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IFCC Molecular Diagnostics Committee (C-MD)
Molecular Diagnostics of SARS-CoV2
Survey 2021
1.
Please provide laboratory key data
Private laboratory
University affiliated laboratory
Medical center affiliated laboratory
Large commercial (processes more than 1000 molecular tests a month)
Other (please specify)
2.
In which country is your laboratory located?
3.
Where do you get the samples from?
Regional
National
International
External partners for retesting
Other (please specify)
4.
How many SARS CoV2 molecular genetic tests are performed per week?
0-100
101-700
701-1400
1401-7000
>7001
5.
What molecular genetic methods are used? (e.g. rt-PCR? and/or LAMP?)
RT-PCR
LAMP (Loop-mediated isothermal amplification)
Transcription mediated Amplification (TMA)
Multiplex PCR with other targets (Influ A, Influ B, etc)
Direct PCR (without nucleic acid isolation)
POCT-PCR
6.
Are samples heated prior to processing to decrease exposure to personal?
No.
Yes. We use a temperature less than 55°C.
Yes. We use a temperature between 55-60°C.
Yes. We use a temperature between 60-65°C.
Yes. We use a temperature greater than 65°C.
7.
How many SARS-CoV2 specific genes (e.g. N genes) are detected in the detection procedure?
N-genes
RdRP
E-gene
S-gene
I don´t know
Other (please specify)
8.
Which specimens are mainly examined?
Nasopharyngeal swabs
Bronchoalveolar lavage (BAL)
Sputum/pharyngeal wash
Saliva
Other (please specify)
9.
How are the SARS-CoV2 detections performed?
RNA isolation and PCR setup manually
RNA isolation automated / PCR setup manually
RNA isolation and PCR setup automated
No RNA isolation + direct PCR
Other (please specify)
10.
What is the internal quality control (IC)?
An internal QC is integrated in each sample.
There is a positive and negative control in every run.
In addition to the kit control, already characterized samples are also run.
There Is a human collection control included in each sample
There is no internal QC.
11.
How many different tests are used?
Most frequently used assay/test method
Second test procedure
Third test procedure
12.
What is the average turn around time (in hours)?
0-3
3-6
6-12
12-24
>24
13.
Do you participate in EQAs for SARS-CoV2?… which one? Please name the provider.
14.
Are reference materials of defined concentration used for test validation?
Yes
No
if so which and how often?
15.
Are calibrators used to determine the lower limit of quantification (LoQ)?
Yes
No
16.
How many calibrators are used for quantitative reporting of results?
1
2
3
>3
We do not provide quantitative reporting of results.
17.
If a sample is positive, are the variants genotyped in your laboratory?
Yes
No
18.
Which sequence variants are currently being investigated?
N501Y
69/70del
E484K
K417T
K417N
L452R
P681R
Other (please specify)
19.
Which assay do you use for genotyping of the variants?
20.
How are the findings predominantly transmitted?
Fax
Email
Via direct connection/Electronic transmission of laboratory results
By mail/letter
21.
Which result is transmitted in a positive case?
Ct value
Number of detected copies/ml
TC50
Only qualitative result (pos/neg)
Other (please specify)
22.
Is infectivity information provided based on the result?
Yes
No
23.
Does your laboratory also perform sequencing?
Yes
No
If yes how many/week?
24.
Does your laboratory send patient samples for SARS-CoV2 sequencing?
Yes
No
If yes how many/week?
25.
If a variant is detected, is this information reported to the healthcare provider?
Yes
No
26.
If a variant is detected, is this information reported to a public health or governmental organization?
Yes
No
27.
Is variant analysis performed....
on every samples with detectable results.
When healthcare provider orders the test.
for surveillance purposes only.
only on samples with large amounts of detectable nucleic acid.
28.
By whom are the tests reimbursed?
health-insurance
person tested
public healthcare
Other (please specify)
29.
Who is validating the results of the analysis?
Technical Assistant
Laboratory doctor
Head of Department
Other (please specify)
Current Progress,
0 of 29 answered