CN111876315A - Blood collection aid and blood collection device and method for reducing blood culture contamination rate - Google Patents
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Abstract
Description
技术领域technical field
本发明涉及血培养技术领域,特别涉及采血辅助器和采血装置及降低血培养污染率的方法。The invention relates to the technical field of blood culture, in particular to a blood collection aid, a blood collection device and a method for reducing the contamination rate of blood culture.
背景技术Background technique
在医院临床和医学研究试验中,自动化血培养是用于检验血液样品中有无细菌存在的一种微生物学检查方法,对于快速检测临床上严重危及患者生命的败血症、菌血症患者血液中否有细菌生长以明确诊断有着十分重要的作用,因此血液培养是一种最重要和最常见的细菌检验项目之一。目前临床上用于血液培养的仪器及配套的血液培养瓶主要依靠进口为主,有美国BD公司的Bactct 9000系列和法国梅里埃Bact/Alert3D,它们通常采用检测包被与培养瓶底部的硅橡胶传感器,根据底部感受器荧光或颜色传感的方法观察细菌生长过程中产生的CO2的变化量来判断是否有细菌生长,得到了临床的认可。In hospital clinical and medical research experiments, automated blood culture is a microbiological examination method used to check the presence or absence of bacteria in blood samples. The presence of bacterial growth in order to confirm the diagnosis plays a very important role, so blood culture is one of the most important and common bacterial tests. At present, the clinical instruments used for blood culture and the supporting blood culture bottles are mainly imported, such as the Bactct 9000 series from BD Company in the United States and the Bact/Alert3D from Mérieux in France. They usually use the detection coating and the silicone rubber at the bottom of the culture bottle. The sensor, according to the bottom photoreceptor fluorescence or color sensing method, observes the change of CO2 produced during bacterial growth to judge whether there is bacterial growth, which has been clinically recognized.
血培养应该按照标准程序进行收集,严格执行无菌操作。但是由于患者皮肤存在定植菌,会对血培养造成污染的问题。即血培养中生长的细菌是在样本采集或操作过程中被带入培养的,而非来自病人的血液。Blood cultures should be collected according to standard procedures with strict aseptic practices. However, due to the presence of colonized bacteria on the patient's skin, it will cause contamination of the blood culture. That is, bacteria grown in blood cultures were brought into the culture during sample collection or manipulation, not from patient blood.
目前大多数血培养是静脉穿刺抽得。为了减小皮肤定植菌的污染,静脉穿刺部位应该消毒。在过去的50年里,临床上使用许多的消毒方法,包括外用酒精(70%异丙基)、碘酒、聚维酮碘、碘氟、二氧化氯和葡糖酸氯已定。许多研究发表了对这些消毒剂的比较,以下是得出的结论,碘酒、二氧化氯和葡糖酸氯已定比聚维酮碘更好。碘酒和葡糖酸氯已定很可能具有同等效果。At present, most blood cultures are obtained by venipuncture. The venipuncture site should be sterilized to minimize contamination by skin-colonizing bacteria. Over the past 50 years, many methods of disinfection have been used clinically, including rubbing alcohol (70% isopropyl), iodine, povidone-iodine, iodine-fluoride, chlorine dioxide, and chlorhexidine gluconate. A number of studies have published comparisons of these disinfectants, and here is the conclusion that iodine, chlorine dioxide, and chlorhexidine gluconate are better than povidone-iodine. Iodine and chlorhexidine gluconate are likely to be equally effective.
当前主要采用的皮肤消毒方式为三步消毒法。①70%酒精擦拭静脉穿刺点。待干。②1%-2%的碘酊30秒或者10%潜伏消毒1.5-2分钟。待干。③70%酒精脱碘。经过皮肤消毒后,定植菌的数量大大减少,但是仍可能存在消毒不彻底的问题,造成微量定植菌进入培养瓶中,出现污染问题。在目前的检测技术下,实验室对于污染的可接受范围≤3%,但是血培养的检测的阳性率只有10%左右,意味着污染对于血培养检测结果存在较大的干扰。The current main method of skin disinfection is the three-step disinfection method. ①70% alcohol wipe the venipuncture point. to dry. ②1%-2% iodine tincture for 30 seconds or 10% latent disinfection for 1.5-2 minutes. to dry. ③ 70% alcohol deiodination. After skin disinfection, the number of colonized bacteria is greatly reduced, but there may still be a problem of incomplete disinfection, resulting in a small amount of colonized bacteria entering the culture bottle, causing pollution problems. Under the current detection technology, the laboratory's acceptable range for contamination is ≤3%, but the positive rate of blood culture tests is only about 10%, which means that contamination has a great influence on blood culture test results.
对于血培养污染率影响较大的环节为血培养样本的采集过程。首先消毒技术已经多方实践,建立了可靠的控制措施。另外就是静脉穿刺过程,对于血培养的静脉穿刺,一般有两种采集方式。一是采用注射器直接在消毒后的皮肤进行穿刺采集,然后再转移至培养瓶中;二是目前商品化的血培养瓶内部均为负压,可以直接采用静脉蝶形采血针进行穿刺采集,使血液样本直接进行培养瓶中。该两种措施均不具有对于微量皮肤定植菌的隔离功能,造成血培养的污染发生。The link that has a greater impact on the blood culture contamination rate is the collection process of blood culture samples. First of all, disinfection technology has been practiced in many ways, and reliable control measures have been established. The other is the venipuncture process. For blood culture venipuncture, there are generally two collection methods. One is to use a syringe to directly puncture the sterilized skin, and then transfer it to a culture bottle; the other is that the current commercial blood culture bottles are under negative pressure, and the venous butterfly blood collection needle can be directly used for puncture collection, so that the Blood samples are taken directly into culture flasks. Neither of these two measures has the function of isolating trace amounts of skin-colonizing bacteria, resulting in contamination of blood cultures.
所以目前血培养采集方法存在以下缺点:污染率高,血培养的检测结果不准确,排除污染难度较高,造成医疗资源的浪费等问题。Therefore, the current blood culture collection method has the following shortcomings: high pollution rate, inaccurate blood culture detection results, high difficulty in eliminating pollution, and waste of medical resources.
发明内容SUMMARY OF THE INVENTION
有鉴于此,本发明提供了采血辅助器和采血装置及降低血培养污染率的方法。该采血辅助器和采血装置可实现静脉采血前段血液的隔离,使微量皮肤定植菌隔离在腔体内,从而可降低血培养污染率。In view of this, the present invention provides blood collection aids and blood collection devices and methods for reducing blood culture contamination rates. The blood collection aid and the blood collection device can realize the isolation of blood in the front section of venous blood collection, so that a small amount of skin colonization bacteria is isolated in the cavity, thereby reducing the blood culture contamination rate.
为了实现上述发明目的,本发明提供以下技术方案:In order to achieve the above-mentioned purpose of the invention, the present invention provides the following technical solutions:
本发明提供了一种采血辅助器,包括管体1、第一接口2、第二接口3;管体1设置有隔离腔体4。The present invention provides a blood sampling aid, comprising a
本发明所解决的技术问题在于提供一种血培养样本采集方法,可适配现有市场主流具有真空负压的培养瓶。由于血液流动,微量皮肤定植菌仅存在于采血的前段,转移隔离前端血液对于降低污染有所帮助。通过该方法可实现静脉采血前段约0.01~10mL血液隔离在隔离腔体中,同时使微量皮肤定植菌隔离在此腔体内,使之不进入培养瓶中,降低血培养的污染率,提升血培养检测的准确性。The technical problem solved by the present invention is to provide a blood culture sample collection method, which can be adapted to the mainstream culture bottles with vacuum negative pressure in the existing market. Due to blood flow, a small amount of skin colonized bacteria only exists in the front part of blood collection, and transferring the blood from the front end of the isolation is helpful to reduce pollution. Through this method, about 0.01 to 10 mL of blood in the front part of venous blood collection can be isolated in the isolation cavity, and at the same time, a small amount of skin-colonizing bacteria can be isolated in this cavity, so that they do not enter the culture bottle, thereby reducing the contamination rate of blood culture and improving blood culture. detection accuracy.
作为优选,隔离腔体的容量为0.01~10mL。Preferably, the volume of the isolation cavity is 0.01-10 mL.
作为优选,在本发明提供的一具体实施例中,管体1依次设置有隔离腔体4、第一管道5、第二管道6和可推动活塞7;Preferably, in a specific embodiment provided by the present invention, the
第一管道5分别与第一接口2、隔离腔体4相连通;第一接口2可与采血针连接,使采集的前段血液置于隔离腔体中;The
可推动活塞7向隔离腔体4端移动后,第二管道6分别与第一接口2、第二接口3相连通,使采集的后段血液流入可与第二接口3连接的容器中。After the
作为优选,隔离腔体内为负压状态。Preferably, the isolation chamber is in a negative pressure state.
作为优选,可推动活塞7与第一管道5外壁之间设置有支架。Preferably, a bracket is provided between the
作为优选,第一管道5内壁之间设置有支架。Preferably, a bracket is provided between the inner walls of the
在本发明提供的另一具体实施例中,管体1为U型管体,管体1一端分别设置有第一接口2和第二接口3,另一端为封闭状态。In another specific embodiment provided by the present invention, the
在本发明中,采血辅助器内部均为无菌状态。In the present invention, the inside of the blood sampling aid is in a sterile state.
上述设置使得隔离腔体隔离前段血液后,不影响后续样本采集。The above-mentioned settings make the subsequent sample collection not affected after the isolation chamber isolates the blood in the front section.
本发明还提供了一种采血装置,包括上述采血辅助器和采血针。The present invention also provides a blood collection device, comprising the above blood collection aid and a blood collection needle.
作为优选,采血针为蝶形采血针。通用蝶形采血针用于皮肤穿刺,使外周静脉血可通过穿刺点进行采集。Preferably, the lancet is a butterfly-shaped lancet. Universal butterfly lancet is used for skin puncture, allowing peripheral venous blood to be collected through the puncture point.
作为优选,采血辅助器与采血针为一体结构或可拆卸式连接。Preferably, the blood collection aid and the blood collection needle are integrally or detachably connected.
作为优选,采血装置还包括培养瓶。Preferably, the blood collection device further includes a culture bottle.
作为优选,采血装置还包括培养瓶穿刺头,可使培养瓶穿刺小孔,通过小孔将采集的血液样本进入培养瓶中。Preferably, the blood collection device further includes a culture bottle piercing head, which can make the culture bottle pierce a small hole, and the collected blood sample is introduced into the culture bottle through the small hole.
本发明还提供了一种降低血培养污染率的方法,采用上述采血辅助器进行辅助采血,或者采用上述采血装置进行采血,然后将采集的血液进行血液培养。The present invention also provides a method for reducing the contamination rate of blood culture, which uses the above blood collection aid for auxiliary blood collection, or uses the above blood collection device for blood collection, and then carries out blood culture on the collected blood.
本发明提供了采血辅助器和采血装置及降低血培养污染率的方法。该采血辅助器包括管体1、第一接口2、第二接口3;管体1设置有隔离腔体4。本发明具有的有益效果为:The invention provides a blood sampling aid, a blood sampling device and a method for reducing the contamination rate of blood culture. The blood sampling aid includes a
目前没有任何手段能明确分辨污染和真阳性的血培养结果。所以降低血培养的污染率对于血培养检测具有重要意义。本发明设计了一种血液采集方法及配套装置,通过隔离腔体的引入,降低了血培养皮肤定植菌造成的污染问题,同时提升了血培养的检测准确性,降低了血培养污染造成假阳性问题对于医疗资源的浪费,降低了检验人员的负担。据统计每个污染造成的假阳性问题导致了平均每个患者增加了3.4美金。因此该项发明对于提升血培养结果的准确性有重要意义,对于挽救危重病人生命具有重要意义,也有降低医疗机构经济负担的作用。There is currently no means of definitively distinguishing between contamination and true positive blood culture results. Therefore, reducing the contamination rate of blood culture is of great significance for blood culture detection. The invention designs a blood collection method and a matching device. Through the introduction of an isolation cavity, the pollution problem caused by blood culture skin colonization bacteria is reduced, the detection accuracy of blood culture is improved, and false positives caused by blood culture pollution are reduced. The problem is a waste of medical resources and reduces the burden on inspectors. According to statistics, the false positive problem caused by each contamination resulted in an average increase of 3.4 US dollars per patient. Therefore, the invention is of great significance for improving the accuracy of blood culture results, for saving the lives of critically ill patients, and for reducing the economic burden of medical institutions.
附图说明Description of drawings
图1、3为实施例1采血辅助器的正视剖面图;Figures 1 and 3 are front sectional views of the blood sampling aid of Example 1;
图2、4为实施例1采血辅助器的俯视剖面图;Figures 2 and 4 are top cross-sectional views of the blood sampling aid in
图5为实施例2采血辅助器的正视剖面图;Fig. 5 is the front sectional view of
其中,1-管体,2-第一接口、3-第二接口,4-隔离腔体、5-第一管道、6-第二管道,7-可推动活塞。Among them, 1-pipe body, 2-first interface, 3-second interface, 4-isolation cavity, 5-first pipeline, 6-second pipeline, 7-pushable piston.
具体实施方式Detailed ways
本发明公开了采血辅助器和采血装置及降低血培养污染率的方法,本领域技术人员可以借鉴本文内容,适当改进工艺参数实现。特别需要指出的是,所有类似的替换和改动对本领域技术人员来说是显而易见的,它们都被视为包括在本发明。本发明的方法及应用已经通过较佳实施例进行了描述,相关人员明显能在不脱离本发明内容、精神和范围内对本文所述的方法和应用进行改动或适当变更与组合,来实现和应用本发明技术。The invention discloses a blood collection aid, a blood collection device, and a method for reducing the contamination rate of blood culture. Those skilled in the art can learn from the content of this article and appropriately improve the process parameters to achieve. It should be particularly pointed out that all similar substitutions and modifications are obvious to those skilled in the art, and they are deemed to be included in the present invention. The method and application of the present invention have been described through the preferred embodiments, and it is obvious that relevant persons can make changes or appropriate changes and combinations of the methods and applications described herein without departing from the content, spirit and scope of the present invention to achieve and Apply the technology of the present invention.
术语解释:Terminology Explanation:
血培养系统是通过选择合适的培养瓶,再辅以合适的培养方式和各种现代化检测技术,自动连续监测接种后培养瓶内的各种变化,以判别培养瓶内有无细菌存在。对于快速检测患者血液中是否有细菌生长以明确诊断具有十分重要的作用,是临床有效治疗的关键。The blood culture system automatically and continuously monitors various changes in the culture bottle after inoculation by selecting the appropriate culture bottle, supplemented by the appropriate culture method and various modern detection technologies, so as to determine whether there is bacteria in the culture bottle. It plays a very important role in quickly detecting whether there is bacterial growth in the blood of patients to confirm the diagnosis, and it is the key to effective clinical treatment.
本发明采血辅助器和采血装置及降低血培养污染率的方法中所用材料均可由市场购得。The materials used in the blood sampling aid, the blood sampling device and the method for reducing the blood culture contamination rate of the present invention can be purchased from the market.
下面结合实施例,进一步阐述本发明:Below in conjunction with embodiment, the present invention is further elaborated:
实施例1:活塞式隔离腔体Example 1: Piston-type isolation chamber
本实施例中可与采血针相连接的活塞式隔离腔体结构如下:The structure of the piston-type isolation cavity that can be connected with the blood collection needle in this embodiment is as follows:
采血辅助器包括管体1、第一接口2、第二接口3;管体1依次设置有隔离腔体4、第一管道5、第二管道6和可推动活塞7;The blood sampling aid includes a
参见图1、2,第一管道5分别与第一接口2、隔离腔体4相连通;第一接口2可与采血针连接,使采集的前段血液置于隔离腔体中;Referring to Figures 1 and 2, the
参见图3、4,可推动活塞7向隔离腔体4端移动后,第二管道6分别与第一接口2、第二接口3相连通,使采集的后段血液流入可与第二接口3连接的容器中。Referring to FIGS. 3 and 4 , after the
采血辅助器内部均为无菌状态。The inside of the blood collection aid is sterile.
作为优选,隔离腔体的容量为0.01~10mL。Preferably, the volume of the isolation cavity is 0.01-10 mL.
作为优选,隔离腔体内为负压状态。Preferably, the isolation chamber is in a negative pressure state.
作为优选,可推动活塞7与第一管道5外壁之间设置有支架。Preferably, a bracket is provided between the
作为优选,第一管道5内壁之间设置有支架。Preferably, a bracket is provided between the inner walls of the
使用方法如下:The method of use is as follows:
1.对患者皮肤进行消毒,皮肤消毒方法已在CLSI文件及血培养操作规范文件中有推荐。1. Disinfect the patient's skin. The method of skin disinfection has been recommended in the CLSI document and the blood culture practice document.
2.使用静脉采血技术,采用蝶形采血针进行静脉穿刺。2. Use the venous blood collection technique to perform venipuncture with a butterfly blood collection needle.
3.将隔离腔体与采血针及培养瓶组装,接口1与采血针相连,接口2与培养瓶相连。3. Assemble the isolation cavity with the blood collection needle and the culture bottle, the
4.血液样本首先通过管道1,流入隔离腔体中。4. The blood sample first passes through the
5.待采集所需前端血液后,向内推动活塞,样本继续通过管道2,流入培养瓶中。5. After collecting the required front-end blood, push the piston inward, and the sample continues to pass through the
实施例2:U型管式隔离腔体Example 2: U-shaped tubular isolation cavity
本实施例中可与采血针相连接的U型管式隔离腔体结构如下:The structure of the U-shaped tubular isolation cavity that can be connected to the blood collection needle in this embodiment is as follows:
采血辅助器包括管体1、第一接口2、第二接口3;管体1设置有隔离腔体4;管体1为U型管体,管体1一端分别设置有第一接口2和第二接口3,另一端为封闭状态。The blood sampling aid includes a
采血辅助器内部均为无菌状态。The inside of the blood collection aid is sterile.
作为优选,隔离腔体的容量为0.01~10mL。Preferably, the volume of the isolation cavity is 0.01-10 mL.
作为优选,隔离腔体内为负压状态。Preferably, the isolation chamber is in a negative pressure state.
具体结构见图5。The specific structure is shown in Figure 5.
使用方法如下:The method of use is as follows:
1.对患者皮肤进行消毒,皮肤消毒方法已在CLSI文件及血培养操作规范文件中有推荐。1. Disinfect the patient's skin. The method of skin disinfection has been recommended in the CLSI document and the blood culture practice document.
2.使用静脉采血技术,采用蝶形采血针进行静脉穿刺。2. Use the venous blood collection technique to perform venipuncture with a butterfly blood collection needle.
3.将隔离腔体与采血针及培养瓶组装,接口1与采血针相连,接口2与培养瓶相连。3. Assemble the isolation cavity with the blood collection needle and the culture bottle, the
4.血液样本流入U隔离腔体中。4. The blood sample flows into the U isolation chamber.
5.待初始流入的血液充满U型隔离腔体后,样本继续通过接口2,流入培养瓶中。5. After the initial inflow of blood fills the U-shaped isolation chamber, the sample continues to flow through the
试验例1Test Example 1
采用实施例1和2的带有隔离腔体的采血辅助器和采血针对同一个体进行采血,血液样本进入培养瓶中。同时以直接采用静脉蝶形采血针进行穿刺采集,使血液样本直接进入培养瓶中为对照。皮肤消毒方法均为前述推荐的三步消毒法。Blood was collected from the same individual using the blood collection aids with isolation chambers and blood collection of Examples 1 and 2, and the blood samples were put into culture bottles. At the same time, the puncture collection was performed directly with a venous butterfly blood collection needle, so that the blood sample was directly entered into the culture bottle as a control. The skin disinfection methods are all three-step disinfection methods recommended above.
血培养方法为:采用Bc120自动化血培养系统配套上机血培养瓶进行血培养检测。系统报告为阳性瓶时,做涂片、革兰染色并转种血琼脂、巧克力琼脂和麦康凯琼脂。并将分离出的菌落作鉴定和标准药敏试验,作最终血培养报告。阴性瓶为常规培养5d后系统报告阴性检测血样污染率,计算公式如下:The blood culture method is as follows: the Bc120 automatic blood culture system is used to carry out blood culture detection with the blood culture bottle on the machine. When the system reports a positive vial, do a smear, Gram stain and transfer to blood agar, chocolate agar and MacConkey agar. The isolated colonies were used for identification and standard drug susceptibility tests, and the final blood culture report was made. The negative bottle is the contamination rate of blood samples reported by the system after routine culture for 5 days. The calculation formula is as follows:
检测结果如下:The test results are as follows:
表1血样污染率Table 1 Blood sample contamination rate
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。The above are only the preferred embodiments of the present invention. It should be pointed out that for those skilled in the art, without departing from the principles of the present invention, several improvements and modifications can be made. It should be regarded as the protection scope of the present invention.
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