Monkeypox Virus Antigen Rapid Test
- Get results quickly in 15 minutes
- CE Mark
- MHRA Mark
The test is a rapid and convenient immunochromatographic assay for the qualitative detection of Monkeypox Virus (MPXV) antigen in human whole blood, serum, plasma, rash exudate,nasal swab and throat swab samples in vitro.
MPXV is an enveloped double-stranded DNA virus that belongs to the Orthopoxvirus genus within the Poxviridae family. Animal-to-human (zoonotic) transmission can occur from direct contact with the blood, body fluids, and cutaneous or mucosal lesions of infected animals. Human-to-human transmission can result from close contact with respiratory secretions, skin lesions of an infected person or recently contaminated objects such as clothes and bedding. The transmission through sexual transmission routes remains unclear. The incubation period of Monkeypox ranges from 5 to 21 days, on average 7 to 14 days.
Monkeypox typically presents clinically with fever, headache, back pain, myalgia, asthenia, rash and swollen lymph nodes and may lead to a range of medical complications.
【PRINCIPLE OF THE PROCEDURE】
It is an antigen-capture immunochromatographic assay, detecting the presence of MPXV antigen in human serum, plasma, whole blood samples, rash exudate, nasal swab and throat swab samples. Monoclonal antibodies specifically against MPXV antigen, are conjugated with colloidal gold and deposited on the conjugate pad, and immobilized on the Test Zone on the nitrocellulose membrane. When a sample is added, it rehydrates the gold-antibody conjugate, and the MPXV antigen present in the sample interacts with the colloidal gold conjugated antibodies. The antigen-antibody-colloidal gold complex migrates towards the test window and through the Test Zone where they are captured by immobilized antibodies, forming a visible red line (indicate positive results). If MPXV antigen is absent in the sample, no red line will appear in the Test Zone, indicating negative results. To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. The absence of a red control line in the Control Zone is an indication of an invalid result.
Tab.1 Main components of the kit
MPXV Antigen detection card
Sample Extraction Buffer
Instruction for Use
Note: The components in the kits of different batches cannot be mixed to avoid erroneous results.
【STORAGE CONDITIONS AND EXPIRY DATE】
The kit should be stored at 2℃~30℃ and protected from light. Do not freeze any of the test kit components. The detection card should be used within 1 hour after being opened under 60% humidity.
See manufacturing date and expiry date on label.
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