Summary and explanation
Respiratory infections caused by viruses appear mainly in children, the elderly and immunosuppressed patients. The main viruses of respiratory infections are known as influenza viruses, parainfluenza viruses (PIV), Respiratory syncytial virus (RSV), enterovirus, adenovirus, etc. In recent years, respiratory infections of Rhinoviruses, coronaviruses and metapneumoviruses (MPV) have increased, and Bocavirus has been included in the main respiratory virus tests.
The coronavirus is a virus that can infect animals and humans. There are six known coronaviruses that can infect humans. Four of them are known as viruses that cause illnesses like the common cold, and the other two are MERS-CoV (Middle East respiratory syndrome coronavirus) and SARS-CoV (severe acute respiratory syndrome) Coronavirus Syndrome), which have been fatal to humans.
SARS-COV-2, which originated in Wuhan, China in 2019, is transmissible between humans, with up to 14 incubation days, and has been reported to have a lower mortality rate and a higher incidence than SARS-CoV or MERS-CoV. Sequencing of the virus revealed that SARS-CoV-2 was 89.1% homologous to SARS (severe acute respiratory syndrome) derived from shakes, such as coronaviruses, bat-SL-CoVZC45, bat-SL-CoVZXC21), and 79% homologous to SARS-CoV. It is also very important to accurately diagnose COVID-19, as it has sequences similar to viruses of the same genus.
Respiratory virus testing requires the selection of appropriate test methods based on the characteristics of the hospital patient population and laboratory conditions. Antigen test, virus culture and molecular. Biological methods have been used to detect viruses. Among them, the molecular biological method that uses reverse transcription-polymerase chain reaction (RT-PCR) is analytically very sensitive and is recognized as a standard method for detecting viruses that cannot be cultured or that exist in low concentrations.
Recently, One-step RT-PCR, in which reverse transcription and polymerase chain reaction (PCR) amplification can be performed in a tube, allows the precise identification of many viruses. The DiaPlexQ ™ Novel the Coronavirus (2019-nCoV) Detection Kit is a real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 nucleic acid extracted from nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, middle turbinate nasal swabs, nasal aspirates, nasal washes, bronchoalveolar lavage fluid (BAL) and sputum.
Handling Precautions and Requirements
- For in vitro diagnostic use.
- For emergency use
- Federal law restricts the sale of this device to or on the order of a licensed physician.
- Results should be interpreted according to the IDU results analysis section after processing in a compatible real-time PCR thermal cycler.
- Only use PCR tubes that are compatible with the corresponding PCR machine.
- Wear powder-free disposable protective gloves, a lab coat, and eye protection when handling specimens.
- Always wear disposable powder-free protective gloves when handling kit components to avoid any contamination that may affect the test result.
- Do not reuse tips, gloves, test tubes, etc. disposable.
- Take care that the reagents for this test do not come into contact with the skin, eyes or mucous membranes. If contact occurs, wash immediately with plenty of water.
- The work area must be disinfected before and after use.
- All reagents should be stored in accordance with the specified storage conditions before and after use.
- Do not leave the reagent cap open.
- Use only sterile pipette tips.
- Dispose of unused kit reagents and human samples in accordance with local, state, and federal regulations. Do not smoke, drink, eat, handle contact lenses, or apply makeup in areas where kit reagents and/or human samples are being used. Follow Universal Precautions and treat all samples, samples, and kit components as potentially infectious.
- Store the control template separately to avoid contamination.
- Thaw the product on the ice.
- When using the product, do not mix components from different kit lots.
- If an item arrives broken or damaged in transit, please contact Solent Co., Ltd.
Warranty and product liability
- The expiration date of the product is 1 year after the date of manufacture.
- Only use the protocol described in this leaflet. Protocol deviations can give wrong results.
- The exchange is not possible in case of a problem due to negligence or fault of the user.
- Do not repeat freeze-thaw more than 5 times.
Safety and First Aid Warnings
- Avoid contact with eyes, skin and respiratory system.
- Contact with the eyes: Wash the eyes with plenty of running water.
- Consult a doctor in case of irritation.
- Skin contact: Wash affected skin area thoroughly with soap and water.
- Do not use the product after the expiration date.
- Use this kit immediately after opening it.
- The quality of the sample and the integrity of the extracted nucleic acid can affect the test results.
- False results may occur due to contamination.
- Dispose of unused reagents and waste in accordance with county, federal, provincial, and state regulations and local regulations.
- Dispose of used devices, pipette tips, and sample tubes in accordance with the safety guidelines for hazardous materials
Storage and handling
The DiaPlexQ ™ Novel Coronavirus (2019-nCoV) Detection Kit should be stored at -20 ℃ ± 5 ℃ and stored away from sunlight. All components should be stored under recommended storage conditions.
- The expiration date of each component of the product is 1 year from the date of manufacture.
- Do not use the product beyond the expiration date.
- Thaw the product on the ice.
- Do not freeze-thaw more than 5 times.
- If there are or have been transportation problems, or the protective packaging is damaged, do not use it. The kit and contact your dealer for guidance.
Material to be supplied by the user
- Microcentrifuge tube
- Pipettes/tips with pipette filter
- Laboratory freezers
- Disposable latex
- Cooling device or ice
- Tubes, plates and other consumables.
- QIAGEN QIAamp Viral RNA Mini Kit (Cat. # 52904 or # 52906) or Magna Pure 96 Nucleic Acid extraction system with software V3.1 and MagNA Pure 96 DNA and Viral NA Small Volume Kit (Cat. # 06543588001) with external lysis buffer (catalogue # 06374913001)
- Real-time PCR instrument system and data analysis software
- AccuPlex ™ SARS-CoV-2 Reference Material Kit (Cat. # 0505-0126)
Compatible real-time PCR thermal cycler
- Applied Biosystems ™ 7500 Real-Time PCR Instrument System with V2.0.6 Software
- Applied Biosystems ™ 7500 Rapid Real-Time PCR Instrument System with V2.0.6 Software
- Bio-Rad CFX96 ™ Real-Time PCR Detection System with V3.1 Software