Prev Article：Dengue Virus Nucleic Acid Detection Kit (Fluorescent RT-PCR) Instructions (Part 1)
【Explanation of The Test Results】
After the reaction, the Anitoa labs MQ/Z/F series fluorescent PCR instrument automatically saves the results.
1.Quality Control
The kit provides positive control and negative control. A complete assay is required all conditions showed in the following table at once, otherwise, experiment results will be regarded as invalid， please retesting one more time.
Sample | FAM Ct Value |
ST NC | Negative |
ST PC | Ct≤32 |
2. Result determination
Select each fluorescent channel to read the Ct value, and determine against the following table:
Channels | Ct Value | Result |
FAM | Ct≤40 and With Typical S-curve | Positive |
FAM | Ct＞40 or Negative | Negative |
【Limitations of The Test Method】
1. This kit is only used for aid clinical diagnosis, not as the sole criteria of clinical diagnosis. Therefore, the clinical symptoms/signs, disease history, other laboratory tests and therapeutic response of the patients should be considered comprehensively.
2. Possibility of false negative results:
2.1 False negative results may be caused by incorrect specimen collection, transportation and treatment, and low pathogen content in the specimen.
2.2 The mutation or various of target sequence related to unknown factors can cause false negative results.
2.3 Other unverified interferences or PCR inhibitors may cause false negative results.
3 If there is a contamination of specimen preparation, false positive results may occur.
4 For kits with inclusions, failure to amplify the inner label can result when the sample concentration is too high.
【Product Performance Indicators】
1. Limit of detection (LOD): 1000 copies/ml.
2. Specificity: No cross-reaction with human genomic DNA and total leukocyte nucleic acid.
3. Precision: The CV of In-batch inspection, batch inspection, and operational difference between two operators are less than 5%.
【Note】
1. FOR IN VITRO DIAGNOSIS USE.
2. This kit is only for the use of professionals, and the operators shall have skilled training and experience.
3. The operator shall collect, transport and store the samples in strict accordance with the instructions, and conduct the test within the specified time.
4. The experiment should be strictly operated in different areas, the articles and work clothes in each area are dedicated, and they should not be cross used to avoid pollution. Please clean the working table immediately after the experiment.
5. In operation, should always take care to avoid RNase and DNase pollution, should use non-fluorescent substances disposable gloves (often replaced), disposable thin-walled 200 uL PCR tube (or 96-hole PCR plate plus optical film), pipette head (with filter dump), can not touch the reaction tube directly by hand.
6. Negative control and positive control shall be set for each test. Reagents of different batches shall not be mixed, and kits shall be used within the validity period.
7. When the reaction liquid is sub packed, try to avoid bubbles. Check whether the reaction pipes are tightly covered before operation to avoid leaking and polluting the instrument.
8. The treatment of specimens should use biosecurity cabinets to ensure operator safety and prevent environmental pollution.
9. Harmful and toxic specimens and reagents in the experiment should be properly placed and kept by special persons; Instruments such as operator stations, pipettes, centrifuges, amplifiers, etc. should often be wiped and disinfected with 1.0% sodium hypochlorite and/or 70% ethanol. Experiment room, ultra-clean workbench should be regularly and after each experiment with UV lamp treatment.
10. Pay attention to the timely cleaning of medical waste.
【Basic Information】
Registrant / Manufacturer Enterprise /After-sale Company: Anitoa Biotechnology（Hangzhou） Co.,LTD.
Address: Room 210,2/F,Building 2,No.658 binan Road,Changhe Street,Binjiang District, Hangzhou City, Zhejiang Provice, China
Approval and Modification Date of The Instructions: March 05,2022. V01
Professional Portable qPCR System Manufacturer - Anitoa
Anitoa is a professional R&D and manufacturing company of molecular diagnostic qPCR instruments and reagents, with independent intellectual property rights of core chip technology, optical technology, rapid heating, microfluidic control and supporting reagents and other patented technologies, so that the instruments developed by Anitoa are characterized by quick and easy small instruments, allowing the development of expensive and complex large PCR instruments into truly portable POCT products.