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Basic Info.
Model NO.
MPV-AG-C
Trademark
David or neutral
Origin
China
Product Description
INTENDED USE
HOW TO READ THE RESULT
The product is a lateral flow chromatographic immunoassay for the qualitative detection of monkeypox virus antigen in human whole blood, serum, plasma, rash exudate or nasal swab. The product is intended for professional use only. Monkeypox is a zoonotic viral disease caused by monkeypox virus (MPXV) infection.
Its clinical symptoms are mainly fever, rash and lymphadenopathy.
HOW TO READ THE RESULT
1.Positive: A red line in the control area (C) with a red line in the test area (T) indicates presence of monkeypox virus antigens in the specimen.
2.Negative: A red line in the control area (C) without a red line in the test area (T) indicates absence of monkeypox virus antigens in the specimen or a monkeypox antigen level below detection limit.
3.Invalid: No red control line (C) appears. Invalid results may be due to incorrect 1 drop of specimen 1 drop of extraction bufferPage 3 of 4 operation or loss of efficacy. Repeat test firstly, if problem remains, stop using products with the same batch number and contact local distributor for support.
NOTE:
1. The intensity of color in test area (T) may vary depending on the concentration of target substance present in the specimen. Therefore, any shade of color in the test area should be considered positive. Besides, the level of target substance cannot be determined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or detection with expired tests are the most likely reasons for control line failure.
| Test Item | Specimen | Packing | Qualification | Format |
| Monkeypox Antigen Rapid Test Kit | whole blood, serum, plasma, rash exudate or nasal swab | 20T/BOX | CE | Cassette |
