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| Kit: | |
|---|---|
| Quantity: | |
ICA2114-12
BioTeke
Professional CE Version
The kit is used for in vitro qualitative detection of Mycoplasma pneumoniae from human oropharyngeal swab specimens.
This kit is suitable for auxiliary diagnosis of respiratory diseases, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision.
The kit is immunochromatographic and uses double-antibody sandwich method to detect Mycoplasma pneumoniae antigen.
During detection, the treated specimens are loaded into the sample wells of the test card. When the concentration of Mycoplasma pneumoniae 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 Mycoplasma pneumoniae in detection zone on nitrocellulose film (T) to form a red 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 red reaction line appears in the detection zone, at this point the result is negative.
Regardless of whether the sample contains viral antigens or not, a red reaction line will appear in the quality control zone (C), the red reaction line that appears in the quality control zone (C) is the criterion for determining if the chromatography process is normal.
| Components | Specification | |
| 1 test/kit | 20 tests/kit | |
| Test card | 1pc | 20pcs |
| Sample extraction tube | 1pc | 20pcs |
| Tube cap | 1pc | 20pcs |
| Oropharyngeal swab | 1pc | 20pcs |
| Waste bag | 1pc | 20pcs |
The kits should be stored at 2~30℃.
Valid for 24 months.
The test card should be used as soon as possible within 1 hour after opening the foil pouch.
Specificity: 96.77%
Sensitivity: 100%
Total coincidence rate: 98.12%
6 in 1 test
7 in 1 test
8 in 1 test
10 in 1 test
Professional CE Version
The kit is used for in vitro qualitative detection of Mycoplasma pneumoniae from human oropharyngeal swab specimens.
This kit is suitable for auxiliary diagnosis of respiratory diseases, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision.
The kit is immunochromatographic and uses double-antibody sandwich method to detect Mycoplasma pneumoniae antigen.
During detection, the treated specimens are loaded into the sample wells of the test card. When the concentration of Mycoplasma pneumoniae 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 Mycoplasma pneumoniae in detection zone on nitrocellulose film (T) to form a red 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 red reaction line appears in the detection zone, at this point the result is negative.
Regardless of whether the sample contains viral antigens or not, a red reaction line will appear in the quality control zone (C), the red reaction line that appears in the quality control zone (C) is the criterion for determining if the chromatography process is normal.
| Components | Specification | |
| 1 test/kit | 20 tests/kit | |
| Test card | 1pc | 20pcs |
| Sample extraction tube | 1pc | 20pcs |
| Tube cap | 1pc | 20pcs |
| Oropharyngeal swab | 1pc | 20pcs |
| Waste bag | 1pc | 20pcs |
The kits should be stored at 2~30℃.
Valid for 24 months.
The test card should be used as soon as possible within 1 hour after opening the foil pouch.
Specificity: 96.77%
Sensitivity: 100%
Total coincidence rate: 98.12%
6 in 1 test
7 in 1 test
8 in 1 test
10 in 1 test
