EpiDisease S.L. offers a service of early detection of suspected cases of active SARS-CoV-2 infection, from respiratory or saliva samples, using the molecular technique of Polymerase Chain Reaction with reverse transcriptase, known by its acronym PCR.
HOW DOES IT WORK?
Viral RNA is extracted from the samples and three viral genes are analysed using the TaqPath COVID-19 CE-IVD RT-PCR kit from Thermo-Fisher, a leader company in in vitro diagnostics.
This kit has high sensitivity, detecting up to 10 copies of the virus in the PCR reaction. In addition, the fact that it detects 3 genes of the virus increases the specificity of the technique and reduces the number of false positives.
Saliva samples (self-sampling)
- You should purchase a CE-IVD marked fluid collection bottle from a pharmacy.
- Do not eat, smoke, chew gum or drink anything for at least 30 minutes before sample collection and do not use mouthwash 1 h before sample collection.
- Drink several sips of water 10 minutes before the sample collection to remove any debris that may be in the mouth.
- Wash your hands with soap and water or hydroalcoholic gel or wear sterile gloves when handling the bottle.
- Open the collection bottle. Avoid contact of the cap with non-sterile surfaces.
- Gently massage the cheeks, both sides of the neck and rub the tongue on the roof of the mouth to increase saliva production.
- Spit out at least 2 ml of saliva (equivalent to 1 tablespoon) regardless of the foam.
- Depositing mucus or sputum should be avoided.
- Label the container with your Name and Surname.
- Close the tube.
- Wrap the tube with absorbent paper.
- Place the tube in a plastic bag (you can use a freezer bag) and close.
- Deliver the sample(s) to the indicated drop-off point.
- EpiDisease staff will assign a code to your sample and give you this code.
*All samples must be accompanied by the appropriate signed Informed Consent Form we will provide you at the web page or in our laboratory.
Within 24 hours after sample collection, you will receive an email with your results report in English and Spanish language. The TaqPath COVID-19 CE-IVD RT-PCR test result can provide you the following results:
- Positive: The presence of at least 10 copies of the virus are detected in the PCR. This means that you are infected by SARS-CoV-2 coronavirus.
- Negative: : none of the three viral genes are detected in your sample. A negative PCR result means there is no presence of SARS-CoV-2 coronavirus in your sample at the time of sample was taken.
- Inconclusive: only one gene amplifies. In this case, our laboratory test will repeat the PCR test in your sample. Positive is reported if the result is consistent with the first test result.
- Invalid: internal positive control is no detected during the PCR analysis. So, we will proceed to repeat the PCR analysis or we will proceed to extract again viral nucleic acid. A new sample can be taken if required.
If the sample is found to be suboptimal for testing, you will be notified, and the total cost of the contracted service will not be charged or will be refunded. This result is not diagnostic. A qualified healthcare professional, i.e., a registered physician, must make a final COVID-19 diagnostic in agreement with the current health guidelines.
Positive PCR cases will be reported to the competent Health Authority of the Regional Administration according to the instructions and criteria agreed for this purpose by the competent Health Authority in agreement with Section Two of Order SND/344/2020.