Description
LABNOVATION
SARS-CoV-2 Rapid Antigen Test Kit
(Immunochromatography)
Description
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 viral nucleocapsid antigens from human anterior nasal secretion specimens of individuals suspected of having COVID-19.
It is an immunochromatographic test that detects the SARS-CoV-2 nucleocapsid antigen in samples with the help of the double antibody "sandwich" method.
If the virus antigen is present in the sample, it binds to the corresponding colloidal antibody. This complex "migrates" across the membrane and binds to the monoclonal antibody on the test line (T). This creates a visible red line indicating a positive result.
However, if the sample does not contain any antigen, the complex cannot be formed and therefore no red line is generated in the test region (T).
Regardless of whether the sample contains antigen or not, a red line forms in the control area (C).
A positive antigen test result can be used for early isolation of patients with suspected infection, but cannot be used as the sole method of diagnosing SARS-CoV-2 infection.
Negative results do not exclude SARS-CoV-2 infection and should not be used as the sole basis for treatment.
An additional nucleic acid detection test should be performed in subjects in whom the antigen test result is positive or negative.
How to use
Before performing the test, leave the cassette and test components in a room at room temperature (15°C to 27°C).
Place all supplied materials on a clean, dry, flat surface.
Open the sealed pouch and remove the test cassette. Place the test with the well (S) facing up on a clean, dry, flat surface.
Open the tube with the extraction reagent and pour its contents into the sample tube and place it on the tube holder.
Gently insert the entire absorbent tip of the swab (about 1.5 cm) into your nostril. Slowly rotate the swab 5 or more times in a circular motion while pressing against the inside walls of your nostril. Be sure to collect any nasal drainage that may be on the swab. Gently remove the swab. Use the same swab to repeat the process in the other nostril and slowly remove the swab.
Take the tube containing the extraction solution and insert the swab. Mix well and press on the walls of the extraction tube 10-15 times, rubbing the swab. To remove it, push the head of the swab against the upper wall of the extraction tube. Release as much liquid as possible. Dispose of the test kit in accordance with applicable local regulations by placing it inside the BIOHAZARD sachet included in the kit, which must be well sealed.
Close the cap of the sample tube. Add, vertically, 3 full drops of the prepared solution into the well (S) of the test cassette.
Read the result 15-20 minutes after adding the sample. The result obtained after 20 minutes is invalid.
Interpretation of results
POSITIVE: Two colored lines appear. One line appears in the control region (C) and another in the test region (T). The color intensity of the test line is irrelevant. Any shade of red in the test line is considered a positive result.
The test result indicates that the SARS-CoV-2 antigen has been detected in the sample. Detection of the antigen indicates a high probability of infection with the new coronavirus. Contact a doctor/family doctor or local public health service immediately. Follow local self-isolation guidelines and perform a molecular test (PCR) to confirm the result.
NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test region (T). The test result indicates that there is no or too little SARS-CoV-2 antigen in the sample and there is probably no current infection with the new coronavirus.
If the test result is negative, continue to follow all applicable rules regarding contact with others and protective measures. Even if the test result is negative, you may still have an infection.
In a suspected case, repeat the test after 1-2 days, as coronavirus cannot be accurately detected at all stages of infection.
INVALID: If there is no control line (C) or only one test line (T) in the result window, the test did not perform correctly and the results are invalid.
An invalid test result is likely caused by incorrect test performance. It is recommended to repeat the test. If the test results remain invalid, contact a doctor or a COVID-19 testing center.
Warnings
This kit is a qualitative detection, which cannot determine the exact amount of antigen.
The test is intended for external use only. The kit is not intended for internal use. Avoid contact of the extraction solution with skin and eyes.
Keep out of reach of children. Any child under the age of 18 should not perform the test without parental guidance or professional help.
Failure to follow the test procedures and instructions for use may affect the outcome of the test.
The final diagnosis must be confirmed by a doctor.
Do not use the test if the packaging is damaged. Do not use damaged test components.
All test components are to be used exclusively for this test. Do not reuse the test or test components.
The test must be performed immediately or within one hour of opening the foil pouch (15-30°C, humidity <60%).
Samples should be processed as soon as possible after collection. If testing cannot be performed immediately, the sample should be stored sealed, at 2/8°C for 8 hours and below -20°C for 1 month. Long-term storage is not recommended.
Reduced vision, color blindness, or poor lighting may affect your ability to correctly interpret test results.
The test kit is provided with a pouch with the BIOHAZARD symbol, it is recommended to insert all the components of the kit inside after use. Seal the pouch and dispose of it in accordance with applicable local regulations.
A negative result does not exclude the possibility of SARS-CoV-2 infection. Therefore, the test should not be used as the sole reference for clinical diagnosis. The result must be confirmed with PCR tests.
The test is not validated on samples from pregnant women.
After use, rinse your hands or, in case of contact with the extraction solution, the affected parts of the body thoroughly with water.
If symptoms persist: consult a doctor.
Conservation
Store in a dry place between 2°C and 30°C. Protect from sunlight, do not freeze.
Do not use after the expiry date printed on the package.
Validity with intact packaging: 24 months.
Format
The kit contains:
- 1 test cassette;
- 1 extraction tube with an extraction reagent;
- 1 sterile swab;
- 1 test tube holder;
- 1 instruction manual;
- 1 disposal bag.
Bibliography
1. Nanshan Chen*, Min Zhou*, Xuan Dong*, Jieming Qu*,Fengyun Gong, Yang Han, Yang Qiu, Jingli Wang, Ying Liu,Yuan Wei, Jia'an Xia, Ting Yu, Xinxin Zhang, Li Zhang Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. LANCET. January 29, 2020
2. World Health Organization (Coronavirus disease 2019) https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technicalguidance/ naming-the-coronavirus-disease-(covid-2019)-and-the- virus-that-causesit( Zugriff am 03.27.2020)
3. World Health Organization (Coronavirus disease 2019) https://www.who.int/health-topics/coronavirus# tab=tab_1 (Zugriff am 27.03.2020)
Cod. LX-401302
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 viral nucleocapsid antigens from human anterior nasal secretion specimens of individuals suspected of having COVID-19.
It is an immunochromatographic test that detects the SARS-CoV-2 nucleocapsid antigen in samples with the help of the double antibody "sandwich" method.
If the virus antigen is present in the sample, it binds to the corresponding colloidal antibody. This complex "migrates" across the membrane and binds to the monoclonal antibody on the test line (T). This creates a visible red line indicating a positive result.
However, if the sample does not contain any antigen, the complex cannot be formed and therefore no red line is generated in the test region (T).
Regardless of whether the sample contains antigen or not, a red line forms in the control area (C).
A positive antigen test result can be used for early isolation of patients with suspected infection, but cannot be used as the sole method of diagnosing SARS-CoV-2 infection.
Negative results do not exclude SARS-CoV-2 infection and should not be used as the sole basis for treatment.
An additional nucleic acid detection test should be performed in subjects in whom the antigen test result is positive or negative.
How to use
Before performing the test, leave the cassette and test components in a room at room temperature (15°C to 27°C).
Place all supplied materials on a clean, dry, flat surface.
Open the sealed pouch and remove the test cassette. Place the test with the well (S) facing up on a clean, dry, flat surface.
Open the tube with the extraction reagent and pour its contents into the sample tube and place it on the tube holder.
Gently insert the entire absorbent tip of the swab (about 1.5 cm) into your nostril. Slowly rotate the swab 5 or more times in a circular motion while pressing against the inside walls of your nostril. Be sure to collect any nasal drainage that may be on the swab. Gently remove the swab. Use the same swab to repeat the process in the other nostril and slowly remove the swab.
Take the tube containing the extraction solution and insert the swab. Mix well and press on the walls of the extraction tube 10-15 times, rubbing the swab. To remove it, push the head of the swab against the upper wall of the extraction tube. Release as much liquid as possible. Dispose of the test kit in accordance with applicable local regulations by placing it inside the BIOHAZARD sachet included in the kit, which must be well sealed.
Close the cap of the sample tube. Add, vertically, 3 full drops of the prepared solution into the well (S) of the test cassette.
Read the result 15-20 minutes after adding the sample. The result obtained after 20 minutes is invalid.
Interpretation of results
POSITIVE: Two colored lines appear. One line appears in the control region (C) and another in the test region (T). The color intensity of the test line is irrelevant. Any shade of red in the test line is considered a positive result.
The test result indicates that the SARS-CoV-2 antigen has been detected in the sample. Detection of the antigen indicates a high probability of infection with the new coronavirus. Contact a doctor/family doctor or local public health service immediately. Follow local self-isolation guidelines and perform a molecular test (PCR) to confirm the result.
NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test region (T). The test result indicates that there is no or too little SARS-CoV-2 antigen in the sample and there is probably no current infection with the new coronavirus.
If the test result is negative, continue to follow all applicable rules regarding contact with others and protective measures. Even if the test result is negative, you may still have an infection.
In a suspected case, repeat the test after 1-2 days, as coronavirus cannot be accurately detected at all stages of infection.
INVALID: If there is no control line (C) or only one test line (T) in the result window, the test did not perform correctly and the results are invalid.
An invalid test result is likely caused by incorrect test performance. It is recommended to repeat the test. If the test results remain invalid, contact a doctor or a COVID-19 testing center.
Warnings
This kit is a qualitative detection, which cannot determine the exact amount of antigen.
The test is intended for external use only. The kit is not intended for internal use. Avoid contact of the extraction solution with skin and eyes.
Keep out of reach of children. Any child under the age of 18 should not perform the test without parental guidance or professional help.
Failure to follow the test procedures and instructions for use may affect the outcome of the test.
The final diagnosis must be confirmed by a doctor.
Do not use the test if the packaging is damaged. Do not use damaged test components.
All test components are to be used exclusively for this test. Do not reuse the test or test components.
The test must be performed immediately or within one hour of opening the foil pouch (15-30°C, humidity <60%).
Samples should be processed as soon as possible after collection. If testing cannot be performed immediately, the sample should be stored sealed, at 2/8°C for 8 hours and below -20°C for 1 month. Long-term storage is not recommended.
Reduced vision, color blindness, or poor lighting may affect your ability to correctly interpret test results.
The test kit is provided with a pouch with the BIOHAZARD symbol, it is recommended to insert all the components of the kit inside after use. Seal the pouch and dispose of it in accordance with applicable local regulations.
A negative result does not exclude the possibility of SARS-CoV-2 infection. Therefore, the test should not be used as the sole reference for clinical diagnosis. The result must be confirmed with PCR tests.
The test is not validated on samples from pregnant women.
After use, rinse your hands or, in case of contact with the extraction solution, the affected parts of the body thoroughly with water.
If symptoms persist: consult a doctor.
Conservation
Store in a dry place between 2°C and 30°C. Protect from sunlight, do not freeze.
Do not use after the expiry date printed on the package.
Validity with intact packaging: 24 months.
Format
The kit contains:
- 1 test cassette;
- 1 extraction tube with an extraction reagent;
- 1 sterile swab;
- 1 test tube holder;
- 1 instruction manual;
- 1 disposal bag.
Bibliography
1. Nanshan Chen*, Min Zhou*, Xuan Dong*, Jieming Qu*,Fengyun Gong, Yang Han, Yang Qiu, Jingli Wang, Ying Liu,Yuan Wei, Jia'an Xia, Ting Yu, Xinxin Zhang, Li Zhang Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. LANCET. January 29, 2020
2. World Health Organization (Coronavirus disease 2019) https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technicalguidance/ naming-the-coronavirus-disease-(covid-2019)-and-the- virus-that-causesit( Zugriff am 03.27.2020)
3. World Health Organization (Coronavirus disease 2019) https://www.who.int/health-topics/coronavirus# tab=tab_1 (Zugriff am 27.03.2020)
Cod. LX-401302
