Clungene® COVID-19 Rapid test
More safety in only 15 minutes
The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay method for the qualitative detection of SARS CoV-2 nucleocapsid antigen in nasopharyngeal and oropharyngeal swabs from individuals suspected by their healthcare provider to be COVID-19 infected.
The COVID-19 Antigen Rapid Detection Kit is intended for use by trained clinical laboratory personnel who have been specifically instructed and trained in the in vitro diagnostic procedure.
- clinical specificity = 100 %
- clinical Sensitivity = 98,5 %
- BfArM approval
- easy usage
- fast and reliable test results in only 15 minutes
- can be performed with naso- and oropharyngeal samples
- storage at room temperature
- all test components are included
- no cross-reactivity with other corona viruses like MERS, 229E, NL63, KHU1 or influenza A, B
- only for in vitro diagnosis
- for healthcare professionals and specialists at locations close to patients
- do not use this product as the sole basis for diagnosing or ruling out SARS-CoV-2 infection or for information on the infection status of COVID-19
- do not use it after the expiration date
- please read all information in this package insert before performing the test
- the detection kit should be stored in a sealed pouch before use
- all specimens should be classified as potentially hazardous and treated as an infectious agent
- the used detection kit should be disposed of according to federal, state and local regulations
SCOPE OF DELIVERY
- 25 test cassettes: Each test cassette packed in foil bags with desiccant
- 25 extraction reagent: ampoule bottle with 0.3 ml extraction reagent
- 25 sterilized swabs: disposable swabs for specimen collection
- 25 extraction tubes
- 25 drip tips
- 1 workstation
- 1 package leaflet
- store it in the sealed pouch at a temperature (4-30 °C or 40-86 °F). The kit must be used within the expiration date indicated on the label
- after opening the pouch, the test should be used within one hour. Prolonged contact with hot and humid environment will cause deterioration of the product
- the batch number and expiration date are printed on the label
SPECIMEN COLLECTION FOR THE NASOPHARYNGEAL SWAB
- Remove the swab from the packaging.
- Tilt the patient’s head back about 70°.
- Insert the swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equal to that from the ear to the patient’s nostril, indicating contact with the nasopharynx. (The swab should reach a depth corresponding to the distance between the nostrils and the external opening of the ear). Gently rub and roll the swab. Leave the swab in place for a few seconds to absorb secretions.
- Remove the swab slowly while rotating it.
SPECIMEN COLLECTION FOR THE OROPHARYNGEAL SWAB
Insert the swab into the posterior pharyngeal and tonsil area. Rub the swab over both tonsils and the posterior oropharynx and avoid touching the tongue, teeth and gums.
DIRECT SWAB TEST METHOD
- Insert the swab specimen into the Extraction Tube containing the Extraction Reagent. Roll the swab at least five times while pressing the swab head against the bottom and side of the Extraction Tube. Allow the swab to remain in the extraction tube for one minute.
- Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. The extracted solution is used as a test sample.
- Cover the extraction tube firmly with a dropper tip.
- Remove the detection kit from the sealed pouch.
- Turn the sample collection tube over, hold the tube upright, slowly add 3 drops (approximately 100 μl) into the sample well (S) of the detection kit and start the timer.
- Wait until colored lines are displayed. Explain the test results after 15 minutes. Do not read the results after 20 minutes.
SWABS IN VIRAL TRANSPORT MEDIA (VTM) TEST METHOD
- Insert the swab sample into the transport tube with a maximum of 3 ml VTM without denaturant.
- Mix the sample stored in VTM by vortexing.
- Transfer 300 μl of the sample containing VTM solution with a calibrated micropipette into the extraction tube containing the extraction reagent. Homogenize the mixture by pipetting on and off.
- Cover the extraction tube firmly with a dropper tip and allow the extracted solution to stand for one minute.
- Follow steps 4 to 6 of the direct swab test procedure above.
EXPLANATION OF THE RESULTS
Two lines appear. One colored line appears in the control region (C) and another colored line appears in the test region (T), regardless of the thickness of the test line.
One colored line appears in the control region (C) and no line appears in the test region (T).
The control line is not displayed.
Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new detection kit. If the problem persists, stop using the batch immediately and contact your local distributor.
Rapid tests are excluded from return and exchange.