IFCC Molecular Diagnostics Committee (C-MD) Molecular Diagnostics of SARS-CoV2 Survey 2021

Question Title

* 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)

Question Title

* 2. In which country is your laboratory located?

Question Title

* 3. Where do you get the samples from?

Regional

National

International

External partners for retesting

Other (please specify)

Question Title

* 4. How many SARS CoV2 molecular genetic tests are performed per week?

0-100

101-700

701-1400

1401-7000

>7001

Question Title

* 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

Question Title

* 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.

Question Title

* 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)

Question Title

* 8. Which specimens are mainly examined?

Nasopharyngeal swabs

Bronchoalveolar lavage (BAL)

Sputum/pharyngeal wash

Saliva

Other (please specify)

Question Title

* 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)

Question Title

* 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.

Question Title

* 11. How many different tests are used?

Most frequently used assay/test method

Second test procedure

Third test procedure

Question Title

* 12. What is the average turn around time (in hours)?

0-3

3-6

6-12

12-24

>24

Question Title

* 13. Do you participate in EQAs for SARS-CoV2?… which one? Please name the provider.

Question Title

* 14. Are reference materials of defined concentration used for test validation?

Yes

if so which and how often?

Question Title

* 15. Are calibrators used to determine the lower limit of quantification (LoQ)?

Yes

Question Title

* 16. How many calibrators are used for quantitative reporting of results?

We do not provide quantitative reporting of results.

Question Title

* 17. If a sample is positive, are the variants genotyped in your laboratory?

Yes

Question Title

* 18. Which sequence variants are currently being investigated?

N501Y

69/70del

E484K

K417T

K417N

L452R

P681R

Other (please specify)

Question Title

* 19. Which assay do you use for genotyping of the variants?

Question Title

* 20. How are the findings predominantly transmitted?

Fax

Via direct connection/Electronic transmission of laboratory results

By mail/letter

Question Title

* 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)

Question Title

* 22. Is infectivity information provided based on the result?

Yes

Question Title

* 23. Does your laboratory also perform sequencing?

Yes

If yes how many/week?

Question Title

* 24. Does your laboratory send patient samples for SARS-CoV2 sequencing?

Yes

If yes how many/week?

Question Title

* 25. If a variant is detected, is this information reported to the healthcare provider?

Yes

Question Title

* 26. If a variant is detected, is this information reported to a public health or governmental organization?

Yes

Question Title

* 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.

Question Title

* 28. By whom are the tests reimbursed?

health-insurance

person tested

public healthcare

Other (please specify)

Question Title

* 29. Who is validating the results of the analysis?

Technical Assistant

Laboratory doctor

Head of Department

Other (please specify)