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Integrated blood nucleic acid screening platform

A nucleic acid and blood technology, applied in the field of blood screening, can solve the problems of long time, failure to issue test reports, lack of humanized design, etc., and achieve the effect of convenient operation

Inactive Publication Date: 2009-09-23
SHANGHAI KEHUA BIO ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Economic factors determine that testing centers in developing countries are unlikely to adopt single blood tests that have been popular abroad in recent years, and imported reagents have not yet been used for large-scale screening tests in China, lack of local primary research data, and mixed samples It also depends on the sensitivity of the screening system and the positive rate of the screening population, the viral load of the "window period" specimens, and the daily screening volume; third, the working hours of the testing personnel are not fully considered, the whole process takes too long, and there is a lack of humanized design
For example, the Procleix TIGRIS system only takes about 9 hours to test 500 samples at a time, and about 14 hours for 1000 samples; the whole process of cobas201 TaqScreen MPX Test takes longer
Both are the working hours of the initial screening. Once the initial screening is positive, it is necessary to review which specific item is positive or split it. The time is longer, and the inspection report cannot be issued on the same day.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 HAMILTON Microlab STAR PLUS / STAR / STARLET (automatic liquid transfer workstation)-Agowa7200 (programmed magneto-thermal processor) is used as a platform for specimen scanning, sample mixing and automatic nucleic acid extraction, and multi-channel fluorescent PCR instrument ABI7300 / 7500 is used as an expansion platform. Increase detection equipment.

[0035] Take HAMILTON Microlab STARLET as an example, load AGOWA Maxisep7200 thermal-magnetic integrated components, and create a desktop plan as attached figure 1 and attached figure 2 shown. The 24 sample mixing mode is adopted when the specimens are pooled. The specimen rack can hold 576 specimens (18 x 32 / strip = 576) and can be mixed into 24 pools (576 = 24 x 24). Repeat 3 times to complete 72 pools, and the number of specimens collected reached 1728. Take a sample of 30-100 μl for each specimen to ensure controllable sampling accuracy. Finally, mix the pool and take a fixed volume such as 360-500 μl of s...

Embodiment 2

[0038] Example 2 HAMILTON Microlab STAR PLUS / STAR / STARLET (automatic liquid transfer workstation)-deep-well plate magnetic frame-heating module-oscillating module is used as a platform for specimen scanning, sample mixing and automatic nucleic acid extraction, multi-channel fluorescent PCR instrument ABI7300 / 7500 is used as amplification detection (the pipetting platform must have a manipulator with plate transfer function)

[0039] The use of 96-well plate as a general consumable for blood screening has many advantages, which is the best embodiment of the idea of ​​the present invention. First, the specimens are collected in a 96-well deep-well plate (Thermo or Greiner). Due to the mobility of the 96-well deep-well plate, sample mixing can be performed continuously and flexibly. The maximum number of specimens processed each time is up to 2304 (96x24), so the detection throughput is higher. At the same time, the operation mode of 96 pools is more compatible with the subsequ...

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Abstract

The invention belongs to the technical field of blood screening and specifically relates to an integrated blood nucleic acid screening platform; the tabletop of the screening platform is divided into five functional zones which are sequentially consumptive material zone, reagent zone, thermomagnetic operation zone, sampling zone and waste zone, wherein, the thermomagnetic operation zone is provided with a dedicated thermomagnetic swiveling mechanismAgowa7200 or a thermomagnetic device consisting of a discrete component deep-well multiwell plate magne, a deep-well multiwell plate bearing rack, a temperature control module and an oscillation module; the screening reagent comprises paramagnetic particle method nucleic acid extraction reagent for simultaneously extracting RNA and DNA and one-step method RT-PCRTaqMan fluorescent probe reagent for simultaneously augmenting HBV DNA, HCV RNA and HIV RNA; special functions such as sample scanning, mixed sample collection, extraction of nucleic acid, preparation of PCR reaction solution, split charging and loading and the like are controlled by programs. The screening platform features convenient operation, designed operating process, which greatly improves screening efficiency, therefore the screening platform is very suitable for daily use in blood centers at home and abroad, the detecting departments in enterprises producing blood products.

Description

technical field [0001] The invention belongs to the technical field of blood screening, and in particular relates to a high-throughput, automatic and integrated blood nucleic acid screening platform. Background technique [0002] The prevention and control of infectious diseases associated with blood transfusion has become the focus of attention of the whole society. The introduction of new technologies is an important means to further improve blood safety. Nucleic acid amplification detection technology is one of the most sensitive and advanced virus detection technologies so far. It can significantly shorten the "window period" and reduce the risk of blood-borne virus transmission. It is an important and effective supplement to traditional immunological detection methods. Since 1999, Europe, the United States and Japan have conducted nucleic acid detection in plasma under the guidance of the new drug review process. From September 2001 to December 2002, the FDA approved s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68G01N21/64
Inventor 周科隆华锦彪王缦
Owner SHANGHAI KEHUA BIO ENG
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