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A company specializing in the development, production and sales of in vitro diagnostic products.
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info@immuno-test.com
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Building 1, 578 No.20 Street, Qiantang District, Hangzhou City, Zhejiang Province
Monkeypox Virus Antigen Rapid Test
Phone:0571-85368996 | Email:info@immuno-test.com
Abbr.:
Specification:
Specimen:
Assay Time:
Model No.:
HMKP054G
Model No.: HMKP054G
Assay Time: 10-15 minutes
Specimen: Whole Blood,serum or plasma
Monkeypox Virus Antigen Rapid Test
Graphic Details
INTENDED USE
The Monkeypox Virus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Monkeypox antigen in human skin lesion swab, or mucous membrane swab specimen in individuals who are suspected of monkeypox-like symptoms or recent contact with monkeypox infected patients.
| [Product Name] | Monkeypox Virus Antigen Rapid Test |
|
| [Product No.] | HMKP054G |
|
| [Assay Time] | 10-15 minutes | |
| [Specimen] |
Whole blood, serum, or plasma |
|
| [Principle] | Rapid chromatographic immunoassay | |
| [Storage Temperature] | 2-30℃, DO NOT FREEZE | |
| [Usage] | Monkeypox is used to be a viral zoonosis with symptoms very similar to those in smallpox patients, caused by by infection with Monkeypox virus. |
|
| [Materials Provided] | Foil pouches, each contains one test cassette, and one disposable dropper with desiccant bags |
|
| Assay buffer tubes (0.8ml each) |
||
| Disposable sampling swabs |
||
|
Paper tube holder |
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| Instruction for use |
PRINCIPLE
The Monkeypox Virus Antigen Rapid Test is consist with one test strips which could be observed in the window of the rapid test cassette. The strip is based on sandwich method immunochromatographic assay.
TEST PROCEDURE
1. Allow the rapid test, specimen, buffer, and/or controls to equilibrate to room temperature (15 - 30°C) prior to testing.
2. Remove the rapid test cassette from the sealed pouch and use it as soon as possible.
3. Place the test device on a clean and horizontal surface. Suck the treated sample extraction from the assay buffer tube and place 3 drops into the specimen well (S) of the test cassette. Start the timer.
4. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS
PERFORMANCE CHARACTERISTICS
1. Sensitivity, Specificity and Accuracy
The relative sensitivity and specificity of the Monkeypox Virus Antigen Rapid Test has been studied with the simulate positive cases and clinical negative cases. Below are the data we observed.
| Method | Gold standard reagent (PCR) |
Total Results |
||
| Monkeypox Virus Antigen Rapid Test |
Results | Positive | Negative | |
| Positive | 10 | 0 | 10 | |
| Negative | 0 | 201 | 211 | |
| Total Result | 10 | 201 | 211 | |
Relative Sensitivity: 100.00% (95%CI: 67.91%～100.00%)
Relative Specificity: 100.00% (95%CI: 97.74%～100.00%)
Accuracy: 100.00% (95%CI: 95.87%～100.00%)
2. Detection of Limit
The detection limit of monkeypox A29L protein was studied by the Monkeypox Virus Antigen Rapid Test. According to the test results, the lowest detection limit of the rapid test is 0.1ng/ml to A29L protein.
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