Result Interpretation

COBAS AmpliPrep/COBAS® TaqMan® Virology

Tests
& COBAS® TaqMan® High Pure System Tests
Objectives

Upon completing this section, the trainee should be able to:

Produce valid results during routine runs

Recognize invalid results

Be familiar with terminology

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 2
Results

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 3
Results
Review Tabs

• Double click on a result row to

open the Sample Result Detail
window.
• Access the following tabs:
Tracking Info, Measurement
Details, Detail Flags.

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 4
Results – Details (1)
Tracking Info

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 5
Results – Details (2)
Measurement Details

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 6
Results – Details (3)
Detail Flags Tab

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 7
Results

Seven possible result cases are generated:

1. “Invalid”
a) Failure or abort during titer calculation. Result calculation is not possible.
b) Following a control failure the whole batch is set to “Invalid” (according to control failure handling
settings in the AMPLILINK software).
2. „Failed“
Preparation on the COBAS® AmpliPrep Instrument failed.

3. “Aborted”
Aborted order after processing has started, no flag remark will be displayed
4. “>[TiterMax]”
Elbow in range, but calculated titer is above the range defined for the test.
or
Elbow below range, result is set to >[TiterMax] without calculation.
5. “[Titer]”
Elbow in range and calculated titer within range.
6. “<[TiterMin]”
Elbow in range, but calculated titer below the range defined for the test.
7. “Target Not Detected”
Result is below the detectable limit.
Roche Molecular Diagnostics Version 2.0 Result Interpretation
November 2009 Page 8
Range Checks

ElbowMin ElbowMax

Elbow

TiterMax TiterMin

Titer

>[TiterMax] [Titer] <[TiterMin] Target Not Detected

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 9
HIV General Overview
Life Cycle

June 2014 / Version 1.0 DRAFT Global Customer Support IVD – Portfolio and Clinical Information
Page 10
HIV Clinical Information
HIV pathogenesis: Viral replication drives
disease progression

June 2014 / Version 1.0 DRAFT Global Customer Support IVD – Portfolio and Clinical Information
Page 11
HIV Clinical Information
HIV pathogenesis: Anti-viral drugs allow the
immune system to recover

June 2014 / Version 1.0 DRAFT Global Customer Support IVD – Portfolio and Clinical Information
Page 12
Result Interpretation

Titer Result Example* Test range* Interpretation

(AMPLILINK
display)

Target Not
Target Not Detected Target Not Detected Report results as ‘HCV RNA not detected’
Detected

< 1.5E+01
Titer < Limit of Detection < 1.5E+01 IU/ml Target DNA or RNA detected, below limit of detection
IU/ml

Calculated result is below the lower limit of linear range.

≥ 1.5E+01
Limit of Detection < Titer Such a result has a high degree of variability and cannot
IU/ml &
< Lower Limit of Linear 2.7E+01 IU/ml be considered accurate. This result should be
< 4.3E+01
Range interpreted with caution. (No flag or other warning is
IU/ml
generated)
≥ 4.3E+01
Lower Limit of Linear Target DNA or RNA detected. The calculated titer is
IU/ml &
Range < Titer < Upper 8.8E + 5 IU/ml within linear range of the assay (report titer result as
≤ 6.9E+07
Limit of Linear Range ‘8.8E + 5 HCV RNA IU/ml)
IU/ml
Target DNA or RNA detected. Report result as ‘greater
Titer > Upper Limit of > 6.9E+07 than 6.9E+07 HCV RNAIU/ml’. The titer is above the
> 6.9E+07 IU/ml
Linear Range IU/ml upper limit of linear range. If quantitative result is
required, dilute the sample and retest
* COBAS® AmpliPrep / COBAS® TaqMan® HCV Test
Roche Molecular Diagnostics Version 2.0 Result Interpretation
November 2009 Page 13
Example Result Case (1a)
Invalid

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 14
Example Result Case (1b)
Invalid sample due to control failure

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 15
Example Result Case (2)
Failed due to K-tube handling error

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 16
Example Result Case (3)
> TiterMax (above test range)

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 17
Example Result Case (4b)
In range titer (low titer)

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 18
Example Result Case (4c)
In range titer (high titer)

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 19
Example Result Case (5)
< TiterMin (below test range)

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 20
Example Result Case (6)
Target Not Detected (TND)

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 21
Control Interpretation

Result AMPLILINK Result Flag Remark

Display
No target detected Target Not Detected
NC An invalid result Invalid NC_INVALID
A “valid” result (not a negative) Invalid NC_INVALID

No target detected Invalid LPCINVALID

A result below control range Invalid LPCINVALID
LPC An "in range" control 4.00E+1 C/ml
A result above control range Invalid LPCINVALID
An invalid result Invalid LPCINVALID

No target detected Invalid HPCINVALID

A result below control range Invalid HPCINVALID
HPC An "in range" control 1.98E+6 IU/ml
A result above control range Invalid HPCINVALID
An invalid result Version 2.0
Invalid HPCINVALID
Roche Molecular Diagnostics Result Interpretation
November 2009 Page 22
Result Interpretation
COBAS® AmpliPrep – COBAS® TaqMan® / COBAS®
TaqMan® 48 Assays CE IVD
Parameter HCV HIV 2.0 HBV 2.0
No growth curve Target Not Detected Target Not Detected Target Not Detected
Titer < [TiterMin] < 15 IU/ml < 20 cp/ml < 20 IU/ml
[TiterMax] >
Titer> 1.69E+2 IU/ml 2.75E+3 cp/ml 2.93E+4 IU/ml
[TiterMin]
Titer> [TiterMax] > 6.90E+7 IU/ml > 1.0E+7 cp/ml > 1.7E+8 IU/ml
Lower Limit of
43 IU/ml 20 cp/ml 20 IU/ml
Linear Range
Target Elbow Min 12 13 10
Target Elbow Max 48 42 50
QS Elbow Min 25 23 25
QS Elbow Max 38 31 40
An invalid result Invalid Invalid Invalid
An abortion during
Failed Failed Failed
sample preparation

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 23
Result Interpretation
COBAS® AmpliPrep – COBAS® TaqMan® / COBAS®
TaqMan® 48 Assays US IVD
Parameter HCV HIV
No growth curve Target Not Detected Target Not Detected
Titer < [TiterMin] < 43 IU/ml < 48 cp/ml
[TiterMax] >
Titer> 1.69E+2 IU/ml 2.75E+3 cp/ml
[TiterMin]
Titer> [TiterMax] > 6.90E+7 IU/ml > 1.00E+7 cp/ml
Lower Limit of
43 IU/ml 48 cp/ml
Linear Range
Target Elbow Min 12 10
Target Elbow Max 48 42
QS Elbow Min 25 23
QS Elbow Max 38 31
An invalid result Invalid Invalid
An abortion during
Failed Failed
sample preparation

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 24
Result Interpretation
COBAS® TaqMan® 48 / High Pure Assays CE IVD

Parameter HCV V2.0 HIV HBV

No growth curve Target Not Detected Target Not Detected Target Not Detected
Titer < [TiterMin] < 25 IU/ml < 47 cp/ml < 6 IU/ml
Example for
[TiterMax] > 1.96E+2 IU/ml 5.72E+3 cp/ml 3.29E+4 IU/ml
Titer> [TiterMin]
Titer> [TiterMax] > 3.91E+8 IU/ml > 1.00E+7 cp/ml > 1.10E+8 IU/ml
Lower Limit of
25 IU/ml 47 cp/ml 29 IU/ml
Linear Range
Target Elbow Min 12 10 9
Target Elbow Max 48 55 50
QS Elbow Min 25 20 20
QS Elbow Max 40 29 50
An invalid result Invalid Invalid Invalid

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 25
Result Interpretation
COBAS® TaqMan® 48 / High Pure Assays US IVD

Parameter HBV
No growth curve Target Not Detected
Titer < [TiterMin] < 6 IU/ml
Example for
[TiterMax] > 3.29E+4 IU/ml
Titer> [TiterMin]
Titer> [TiterMax] > 1.10E+8 IU/ml
Lower Limit of
29 IU/ml
Linear Range
Target Elbow Min 9
Target Elbow Max 50
QS Elbow Min 20
QS Elbow Max 50
An invalid result Invalid

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 26
Results
Rack View

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 27
Results
Cycler Batch View

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 28
Result Interpretation
Version History

Version Date Modifications

1.4 April 2007 Remove the sample rack picture from the “Components: Status Mapping” slide.
DRAFT This is only applicable for the COBAS® TaqMan® /TaqMan48 TC.

1.5 July 2007 Removed COBAS® TaqMan® & TaqMan 48 from title.
DRAFT
„Objectives“: removed „Be familiar with result calculation“
„Results“: added „INVALID“ and „Failed“ to the possible results
„Result Interpretation“: added disclaimer regarding result interpretation between
LOD and LLoLR.

Replaced Printscreens with AL3.2 where appropriate

Added slide „Result Interpretation – Flags in Combination with a Numerical
Result“

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 29
Result Interpretation
Version History (2)

Version Date Modifications

1.5 July Added Slide “Result Interpretation - _S_ ABOVE_RANGE / _S_ BELOW_RANGE”
2007
Added Slide “Result Interpretation -RFITOOLOW Example”
Removed „Result Summary“ Slide
Removed „Detail Flag Display“ Slide
1.6 DEC Added slide „High titer Samples PI note“
2007
Slide 4: only HBV test has results needs users‘ judgement

Slide 17: change the parameter for HCV v2.0.

Previous changes refer to presentation „Result Interpretation“: Extracted Flag

interpretation slides and created separate presentation
Extracted slides regarding flag intepretation to a separate presentation „Flag
Interpretation_V1.6_Dec_2007“

Inserted Slide „Result Interpretation for High Titer Samples“ for more clarity

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 30
Result Interpretation
Version History (3)

Versio Date Modifications

n

1.7 SEP Removed special result cases: “Target Not Detected” with target Ct in range, DRIFT High,
2008 Result interpretation high titer specimens. All these were moved to „Flag Interpretation“
Presentation
Inserted Ct/titer range explanation slide
Completed example slides for all result cases
Replaced 3.1 print-screens with 3.2 print-screens
Rearranged slide order (more logical order)
Inserted two slides with US IVD result interpretation for HPS and CAP CTM
1.8 FEB Added QS Ct range for each test.
2009 Added updated information regarding CAP CTM HIV 2.0 and HBV 2.0
2.0 NOV •Updated content with AMPLILINK 3.3 Software screenshots.
2009 –Controls are flagged if not in range (no titer display anymore)

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 31
Doing now what patients need next

Roche Molecular Diagnostics Version 2.0 Result Interpretation

November 2009 Page 32