Description
SARS-CoV-2 Antigen Self Test Nasal
Do-it-yourself test
Description
The SARS-CoV-2 Antigen Self Test Nasal is a lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human nasal specimens. The test allows the detection of SARS-CoV-2 virus antigens in subjects with suspected COVID-19 infection. It is intended for use as a self-test for patients. The clinical performance of the SARS-CoV-2 Antigen Self Test Nasal for self-testing was evaluated using nasal swab samples from 146 prospective study participants (139 of whom were within 7 days of symptom onset) at a clinical center in Germany. The clinical evaluations were performed independently of the manufacturer and distributor, in a collaboration between the Charité University Hospitals in Berlin and Heidelberg. The study cohort included symptomatic adults (18 to 68 years of age) with clinical suspicion of SARS-CoV-2 infection. In the self-test group, study participants followed written instructions with illustrations to self-collect a nasal swab sample and perform the test themselves. Self-collection and testing were performed in the presence of healthcare workers, who did not intervene at any stage. PCR tests performed on a combination of deep nasal/posterior pharyngeal swab samples were used as a comparison method. Nasal sampling by the self-test group always preceded deep nasal/posterior pharyngeal swab sampling for the comparative RT-PCR method. SARS-CoV-2 infection was diagnosed (by PCR) in 27.4% of patients. The clinical performance of the SARS-CoV-2 Antigen Self Test Nasal was also evaluated in comparison to professional tests, performed after self-collection and professional nasal swab sampling at the same clinical site. 229 adults with clinical suspicion of SARS-CoV-2 infection were included in the prospective study. 133 study participants (126 of whom were within 7 days of symptom onset) underwent nasal sampling by healthcare workers, while 96 study participants (83 of whom were within 7 days of symptom onset) followed instructions for self-collection of nasal swab specimens. Self-collection of specimens occurred in the presence of healthcare workers. PCR tests were performed as previously described.
How to use
Sample collection and preparation:
1. Before performing the test, wash your hands with soap and water or use hand sanitizer.
2. Check the expiration date on the back of the foil pouches. Do not use the test if it has passed the expiration date.
3. Open one of the foil pouches 1 by tearing it gently along the perforated line, then remove the test cassette and the desiccant sachet. Use the test immediately after opening the foil pouch.
4. Verify that the test cassette is intact and that the desiccant sachet does not contain any green pellets. Do not open the desiccant sachet. Before starting the procedure, it is necessary to equilibrate the test cassette and reagents to room temperature (15-30 °C/59-86 °F).
Directions for use:
1. Open the aluminum bag 2 by tearing it gently along the perforated line, then remove one of the test tubes with the liquid and a measuring cap and place them on a flat surface.
2. Carefully unseal the test tube, avoiding spilling the liquid inside. Insert the test tube into the test tube holder.
3. Blow your nose once into a tissue.
4. Remove the swab from the package. Be careful to touch only the shaft and not the cotton tip.
5. Tilt your head back slightly.
6. Insert the swab into the left nostril, from the side of the cotton tip. Slowly advance about 2 cm in a straight line (parallel to the upper palate, without tilting upwards) until resistance is encountered. Do not apply pressure.
7. Rotate the swab 4 times (for a total of about 15 seconds) against the nasal wall, then remove the swab from the nostril.
8. Repeat steps 6 and 7 in the right nostril using the same swab.
9. Insert the swab into the test tube, dipping the cotton tip into the liquid. Squeeze the test tube at the bottom and keep it squeezed. Rotate the swab more than 10 times to facilitate the transfer of the biological material from the swab to the liquid.
10. Remove the swab by continuing to squeeze the sides of the tube to extract the liquid from the swab. Throw away the swab and close the tube tightly with the measuring cap. The same swab should be used to collect samples from both nostrils.
Running a test:
- Place the test cassette on a flat surface.
- Hold the tube upright over the circular well on the test cassette (not over the rectangular result window).
- Drop exactly 4 drops into the circular well. Gently squeeze the sides of the tube if necessary.
Note: You can continue testing even if 5 drops accidentally fall onto the test cassette.
- Set the timer and read the test result after 15-30 minutes.
- After performing the test, wash your hands with soap and water or use hand sanitizer. Failure to squeeze the tube properly may result in incorrect results due to too much swab in the stick. Test results that are read before 15 minutes or after 30 minutes may be incorrect.
Interpretation of results:
POSITIVE: If a test line (T) is visible, in addition to a control line (C), the result is positive. Observe the result carefully: the test is considered positive if both lines are visible, however faint.
NEGATIVE: If a control line (C) is visible, even if faint, but a test line (T) is not visible, the result is negative.
INVALID: If a control line (C) is not visible, the test result is invalid. The test did not work properly, so it is recommended to perform another test with a new package. The test may not have performed properly.
Warnings
- Use the package only once.
- Remove the test cassette from the sealed pouch only when everything is ready to perform the test.
- Do not use the test kit if the pouch is damaged.
- In case of liquid spillage, be careful to clean thoroughly with a suitable disinfectant.
- Use only the components contained in this test kit.
- If the sample collected is insufficient or is taken incorrectly, the results may be inaccurate or false.
- Avoid contact with eyes and skin. In case of accidental contact, wash thoroughly to prevent skin irritation. If in doubt, consult a doctor.
- Keep the test package out of the reach of children to avoid the risk of accidental ingestion of the buffer liquid or small parts.
- Do not use any of the test components on the body, except the test stick included in the package. Do not ingest any component.
- Consult a doctor to discuss the test result and whether further testing is needed. Also consult a doctor if you are concerned about your health, or if your symptoms persist or worsen.
- Even if the test result is negative, continue to observe all the hygiene and safety precautions provided.
- Dispose of all waste in accordance with local regulations.
For customers in the European Economic Area: Contains SVHC (octylphenol ethoxylate).
Only for use in an IVD method and under controlled conditions, according to Articles 56.3 and 3.23 of the REACH Regulation. Avoid release to the environment, sewers and water systems.
Conservation
Store the package at 2-30 °C/36 - 86 °F and avoid exposure to direct sunlight. The expiry date of the materials is indicated on the outer packaging.
Validity: 15 months.
Do not freeze the package.
Sensitivity and specificity of the test
In the self-test study, the SARS-CoV-2 Antigen Self Test Nasal correctly identified 91.2% (CI: 76.3%-98.1%) of infected participants with a relatively high viral load (Ct = 30). Subjects with a high viral load are considered to be at higher risk of infectivity and transmission of the virus to others. For all study participants, the rapid antigen test correctly identified 82.5% (CI: 67.2%-92.7%) of infected participants and 100.0% (CI: 96.5%-100.0%) of uninfected participants. Overall, 110 PCR-positive and 263 PCR-negative study participants were assessed across all 3 cohorts using the SARS-CoV-2 Antigen Self Test Nasal. For patients with a relatively high viral load (Ct = 30), the relative sensitivity was 91.1% (95% CI: 83.8%-95.8%, N = 101). For all samples, the overall relative sensitivity and overall relative specificity were 86.4% (95% CI: 78.5%-92.2%) and 99.6% (95% CI: 97.9%-100.0%), respectively. For patients tested within 7 days of symptom onset (days post-symptom onset: DPSO), the relative sensitivity was 87.4% (95% CI: 79.4%-93.1%) and the relative specificity was 99.6% (95% CI: 97.7%-100.0%).
*1 sample was excluded from analysis due to unavailability of the PCR test result.
**1 sample (PCR negative) was excluded from analysis due to the unavailability of the antigen test result.
***Ct values generally indicate an estimate of the viral material present in the samples. A low Ct value is indicative of a large amount of viral material, while a high Ct value is indicative of lower levels of viral material.
Format
The package contains:
- Test cassette (packaged in foil pouch 1, desiccant sachet included)
- Test tube containing liquid and measuring cap (in the aluminium bag 2)
- Sterile swab
- Test tube holder support
- Instructions for use and Quick Guide
Bibliography
1 Wu et al. Nature. 2020. 579:265-9.
2 Coronaviruses. European Center for Disease Prevention and Control. https://www.ecdc.europa.eu/en/covid-19/latest-evidence/coronaviruses. Accessed 6 Jan 2021.
3 Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. Nat Microbiol. 2020. 5:536-44.
4 https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technicalguidance/ naming-the-coronavirus-disease-%28covid-2019%29-and-the-virus-that-causes-it.
5 WHO. https://www.who.int/publications-detail-redirect/diagnostic-testing-for-sars-cov-2. Accessed 6 Jan 2021. 6 Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Accessed 6 Jan 2021.
The SARS-CoV-2 Antigen Self Test Nasal is a lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human nasal specimens. The test allows the detection of SARS-CoV-2 virus antigens in subjects with suspected COVID-19 infection. It is intended for use as a self-test for patients. The clinical performance of the SARS-CoV-2 Antigen Self Test Nasal for self-testing was evaluated using nasal swab samples from 146 prospective study participants (139 of whom were within 7 days of symptom onset) at a clinical center in Germany. The clinical evaluations were performed independently of the manufacturer and distributor, in a collaboration between the Charité University Hospitals in Berlin and Heidelberg. The study cohort included symptomatic adults (18 to 68 years of age) with clinical suspicion of SARS-CoV-2 infection. In the self-test group, study participants followed written instructions with illustrations to self-collect a nasal swab sample and perform the test themselves. Self-collection and testing were performed in the presence of healthcare workers, who did not intervene at any stage. PCR tests performed on a combination of deep nasal/posterior pharyngeal swab samples were used as a comparison method. Nasal sampling by the self-test group always preceded deep nasal/posterior pharyngeal swab sampling for the comparative RT-PCR method. SARS-CoV-2 infection was diagnosed (by PCR) in 27.4% of patients. The clinical performance of the SARS-CoV-2 Antigen Self Test Nasal was also evaluated in comparison to professional tests, performed after self-collection and professional nasal swab sampling at the same clinical site. 229 adults with clinical suspicion of SARS-CoV-2 infection were included in the prospective study. 133 study participants (126 of whom were within 7 days of symptom onset) underwent nasal sampling by healthcare workers, while 96 study participants (83 of whom were within 7 days of symptom onset) followed instructions for self-collection of nasal swab specimens. Self-collection of specimens occurred in the presence of healthcare workers. PCR tests were performed as previously described.
How to use
Sample collection and preparation:
1. Before performing the test, wash your hands with soap and water or use hand sanitizer.
2. Check the expiration date on the back of the foil pouches. Do not use the test if it has passed the expiration date.
3. Open one of the foil pouches 1 by tearing it gently along the perforated line, then remove the test cassette and the desiccant sachet. Use the test immediately after opening the foil pouch.
4. Verify that the test cassette is intact and that the desiccant sachet does not contain any green pellets. Do not open the desiccant sachet. Before starting the procedure, it is necessary to equilibrate the test cassette and reagents to room temperature (15-30 °C/59-86 °F).
Directions for use:
1. Open the aluminum bag 2 by tearing it gently along the perforated line, then remove one of the test tubes with the liquid and a measuring cap and place them on a flat surface.
2. Carefully unseal the test tube, avoiding spilling the liquid inside. Insert the test tube into the test tube holder.
3. Blow your nose once into a tissue.
4. Remove the swab from the package. Be careful to touch only the shaft and not the cotton tip.
5. Tilt your head back slightly.
6. Insert the swab into the left nostril, from the side of the cotton tip. Slowly advance about 2 cm in a straight line (parallel to the upper palate, without tilting upwards) until resistance is encountered. Do not apply pressure.
7. Rotate the swab 4 times (for a total of about 15 seconds) against the nasal wall, then remove the swab from the nostril.
8. Repeat steps 6 and 7 in the right nostril using the same swab.
9. Insert the swab into the test tube, dipping the cotton tip into the liquid. Squeeze the test tube at the bottom and keep it squeezed. Rotate the swab more than 10 times to facilitate the transfer of the biological material from the swab to the liquid.
10. Remove the swab by continuing to squeeze the sides of the tube to extract the liquid from the swab. Throw away the swab and close the tube tightly with the measuring cap. The same swab should be used to collect samples from both nostrils.
Running a test:
- Place the test cassette on a flat surface.
- Hold the tube upright over the circular well on the test cassette (not over the rectangular result window).
- Drop exactly 4 drops into the circular well. Gently squeeze the sides of the tube if necessary.
Note: You can continue testing even if 5 drops accidentally fall onto the test cassette.
- Set the timer and read the test result after 15-30 minutes.
- After performing the test, wash your hands with soap and water or use hand sanitizer. Failure to squeeze the tube properly may result in incorrect results due to too much swab in the stick. Test results that are read before 15 minutes or after 30 minutes may be incorrect.
Interpretation of results:
POSITIVE: If a test line (T) is visible, in addition to a control line (C), the result is positive. Observe the result carefully: the test is considered positive if both lines are visible, however faint.
NEGATIVE: If a control line (C) is visible, even if faint, but a test line (T) is not visible, the result is negative.
INVALID: If a control line (C) is not visible, the test result is invalid. The test did not work properly, so it is recommended to perform another test with a new package. The test may not have performed properly.
Warnings
- Use the package only once.
- Remove the test cassette from the sealed pouch only when everything is ready to perform the test.
- Do not use the test kit if the pouch is damaged.
- In case of liquid spillage, be careful to clean thoroughly with a suitable disinfectant.
- Use only the components contained in this test kit.
- If the sample collected is insufficient or is taken incorrectly, the results may be inaccurate or false.
- Avoid contact with eyes and skin. In case of accidental contact, wash thoroughly to prevent skin irritation. If in doubt, consult a doctor.
- Keep the test package out of the reach of children to avoid the risk of accidental ingestion of the buffer liquid or small parts.
- Do not use any of the test components on the body, except the test stick included in the package. Do not ingest any component.
- Consult a doctor to discuss the test result and whether further testing is needed. Also consult a doctor if you are concerned about your health, or if your symptoms persist or worsen.
- Even if the test result is negative, continue to observe all the hygiene and safety precautions provided.
- Dispose of all waste in accordance with local regulations.
For customers in the European Economic Area: Contains SVHC (octylphenol ethoxylate).
Only for use in an IVD method and under controlled conditions, according to Articles 56.3 and 3.23 of the REACH Regulation. Avoid release to the environment, sewers and water systems.
Conservation
Store the package at 2-30 °C/36 - 86 °F and avoid exposure to direct sunlight. The expiry date of the materials is indicated on the outer packaging.
Validity: 15 months.
Do not freeze the package.
Sensitivity and specificity of the test
In the self-test study, the SARS-CoV-2 Antigen Self Test Nasal correctly identified 91.2% (CI: 76.3%-98.1%) of infected participants with a relatively high viral load (Ct = 30). Subjects with a high viral load are considered to be at higher risk of infectivity and transmission of the virus to others. For all study participants, the rapid antigen test correctly identified 82.5% (CI: 67.2%-92.7%) of infected participants and 100.0% (CI: 96.5%-100.0%) of uninfected participants. Overall, 110 PCR-positive and 263 PCR-negative study participants were assessed across all 3 cohorts using the SARS-CoV-2 Antigen Self Test Nasal. For patients with a relatively high viral load (Ct = 30), the relative sensitivity was 91.1% (95% CI: 83.8%-95.8%, N = 101). For all samples, the overall relative sensitivity and overall relative specificity were 86.4% (95% CI: 78.5%-92.2%) and 99.6% (95% CI: 97.9%-100.0%), respectively. For patients tested within 7 days of symptom onset (days post-symptom onset: DPSO), the relative sensitivity was 87.4% (95% CI: 79.4%-93.1%) and the relative specificity was 99.6% (95% CI: 97.7%-100.0%).
| Antigen Positive/PCR Positive | Antigen negative/PCR negative | Relative sensitivity (95% confidence interval) | Relative specificity (95% confidence interval) | |
| Do-it-yourself test** | 33 out of 40 | 105 out of 105 | 82.5% (67.2%-92.7%) | 100% (96.5%-100%) |
| Self-collection | 31 out of 34 | 61 out of 62 | 91.2% (76.3%-98.1%) | 98.4% (91.3%-100%) |
| Professional withdrawal* | 31 out of 36 | 96 out of 96 | 86.1% (70.5%-95.3%) | 100% (96.2%-100%) |
| Combined*,** | 95 out of 110 | 262 out of 263 | 86.4% (78.5%-92.2%) | 99.6% (97.9%-100%) |
| Ct = 30*** | 92 out of 101 | no | 91.1% (83.8%-95.8%) | no |
| DPSO = 7*,** | 90 out of 103 | 242 out of 243 | 87.4% (79.4%-93.1%) | 99.6% (97.7%-100%) |
*1 sample was excluded from analysis due to unavailability of the PCR test result.
**1 sample (PCR negative) was excluded from analysis due to the unavailability of the antigen test result.
***Ct values generally indicate an estimate of the viral material present in the samples. A low Ct value is indicative of a large amount of viral material, while a high Ct value is indicative of lower levels of viral material.
Format
The package contains:
- Test cassette (packaged in foil pouch 1, desiccant sachet included)
- Test tube containing liquid and measuring cap (in the aluminium bag 2)
- Sterile swab
- Test tube holder support
- Instructions for use and Quick Guide
Bibliography
1 Wu et al. Nature. 2020. 579:265-9.
2 Coronaviruses. European Center for Disease Prevention and Control. https://www.ecdc.europa.eu/en/covid-19/latest-evidence/coronaviruses. Accessed 6 Jan 2021.
3 Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. Nat Microbiol. 2020. 5:536-44.
4 https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technicalguidance/ naming-the-coronavirus-disease-%28covid-2019%29-and-the-virus-that-causes-it.
5 WHO. https://www.who.int/publications-detail-redirect/diagnostic-testing-for-sars-cov-2. Accessed 6 Jan 2021. 6 Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Accessed 6 Jan 2021.
