LaShondra Berman, MSc.

Transcription

LaShondra Berman, MSc.
Influenza Division, Centers for Disease Control and Prevention
Respiratory Disease Surveillance in the Americas– SARInet
Inaugural Meeting May 29-30, 2014
Quality Assessment Background….
o Due the limited number of proficiency testing programs
available to US PHLs, the CDC Influenza division diagnostic
team decided to make available a means for laboratories to assess
their performance using the CDC Human Influenza Virus RealTime RT-PCR Diagnostic Panel.
o The Molecular Diagnostic Performance Evaluation Panel has
been offered in 2011, 2012, and 2013 to US PHLs that received the
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic
Panel (FluIVD03).
o Laboratories representing all 50 states, Washington, D.C., and
Puerto Rico have participated in this exercise.
o The performance of individual laboratories was assessed based
on the laboratory’s ability to detect and correctly identify the
included viruses.
Method…
 All evaluation panels have been composed of 9 simulated human
specimens that included 8 evaluation samples and 1 challenge
sample. Simulated specimens contained inactivated influenza
viruses and/or cultured human cells, including influenza A
samples (A/H3N2, A/H3N2v, A/H1N1pdm09, A/H5N1, A/H7N9),
influenza B samples, and negative samples.
 While Ct values were collected and evaluated, reported Ct values
were not considered in the assessment of laboratory
performance, and no grades or rankings were assigned.
 Evaluation of Ct values did allow us to assess the participant’s
algorithm for processing samples within their laboratory.
Summary of Participation…
October – December 2011
Sample
ID
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
Sample 6
Sample 7
Sample 8
Sample 9
Virus
Influenza A/H3
Influenza
A/H1pdm09
Influenza A/H3
Negative
Control
Influenza B
Influenza A/H1
Influenza B
Negative
Influenza
A/H1pdm09
80 labs
October 2012 – January 2013
No. (%) of
participants
with correct
results
80 (100)
80 (100)
61 (76)
80 (100)
80 (100)
78 (98)
76 (95)
80 (100)
80 (100)
Sample
ID
Virus
Sample 2
Influenza
A/H1pdm09
Influenza B
Sample 3
Influenza A/H3
Sample 1
Negative
Control
Influenza
Sample 5
A/H3v
Sample 6 Influenza B
Influenza
Sample 7
A/H1pdm09
Sample 4
No. (%) of
participants
with correct
results
89 (100)
89 (100)
89 (100)
89 (100)
80 (90)
88 (98.9)
88 (98.9)
Sample 8 Influenza A/H3
89 (100)
88 (98.9)
89 labs
Challenge samples…
 In 2011 Sample 3, which was an H3N2 virus with a high expected
Ct value, was included in the panel as a challenge sample. Sixtyone laboratories were able to successfully identify this sample,
with eleven laboratories reporting negative results, and eight
laboratories reporting an unsubtypeable or inconclusive results.
 In 2012 eighty laboratories were able to successfully identify the
challenge sample, a variant H3N2 virus (H3v)that was included
in the panel. For this sample, an identification of Influenza
A/H3v or Inconclusive was accepted as a correct answer if the
laboratories reported Ct values less than 38 for the InfA,
pdmInfA, H3, and RP targets only. Either identification was
considered incorrect if Ct values less than 38 were reported for
any other targets.
Summary of Participation…
August 2013 – October 2013
Sample ID
Virus
No. (%) of
participants
with correct results
Sample 1
Sample 2
Influenza B
Influenza A/H3v
89 (100)
82 (92.1)
Sample 3
Negative Control
88 (98.9)
Sample 5
Sample 6*
Influenza
A/H1pdm09
Influenza A/H3
Influenza A/H7**
85 (95.5)
49 (55.1)
Sample 7
Influenza B
88 (98.9)
Sample 4
Sample 8
Sample 9
Influenza
A/H5***
Influenza
A/H1pdm09
89 (100)
86 (96.6)
89 (100)
• *Indicates challenge sample.
• **2/49 laboratories detected Influenza A but did not test with the A/H7 Assay
• ***11/86 laboratories detected Influenza A but did not test with the A/H5 Assay
89 labs
Challenge samples(cont’d)…
 In 2013, Forty-nine laboratories were able to successfully identify
the challenge sample (Sample 6), a low titer H7N9 virus that was
included in the panel. For samples 6 and 8(A/H5N1), an
identification of Influenza A/Unsubtypable or Inconclusive was
accepted as correct if the laboratories did not test with the
Influenza A/H7 (Eurasian Lineage) Assay or Influenza A/H5
Subtyping Kit.
Overall Performance …
Table 3. Overall laboratory performance
Number of Correct
Number (%) of
Results (Max=8)
Participants
8
75 (94)
7
4 (5)
6
1 (1)
on evaluation samples
Number of Correct
Number (%) of
Results (Max=8)
Participants
8
87 (97.8)
7
1 (1.1)
6
1 (1.1)
2011
2012
on evaluation samples
Number of Correct
Number (%) of
Results (Max=8)
Participants
8
76 (85.4)
7
10 (11.2)
6
3 (3.4)
2013
Molecular Diagnostic Performance Evaluation Panel
Results 2013
M*
InfA
R*
*E
M
InfB
R
E
27.3
22-33
23.9
Primers/Probe
pdmInfA
M
R
E
M
AH3
R
E
26.7
23-33
23.5
M
pdmH1
R
E
Sample ID
Sample 1
Sample 2
24.0 20-29 19.5
25.5
20-31
22.1
Sample 4
26.8 22-35 19.2
26.5
21-34
19.3
Sample 5
34.8 30-38 31.9
Sample 6
Sample 7
Sample 8
35.7 24-42 31.7
28.0 22-33 25.1
Sample 9
31.5 26-36 29.2
Sample 3
34.8
30-38
28.3
22-36 22.9
33.0
28-41
33.9
29.2 25-33 26.0
31.1
25-35
29.0
*M=Mean *R=Range *E=Expected
Mean & Range values exclude Ct values that were reported as 0
31.7
Problems encountered…
 Transcription errors:
 Giving Ct values for the wrong primer/probe target
 Final results interpretation:
 Misinterpretation of obtained results (A/H3≠ A/H3v)
 Specimen handling/processing:
 mislabeling of processed samples.
 Testing of incorrect panel(previous year panel) and
reporting the results
Molecular Diagnostic Performance Evaluation Panel 2014
o As of now, we plan to offer 2 US quality assessment panels in
2014.
o Many PHLs have requested that this be an ongoing activity to use
as a proficiency test for their diagnostic influenza clinical
reporting.
o Although we are not a accrediting authority, laboratories are able
to use these assessments as split sample PT testing.
Conclusions….
o Overall, US PHLs using the CDC Influenza Dx assay performed at a
very high level and performed testing in accordance with the package
insert.
o As a result of the QA exercise we were able to provide PHLs with an
assessment of their performance at the beginning of the upcoming
influenza diagnostic and surveillance season and understand the
current influenza testing capabilities of US PHLs.
Data usage…
 Information gathered from this activity was used to address
technical issues faced by participating countries such as
RNA recovery, real-time RT-PCR assay issues, and platform
specific data analysis issues.
 This has helped us gain a better understanding of what
instruments and testing algorithms are being used in the
countries that we cooperatively support.
 Ultimate goal is to improve the quality and confidence of
results obtained from laboratories that provide seasonal
influenza surveillance.
CDC/PAHO Quality Assessment
 In 2013 following the PAHO annual meeting in Brazil,
it was decided that a quality assessment of the PAHO
region laboratories was necessary.
 A letter of intent was sent to laboratories stating the
purpose of the panel exercise and the type of
information that we hope to obtain.
 This exercise was strictly voluntary.
Panel composition….
Sample 2 Influenza A/pdmH1N1
Sample 4 Negative
Sample 6 Influenza A/H3N2 variant
Sample 9 Negative
Sample 10 Influenza A/pdmH1N1
Participating countries/laboratories
 Colombia- 4 laboratories
 Haiti
 Paraguay
 Guatemala
 Bolivia- 2 laboratories
 Costa Rica- 2 laboratories
Overall performance..
Sample ID
Virus
Number Answered
Correctly (% )
Sample 1
Influenza A/H3
11(100)
Sample 2
Influenza A/pdmH1N1
7(63.6)
Sample 3
Influenza B
7(63.6)
Sample 4
Negative
11(100)
Sample 5
Influenza A/H3
10(90.0)
Sample 6
Influenza A/H3N2 variant
8(72.7)
Sample 7
Influenza B
7(63.6)
Sample 8
Influenza A/H3
7(63.6)
Sample 9
Negative
11(100)
Sample 10
Influenza A/pdmH1N1
3(27.2)
Sample 10…..
 Low titer Influenza A/pdm H1N1 virus with Ct values
low to mid 30s
 Efficiency of extraction method displayed
 Low recovery of RNA yields high or no Ct values
QA for Chile and Brazil…
 Received QA panels for evaluation of their regional
laboratories.
 Panels were tested for quality control measures.
 Panel results along with results reporting worksheets
were forwarded.
 Countries received results and assessed their
participants
Future QA Panels
 Currently planning to provide another QA exercise for
the PAHO region
 Please inform Rahkee if participation is desired.
CDC Laboratory Support for Influenza Surveillance
Sharepoint Site!
Alias
( C-L-S-I-S )
 CLSIS is a standalone registration support system for US
domestic and international laboratories to provide access
to all documents and protocols.
 Serves as a communication channel that allows users to
send questions regarding the CDC real-time protocols
and assays and receive FAQ based help.
 In the future: Provide mechanism to record and evaluate
quality assessment panel results- (phase II release)
CDC Laboratory Support for Influenza Surveillance Sharepoint Site!
Request Access to CLSIS
www.cdc.gov/flu/clsis
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Current CLSIS Registered Users by Country:
 Argentina: 3 users
 Brazil: 4 users
 Chile: 1 user
 Costa Rica: 1 user
 El Salvador: 2 users
 Guatemala: 4 users
 Mexico: 3 users
 Trinidad & Tobago: 1 user
 Venezuela: 1 user

LaShondra Berman, MSc.

Transcription

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