Monkeypox Virus Nucliec Acid Detection

PRODUCT SPECIFICATION

96 tests/box

INTENDED USE

This kit is intended for the qualitative detection of monkey pox virus (MPV) in serum or lesion secretions Detection results can be used to assist clinical diagnosis ofrnonkeypox.

SUMMARY

The monkeypox virus is the causative pathogen of monkeypox, which is a viral zoonotic disease with symptoms in humans similar to those seen in smallpox patients. Early symptoms include fever. headache, muscle pains. fatigue, and swollen glands After a few days of early symptoms, patients may develop a few to thousands of characteristic lesions on the face. hands, and feet_ The monkeypox virus can be found in the patients' body 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 PCR Buffer provided in the kit contains a pair of specific PCR primers to amplify the MPV DNA fragment, and a Gagman  probe that bind to amplified DNA fragment to monitor the reaction progress in real time. Besides, the buffer also includes an external control systemic. monitor presence of inhibitory substances.

COMPONENTS

1_ MPV PCR Buffer,           2 tubes,96 tests

2_ PCR Enzyme,               1 tube, 96 tests

3_ MPV Positive Control,    1 tube, 48 tests

4_ MPV Negative Control,   1 tube, 48 tests

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

1_ Read the package insert carefully prior to first use

2_ The Kit should be used by PROFESSIONAL PERSONNEL ONLY.

3_ Wear personal protective equipment (PPE) before handling materials with potential biohazard risks.

4_ Avoid repeated thawing and freezing of product components.

5_ Once the components is thawed, vortex and centrifuge briefly before use

6_Dispose of used products, pipette tips, and other consumables as

bio-hazard wastes_ Do not reuse them.

TEST PROCEDURES

Read the Package Insert Carefully Prier to First Use.

Equipment 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_ Vortex mixer

5_ High-speed centrifuge

6_ Refrigerator and freezer

7_ Pipettes and pipette tips

8_ Disposable gloves

9_ 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 according to the number of tests. 14ul.of the MPV PCR Buffer and 1 ul of PCR Enzyme is required for each single test. Pipette the Reaction Mix several times to mix its ingredients.

5_Dispense the Reaction Mix into PCR tubes, 15 ul. for each PCR tube.

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

7_Pipette 5ul of the MPV Negative Control into PCR tube. Pipette 3-3 times to mix the solution. Close the PCR tubes.

8_Pipette 5ul of the MPV Positive Control into a PCR tube. Pipette 3-5 limes to mix the solution_ Close the PCR tubes.

9_Put the PCR tubes into a Fluorescent PCR instrument. Set the program parameter as described in table below.

Table 1. RT-PCR Program Parameters

For ABI 7500 PCR systems or other similar systems, the "Passive Reference Dye” should be set as "None".

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

Table 2. Expected Ct Values of Positive and Negative Control

Table 3. Interpreration of Tesy Results.

PRODUCT PERFORMANCE

Limit of Detection (L0D): the kit LoD is about 500 MPV genomes/ml

Sensitivity, Specificity & Total Accuracy

The product performance was evaluated with clinical specimens. using clinical diagnosis as the reference method.

Cross-Reactivity with Other Pathogen Genomes

No cross-reactivity observed with 10' copies/ml genome solution from the following pathogens: Staphylococcus aureus., Streptococcus pneumoniae, Measles virus, Mumps virus, Adenovirus type 3, Mycoplasma pneurnoniae, Parainfluenza virus 2, Metapneurnovirus, SARS-CoV, SARS-CoV-2, MERS-CoV, Human coronavirus- OC43, Human coronavirus 229 E, Human coronavirus NL63., Human coronavirus HKU I, Bordetella parapertussis, Influenza B virus (Victoria Lineage), Influenza B virus (strain B/Yamagata/16/1988),2009 pandemic influenza A (H1N1.) virus, Influenza A (H3N2) virus, Avian influenza A (H7NP) virus, Avian influenza A (H5N1) virus, Epstein-Barr virus, Enterovirus CA16, Rhinovirus, Neisseria meningitidis, and Respiratory.- syncytical virus.

Interference Test

No interference observed with 1% of the following interfering materials: Aluminum hydroxide, Azithrornycin„ Beclomethasone, Bilirubin, Budesonide, Ceftriaxone, Dexameth.a.one, Flunisolide, Fluticasone,. Hemo2lobin, Histamine hydrochloride, Levofloxacin Lopinavir, Meropenem. Mometasone, Mucin, Oseltarnivir Oxymetazoline, Paramivir, Phenylephrine, Ribavirin, Ritonavir,