Descrizione Clinica
Diagnostics - Hotgen 2019-ncov ag autotest diagnostics
Hot
Coronavirus (2019-nCoV)
Rapid antigenic test
Description
This kit is intended for autodiagnostic in vitro use for qualitative determination of the SARS-CoV-2 antigen in human samples obtained from nasal swab.
The test can be used for rapid detection of SARS-CoV-2 antigen by subjects with suspected COVID-19 infection within the first 7 days of the appearance of symptoms.
Children and minors must be supported by an adult for testing.
Mode of use
Wash and dry your hands thoroughly before running the test. Read the user instructions carefully before testing.
Extract the pad from the box trying not to touch the ovate tip with your hands. Gently insert the pad for 1.5 cm in the nostril until there is resistance. With moderate pressure, rotate the buffer 4-6 times in the nostril for at least 15 seconds. Repeat the procedure with the same swab also in the other nostril.
After sampling, remove the purple cap of the tube and immerse yourself in the tampon. Keep the buffer immersed in the buffer solution for at least 15 seconds, routing it several times and pressing the ovate tip towards the bottom of the tube for at least 3 times. Before extracting the swab from the test tube, squeeze the tip, crushing the flexible tube from the outside several times with the fingers. Close the test tube with the purple cap.
Open the package and place the reactive card on a flat surface. Remove the transparent cap and add 4 drops of the compound in the reactive card pot (S).
Read the results after 15 minutes. The results read after 30 minutes are no longer valid.
After running the test, seal all the components used in the special organic waste bag. Don't reuse.
Wash or disinfect your hands again.
Interpretation of results:
- POSITIVE: Two red bands appear in the reading window. A red or purple band appears in the control area (C) and the other near the test zone (T), thus indicating the positivity of the test and a suspected COVID-19 infection.
- NEGATIVE: in the reading window only one red-violet band is visible in the control area (C), thus indicating the absence of the SARS-CoV-2 virus in the analyzed sample or that the concentration of the virus is lower than the detection limit of the kit.
- NOT VALIDO: no red-violet line appears in the reading window. The test is therefore not valid. It is recommended to review the procedure and repeat the test with a new kit.
Warnings
This kit is only for in vitro diagnostic use. Please read the instructions carefully before testing.
Use only the components provided in the kit, do not replace the kit material.
Use only undamaged components.
Conform to the instructions for use and do not mix components of different batches.
Never drink the buffer solution. If ingested, contact your doctor immediately.
The kit provides only a qualitative result, it is not able to quantify the concentration of the SARS-CoV-2 antigen in the sample.
The result of the test cannot be used as the only confirmation element of the diagnosis. Symptoms, anamnesis, other laboratory tests and patient information should be carefully considered before clinical management.
Children and minors must be supported by an adult.
The test cannot be used with nonhuman samples.
Conservation
Store at a temperature ranging from 4 °C to 30 °C.
Validity of whole packaging: 12 months.
Format
The kit contains:
- SARS-CoV-2 antigenic test card
- buffer extraction test
- disposable sterile buffer
- organic waste bag
- instructions for use
Bibliography
1. Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, et al. (February 2020). "Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods". Acta Pharmaceutica Sinica B. doi:10.1016.
Cod. HGCG134S0120
This kit is intended for autodiagnostic in vitro use for qualitative determination of the SARS-CoV-2 antigen in human samples obtained from nasal swab.
The test can be used for rapid detection of SARS-CoV-2 antigen by subjects with suspected COVID-19 infection within the first 7 days of the appearance of symptoms.
Children and minors must be supported by an adult for testing.
Mode of use
Wash and dry your hands thoroughly before running the test. Read the user instructions carefully before testing.
Extract the pad from the box trying not to touch the ovate tip with your hands. Gently insert the pad for 1.5 cm in the nostril until there is resistance. With moderate pressure, rotate the buffer 4-6 times in the nostril for at least 15 seconds. Repeat the procedure with the same swab also in the other nostril.
After sampling, remove the purple cap of the tube and immerse yourself in the tampon. Keep the buffer immersed in the buffer solution for at least 15 seconds, routing it several times and pressing the ovate tip towards the bottom of the tube for at least 3 times. Before extracting the swab from the test tube, squeeze the tip, crushing the flexible tube from the outside several times with the fingers. Close the test tube with the purple cap.
Open the package and place the reactive card on a flat surface. Remove the transparent cap and add 4 drops of the compound in the reactive card pot (S).
Read the results after 15 minutes. The results read after 30 minutes are no longer valid.
After running the test, seal all the components used in the special organic waste bag. Don't reuse.
Wash or disinfect your hands again.
Interpretation of results:
- POSITIVE: Two red bands appear in the reading window. A red or purple band appears in the control area (C) and the other near the test zone (T), thus indicating the positivity of the test and a suspected COVID-19 infection.
- NEGATIVE: in the reading window only one red-violet band is visible in the control area (C), thus indicating the absence of the SARS-CoV-2 virus in the analyzed sample or that the concentration of the virus is lower than the detection limit of the kit.
- NOT VALIDO: no red-violet line appears in the reading window. The test is therefore not valid. It is recommended to review the procedure and repeat the test with a new kit.
Warnings
This kit is only for in vitro diagnostic use. Please read the instructions carefully before testing.
Use only the components provided in the kit, do not replace the kit material.
Use only undamaged components.
Conform to the instructions for use and do not mix components of different batches.
Never drink the buffer solution. If ingested, contact your doctor immediately.
The kit provides only a qualitative result, it is not able to quantify the concentration of the SARS-CoV-2 antigen in the sample.
The result of the test cannot be used as the only confirmation element of the diagnosis. Symptoms, anamnesis, other laboratory tests and patient information should be carefully considered before clinical management.
Children and minors must be supported by an adult.
The test cannot be used with nonhuman samples.
Conservation
Store at a temperature ranging from 4 °C to 30 °C.
Validity of whole packaging: 12 months.
Format
The kit contains:
- SARS-CoV-2 antigenic test card
- buffer extraction test
- disposable sterile buffer
- organic waste bag
- instructions for use
Bibliography
1. Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, et al. (February 2020). "Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods". Acta Pharmaceutica Sinica B. doi:10.1016.
Cod. HGCG134S0120
