Certificate: | CE self-test certificate, BfArM certified, ANSM certified |
Features: | Result after 12mins, Easy to use, Nasal self-test |
Performance: | 92.44% Sensitivity, 99.32% Specificity |
Packaging: | 1 Test/ Kit, 5 Tests/Kit, 25 Tests/Kit |
Component: | 1*Pouch (test cartridge and desiccant), 1*Swab, 1*Tube with buffer, 1*Instructions for use |
Shelf Life: | 18 months |
Intended Use
The SARS-CoV-2 Antigen Kit (Colloidal Gold) is a single use, in vitro visually read rapid immunochromatographic test for the qualitative detection of SARS-CoV-2 nucleocapsid (N) antigen in human nasal swab specimens. The SARS-CoV-2 Antigen Kit (Colloidal Gold) is intended to be used manually by lay users (self-testing) in a private setting to aid in the rapid diagnosis of SARS-CoV-2 infections.
Features
1. It is easy to use and accurately delivers results within 12 minutes.
2. The test has been designed to identify proteins from the COVID-19 virus via nasal swabs.
3. It is suitable for both symptomatic and asymptomatic individuals suspected of Covid.
4. Certified Quality Standards - Manufactured under ISO13485:2016, received CE self-test certificate
Instructions
Sample Collection
Insert into one nostril up to 2 cm, rotate 5 times,
and repeat the process for the other nostril
Test Procedure
Result Interpretation
Performance Characteristic
SARS-CoV-2 Antigen Kit (Colloidal Gold) | Comparative RT-PCR Test Results | ||
Positive (+) | Negative (-) | Total | |
Positive | 110 | 1 | 111 |
Negative | 9 | 147 | 156 |
Total | 119 | 148 | 267 |
Clinical sensitivity: 92.44% (95% CI: 86.13 – 96.48%) | |||
Clinical specificity: 99.32% (95% CI: 96.29 – 99.98%) | |||
Overall percent agreement: 96.25% (95% CI: 93.22 – 98.19%) | |||
Intended Use
The SARS-CoV-2 Antigen Kit (Colloidal Gold) is a single use, in vitro visually read rapid immunochromatographic test for the qualitative detection of SARS-CoV-2 nucleocapsid (N) antigen in human nasal swab specimens. The SARS-CoV-2 Antigen Kit (Colloidal Gold) is intended to be used manually by lay users (self-testing) in a private setting to aid in the rapid diagnosis of SARS-CoV-2 infections.
Features
1. It is easy to use and accurately delivers results within 12 minutes.
2. The test has been designed to identify proteins from the COVID-19 virus via nasal swabs.
3. It is suitable for both symptomatic and asymptomatic individuals suspected of Covid.
4. Certified Quality Standards - Manufactured under ISO13485:2016, received CE self-test certificate
Instructions
Sample Collection
Insert into one nostril up to 2 cm, rotate 5 times,
and repeat the process for the other nostril
Test Procedure
Result Interpretation
Performance Characteristic
SARS-CoV-2 Antigen Kit (Colloidal Gold) | Comparative RT-PCR Test Results | ||
Positive (+) | Negative (-) | Total | |
Positive | 110 | 1 | 111 |
Negative | 9 | 147 | 156 |
Total | 119 | 148 | 267 |
Clinical sensitivity: 92.44% (95% CI: 86.13 – 96.48%) | |||
Clinical specificity: 99.32% (95% CI: 96.29 – 99.98%) | |||
Overall percent agreement: 96.25% (95% CI: 93.22 – 98.19%) | |||
