SARS-CoV-2 Antigen IVD Kit SWAB REAGEN® 20 TEST

SARS-CoV-2 Antigen IVD Kit SWAB REAGEN®

Rapid antigen test for the qualitative determination of sars-cov-2 antigens in nasopharyngeal / oropharyngeal swabs by immunochromatography. Antigen IVD Kit SWAB

In vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human nasopharyngeal and oropharyngeal swabs, using the rapid immunochromatographic method.
Identification is based on monoclonal antibodies specific for the novel coronavirus antigen. It will provide information to clinicians to prescribe correct medications.
It is a membrane immunochromatographic test that uses highly sensitive monoclonal antibodies against the novel coronavirus.
The test strip consists of sample buffer, reagent buffer and reaction membrane. The reagent membrane contains colloidal gold conjugated with monoclonal antibodies against the new coronavirus; the reaction membrane contains the secondary antibodies to the novel coronavirus and the polycolnal antibodies against mouse globulin, which are pre-immobilized on the membrane.
When the sample is added to the device, the dried conjugates in the reagent buffer are dissolved and migrate along with the sample.
If coronavirus is present in the sample, a complex formed between the anti-coronavirus conjugate and the virus will be captured by the specific anti-coronavirus monoclonal antibody coated on the T region.
Regardless of whether the sample contains the virus or not, the solution continues to migrate to meet another reagent (an anti-mouse IgG antibody) which binds to the remaining conjugates, thus producing a red line on the C region.
The test is intended for use by healthcare professionals or trained operators familiar with performing rapid antigen tests.

How to use

Sample collection and preparation
The sample must be collected using the collection tools provided with the kit. Follow the instructions for use. No other collection tools should be used for this test.

Nasopharyngeal Swab: Insert the swab into the nasal cavity, slowly and gently. Don't overdo it to avoid traumatic bleeding. When the tip of the swab touches the posterior parts of the pharyngonasal cavity, leave the swab in place for a few seconds (approximately 3 seconds) and rotate it gently. Then remove the swab.

Oropharyngeal Swab: Do not put anything into your mouth, including food, beverages, gum, tobacco, water, and mouth cleaners for at least 10 minutes prior to sample collection. Tilt the patient's test back and open his mouth, thus exposing the tonsils on both sides. Rub the swab on the root of the tongue Clean the pharyngeal tonsils on both sides, exerting a little force at least three times.

Test procedure

Allow the test device, sample and extraction tube to reach room temperature (15-30 ° C) before testing.
Remove the foil seal from the sample extraction tube. Immerse the swab containing the sample in the tube, rotate it and press it 5 times. Remove the swab and discard it. Insert the cap on the extraction tube.
Gently shake the extraction tube for approximately 5 seconds to ensure that the sample mixes well with the extraction solution.
Vertically transfer 2-3 drops of solution to the test card and start the timer.
Read the result at 15 minutes. Do not interpret the result after 20 minutes.

Interpretation of results

POSITIVE: two red lines appear. A red line appears in the control region (C) and a red line in the test region (T). The result is to be considered positive regardless of the color gradient of the line in the test region (T).

NEGATIVE: only a red line appears in the control region (C), while no line appears in the test region (T). A negative result indicates that there are no new coronavirus particles in the sample or that the number of virus particles is below the detection limit of the test.

INVALID: No red lines appear in the control region (C). The test is invalid even if there is a line in the test region (T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for the control line not appearing. Review the test procedure and repeat the test using a new device. If the problem persists, stop using the kit and contact your local distributor.

Warnings

For in vitro diagnostic use only.
Do not use after the expiration date.
Make sure the foil pouch containing the test device is not damaged before opening for use.
Wear gloves when handling specimens. Avoid touching the reagent membrane and the sample window on the test card.
All used samples and components should be treated as infectious agents and disposed of according to local regulations.
Do not use bloody samples.
The kit is an acute phase screening test for qualitative detection. The collected sample may contain antigen concentration below the reagent detection limit, so a negative test result does not rule out new coronavirus infection.
The kit detects viable and non-viable antigen of the novel coronavirus. The performance of the test depends on the antigen load in the sample and may not be related to the cell culture performed on the same sample.
A positive result does not rule out the possibility that other pathogens may be present. The results must therefore be compared with all available clinical and laboratory information to make an accurate diagnosis.
If the level of antigen extracted in a sample is below the detection limit of the test or if the sample is collected inaccurately, a negative test result may be generated.
The positive results do not rule out co-infections with other pathogens.
Negative results do not rule out the possibility of other coronavirus infections (not SARS-CoV-2).

storage

Store at room temperature or in a refrigerator (4-30 ° C). Do not freeze.
Validity for intact packaging: 24 months.

Format

20-piece kit for professional use.