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Quality control product for novel coronavirus detection kit and preparation method thereof

A technology for detection kits and coronaviruses, which is applied in the field of preparation of quality control products for novel coronavirus fluorescence quantitative detection kits, which can solve problems such as delayed disease, individual misjudgments, false negatives, etc., to ensure effective storage and prolong storage time , to ensure the effect of detection sensitivity

Active Publication Date: 2020-10-09
ZHONGCHONG XINNUO BIOTECH TAIZHOU CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, false negative results often occur during kit development
False negatives will not only lead to misjudgment of individuals and delay the treatment of patients, but also may cause the omission of the source of infection and cause serious impacts.

Method used

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  • Quality control product for novel coronavirus detection kit and preparation method thereof
  • Quality control product for novel coronavirus detection kit and preparation method thereof
  • Quality control product for novel coronavirus detection kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] ——Quality control product IBV QXL87 strain virus content and purity detection

[0042] According to the third part of the 2015 edition of the Veterinary Pharmacopoeia of the People's Republic of China, the purity of the virus seeds of the QXL87 strain was tested to determine the purity of the virus seeds.

[0043] Carry out virus content determination to virus seed according to the following method, QXL87 strain chicken embryo allantoic fluid is made 10 times of serial dilutions with sterile normal saline, takes 10 -5 、10 –6 、10 –7 、10 –8 For 4 dilutions, 5 10-day-old SPF chicken embryos were inoculated into each allantoic cavity, 0.1ml per embryo, and incubated at 36-37°C. Chicken embryos that died before 24 hours were discarded, and chicken embryos that died within 24 to 144 hours were taken out at any time, until 144 hours, all live embryos were taken out. 24-144 hours after the inoculation, the dead chicken embryos and the surviving chicken embryos showed speci...

Embodiment 2

[0048] ——Quality control product IBV QXL87 strain S1 gene identification strain

[0049] According to the sequence of chicken infectious bronchitis virus (IBV) S1 gene included in GenBank, primers were designed for the conserved region after comparison, and were synthesized by Shanghai Sangon Bioengineering Co., Ltd.

[0050] Sequence 1 upstream primer S1–F: 5′–atgttgggga agtcactgtt–3′20

[0051] Sequence 2 downstream primer S1–R: 5′–tgcgacgatg tgagctattg–3′20

[0052] The IBV QXL87 strain was inoculated into 10-day-old SPF chicken embryos, and the allantoic fluid of 42-hour chicken embryos was collected. The S1 gene of QXL87 strain was amplified by RT-PCR, and the amplified product was cloned, sequenced, and compared with the gene sequence. Viral RNA was extracted from the allantoic fluid according to the instructions of the RNA extraction kit of Jiangsu Kangwei Century Biotechnology Co., Ltd. After reverse transcription (RT), RT-PCR amplification, electrophoresis and othe...

Embodiment 3

[0055] ——Quality control product IBV QXL87 strain fluorescence quantification

[0056] According to the sequence of the S1 gene of the QXL87 strain, specific primers and probes were designed using software, RNA was extracted using the RNA extraction kit of Jiangsu Kangwei Century Biotechnology Co., Ltd., and the virus species of the QXL87 strain was detected by one-step qPCR (TaqMan). Optimize detection conditions, analyze primer melting curves, verify the specificity and sensitivity of fluorescent probes and primers, and ensure the specificity of primers and fluorescent probes. The reaction system is a 25 μL system, including 19 μL of reaction solution (including specific primers, probes, and reaction buffer), 1 μL of enzyme solution (including reverse transcriptase, hot-start DNase, etc.), and 5 μL of sample to be tested.

[0057] Sequence 1 upstream primer S1–F: 5′–ctgttcgatt agtcactgtt–3′20

[0058] Sequence 2 downstream primer S1–R: 5′–tcctt cgatg tgagc caatt–3′20

[00...

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Abstract

The invention relates to a preparation method of a quality control standard substance of a novel coronavirus detection kit. According to the invention, the avian infectious bronchitis virus of the same family as the novel coronavirus (SARS-CoV-2) is used as the quality control standard substance of the novel coronavirus nucleic acid detection kit. At present, novel coronavirus detection kits are uneven in quality level, positive quality control is plasmid samples (DNA), and the virus reverse transcription process cannot be supervised and evaluated. Meanwhile, due to the diversity and complexity of clinical samples, the instability of a detection result is also caused. The quality control product provided by the invention can provide sensitivity and specificity evaluation support in the processes of novel coronavirus detection kit development, delivery inspection and preservation period monitoring; influences of various factors on the quality of the kit in the production process are effectively monitored, and meanwhile, the kit is used for evaluating the inactivation effect of a sample preservation solution on viruses, so that thorough inactivation of the viruses in a sample is ensured, effective preservation of viral nucleic acid is also ensured, the preservation time of the nucleic acid is prolonged, and the detection sensitivity is ensured.

Description

technical field [0001] The invention relates to the technical field of virus detection kit quality control, in particular to a method for preparing a quality control product of a novel coronavirus (2019-nCoV) fluorescence quantitative detection kit. Background technique [0002] The 2019 novel coronavirus (2019-nCoV) was discovered, and on February 11, 2020, the International Committee on Taxonomy of Viruses (ICTV) officially named the novel coronavirus (2019-nCoV) as severe acute respiratory syndrome Coronavirus 2 (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2). People infected with the new coronavirus are often accompanied by symptoms such as dyspnea, fever, cough and shortness of breath. In more severe cases, infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure, and even death. [0003] It is important to develop a rapid and accurate detection method for the currently popular 2019 novel coronavirus. Fluorescence quantitative R...

Claims

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Application Information

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IPC IPC(8): C12Q1/70C12Q1/6851C12N7/00C12R1/93
CPCC12Q1/701C12Q1/6851C12N7/00C12Q2600/166C12N2770/20021C12Q2563/107Y02A50/30
Inventor 何海蓉刁小龙陈启稳王飞张家铭王秋娟贾正
Owner ZHONGCHONG XINNUO BIOTECH TAIZHOU CO LTD
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