| Package: | |
|---|---|
| Quantity: | |
Bioteke
This kit is intended for in vitro qualitative detection of monkeypox virus antigen in human anterior nasal swab, oropharyngeal swab and rash exudate swab samples only.
This kit is intended to be used as an aid to diagnosis only, and the results are for clinical reference only and should not be used as the sole basis for diagnosis and exclusion decisions. Clinical diagnosis and treatment should be considered in conjunction with the patient's symptoms/signs, medical history, other laboratory tests and response to treatment.
The kit is immunochromatographic and uses double-antibody sandwich method to detect Monkeypox virus antigen.
During detection, the treated sample are loaded into the sample wells of the test card. When the concentration of Monkeypox virus antigen in specimen is higher than the minimum detection limit, the Monkeypox virus 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 Monkeypox virus antigen in detection zone on nitrocellulose film to form a red reaction line on the detection zone, at this point the result is positive; conversely, if there is no Monkeypox virus 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 Monkeypox virus 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.
C. PACKAGE SPECIFICATION
| Components | Main Ingredients | Laoding Quantity (Specification) | |||
| Test card | Test strip containing Monkeypox virus monoclonal antibody, Anti-mouse IgG polyclonal antibody | 1 Test/Kit | 2 Tests/Kit | 5 Tests/Kit | 20 Tests/Kit |
| Sample extraction tube（0.5mL/PC） | 1 pc | 2 pcs | 5 pcs | 20 pcs | |
| Tube cap | 1 pc | 2 pcs | 5 pcs | 20 pcs | |
| Swab | 1 pc | 2 pcs | 5 pcs | 20 pcs | |
| Waste bag | 1 pc | 2 pcs | 5 pcs | 20 pcs | |
| User manual | 1 pc | 1 pc | 1 pc | 1 pc | |
Note:
1. Test cards are sealed together with desiccant in aluminum foil pouch.
2. Do not mix use different batches of test cards and sample extraction tube.
3.The test card and extraction buffer should be stored at 2℃~30℃, valid for 24 months.
4.There is an option to collect an anterior nasal swab, an oropharyngeal swab, and a rash exudate swab. Once the collection is complete, the later steps of the test are the same.
【Positive】
Two colored lines appear in the test window. A red line is in the (C) section and another red line is in the (T) section. The positive results means that the sample contained Monkeypox virus antigens.
【Negative】
In the detection window, a red line in the quality control area (C) and no line in the detection area. Negative results means that the sample did not contain Monkeypox virus antigens or that the levels were below the detectable range.
【Invalid】
If the control (C) lines do not appear, the test is considered invalid.
An invalid test result means that your test has encountered an error and the results cannot be interpreted. You will need to retest using a new test card. The test results are for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment, they should be combined with the patient's condition, clinical manifestations, and other test results to make a comprehensive judgment; subject to the limitations of analytical sensitivity, negative results may be due to the low concentration of antigens in the samples, and it is recommended that the negative results be reviewed by other methods if there is any doubt about the negative results.
Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)
This kit is intended for in vitro qualitative detection of monkeypox virus antigen in human anterior nasal swab, oropharyngeal swab and rash exudate swab samples only.
This kit is intended to be used as an aid to diagnosis only, and the results are for clinical reference only and should not be used as the sole basis for diagnosis and exclusion decisions. Clinical diagnosis and treatment should be considered in conjunction with the patient's symptoms/signs, medical history, other laboratory tests and response to treatment.
The kit is immunochromatographic and uses double-antibody sandwich method to detect Monkeypox virus antigen.
During detection, the treated sample are loaded into the sample wells of the test card. When the concentration of Monkeypox virus antigen in specimen is higher than the minimum detection limit, the Monkeypox virus 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 Monkeypox virus antigen in detection zone on nitrocellulose film to form a red reaction line on the detection zone, at this point the result is positive; conversely, if there is no Monkeypox virus 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 Monkeypox virus 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.
C. PACKAGE SPECIFICATION
| Components | Main Ingredients | Laoding Quantity (Specification) | |||
| Test card | Test strip containing Monkeypox virus monoclonal antibody, Anti-mouse IgG polyclonal antibody | 1 Test/Kit | 2 Tests/Kit | 5 Tests/Kit | 20 Tests/Kit |
| Sample extraction tube（0.5mL/PC） | 1 pc | 2 pcs | 5 pcs | 20 pcs | |
| Tube cap | 1 pc | 2 pcs | 5 pcs | 20 pcs | |
| Swab | 1 pc | 2 pcs | 5 pcs | 20 pcs | |
| Waste bag | 1 pc | 2 pcs | 5 pcs | 20 pcs | |
| User manual | 1 pc | 1 pc | 1 pc | 1 pc | |
Note:
1. Test cards are sealed together with desiccant in aluminum foil pouch.
2. Do not mix use different batches of test cards and sample extraction tube.
3.The test card and extraction buffer should be stored at 2℃~30℃, valid for 24 months.
4.There is an option to collect an anterior nasal swab, an oropharyngeal swab, and a rash exudate swab. Once the collection is complete, the later steps of the test are the same.
【Positive】
Two colored lines appear in the test window. A red line is in the (C) section and another red line is in the (T) section. The positive results means that the sample contained Monkeypox virus antigens.
【Negative】
In the detection window, a red line in the quality control area (C) and no line in the detection area. Negative results means that the sample did not contain Monkeypox virus antigens or that the levels were below the detectable range.
【Invalid】
If the control (C) lines do not appear, the test is considered invalid.
An invalid test result means that your test has encountered an error and the results cannot be interpreted. You will need to retest using a new test card. The test results are for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment, they should be combined with the patient's condition, clinical manifestations, and other test results to make a comprehensive judgment; subject to the limitations of analytical sensitivity, negative results may be due to the low concentration of antigens in the samples, and it is recommended that the negative results be reviewed by other methods if there is any doubt about the negative results.
Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)
