Genbody COVID-19 Antigen
Rapid Test Kit
Genbody COVID-19 Ag
GenBody COVID-19 Ag is an immunoassay kit for rapid and qualitative determination of SARS-CoV-2 infection from swab specimens. Antigens of SARS-CoV-2 in the specimens are allowed to react with the anti-SARS-CoV-2 monoclonal antibody-coupled gold conjugate followed by reaction with anti-SARS-CoV-2 monoclonal antibodies immobilized in the test line. When the sample contains SARS-CoV-2 antigens, a visible line appears in the test region on the membrane. The solution continues to migrate to encounter a control reagent that binds a control conjugate, thereby producing another band in the control region. GenBody COVID-19 Ag is also very useful to directly detect SARS-CoV-2 antigens from human swab samples.
SPECIMEN COLLECTION AND STORAGE
1. Specimen to be tested should be obtained and handled by standard methods for their collections.
2. Nasopharyngeal swab specimen: To collect nasopharyngeal specimen, carefully insert the sterile swab into the nostril that presents the most secretion under visual inspection. Using gentle rotation, push the swab tlil resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab several times against the nasal wall.
3. [Optional] Oropharyngeal swab specimen: Insert swab from oral cavity into pharynx slowly and collect mucous membrane epidermis by rubbing posterior pharyngeal wall or faucial tonsil several times. Antigen of enough quantity cannot be collected with upper respiratory tract. Collection specimen by letting the spherical trip touch the part near posterior pharyngeal wall surely so as to rub a part near lower respiratory tract. In addition, do not use nasopharyngeal swab when collecting samples as it may cause insufficient collection of specimen.
4. All specimens should be tested as soon as they are collected.
5. In case of direct sampling (using Nasopharyngeal/Oropharyngeal swab), extraction solution contain specimen may be stored at room temperature for up to 1 hour or at 2-8°C (36-46 °F) for up to 12 hours prior to testing.
In case of using VTM/UTM samples, avoid multiple freeze/thaw cycles.
TEST PROCEDURE
[Nasopharyngeal swab/Oropharyngeal swab* test procedure]
1. Place all specimens, test devices, and Extraction solution at room temperature prior to testing (15~30min).
2. Place the device on a flat surface.
3. Fill the Extraction tube with Extraction solution up to the buffer line (400 ㎕).
4. Insert the nasopharyngeal (and oropharyngeal) swab sample(s) into the extraction solution, then, mix the swab 8~10 times.
5. Remove the swabs while pressing against the solution tube in order to extract most of the specimen.
6. Place the dropper cap and drop 4 drops (~100 ㎕) into the sample well [S]
7. After 15~20 minutes, interpret the test results.
Please do not read the results after 30 minutes of this testing.
The using of oropharyngeal swab is optional.
[Viral Transport Media (VTM) or Universal Transport Media (UTM) test procedure]
1. Place all specimens, test devices, and Extraction solution at room temperature prior to testing (15~30min).
2. Place the device on a flat surface.
3. Fill the Extraction tube with Extraction solution up to 4 drops (~100 ㎕).
4. Using pipette, add 100 ㎕ VTM (or UTM) sample in the Extraction tube, then, mix strongly
5. Add 100 ㎕ of the mixture to the sample well [S].
6. After 15~20 minutes, interpret the test results.
Please do not read the results after 30 minutes of this testing.
Please do not use the Nucleic Acid Preservation & Transport (NAPT) Medium.
INTERPRETATION OF THE RESULTS
1. Negative result: ONLY one band in the control line (C).
2. Positive result: Two bands are appeared in the test line (T) and control line (C).
3. Invalid result: If a red color band does not appear in the control line (C) after 30 minutes, the result is considered invalid regardless of any shade of a pink-to-red test line (T) appears. If the test is invalid, a new test should be performed with a new patient sample and a new test device.
[Use analyzer]
· Using Confiscope G20 is optional.
· Please refer to instructions for use in the analyzer package.
STORAGE & EXPIRATION
1. GenBody COVID-19 Ag kit should be stored between 2 to 30 °C (35.6 to 86 °F).
2. Expiration date of this kit is 12 months after its manufacture date.
PRECAUTIONS
1. The presence of humidity may decrease the stability of the reagents. Thus, please carry out the test immediately after removing the device from the foil pouch.
2. For in vitro diagnostic use only. DO NOT re-use the test device.
3. Collected specimen should be prepared as sample in accordance with after-mentioned "Specimen Collection and Storage" and tested as soon as possible.
4. Add the fixed volume (4 drops) to the center of sample well area.
5. Bring the test kit and extraction solution at room temperature (15-30°C) prior to testing (15 -30 min).
6. Keep interpretation time because it causes false negative and false positive.
7. When using samples from viral/universal transport media, it may cause inaccurate results due to decreasing the sensitivity of the test.
8. When using transport media for collecting specimen, DO NOT use Nucleic Acid Preservation & Transport (NAPT) Medium.
HOW TO USE
KIT TYPE
Genbody COVID-19 Ag
SARS-CoV-2 antigen in nasopharyngeal and oropharyngeal swab immunochromatographic assay kit
SPECIMENS
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Blood Sample
ORDERING INFORMATION
Product:
Genbody COVID-19 Antigen Rapid Test Kit