Description

Monkeypox Virus Nuclei Acid Detection Kit (Fluorescence PCR Method) | yY22PCR096 | GEN-MPV-04

Intended Use

This kit is intended for the qualitative detection of monkeypox virus (MPV) in serum or lesion secretions. Detection results can be used to assist clinical diagnosis of monkeypox.The monkeypox virus is the causative pathogen of monkeypox, which is a viral zoonotie disease with symptoms in humans similar to those seen in smallpox patients. Farly symptoms include lever, headache, muscle pains, fatigue, and swollen glands. After a few days of carly symptoms, patients may develop a few to thousands of characteristic lesions on the face hands, and feet The monkeypox virus can be lound in the patients hody fluid and contaminated belongings, and spread by close contact with contaminated items.

Principle

The Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR Method) uses the real time polymerase chain reaction method to detect MPV DNA fragments in body fluid samples from suspected patients, The PC Buffer provided in the kit contains a pair of specific PR primers to amplify the MPV DNA fragment, and a taqman probe that bind to amplified DNA fragment to monitor the reaction progress in real time. Besides, the buffer also includes an external control system to monitor presence of inhibitory substances.

COMPONENTS

1. MPV PCR Buffer (2 Tube/96 Test )

2. PCR Enzyme (1 Tube /96 Test)

3. A MPV Positive Control (1 Tube/48 Test)

4. MPV Negative Control (1 Tube/48 Test)

5. Package Insert (1 Copy)

STORAGE AND VALIDITY PERIOD

Store the product at -20°C*5°C, keep away from exposure to sunlight Under proper storage conditions, the kit is valid for 24 months.

WARNINGS AND PRECAUSIONS

Read the package insert carefully prior to first use.
The Kit should be used by PROFESSIONAL PERSONNEL ONLY.
Wear personal protective equipment (PPE) before handling materials with potential biohazard risks.
A void repeated thawing and freezing of product components. Once the components is thawed, vortex and centrifuge briefly before use.
Dispose of used products, pipette tips, and other consumables as bio-hazard wastes. Do not reuse them.

TEST PROCEDURES

Read the Package Insert Carefully Prior to First Use. Fquipment and Instruments Required but Not Provided in This Product

1. Real time PCR system

2. Real time PCR reaction tubes/plates

3. Viral DNA extraction kit

4. A Vortex mixer

5. High-speed centrifuge

6. Refrigerator and freezer

7. Pipettes and pipelte lips X Disposable gloves Q Safety goggles

Procedures

1. Collect body fluid samples or lesion secretion samples from disease suspects.

2. Use a Viral DNA Extraction kit to get purified Sample DNA solution from these samples.

3. Calculate the number of tests required for the current test run. A positive control and a negative control are recommended for each Test run

4. Prepare the Reaction Mix aceording to the number of tests. 14uL of the MPV PCR Buffer and 1uL of PR Enzyme is required for each single test. Pipette the Reaction Mix several times to mix its ingrecients.

5. Dispense the Reaction Mix into PR tubes, 15 uL for each PCR tube.

6. Pipette Sul of a Sample DNA Solution into a PR tube. Pipette 3-5 times to mix the solution Close the PCR tube

7. Pipette SuL of the MPV Negalive Control into a PCR tube Pipette -3-5 times to mix the solution Close the PR tubes.

8. Pipette 5uL of the MPV Positive Control into a PCR tube. Pipette 3-5 times to mix the solution. Close the PER tubes

9. Put the PCR tubes into a Fluorescent PCK instrument Set the program parameter as described in table belon (RT-PCR Programe Parameters)

10. Record the Ct value in each fluorescence channel. Interpret test results according to the following criteria.

Expected Ct Values of Positive and Negative Control Sample Group

Interpretation of test Results

Cross-Reactivity with Other Pathogen Genomes

No cross-reactivity observed with 10^6 copies/ml genome solution from the following pathogens: Staphylococcus aureus, Streptococcus pneumonia, Measles virus, Mumps virus, Adenovirus type 3, Mycoplasma pneumonia, Parainfluenza virus 2, Metapneumovirus, SARS-CoV. SARS-CoV-2. MERS-CoV. Human coronavirus OC43, Human coronavirus 229 E, Human coronavirus NL63, Human coronavirus HKU1, Bordetella parapertussis, Influenza B virus (Victoria Lineage), Influenza B virus (strain B/Yamagata/16/1988), 2009 pandemic influenza A (HINI) virus, Influenza A (H3N2) virus, Avian influenza A (H7N9) virus, Avian influenza A (H5N1) virus, Epstein-Barr virus. Enterovirus CA16, Rhinovirus, Neisseria meningitidis, and Respiratory syncytial virus.

Interference Test

No interference observed with 1% of the following interfering materials: Abidol, Aluminum hydroxide. Azithromycin, Beclomethasone, Bilirubin, Budesonide, Ceftriaxone. Dexamethasone, Flunisolide, Fluticasone, Hemoglobin, Histamine hydrochloride, Levofloxacin, Lopinavir, Meropenem, Mometasone, Mucin, OseltamivIr, Oxymetazoline, Paramivir, Phenylephrine, Ribavirin, Ritonavir, Zanamivir, and a-interferon.

LIMITATIONS

1. This kit is intended for assisted diagnosis of viral infections only. A final clinical diagnosis should also consider factors like symptoms, results of other tests as well.

2. A negative result indicates that the viral load in tested sample is below the limit of detection of this product. It cannot completely exclude the possibility of viral infection

3. A positive result indicates that the tested sample has viral load higher than the limit of detection of this product However, the viral load may not correlate with the severity of infection or disease progression.

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