FOR LAB RESEARCH USE ONLY
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Product Description
1）This freeze-dried PCR kit can be used to detect 29 common respiratory multiple pathogens, including 17 viruses, 9 bacteria and 3 fungi.
(See Table 1 for specific test targets)
2）Specific primers and probes were designed for common respiratory pathogens. Reverse transcription-polymerase chain reaction (RT-qPCR) and fluorescent probe technology were used to achieve the amplification and detection of specific nucleic acid sequences of pathogens in Table 1, and RNaseP gene /UDG enzyme /dUTP system was added to avoid false negative and false positive results.
3) This kit is a fully premixed lyophilized system. Reverse transcriptase, nucleic acid amplification enzyme, reaction buffer and specificity required for amplification are introduced. All samples and probes were freeze-dried in PCR tubes.
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Product Packaging
Respiratory PCR kit
Reagents and Reaction tube
Package components
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Detection Target (Table 1.)
Virus | Covid 2019 | Bacteria | Klebsiella pneumoniae | Fungus | Aspergillus |
| Flu A, Flu B | Mycoplasma pneumoniae | Cryptococcus | |||
| Syncytial virus | Chlamydia pneumoniae | Pneumospora | |||
| Adenovirus | Streptococcus pneumoniae | ||||
| Enterovirus | Legionella pneumophila | ||||
Human metapneumovirus | Bordetella pertussis | ||||
| Human boca virus | Haemophilus influenzae | ||||
| Rhinovirus | Chlamydia psittaci | ||||
| Parainfluenza virus type 1, 2, 3, 4 | Group A streptococcus | ||||
| Coronavirus 229E | |||||
| Coronavirus OC43 | |||||
| Coronavirus NL63 | |||||
Coronavirus HKU1 |
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Components
| Item | 8 Tests/Kit | 24 Tests/Kit | Ingredient |
| Lyophilized reagent | 8*8 Union tube | 24*8 Union tube | Specific primers probe, dNTP/dUTP, Mix, Mg2+, Taq enzyme, reverse transcriptase, RNase inhibitor, UDG enzyme |
| Positive quality control | 200μL*1 tube | 400μL*1 tube | Target gene fragment |
| Negative quality control | 200μL*1 tube | 400μL*1 tube | RNaseP gene detection sequence of RNA pseudovirus |
| Rehydration solution | 1ml*1 tube | 1ml*3 tubes | Stabilizer |
Note:
Components of different batches cannot be mixed.
Sample nucleic acid extraction should be carried out at the same time with negative quality control products and positive quality control products.
Freeze-dried reagents are sealed packaging, please use immediately after opening, do not expose to the air for a long time. Freeze-dried reagent is encapsulated in 0.2mL PCR eight-tube, if the fluorescent PCR instrument used cannot use the consumable, the liquid of each hole should be imported and applied before loading the machine consumables.
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Sample Type
Oropharyngeal swab, Nasopharyngeal swab, Sputum, Alveolar lavage fluid.
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Storage Conditions and Validity
2). Short-term use can be temporarily stored at 4℃, not more than 6 months.
3). The kit can be transported at room temperature for no more than 1 month.
4). Repeated freezing and thawing not more than 7 times.
| Product Presentation
| Features and Advantages
1). Multiplex Testing:
Customized selections can be made based on the pathogens that customers need to detect, and test results for a variety of pathogens can be obtained.
2). Stable and Reliable：
This kit is a freeze-dried PCR system. The active substances required in the detection process (enzymes, dNTPs, primer probes, etc.) are pre-placed in the system. It supports room temperature transportation within 1 month and has good storage stability, ensuring reliable and accurate test results.
3). Fast and Convenient：
The whole process of testing with this reagent can be completed within 90 minutes. If used with PCR equipment, the testing time can be shortened to 50 minutes. In addition, this system does not need liquid preparation and packaging operations, saving time and labor costs.
4). Sensitive and Accurate：
The analytical sensitivity of this kit is 1000 copies/mL. It includes human internal standard monitoring, the entire process from sampling, nucleic acid extraction to nucleic acid detection, to avoid false negatives. The detection system always includes the UDG/dUTP system, which can effectively avoid false negative results caused by contamination of amplification products.
| Test data
Performance Index
1. The analytical sensitivity of this kit was 1000 copies/mL.
2. Precision: The coefficient of variation (CV, %) of precision Ct value within/between batches is less than 5%.
3, accuracy: the test enterprise negative/positive reference conformity rate is 100%.
Product Qualification（by Oct.12th,2022）
| Multiple Respiratory Pathogens nucleic acid detection kit (Fluorescence PCR method) | |
| CE Certification – CIBG Registration Letter | |
| CE Certification–EC Declaration | |
| CE Certificate-CIBG Website notify (Taizhou Branch) | |
| Export Qualified Suppliers | |
| ISO 13485 Certificate | |
| ISO 13485 Certificate-MDSAP | |
| ISO 9001 Certificate | |
| ISO 45001 Certificate | |
| ISO 14001 Certificate | |
| IPMS Certificate |
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