Frequently asked questions

Detection of SARS-CoV-2 in human samples by PCR

To perform the analysis of SARS-CoV-2, the methodology including quality assurance measures is briefly described below:

We currently use a fully automated system for RNA extraction based on the use of magnetic particles that can specifically bind RNA. The RNA is washed several times and is protected by artificial "carrier RNA" at the end of the extraction process.

For process control of the extraction, a negative process control and a positive process control are always included and processed in parallel with the patient samples. After extraction, we use a "one-step reverse transcriptase real-time PCR" protocol to detect the viral RNA. In this protocol, the RNA is translated into DNA by a reverse transcriptase in a first step, followed by real-time detection in the same reaction vessel. To check the detection we use a positive kit control and a negative kit control.

So, in total, we have four controls per analysis:

• Negative process control: verification of the quality/integrity of all reagents used.
• Positive process control: functionality of the analysis (extraction and detection)
• Negative kit control: Checking the quality/integrity of the reagents for detection
• Positive kit control: functionality of the analysis (detection)

Detection is performed in the Dual Target System on N1 and N2 according to the internationally recognized CDC method. In addition to the detection of SARS-CoV-2, we simultaneously detect the Beta-Actin gene or the RNase P gene (depending on the test kit used) as evidence of human RNA. This detection is used to verify sampling, RNA extraction as well as to detect possible inhibition.

The method described has been validated and its functionality confirmed in interlaboratory comparisons and ring tests.

Of course, we only use certified consumables.

Since December 2022, the molecular biological SARS-CoV-2 analysis is accredited.

Short Version

Long version

The following important notes should be observed!

• Correct performance of the sampling is a prerequisite for a correct result!
• There is a risk of injury when sampling the nasopharynx! It is the responsibility of the person taking the sample to inform themselves about the medical risks (e.g. irritation of the vagus nerve, mechanical injuries, etc.) when sampling the nasopharynx. We recommend that sampling be performed by medically trained personnel (e.g., physician).
• For your own safety, gloves and face mask should be worn during sampling! A second, non-powdered nitrile glove should be put on over a first glove. In order to be able to correctly assign the results of the examination, sampled materials must be clearly labeled with a waterproof pen (e.g. Edding)! The sample containers must be able to be assigned to the correct address(es). A sampling protocol should be included.
• Sampling is done at your own risk. The examining laboratory assumes no liability for any consequences of sampling.

Please refer to the enclosed info sheet for the exact sampling procedure.

The unsampled test kits should be stored at room temperature, dry and preferably protected from sunlight. The best-before date is printed on the individual materials.

The sampled swabs should be stored in a cool place and sent to the laboratory as soon as possible! Storage of moist swabs is possible at approx. 4 °C for max. 72 h (until processing in the laboratory!).

Dry swabs must not be stored! If samples are sent by mail, they must be refrigerated and labeled and shipped as "Biological Material, Category B" according to UN No. 3373. The packing instruction P650 must be followed.

After prior consultation, transport back to the laboratory can be carried out by our pick-up service.

Taking into account the respective order situation, the results and certificates are available within 24-72 hours. In the case of tests that do not take place on our premises (test center, pharmacy, general practitioner, company headquarters), the laboratory may not receive the results until the day after the sample is taken. Please ask at the collection point for the scheduled laboratory receipt.

You will receive your test result by e-mail to your specified e-mail address or, in the case of certain test centers, made available for download in the portal.

Yes, you can transfer it to these apps

If positive test results are obtained during the examination, we are required by law to report them to your local health department.

Please place yourself in self-isolation after receiving a positive result. Your local health department will contact you.

corona@labor-kneissler.de

By phone at 09471 606 330 0