG_ERROR

AP03 Lysis level missing Lysis reagent missing 358 No A REAG_ERROR

AP04 Probe level missing Probe reagent missing 357 No A REAG_ERROR

AP05 Bead Solution level missing Bead solution reagent missing 356 No A REAG_ERROR

AP06 WashBuf level missing Wash buffer reagent missing 355 No A REAG_ERROR

AP07 Protease reagent missing Protease reagent missing 354 No A REAG_ERROR

AP08 Diluent level missing Specimen diluent missing 353 No A REAG_ERROR

AP09 EluBuf level missing Elution buffer missing 352 No A REAG_ERROR

AP10 MMix level missing Mastermix missing 351 No A REAG_ERROR

Code Flag text Description Priority Reportable

result

Status

mapping

(a)

Flag remark

Table 10 AMPLILINK Software flags

Roche Diagnostics

Flags and Troubleshooting Guide · Version 3.0 19

AMPLILINK Software List of all AMPLILINK Software flags

Software Version 3.3 and 3.4 Series

AP11 General Reag level missing General reagent missing 350 No A REAG_ERROR

AP12 Sample Input missing Sample input missing 349 No A NO_SAMPLE

AP13 S-tube Input missing S-tube input missing 365 No A DISP_ERROR

AP14 S-tube handling error S-tube handling error 364 No A DISP_ERROR

AP15 K-tube handling error K-tube handling error 363 No A DISP_ERROR

AP16 SPU handling error SPU handling error 362 No A DISP_ERROR

AP17 STip handling error S-tip handling error 361 No A DISP_ERROR

AP18 KTip handling error K-tip handling error 360 No A DISP_ERROR

AP19 Instrument Temp out of

range

Instrument temperature out of

range

379 No W TEMP_RANGE

AP20 Reagent Temp out of range Reagent temperature out of range 378 No W TEMP_RANGE

AP21 IncubationHole out of range Hole incubation temperature out

of range

377 No W TEMP_RANGE

AP22 IncubationSlit out of range Slit incubation temperature out of

range

376 No W TEMP_RANGE

AP23 IncubationTRel out of range Target release incubation

temperature out of range

375 No W TEMP_RANGE

AP24 Preparation aborted Preparation run aborted 366 No A PREP_ABORT

AP25 Sample Input clot detected Sample input clot detected 348 No A SAMPLECLOT

AP26 Test Kit use time exceeded First use stability of test kit

exceeded

347 No W KIT_EXPIRY

AP27 Test Kit on board time

exceeded

Test kit on board time exceeded 346 No W KIT_EXPIRY

HS01 TADM aspiration error TADM aspiration error 901 No A TADM

HS02 TADM dispensing error TADM dispensing error 902 No A TADM

HS03 Not enough liquid found Not enough liquid found 903 No A Liquid

HS04 No liquid found No liquid found 904 No A Liquid

HS05 Clot detected Clot detected 905 No A Clot

HS06 Channel hardware error Channel hardware error 906 No A Channel

HS07 Primary tube mixing error Primary tube mixing error 907 No A Mixing

HS08 Secondary tube mixing error Secondary tube mixing error 908 No A Mixing

(a) - = sample finished (sample status set to green in Systems window),

W = sample warning (sample status set to orange in Systems window),

A = sample failed (sample status set to red in Systems window)

(b) Result is Invalid, if in Configuration > Processing > Result Processing control failure handling is set to Set all sample results in batch to

INVALID.

(c) Result is Invalid, if in Configuration > Processing > Result Processing control failure handling is set to Set all sample results in batch to

INVALID.

Code Flag text Description Priority Reportable

result

Status

mapping

(a)

Flag remark

Table 10 AMPLILINK Software flags

Roche Diagnostics

20 Flags and Troubleshooting Guide · Version 3.0

cobas p 630 instrument flags AMPLILINK Software

TADM flag remark Software Version 3.3 and 3.4 Series

cobas p 630 instrument flags

The flag code of cobas p 630 instrument flags starts with HS.

u

For additional details about cobas p 630 instrument flags, see flags with code HS in List of

all AMPLILINK Software flags (p. 16)

TADM flag remark

Description A TADM flag remark occurs when the predefined pressure bands were exceeded

during pipetting. The TADM flag remark can occur during aspiration as well as

dispensing.

Flags

Cause There are several causes for a TADM flag remark:

o Tube diameter is defined too large. The pipetting channel loses the volume level

during pipetting and air is aspirated.

o Samples with foam. The liquid level is detected at the top of the foam and air is

aspirated during pipetting.

o Sample with unusual physical properties (for example the viscosity of a sample is

too high).

o Leakage of pipetting channels or tips.

Remedy o Ensure that the diameter of primary tubes is defined correctly. In case tubes with

various diameters are used in a run use the smallest diameter for tube definition.

o In case of samples with foam centrifuge the sample or remove the foam manually.

o There are two ways to process samples with unusual physical properties:

1) Centrifuge the sample and process it on the cobas p 630 instrument again.

2) If there is no possibility to centrifuge the sample, pipette the sample manually

and load it on the COBAS

®

AmpliPrep Instrument.

q

Inappropriate storage and treatment of samples affect the physical properties. Pay

attention to store and treat the sample in a correct way.

o Leakage of pipetting channels can be checked by performing daily maintenance.

Liquid flag remark

Description The sample volume is insufficient for the pending pipetting. The cobas p 630

instrument does not move deeper than 6 mm above the bottom of the primary

sample tube to prevent contamination of the pipetting channel and damaging the

instrument.

Code Flag text Flag remark

HS01 TADM aspiration error TADM

HS02 TADM dispensing error TADM

Table 11 Flags generating flag remark TADM

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