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TC1002
Bioteke
The SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold Method) is a lateral flow immunoassay intnded for the in vitro qualitative detection of SARS-CoV-2 nucleocapsid protein antigen from human anterior nasal swabs specimens of individuals who are suspected of COVID-19 within 7 days of symptom onset.
The SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold Method) is immunochromatographic and uses double-antibody sandwich method to detect SARS-CoV-2 antigen. Durng detection,the treated samples are loaded into the sample wells of the test card. When the concentration of SARS-CoV-2 antigen in specimen is higher than the minimum detection limit, the viral antigen will form complexes with labeled antibodies first.
Under chromatography, the complexes move forward along the nitrocellulose membrane till captured by pre-coated monoclonal antibody of SARS-CoV-2 in detection zone on nitrocellulose film (T) to form a pink/purple reaction line on the detection zone, at this point the result is positive; Conversely, if there is no viral antigen or the concentration of antigen in specimen is below the minimum detection limit, no pink/purple reaction line appears in the detection zone, at this point the result is negative.
Regardless of whether the sample contains viralantigens or not, a pink/purple reaction line will appear in the quality control zone (C), the pink/purple reaction line that appeas in the quality control zone (C) is the criterion for determining if the chromatography process is normal.
| Components | Loading Quantity | |||
| 1 test/kit | 3 tests/kit | 5 tests/kit | 25 tests/kit | |
| Test Card | 1pc | 3pcs | 5pcs | 25pcs |
| Sample Diluent | 0.5ml*1 | 0.5ml*3 | 0.5ml*5 | 0.5ml*25 |
| Samples Extraction Tube | 1pc | 3pcs | 5pcs | 25pcs |
| Anterior Nasal Swab | 1pc | 3pcs | 5pcs | 25pcs |
| Waste Bag | 1pc | 3pcs | 5pcs | 25pcs |
Note:
The kit should be stored at 2~30℃.
Valid for 24 months(After QC passed).
The test card should be used within 1 hour after opening the foil pouch.
The swab specimens should be tested immediately after collection.
The kit is suitable for users over 1 years old, children between 1-14 years old should be supervised by adults.
Sensitivity 93.91%
Specificity 100%
Accuracy 98.77%
The Sars-Cov-2 Antigen Test Kit was compared with the PCR Comparator Method on anterior nasal swab specimens.
There's no cross-reactivity and microbial interference between the following 49 pathogens(Please refer to the user manual).
Wash hands→Add sample diluent→Collect nasal sample→Drop 3 drops of samples into the hole→Results interpretation.
[POSITIVE]
Pink/Purple reaction lines appear in both Quality Control zone (C) and Detection zone (T).
[NAGATIVE]
Only Pink/Purple reaction lines appear in the Quality Control zone (C).
[INVALID]
Red/Purple reaction lines appear only in the Detection zone (T), or NO reaction line appear in both Detection zone (T) and Quality Control zone (C).
Note:
The test results should not be read after 20 minutes.
5 in 1 test
6 in 1 test
10 in 1 test
The SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold Method) is a lateral flow immunoassay intnded for the in vitro qualitative detection of SARS-CoV-2 nucleocapsid protein antigen from human anterior nasal swabs specimens of individuals who are suspected of COVID-19 within 7 days of symptom onset.
The SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold Method) is immunochromatographic and uses double-antibody sandwich method to detect SARS-CoV-2 antigen. Durng detection,the treated samples are loaded into the sample wells of the test card. When the concentration of SARS-CoV-2 antigen in specimen is higher than the minimum detection limit, the viral antigen will form complexes with labeled antibodies first.
Under chromatography, the complexes move forward along the nitrocellulose membrane till captured by pre-coated monoclonal antibody of SARS-CoV-2 in detection zone on nitrocellulose film (T) to form a pink/purple reaction line on the detection zone, at this point the result is positive; Conversely, if there is no viral antigen or the concentration of antigen in specimen is below the minimum detection limit, no pink/purple reaction line appears in the detection zone, at this point the result is negative.
Regardless of whether the sample contains viralantigens or not, a pink/purple reaction line will appear in the quality control zone (C), the pink/purple reaction line that appeas in the quality control zone (C) is the criterion for determining if the chromatography process is normal.
| Components | Loading Quantity | |||
| 1 test/kit | 3 tests/kit | 5 tests/kit | 25 tests/kit | |
| Test Card | 1pc | 3pcs | 5pcs | 25pcs |
| Sample Diluent | 0.5ml*1 | 0.5ml*3 | 0.5ml*5 | 0.5ml*25 |
| Samples Extraction Tube | 1pc | 3pcs | 5pcs | 25pcs |
| Anterior Nasal Swab | 1pc | 3pcs | 5pcs | 25pcs |
| Waste Bag | 1pc | 3pcs | 5pcs | 25pcs |
Note:
The kit should be stored at 2~30℃.
Valid for 24 months(After QC passed).
The test card should be used within 1 hour after opening the foil pouch.
The swab specimens should be tested immediately after collection.
The kit is suitable for users over 1 years old, children between 1-14 years old should be supervised by adults.
Sensitivity 93.91%
Specificity 100%
Accuracy 98.77%
The Sars-Cov-2 Antigen Test Kit was compared with the PCR Comparator Method on anterior nasal swab specimens.
There's no cross-reactivity and microbial interference between the following 49 pathogens(Please refer to the user manual).
Wash hands→Add sample diluent→Collect nasal sample→Drop 3 drops of samples into the hole→Results interpretation.
[POSITIVE]
Pink/Purple reaction lines appear in both Quality Control zone (C) and Detection zone (T).
[NAGATIVE]
Only Pink/Purple reaction lines appear in the Quality Control zone (C).
[INVALID]
Red/Purple reaction lines appear only in the Detection zone (T), or NO reaction line appear in both Detection zone (T) and Quality Control zone (C).
Note:
The test results should not be read after 20 minutes.
5 in 1 test
6 in 1 test
10 in 1 test
Telephone: +86-510-8332 3992
