EpiDisease S.L. offers a rapid In Vitro Diagnostic test service for the qualitative detection of SARS-CoV-2 coronavirus antigens (Ag).
HOW DOES IT WORK?
Immunochromatography is performed in a membrane strip with detection of a SARS-Cov-2 specific antigen on the test line (T) and a control antigen on the control line of the technique (C) using the HOTGEN NOVEL CORONAVIRUS 2019-nCoV ANTIGEN TEST (Colloidal Gold) – SALIVA (Reference: 140511).
Samples should be tested immediately after collection or up to two hours after collection at the latest. Results should be read within 15 minutes.
These are the analytical parameters of the kit according to the manufacturer’s declaration:
- Sensitivity: 96,00% [IC 95%: 90,91%, 98,69%].
- Specificity: 99,78% [IC 95%: 98,79%, 99,99%].
- Accuracy: 98,97% [IC 95%: 97,77%, 99,62%].
- Detection limit: 2,5×102,2 TCID50 / mL (TCID = Tissue Culture Infective Dose).
Saliva samples (self-sampling)
- A CE-IVD marked fluid collection bottle should be purchased from a pharmacy.
- Do not eat, smoke, chew gum or drink anything for at least 30 minutes prior to 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 at all costs.
- Label the container with 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.
*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 20 minutes of delivery of the sample you will receive the results report by e-mail.
A negative test result does not eliminate the possibility of SARS-CoV-2 infection. In case of high suspicion of infection and a negative result obtained with the Antigen test, a PCR test is further recommended.
Positive results obtained using this test 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.