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* 1. How would you describe your laboratory

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* 2. In which country is your laboratory located?

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* 3. What is your area(s) of Molecular Diagnostic reporting? You may select multiple areas.

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* 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
for SARS-CoV2 diagnostics
for Mpox diagnostics
Syndromic panel testing

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* 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

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* 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?

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* 7. What is the percentage of nucleic acid tests that are covered by EQAs/PTs in your lab?

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* 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?

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* 9. What testing system do you currently use?

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* 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/
External quality Control of diagnostic Assays and Tests (ECAT) http://www.ecat.nl/
European Molecular Genetics Quality Network (EMQN) https://www.emqn.org/
EQUALIS https://www.equalis.se
INSTAND e. V.  https://www.instand-ev.de
Labquality https://www.labquality.fi
Quality Control for Molecular Devices (QCMD) http://www.qcmd.org/
Reference Institute for Bioanalytics (RfB) https://www.rfb.bio/
Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) https://rcpaqap.com.au/
United Kingdom National External Quality Assessment Service (UK NEQAS) https://ukneqas.org.uk/
none
We do not perform this test.

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* 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?

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* 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.

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* 13. How many alternative assessment procedures do you perform per parameter?

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* 14. How many samples are usually included in your alternative assessment procedure?

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* 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?

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* 16. Please list the tests that generate critical-risk results.

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* 17. Please list the tests that generate significant-risk results

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* 18. What is the reporting time frame for informing the healthcare provider of significant-risk results?

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* 19. What is the reporting time frame for the following assays?

  in general for SARS-CoV2 for MPox for syndromic panel testing
<12 hours
13-24 hours
1-3 days
4-7 days
more than a week
We do not perform this test

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* 20. What is the reporting time frame for informing the health care provider of critical-risk results?

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* 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
for SARS-CoV2 diagnsotics
for Mpox diagnostics

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* 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?

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* 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
Clinical Pathologist
Lab technician
Physician specializing in Pulmonology or Infectious Disease
No one

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* 24. Do you have suggestions, recommendations or points of criticism? Please let us know.

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