LOMINA Covid-19 Ag výtěrem z kraje nosu - určený pro samotestování, krabička 1ks

Sampling options

Use a swab from the nose, throat or nasopharynx to take a sample.

Procedure for swabbing the front of the nose:
It is important to get as much secretion as possible. Insert a sterile swab into one nostril. The tip of the swab should be inserted approximately 2.5 cm from the edge of the nostril. Roll the swab over the mucous membrane of the nostril 5 times to ensure that both mucus and cells are collected. Repeat this procedure for the other nostril to ensure that a sufficient sample is taken from both nostrils (use the same swab).
Procedure for nasopharyngeal swab:
Carefully and slowly insert a sterile nasopharyngeal swab into the nostril with the greatest secretion under visual observation. Gently push the swab until it hits the resistance in the wall. Gently roll the swab against the wall of the nose several timewith. If you cough, wait a while and try again.
Procedure for oropharyngeal swab (from the throat):
When collecting, first rinse the patient's mouth with saline. Alternatively, ask the patient to rinse with a small amount of water (ensure it does not contain chlorine or other disinfectants that could affect the sample! ), which they then spit out or swallow; Ask the patient to open his/her mouth and make an "aaa" sound to expose the oropharyngeal area. If necessary, use a spatula to press the root of the tongue. Insert the swab over the root of the tongue into the back of the pharynx or uvula. Perform the swab through the palatal arch, over the pharynx and tonsils on both sides of the patient, exerting constant gentle pressure and rotating the swab well to increase the contact area. Be careful not to touch your tongue and contaminate the swab with saliva.

After collection, immediately place the swab in the reagent vial. If the body of the swab extends beyond the top of the tube, pinch it so that the top of the swab is just below the top of the tube, allowing the tip of the swab to remain in the solution and allowing the sample to mix sufficiently with the reagent.
! When pushing or pulling the tampon, work gently and do not use force to avoid injury!

Testing method

1. Read the instruction manual carefully and check the test kit before testing.
2. Remove the test cartridge in an environment with a temperature between 15 °C and 28 °C and a humidity between 30 and 50% (avoid a strong ventilation environment).
3. Take a sample using a swab as described above.
4. Place the swab in the reagent tube and mix the analyte well by rotating the swab at least 10 times, then remove the swab.
5. Close the vial with the cap and dropper.
6. Tear the foil bag, take out the test cartridge, put it on a horizontal surface. Drop 3 drops (about 100 µl) of the test solution into the sample opening of the test cartridge.
7. Use the test cartridge as soon as possible, but no later than 15 minuteses after opening the bag. Moisture can impair the sensitivity of the test.
8. Wait 15 - 20 minutes without moving the cartridge.
9. The test is invalid more than 20 minutes after injection of the analyte.

Sensitivity/Specificity

The Lomina SARS-CoV-2 Antigen LTX test is designed to detect SARS-CoV-2 coronavirus nucleocapsid (N) antigen from oropharyngeal or nasopharyngeal swabwith. Overall sensitivity and specificity were determined from the results of the functional capacity assessment.

• Length of testing: 15 minutes
• Sensitivity: 97.83 % (95 % CI: 87,75 % - 97,83 %)
• Specificity: > 100% (95% CI: 98,54 % - 100 %)

Restrictions on testing

1. Sample collection and processing methods have a major impact on the sensitivity of virus detection. Negative test results do not exclude the possibility of viral infection. If the test result is negative and the patient has clinical symptoms, it is recommended to use virus isolation and culture for confirmation and comprehensive diagnosis by the attending physician.
2. The samples collected may be infectious and the processing and testing of samples should be carried out in accordance with local relevant biosecurity regulationwith.

Content and composition of the LOMINA Covid-19 Ag test

1. TESTING PLASTIC CARD consisting of:

• Mouse anti-SARS-Co V-2 N protein antibody and goat anti-rabbit secondary antibody (immobilized on nitrocellulose membrane).
• Mouse monoclonal antibody against SARS-CoV-2 N-protein and rabbit IgG labeled with latex beads (mixed and sprayed on a marker pad).
• The sampling pad.
• Liquid absorbent pad.
• Plastic case/card (often also called a cartridge).

2. MOISTURE ABSORBER
3. REAGENT VIAL - PBS:

• Sodium chloride (NaCl)
• Potassium chloride (KCl)
• Potassium dihydrogen phosphate (KH2PO4)
• Sodium hydrogen phosphate (Na2HPO4)
• dH2O water (PH value ~ 7.1-7.6)

4. NASOFARYNGEAL SAMPLING TAMPON
5. OROFARYNGEAL SAMPLING TAMPON
6. CAP WITH INTEGRATED DROPPER
7. BOTTLES CONTAINING 300 µl (+/- 5 %) of PUFRU to be used as extraction tubes
8. INSTRUCTIONS FOR USE