Monkeypox Virus Real Time PCR Kit MPXV Oropharyngeal Swab Oropharyngeal Swab

INTENDED USE

The Real-Time PCR Kit for Detection of Monkeypox Virus is a qualitative in vitro real-time PCR test for the detection of nucleic acid from monkeypox virus in oropharyngeal swab, nasopharyngeal swab, human pustular or vesicular rash specimens from individuals suspected of monkeypox virus infectious.

Results are for the identification of monkeypox virus DNA. Positive results are indicative of the presence of monkeypox virus DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative results do not preclude monkeypox virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The Real-Time PCR Kit for Detection of Monkeypox Virus is intended for use by qualified and trained clinical laboratory personnel specifically

instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures

SUMMARY

Monkeypox(MPX) is an acute zoonotic infectious disease caused by Monkeypox Virus(MPXV). Monkeypox virus usually invades the body through the respiratory mucosa, propagates in the lymphocytes and invades the blood, produces temporary viremia, multiplies in the cells, and then invades the blood from the cells, runs to the skin of the whole body, and causes lesions. The clinical symptoms of monkeypox infection are similar to those of Variola, but are usually milder. Generally, after a 12-day incubation period, fever, headache, muscle pain, and swollen lymph nodes appear. Papules appear 1-3 days after fever, and papules will appear on the face or other parts of the body. As the disease progresses, the pimples crust and fall off. The course of the disease generally lasts 2-4 weeks, and the mortality rate is 1%-10%. Lymphadenopathy is one of the main differences between this disease and smallpox.

In recent years, the diagnostic technology of monkeypox virus has been greatly developed, from the earliest virus isolation and serological methods to the current ELISA and polymerase chain reaction (PCR). Nucleic acid testing is the gold standard for diagnosing monkeypox infection.

Technical Parameters:

STORAGE AND EXPIRATION DATE

1. Store the kits at 2-35℃. MPXV Reagent Strip (Freeze-Dried) and Positive Control (Freeze-Dried) can be transported at room temperature.

2.The dissolved Positive Control needs to be stored at -20±5℃ and it could be stored for 1 year.

3.The shelf-life of the kit is 12 months. After disassembling, it is recommended to store tightly.

4.Always check the expiration date before use, and do not use any expired reagent. For the manufacturing date and expiration date, see the outer packaging box. 5.After opening, the Kit is stable up to the expiration date indicated on the packaging provided that the components have been stored correctly according to the recommendations.

SAMPLE REQUIREMENTS

The Kit is designed to detect DNA from Monkeypox virus in specimens such as vesicular or pustular lesion fluid and diseased tissue samples collected from individuals based on clinical and/or epidemiological criteria.

Use the specimen collection, transportation, storage medium following reagent manufacturer instructions. Perform nucleic acid extraction following reagent manufacturer instructions.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world