2023 IFCC C-MD survey on quality assurance in molecular diagnostics focusing on infectious disease and syndromic testing.
1.
How would you describe your laboratory
Private
University Affiliated
Affiliated to a private hospital
Affiliated to a public hospital
Large commercial (processes more than 1000 molecular tests a month)
I do not work in a laboratory but in a department using point of care (POCT) devices for molecular genetic testing.
Other (please specify)
2.
In which country is your laboratory located?
3.
What is your area(s) of Molecular Diagnostic reporting? You may select multiple areas.
Inherited diseases
Microbiology (infectious diseases)
Microbiology - single order tests comprised of molecular panels of multiple analytes also known as syndromic testing syndromic testing (infectious diseases)
Pharmacogenomics
Personalized/Precision diagnostics
Noninvasive pregnancy testing
Oncology
Transplantation
Other (please specify)
4.
Background: The following questions are designed to better understand the testing methods that are used in the laboratory for molecular tests.
Syndromic tests are panels of tests that include analytes that are commonly associated with the syndrome. An example of a syndromic test would be a respiratory panel that includes numerous viruses and bacterial associated with respiratory illnesses. The health care provider typically requests all of these rather than individually ordering each suspected organism.
Does your laboratory use commercial kits or lab developed tests (LDT) for molecular diagnostics?
We only use commercial kits.
We only use Lab developed tests (LDT).
We use both (commercial kit and lab developed tests).
We do not perform this.
General
We only use commercial kits.
We only use Lab developed tests (LDT).
We use both (commercial kit and lab developed tests).
We do not perform this.
for SARS-CoV2 diagnostics
We only use commercial kits.
We only use Lab developed tests (LDT).
We use both (commercial kit and lab developed tests).
We do not perform this.
for Mpox diagnostics
We only use commercial kits.
We only use Lab developed tests (LDT).
We use both (commercial kit and lab developed tests).
We do not perform this.
Syndromic panel testing
We only use commercial kits.
We only use Lab developed tests (LDT).
We use both (commercial kit and lab developed tests).
We do not perform this.
5.
How many molecular genetic tests are performed per week in general, for SARS-CoV2, Mpox and syndromic testing?
1-10
11-100
101-500
501-1000
1001-10000
We do not perform this.
General
SARS-CoV2
Mpox
Syndromic testing
6.
Background: An external quality assessment (EQA) is an interlaboratory comparison. It is regarded as an important cornerstone in quality assurance of a lab.
Is it mandatory for your lab to participate in external quality assessment schemes (EQA) or proficiency testing if they are available?
Yes
No
7.
What is the percentage of nucleic acid tests that are covered by EQAs/PTs in your lab?
0-25%
26-50%
51-75%
76-100%
8.
Syndromic panels have allowed clinical microbiology laboratories to rapidly identify bacteria, viruses, fungi, and parasites and are can be fully integrated into the standard testing practices of many clinical department or laboratories. Which panels are carried out in syndrome testing?
blood culture identification
gastrointestinal infection (GI)
acute meningitis and encephalitis (ME)
respiratory tract infections (RTI)
urinary tract infection (UTI)
bone and joint infection
We do not perform syndromic testing
Other (please specify)
9.
What testing system do you currently use?
Biofire/Biomerieux FilmArray
QIAstat-DX
Qiagen/NeuMoDX
Seegene (e.g. STARlet-AIOS)
eplex - GenMark Diagnostics/Roche
Illumina NGS
Cepheid
Hologic - Novodiag
Hologic - Panther
Alinity - Abbott
Roche Cobas 5800/6800/8800
Other (please specify)
10.
Which PT/EQA provider do you use for the majority of assays in your lab? You may select more than one answer.
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
College of American Pathology (CAP) http://www.cap.org/
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
External quality Control of diagnostic Assays and Tests (ECAT) http://www.ecat.nl/
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
European Molecular Genetics Quality Network (EMQN) https://www.emqn.org/
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
EQUALIS https://www.equalis.se
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
INSTAND e. V. https://www.instand-ev.de
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
Labquality https://www.labquality.fi
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
Quality Control for Molecular Devices (QCMD) http://www.qcmd.org/
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
Reference Institute for Bioanalytics (RfB) https://www.rfb.bio/
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) https://rcpaqap.com.au/
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
United Kingdom National External Quality Assessment Service (UK NEQAS) https://ukneqas.org.uk/
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
none
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
We do not perform this test.
for genotyping
for SARS-CoV2
for Mpox
for Syndromic testing
Other (please specify)
11.
Background: When Proficiency Testing materials are not available, the laboratory is responsible for establishing an alternative assessment procedures (AAP) for verifying the acceptability of test performance per CLSI QMS24 Proficiency and Alternate Assessment Procedures. The next questions are addressing how this procedure is done in your lab.
Do you perform alternative assessment procedures (AAP) in your lab?
We perform alternative assessment procedures (AAP) for every analyte in our lab even if an EQA scheme is available
We only perform alternative assessment procedures (AAP) if there is no EQA available.
We only perform alternative assessment procedures (AAP) for representative analytes using specific detection techniques.
We do not perform alternative assessment (AAP) procedures.
12.
According to the Clinical and Laboratory Standards Institute (CLSI) QMS24 Alternate Assessment Procedures (AAP) can include the following: What kind of AAP is performed in your lab? You may select more than one answer.
Internal split samples
Characterized material from an outside laboratory
Manufacturer control material
Reevaluation for previously tested material
Surrogate organisms
Clinical correlation studies.
Other (please specify)
13.
How many alternative assessment procedures do you perform per parameter?
We perform AAP once after installation of a new diagnostic assay..
We perform AAP once a year per parameter
We perform AAP twice a year per parameter
We do not perform AAP at all
We do not have a defined frequency for performing AAP
14.
How many samples are usually included in your alternative assessment procedure?
1-5
6-10
11-20
21-50
51 and more
15.
Background:
Critical-risk
results
require immediate medical attention and action because they indicate a high risk of imminent death or major patient harm.
An example of a critical-risk test result would be detection of an infectious agent (specifically, bacterial or viral) from a cerebral spinal fluid (CSF) specimen from a patient suspected as having encephalitis/meningitis. Treatment for encephalitis/meningitis is guided by the causative agent.
Significant-risk results
are not imminently life-threatening, but signify significant risk to patient well-being and therefore require medical attention and follow-up action within a clinically justified time limit.
An example of a significant-risk molecular test result would be detection of a predefined threshold increase of BCR-ABL mRNA in patients with chronic myeloid leukemia (CML).
Does your laboratory generate molecular diagnostic results that are considered critical-risk and/or significant-risk?
My lab offers testing that generates both critical-risk and significant-risk results
My lab offers testing that generates critical-risk results but not significant-risk results
My lab offers testing that generates significant-risk results but not critical-risk results
My lab offers testing that is standard risk only
16.
Please list the tests that generate critical-risk results.
17.
Please list the tests that generate significant-risk results
18.
What is the reporting time frame for informing the healthcare provider of significant-risk results?
less than 1 hour
1 - 6 hours
7 - 12 hours
13 - 24 hours
Other (please specify)
19.
What is the reporting time frame for the following assays?
in general
for SARS-CoV2
for MPox
for syndromic panel testing
<12 hours
in general
for SARS-CoV2
for MPox
for syndromic panel testing
13-24 hours
in general
for SARS-CoV2
for MPox
for syndromic panel testing
1-3 days
in general
for SARS-CoV2
for MPox
for syndromic panel testing
4-7 days
in general
for SARS-CoV2
for MPox
for syndromic panel testing
more than a week
in general
for SARS-CoV2
for MPox
for syndromic panel testing
We do not perform this test
in general
for SARS-CoV2
for MPox
for syndromic panel testing
20.
What is the reporting time frame for informing the health care provider of critical-risk results?
less than 1 hour
1 - 6 hours
7 - 12 hours
13 - 24 hours
We do not perform this test.
Other (please specify)
21.
What molecular genetic methods are mainly used (e.g. rt-PCR? and/or LAMP?)?
RT-PCR
LAMP (Loop-mediated isothermal amplification)
Transcription mediated Amplification (TMA)
digital droplet PCR (ddPCR)
Multiplex PCR with other targets (Influ A, Influ B, etc)
Direct PCR (without nucleic acid isolation)
NGS
Sanger
in general
RT-PCR
LAMP (Loop-mediated isothermal amplification)
Transcription mediated Amplification (TMA)
digital droplet PCR (ddPCR)
Multiplex PCR with other targets (Influ A, Influ B, etc)
Direct PCR (without nucleic acid isolation)
NGS
Sanger
for SARS-CoV2 diagnsotics
RT-PCR
LAMP (Loop-mediated isothermal amplification)
Transcription mediated Amplification (TMA)
digital droplet PCR (ddPCR)
Multiplex PCR with other targets (Influ A, Influ B, etc)
Direct PCR (without nucleic acid isolation)
NGS
Sanger
for Mpox diagnostics
RT-PCR
LAMP (Loop-mediated isothermal amplification)
Transcription mediated Amplification (TMA)
digital droplet PCR (ddPCR)
Multiplex PCR with other targets (Influ A, Influ B, etc)
Direct PCR (without nucleic acid isolation)
NGS
Sanger
Other (please specify)
22.
Does your syndromic panel testing include detection of bacterial resistance genes (e.g., extended-spectrum ß-lactamases (ESBL) or carbapenemases like KPC, OXA-48 or NDM)) and are the results included in the reporting?
No.
Yes, we detect these genes (partially) but they are not included in the findings.
Yes, we detect these genes (partially) and they are included in the findings.
Yes, we detect these genes (partially), they are included in the diagnosis and the sender of the sample is informed immediately.
23.
Who provides the clinical advice if a sample is tested positive?
for Genotyping
for SARS-CoV
for Mpox
based on syndromic panel testing
Microbiologist
for Genotyping
for SARS-CoV
for Mpox
based on syndromic panel testing
Clinical Pathologist
for Genotyping
for SARS-CoV
for Mpox
based on syndromic panel testing
Lab technician
for Genotyping
for SARS-CoV
for Mpox
based on syndromic panel testing
Physician specializing in Pulmonology or Infectious Disease
for Genotyping
for SARS-CoV
for Mpox
based on syndromic panel testing
No one
for Genotyping
for SARS-CoV
for Mpox
based on syndromic panel testing
24.
Do you have suggestions, recommendations or points of criticism? Please let us know.
Current Progress,
0 of 24 answered
