Clungene Covid-19 Antigen Rapid Test Cassettes for Professional Use

Lateral flow immunotest for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal, nasal or oropharyngeal swabs of subjects suspected of COVID-19 by the healthcare professional.
The purpose is detect the SARS-CoV-2 nucleocapsid antigen. The antigen is generally detectable in the nasopharyngeal, nasal and oropharyngeal swab in the acute phase of the infection. a lateral immunoassay based on the principle of double antibody sandwich technique. SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugated with colored microparticles is used as a detector and is sprayed onto the conjugation pad.
During the test, the SARS-CoV-2 antigen in the sample interacts with the The SARS-CoV-2 antibody conjugated with colored microparticles making the antigen-antibody complex a labeled complex. This complex migrates by capillary action on the membrane up to the test line, where it will be absorbed. captured by the pre-coated SARS-CoV-2 nucleocapsid protein monoclonal antibody.
A colored test line (T) will be visible in the results window if SARS-CoV-2 antigens are present in the sample.
The lack of the T line indicates a negative result.
The control line (C) is used for procedural control, and must be displayed if the test procedure is performed correctly.
Positive test results indicate the presence of viral antigens, but the clinical correlation to the patient's medical history and other diagnostic information is unclear. necessary to determine the status of the infection. Positive results do not exclude the presence of infection or co-infection with other viruses. The agent detected may not be the definitive cause of the disease.
Negative results do not exclude the presence of SARS-CoV-2 infection and should not be used as the sole basis for treatment or management decisions patients, including decisions about infection management. Negative results must be considered in the context of recent exposures, a patient's medical history, and the presence of typical clinical signs and symptoms of COVID-19, and are confirmed with molecular testing if necessary for patient management.
The kit is intended for use by healthcare professionals or personnel qualified to perform lateral flow tests.

Mode instructions for use
1. Collection of samples
Samples obtained at the beginning of the onset of symptoms will contain the most high viral levels; specimens obtained within 5 days of the onset of symptoms will most likely yield negative results when compared to an RT-PCR assay.
Inadequate specimen collection, improper handling and/or transportation of specimens may cause give false results; therefore Sample collection training is essential. highly recommended given the importance of quality of sample to obtain accurate test results.
The type of sample acceptable for the test is a direct swab sample or a swab sample in viral transport medium (VTM) without denaturing agents.
Prepare the extraction reagent tube according to the test procedure and use the sterile swab provided in the kit for specimen collection.

Nasopharyngeal swab sample: remove the swab from the packaging. Lower your head back to an angle of approximately 70°. Slowly insert the swab into the nostril parallel to the palate (not upwards) until resistance is encountered or at a distance equivalent to that from the ear to the patient's nostril, indicating contact with the nasopharynx (the swab must reach a depth equal to the distance from the nostrils to the external opening of the ear). Rub gently and rotate gently. Do not move the swab from that position for a few seconds, so that the secretions can be absorbed. Slowly remove the swab, while rotating it.
Samples can be collected from both sides using the same swab, however is not serious; It is necessary to collect samples from both sides if the mini-tip is filled with fluid from the first collection.
If a deviated septum or blockage makes it difficult to obtain the sample from one nostril, use the same swab to collect the sample from the other nostril.

Nasal swab sample: with a slight rotation, insert the swab to a depth approximately 2.5 cm into the nostril until it meets the resistance of the turbinates. Rotate the swab several times against the nasal wall and repeat the procedure in the other nostril with the same swab.

Oropharynx swab sample: insert the swab into the back part of the pharynx and into the tonsils. Rub the swab on both tonsils and on the back of the oropharynx and avoid touching the tongue, teeth and gums.

Do not return the swab to the original swab packaging. Freshly collected samples must be treated as quickly as possible. soon possible, but no longer one hour after sample collection.
The collected sample can be Store at a temperature of 2-8°C for no longer than 24 hours.
Store at a temperature of -70°C for a long time, but avoid repeated freezing/thawing cycles.

2. Test Procedure
Bring the test cassettes, reagents and samples to room temperature (15-30°C or 49-86°F) before testing.
Tear off with be careful with the film on the extraction reagent tube. Do not spill the extraction reagent.
Place the extraction reagent tube on the workstation. Insert the sample into the extraction tube containing the extraction reagent. Rotate the swab at least 5 times while compressing the head against the bottom and side of the extraction tube. Do not remove the swab from the tube for one minute.
Remove the swab while squeezing the sides of the extraction tube to extract the liquid from the swab. The extracted solution will be used as a test sample.
Cover the extraction tube tightly with the attached dropper tip.
Take the test cassette out of the sealed pouch. Invert the extraction tube, holding the tube upwards, transfer 3 drops (approximately 100 mcL) slowly into the sample well (S) of the test cassette, then start the timer.
Wait for the colored lines to appear . Interpret test results in 15 minutes. Do not read the results after 20 minutes.

In case of testing in Viral Transport Medium (VTM): insert the sample into the transport tube containing a maximum of 3 mL VTM without denaturing agents. Mix the sample stored in VTM with vortex. Transfer 300 mcL of the VTM solution containing the sample into the extraction tube, which contains the extraction reagent, with a calibrated micropipette. Homogenize the mixture by pipetting it repeatedly. Cover the extraction tube with a dropper tip and leave the solution extracted for one minute.
Take the test cassette out of the sealed pouch. Invert the extraction tube, holding the tube upwards, transfer 3 drops (approximately 100 mcL) slowly into the sample well (S) of the test cassette, then start the timer.
Wait for the colored lines to appear . Interpret test results in 15 minutes. Do not read the results after 20 minutes.

3. Interpreting the results
POSITIVE: Two colored lines are displayed. One colored line appears in the control section (C) and the other line appears in the test section (T), regardless of the intensity. of the test line.

NEGATIVE: One line is displayed in the control section (C) and no line is displayed in the test section (T).

INVALID: The control line fails to visualize. Insufficient sample volume or incorrect procedural techniques are the most common causes. probable reasons for the lack of the control line. Review the procedure and repeat the test, using a new cassette. If the problem persists, discontinue use of the batch and contact your local distributor.

Warnings
For in vitro diagnostic use only. For healthcare professionals and professionals at healthcare points.
Do not use the product as the sole basis for diagnosing or excluding infection with SARS-CoV-2 or for inquiring about infection status with COVID-19.
Do not use after the expiry date.
Consult the information in the package leaflet before carrying out the test.
The test cassette must always be placed in a sealed bag until used.
All samples should be considered potentially hazardous and should be treated in the same manner as an infectious agent.
The product is limited to providing qualitative detection. The intensity of the test line is not necessarily related to the antigen concentration in the samples.
Negative results do not preclude the possibility of infection with SARS-CoV-2 and should not be used as the sole basis for patient management decisions.
A clinician should interpret the results in conjunction with the patient's medical history, physical data, and other diagnostic procedures.
A negative result can cause occur in the event that the quantity of the SARS-CoV-2 antigens present in the sample is below the detection threshold of the immunological test, or in the case in which the virus has undergone slight mutation(s) of amino acids in the target epitope section identified by the monoclonal antibodies used in the test.
The cassette used for the test must be disposed of in accordance with federal, state and local regulations.

Storage
Store in the sealed bag at a temperature of 4- 30°C (40-86°F).
After opening the bag, the test should be used within one hour. Prolonged exposure to hot and humid environments may cause cause deterioration of the product.
Validity with intact packaging: 24 months.

Format
The kit contains:
- 25 test cassettes;
- 25 extraction reagent tubes: vial containing 0.3 mL of extraction reagent;
- 25 sterilized swabs: disposable swab for sample collection;
- 1 work-station;
- 1 information leaflet.