Monkeypox Virus Nuclear Acid Detection Kit (Real-time PCR)

• Type: IVD Reagent
• Intended Use: Detection Monkeypox Virus
• Certificate: CE
• Transport Package: Carton Box
• Specification: 50 tests/kit
• Trademark: ultrassay
• Model NO.: UBP-O09050H
• Origin: China
• HS Code: 3822009020
• Production Capacity: 500000tests/Month

Product Description

Background

On May 7, 2022, a local case of monkeypox virus infection was reported in the UK.
According to the British Reuters report, on the 20th local time, with more than 100 confirmed and suspected cases of monkeypox in Europe, the World Health Organization confirmed that it would hold an emergency meeting on monkeypox on the same day. At present, it has involved many countries including the United Kingdom, the United States, Spain, etc. A total of 80 monkeypox cases and 50 suspected cases have been reported worldwide.

Monkeypox is a rare viral zoonotic disease that usually spreads among monkeys in Central and West Africa, but occasionally to humans. Monkeypox is a disease caused by monkeypox virus, which belongs to the orthopoxvirus subgenus of the Poxviridae family. In this subgenus, there are only four types of smallpox virus, vaccinia virus, vaccinia virus and monkeypox virus that can cause human infection. There is cross immunity. Monkeypox virus is rectangular in shape and can grow in African green monkey kidney cells, causing cytopathic effects.

Humans are infected with monkeypox, mainly through the bite of an infected animal, or direct contact with the blood, body fluids, and monkeypox lesions of an infected animal; usually transmitted from animals to humans, and occasionally human-to-human monkeys can also occur. Acne spreads. It is generally believed to be transmitted through toxic respiratory droplets during direct, prolonged face-to-face contact. In addition, monkeypox can also be spread through direct contact with an infected person's bodily fluids or virus-contaminated items such as clothing and bedding.
The UK Health Safety Agency (UKHSA) said initial symptoms of monkeypox infection include fever, headache, muscle aches, back pain, swollen lymph nodes, chills and fatigue. Patients also sometimes develop a rash, usually first on the face and then on other parts of the body. Most infected people recover within a few weeks, but others develop severe illness. In view of the successive reports of monkeypox cases in many countries, the development of rapid detection reagents is urgently needed to avoid the rapid spread of the virus and endanger the world.

The monkeypox DNA virus detection kit (Real-time PCR) and the orthopox virus universal type and monkeypox virus DNA detection kit (Real-time PCR) developed by ULTRASSAY can help detect monkeypox virus and detect monkeypox infection cases in time.

[Intended Use]
Ultrassay Monkeypox Virus Nuclear Acid Detection Kit (Real-time PCR) is used for in vitro qualitative detection of monkeypox virus nucleic acid in human rash fluid, nasopharyngeal swabs, throat swabs and serum samples.
Monkeypox (MP) is an acute zoonotic infectious disease caused by Monkeypox Virus (MPV). MPV is round-bricked or oval in shape, and is a double-stranded DNA virus with a length of about 197Kb[1]. The disease is mainly transmitted by animals, and humans could become infected by 
being bitten by infected animals or by direct contact with the blood, body fluids and rash of infected animals. The virus can also be transmitted between people, primarily through respiratory droplets during prolonged, direct face-to-face contact or through direct contact with a patient's body fluids or contaminated objects[2-3]. The clinical symptoms of monkeypox infection in humans are similar 
to those of smallpox, generally after a 12-day incubation period, appearing fever, headache, muscle and back pain, enlarged lymph nodes, fatigue and discomfort. The rash appears after 1-3 days of the fever, usually first on the face, but also in other parts. The disease course generally lasts 2-4 weeks, and the mortality rate is 1%-10%. Lymphadenopathy is one of the main differences between this disease and smallpox[4]. 
The test results of this kit are not used as the only indicator for the diagnosis of monkeypox virus infection in patients, which must be combined with the clinical characteristics of the patient and other laboratory test data to correctly determine the infection of the pathogen, and formulate a reasonable treatment plan to make the treatment safe and effective.
 

[Advantage]
1. Orthopox virus universal type and monkeypox virus DNA detection kit (Real-time PCR) can cover four types of orthopoxviruses that cause human infection, and at the same time detect the currently popular monkeypox virus to make the diagnosis more accurate and avoid missed detection. And a tube of reaction solution is used, which is easy to operate and saves costs;
2. Ultrassay Monkeypox Virus Nuclear Acid Detection Kit (Real-time PCR) is using rapid PCR amplification which can obtain the results in 40 minutes;
3. The internal control is introduced into the system, which can comprehensively monitor the experimental process and ensure the experimental quality;
4. With high specificity and high sensitivity, it can detect viruses at a concentration of 300Copies/mL in samples. The monkeypox virus detection has no cross with smallpox virus, vaccinia virus, vaccinia virus, etc.;

[Acceptable Specimens]
1.Sample Collection
1.1 Rash Fluid
Select the typical or clear and fresh rash. Clean the surface twice with a sterile saline cotton swab and dipped the skin to dry, puncture the rash with a sterile needle tip, squeeze out with a sterile cotton swab and dip the rash fluid into the preservation solution immediately, and tighten the screw cap. Wipe the needle insertion site again with normal saline or sterile alcohol, and press with a sterile dry cotton swab for a while to prevent infection.
1.2 Nasopharyngeal swab
A swab with a polyester fiber tip is used to enter through the anterior nostril and proceed slowly back and forth along the base of the inferior meatus. When the top of the swab reaches the posterior wall of the nasopharyngeal cavity (with a touch of the wall), let the swab stand for a while (about 3 seconds), then gently rotate it for a round, slowly remove the swab, and put it into the tube. Break the plastic handle by hand, immerse the swab in the sampling solution, and tighten the cap. It is validated that nasopharyngeal swab samples can be preserved with normal saline or Hank's solution preservation solution. 
1.3 Oropharyngeal swab
Wipe the posterior pharyngeal wall and bilateral tonsils at the back of the uvula (palatine or uvula) with moderate force with a polyester fiber head swab. Avoid touching the tongue, take out the posterior sampling tube, and break the plastic handle at the contact part of the hand. Put the swab into the sampling solution, and tighten the cap. It is validated that oropharyngeal swab samples can be preserved with normal saline or Hank's solution preservation solution. 
1.4 Serum
Use a sterile syringe to collect 3-5mL of venous blood from the subject in a vacuum blood collection tube (preferably with a separating gel). Leave it at room temperature for no more than 4 hours, centrifuge at 3000 rpm for 10 minutes, suck the upper serum (do not suck red blood cells) and transfer it to another sterile centrifuge tube for use.