JP4444880B2 - Urine collection preservation solution and urine collection preservation method using the same - Google Patents
Urine collection preservation solution and urine collection preservation method using the same Download PDFInfo
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- JP4444880B2 JP4444880B2 JP2005150841A JP2005150841A JP4444880B2 JP 4444880 B2 JP4444880 B2 JP 4444880B2 JP 2005150841 A JP2005150841 A JP 2005150841A JP 2005150841 A JP2005150841 A JP 2005150841A JP 4444880 B2 JP4444880 B2 JP 4444880B2
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- 210000002700 urine Anatomy 0.000 title claims description 111
- 239000003761 preservation solution Substances 0.000 title claims description 28
- 238000000034 method Methods 0.000 title claims description 9
- 238000004321 preservation Methods 0.000 title description 8
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 36
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 claims description 32
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 28
- 239000000243 solution Substances 0.000 claims description 23
- 239000007864 aqueous solution Substances 0.000 claims description 15
- CDQSJQSWAWPGKG-UHFFFAOYSA-N butane-1,1-diol Chemical compound CCCC(O)O CDQSJQSWAWPGKG-UHFFFAOYSA-N 0.000 claims description 13
- WERYXYBDKMZEQL-UHFFFAOYSA-N butane-1,4-diol Chemical compound OCCCCO WERYXYBDKMZEQL-UHFFFAOYSA-N 0.000 claims description 13
- 239000002202 Polyethylene glycol Substances 0.000 claims description 10
- 229920001223 polyethylene glycol Polymers 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- WSFSSNUMVMOOMR-NJFSPNSNSA-N methanone Chemical compound O=[14CH2] WSFSSNUMVMOOMR-NJFSPNSNSA-N 0.000 claims description 7
- 229920001515 polyalkylene glycol Polymers 0.000 claims description 7
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 16
- 230000001580 bacterial effect Effects 0.000 description 15
- 238000011109 contamination Methods 0.000 description 14
- 230000007850 degeneration Effects 0.000 description 14
- 238000012360 testing method Methods 0.000 description 13
- 238000007689 inspection Methods 0.000 description 4
- 239000011259 mixed solution Substances 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 239000008213 purified water Substances 0.000 description 4
- 239000013049 sediment Substances 0.000 description 4
- 238000003756 stirring Methods 0.000 description 4
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 238000009535 clinical urine test Methods 0.000 description 3
- 230000002380 cytological effect Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000011521 glass Substances 0.000 description 3
- 238000010186 staining Methods 0.000 description 3
- 239000006228 supernatant Substances 0.000 description 3
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 2
- 208000012931 Urologic disease Diseases 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 208000017169 kidney disease Diseases 0.000 description 2
- 230000003405 preventing effect Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 208000014001 urinary system disease Diseases 0.000 description 2
- 208000035404 Autolysis Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 206010057248 Cell death Diseases 0.000 description 1
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 description 1
- CDXSJGDDABYYJV-UHFFFAOYSA-N acetic acid;ethanol Chemical compound CCO.CC(O)=O CDXSJGDDABYYJV-UHFFFAOYSA-N 0.000 description 1
- 238000010876 biochemical test Methods 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 235000019437 butane-1,3-diol Nutrition 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000000120 cytopathologic effect Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 150000002222 fluorine compounds Chemical class 0.000 description 1
- JEGUKCSWCFPDGT-UHFFFAOYSA-N h2o hydrate Chemical compound O.O JEGUKCSWCFPDGT-UHFFFAOYSA-N 0.000 description 1
- 230000003100 immobilizing effect Effects 0.000 description 1
- 238000005342 ion exchange Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- -1 polyethylene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001451 polypropylene glycol Polymers 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000028043 self proteolysis Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000007447 staining method Methods 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 210000001635 urinary tract Anatomy 0.000 description 1
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- Investigating Or Analysing Biological Materials (AREA)
Description
本発明は、尿細胞診検査、尿生化学検査、一般尿検査等の各種尿検査に使用する採尿保存液と、この採尿保存液を用いた採尿保存方法に関する。 The present invention relates to a urine collection storage solution used for various urine tests such as a urine cytology test, a urine biochemistry test, and a general urine test, and a urine collection storage method using the urine collection storage solution.
尿中に排出される生体細胞の性状は、腎・尿路系の疾患を診断する上での非常に重要な指標となり、また腎・尿路系のスクリーニング、腎・尿路系疾患の進行状況観察と治療法決定、治療効果の判定、薬物に対する適性（毒性）の判定等にも利用される。そして、尿細胞診検査では、一般的に尿検体を遠心分離機にかけて含有細胞を沈渣させ、上澄みを捨てて沈渣物をスライドグラスに塗抹し、染色を施して顕微鏡による観察を行う。 The nature of living cells excreted in the urine is a very important index for diagnosing renal and urinary tract diseases, as well as screening of the renal and urinary tract systems, and the progress of renal and urinary tract diseases. It is also used for observation and treatment determination, determination of therapeutic effect, determination of suitability (toxicity) for drugs, and the like. In urine cytodiagnosis, the urine specimen is generally centrifuged to precipitate the contained cells, the supernatant is discarded, the sediment is smeared on a slide glass, stained, and observed with a microscope.
しかるに、尿検体中の細胞は自己融解や尿中細菌の攻撃等で数を減じると共に、細胞変性や細菌汚染を生じ易いことから、採尿後の時間が経過するほど、尿細胞診による判定が困難になる。そこで、尿検体中の細胞数減少と細胞変性を抑えるために、採取した尿に固定化剤としてエタノール−酢酸、グルタルアルデヒド等を加えることが行われている。また同様目的で、クエン酸とＥＤＴＡ（エチレンジアミン四酢酸）を加えたり（特許文献１）、これらに更にフッ素化合物を追加する（特許文献２）といった提案もなされている。
しかしながら、前記従来の固定化剤を用いても、尿検体の細胞変性や細菌汚染を確実に防止することは困難であり、一般的に細胞診検査が可能なのは採尿からせいぜい２日程度でしかないから、採尿から検査まで日数を要する場合には対処できなかった。従って、例えば離島や山間部、未開地等の尿細胞診技術を備えた医療・検査機関が近在しない地域では、現地で採取した尿検体を当該機関へ輸送して検査に供することができず、被験者自らが当該機関に出向く必要があるため、非常に不便である上、病気等の身体的理由や経済的理由で受診できないことも多々あった。また、医療・検査機関においても、尿検体をある程度の数量に達するまで保管して一斉に検査するような手段を採用できず、スケジュール的に非常に煩雑になり、検査に多大な労力を費やすという問題があった。 However, it is difficult to reliably prevent cell degeneration and bacterial contamination of a urine sample even if the conventional immobilizing agent is used, and in general, cytological examination can be performed only for about 2 days from urine collection. Therefore, it was not possible to deal with cases where it took days from urine collection to examination. Therefore, for example, in areas where there are no medical / testing institutions equipped with urine cytology technology, such as remote islands, mountainous areas, and undeveloped land, urine samples collected locally cannot be transported to the relevant institutions for testing. In addition, because the subject himself / herself needs to visit the relevant institution, it is very inconvenient and in many cases he / she cannot be consulted for physical reasons such as illness or economic reasons. In addition, medical and testing institutions cannot adopt a method for storing urine samples until they reach a certain quantity and testing them at the same time, which makes the schedule very cumbersome and expends a great deal of labor for testing. There was a problem.
本発明は、上述の情況に鑑み、採取した尿検体に添加混合することにより、該尿検体の細胞変性や細菌汚染を長期間確実に防止でき、もって採尿から尿細胞診等の検査まで日数を要する場合でも確実な判定を可能にする採尿保存液と、これを用いた採尿保存方法を提供することを目的としている。 In view of the above situation, the present invention can reliably prevent cell degeneration and bacterial contamination of a collected urine sample for a long period of time by adding and mixing it to the collected urine sample. An object of the present invention is to provide a urine collection storage solution that enables reliable determination even when necessary, and a urine collection storage method using the urine collection storage solution.
上記目的を達成するために、請求項１の発明に係る採尿保存液は、必須成分として３００〜６００ｇ／Ｌの低級一価アルコール、１００〜５００ｇ／Ｌのポリアルキレングリコール、１〜３０ｇ／Ｌのホルムアルデヒド、２〜２０ｇ／Ｌの酢酸、３０〜２００ｇ／Ｌのブタンジオールを含む水溶液からなるものとしている。 In order to achieve the above object, the urine collection preservation solution according to the invention of claim 1 comprises 300 to 600 g / L lower monohydric alcohol, 100 to 500 g / L polyalkylene glycol, 1 to 30 g / L as essential components. It consists of an aqueous solution containing formaldehyde, 2 to 20 g / L acetic acid, and 30 to 200 g / L butanediol.
また、この請求項１の採尿保存液におけるブタンジオールとして、請求項２の発明は１・３ブタンジオールを含有する構成を、請求項３の発明は１・３ブタンジオール及び１・４ブタンジオールを含有する構成を、それぞれ採用している。 Further, as the butanediol in the urine collection / preservation solution of claim 1, the invention of claim 2 has a structure containing 1.3 butanediol, and the invention of claim 3 has 1.3 butanediol and 1.4 butanediol. Each containing structure is adopted.
更に、請求項４の発明に係る採尿保存液は、４００〜６００ｇ／Ｌのエタノール、２００〜４００ｇ／Ｌのポリエチレングリコール、２〜１０ｇ／Ｌのホルムアルデヒド、２〜１０ｇ／Ｌの酢酸、４０〜１００ｇ／Ｌの１．３ブタンジオール、２０〜１００ｇ／Ｌの１．４ブタンジオール及び残余の水より構成されるものとしている。 Further, the urine collection preservation solution according to the invention of claim 4 is 400 to 600 g / L ethanol, 200 to 400 g / L polyethylene glycol, 2 to 10 g / L formaldehyde, 2 to 10 g / L acetic acid, 40 to 100 g. / L of 1.3 butanediol, 20 to 100 g / L of 1.4 butanediol and the remaining water.
一方、請求項５の発明に係る採尿保存方法は、採取尿に対して請求項１〜４のいずれかに記載の尿細胞診用保存液０．１〜１容量倍を混合することを特徴としている。 On the other hand, the urine collection preservation method according to the invention of claim 5 is characterized in that the urine cytodiagnosis preservation solution 0.1 to 1 volume times according to any one of claims 1 to 4 is mixed with the collected urine. Yes.
請求項１の発明に係る採尿保存液によれば、該保存液が特定の組成を有するため、採取した尿検体に添加混合することにより、該尿検体の細胞変性や細菌汚染を長期間防止でき、採尿から尿細胞診等の検査まで日数を要しても確実な判定が可能になる。 According to the urine collection preservation solution of the invention of claim 1, since the preservation solution has a specific composition, cell degeneration and bacterial contamination of the urine specimen can be prevented for a long period of time by adding and mixing the collected urine specimen. Even if it takes days from urine collection to examination such as urine cytodiagnosis, reliable determination is possible.
請求項２の発明によれば、前記採尿保存液の必須成分であるブタンジオールとして１・３ブタンジオールを含有することから、尿検体の細胞変性や細菌汚染を長期間確実に防止できる。 According to the invention of claim 2, since 1.3 butanediol is contained as the butanediol which is an essential component of the urine collection preservation solution, cell degeneration and bacterial contamination of the urine specimen can be reliably prevented for a long period of time.
請求項３の発明によれば、前記採尿保存液の必須成分であるブタンジオールとして１・３ブタンジオール及び１・４ブタンジオールを含有することから、尿検体の細胞変性や細菌汚染をより長期間確実に防止できる。 According to the invention of claim 3, since 1,3 butanediol and 1,4 butanediol are contained as butanediol which is an essential component of the urine collection preservation solution, cell degeneration and bacterial contamination of the urine specimen are caused for a longer period of time. It can be surely prevented.
請求項４の発明に係る採尿保存液によれば、該保存液が特定の組成を有するため、採取した尿検体に添加混合することにより、該尿検体の細胞変性や細菌汚染を１週間以上もの長期間にわたって防止でき、採尿から尿細胞診等の検査まで日数を要しても確実な判定が可能になる。 According to the urine collection preservation solution according to the invention of claim 4, since the preservation solution has a specific composition, the urine specimen can be added to and mixed with the collected urine specimen to cause cell degeneration or bacterial contamination for one week or more. This can be prevented over a long period of time, and reliable determination can be made even if it takes days from urine collection to urine cytodiagnosis.
請求項５の発明に係る採尿保存方法によれば、採取尿に対して上記の採尿保存液を特定割合で混合することから、該尿検体の細胞変性や細菌汚染を長期間防止できる。 According to the urine collection and storage method of the fifth aspect of the invention, since the urine collection and storage solution is mixed at a specific ratio with the collected urine, cell degeneration and bacterial contamination of the urine specimen can be prevented for a long period of time.
本発明の採尿保存液は、必須成分として低級一価アルコール、ポリアルキレングリコール、ホルムアルデヒド、酢酸、ブタンジオールをそれぞれ特定濃度範囲で含む含む水溶液からなり、採取した尿検体に添加混合することによって該尿検体の細胞変性及び細菌汚染を長期間防止する作用を持つ。しかして、このような作用は、各成分の尿保存液中の含有量（濃度）が少な過ぎても多過ぎても充分に発揮できなくなる。 The urine collection preservation solution of the present invention comprises an aqueous solution containing lower monohydric alcohol, polyalkylene glycol, formaldehyde, acetic acid, and butanediol as essential components in specific concentration ranges, and is added to and mixed with the collected urine sample. It has the effect of preventing specimen cell degeneration and bacterial contamination for a long time. Therefore, such an effect cannot be sufficiently exerted even if the content (concentration) of each component in the urine preservation solution is too small or too large.
上記の低級一価アルコールとしては、エタノール、イソプロピルアルコール等が挙げられるが、特にエタノールが好適である。そして、この低級一価アルコールの採尿保存液中の含有量は、３００〜６００ｇ／Ｌの範囲、特に好ましくは４００〜６００ｇ／Ｌとする。 Examples of the lower monohydric alcohol include ethanol and isopropyl alcohol. Ethanol is particularly preferable. The content of the lower monohydric alcohol in the urine collection solution is in the range of 300 to 600 g / L, particularly preferably 400 to 600 g / L.
上記のポリアルキレングリコールとしては、ポリエチレングリコール、ポリプロピレングリコール、ポリエチレン・プロピレングリコール等が挙げられるが、特にポリエチレングリコールが好適である。そして、このポリアルキレングリコールの採尿保存液中の含有量は、１００〜５００ｇ／Ｌの範囲、特に好ましくは２００〜４００ｇ／Ｌとする。また、ポリアルキレングリコールの平均分子量は、特に制約されないが、５００〜５０００程度がよい。 Examples of the polyalkylene glycol include polyethylene glycol, polypropylene glycol, and polyethylene / propylene glycol, and polyethylene glycol is particularly preferable. And content of this polyalkylene glycol in the urine collection preservation | save liquid shall be the range of 100-500 g / L, Most preferably, you may be 200-400 g / L. The average molecular weight of the polyalkylene glycol is not particularly limited, but is preferably about 500 to 5,000.
上記のホルムアルデヒドは、防腐剤として細菌の繁殖を防止する成分であり、通常はその水溶液であるホルマリンの形態で他の成分と混合される。このホルムアルデヒドの採尿保存液中の含有量は、１〜３０ｇ／Ｌの範囲、特に好ましくは２〜１０ｇ／Ｌとする。 The above formaldehyde is a component that prevents the growth of bacteria as a preservative, and is usually mixed with other components in the form of formalin, which is an aqueous solution thereof. The content of formaldehyde in the urine storage solution is in the range of 1 to 30 g / L, particularly preferably 2 to 10 g / L.
上記の酢酸は、従来より尿検体用の固定化剤成分としてエタノールと共に使用されている成分であるが、この採尿保存液においても２〜２０ｇ／Ｌの範囲、特に好ましくは２〜１０ｇ／Ｌの割合で含有させる。 The acetic acid is a component conventionally used together with ethanol as a fixing agent component for a urine sample, but also in this urine collection storage solution, it is in the range of 2 to 20 g / L, particularly preferably 2 to 10 g / L. Include in proportions.
上記のブタンジオールは、本発明の採尿保存液における最も特徴的な成分であり、その存在によって尿検体の細胞変性及び細菌汚染の防止作用が飛躍的に向上する。しかして、このブタンジオールとしては、１．３ブタンジオール及び１．４ブタンジオールが好適であり、特に１．３ブタンジオールと１．４ブタンジオールとの併用が推奨される。 The above butanediol is the most characteristic component in the urine collection preservation solution of the present invention, and its presence dramatically improves the cytopathic and bacterial contamination preventing action of the urine specimen. Therefore, as this butanediol, 1.3 butanediol and 1.4 butanediol are suitable, and the combined use of 1.3 butanediol and 1.4 butanediol is particularly recommended.
ブタンジオールの採尿保存液中の含有量は３０〜２００ｇ／Ｌの範囲とするが、最適には４０〜１００ｇ／Ｌの１．３ブタンジオールと２０〜１００ｇ／Ｌの１．４ブタンジオールの両者を含むのがよい。 The content of butanediol in the urine collection and storage solution is in the range of 30 to 200 g / L, optimally both 40 to 100 g / L of 1.3 butanediol and 20 to 100 g / L of 1.4 butanediol. Should be included.
本発明の採尿保存液を製造するには、通常、イオン交換水又は精製水に所定量の低級一価アルコールを加えて混合したのち、他の成分であるポリアルキレングリコール、ホルムアルデヒド、酢酸、ブタンジオールの各所定量を任意の順序で添加して充分に攪拌混合し、好ましくは濾過によって固形異物を除去した上で、所要の容器に充填すればよい。 In order to produce the urine collection preservation solution of the present invention, usually, a predetermined amount of lower monohydric alcohol is added to and mixed with ion-exchanged water or purified water, and then other components such as polyalkylene glycol, formaldehyde, acetic acid, butanediol. Each predetermined amount of the above is added in an arbitrary order and sufficiently stirred and mixed, preferably after removing solid foreign matters by filtration and then filled into a required container.
本発明の採尿保存液は採取した尿検体に対して容量比で０．１〜１の割合で混合すればよい。なお、標準手法では、予め採尿保存液３ｍｌを入れた検体容器に、採取した尿を約７ｍｌ加え、数回軽く振ってから保管する。 The urine collection preservation solution of the present invention may be mixed with the collected urine specimen at a volume ratio of 0.1 to 1. In the standard method, about 7 ml of the collected urine is added to a sample container in which 3 ml of a urine collection storage solution is placed in advance, and is shaken several times and stored.
かくして、本発明の採尿保存液を混合した尿検体は、細胞変性や細菌汚染が長期間防止されるため、採尿から尿細胞診等の検査まで日数を要しても確実な判定が可能になる。従って、尿細胞診技術を備えた医療・検査機関が近くにない地域でも、現地で採取した尿検体に本発明の採尿保存液を混合した形態で当該機関へ輸送して検査に供することが可能となる。また、医療・検査機関においても、保管した尿検体を定期的に一斉検査する手法により、検査能率を高めることができる。 Thus, since the urine sample mixed with the urine collection preservation solution of the present invention is prevented from cell degeneration and bacterial contamination for a long period of time, reliable determination can be made even if it takes days from urine collection to examination such as urine cytology. . Therefore, even in areas where there are no medical / inspection institutions equipped with urine cytology technology, it is possible to transport to the institute the urine sample collected on-site and mix it with the urine collection preservation solution of the present invention for examination. It becomes. Also in medical / testing institutions, testing efficiency can be improved by a method of periodically testing stored urine samples.
なお、本発明の採尿保存液として最も好結果が得られるのは、４００〜６００ｇ／Ｌのエタノール、２００〜４００ｇ／Ｌのポリエチレングリコール、２〜１０ｇ／Ｌのホルムアルデヒド、２〜１０ｇ／Ｌの酢酸、５０〜１００ｇ／Ｌの１．３ブタンジオール、２０〜１００ｇ／Ｌの１．４ブタンジオール及び残余の水よりなる組成である。すなわち、このような組成によれば、後述する実施例で示すように、これを混合した尿検体の細胞変性や細菌汚染を１週間以上も防止することができる。 In addition, the best results are obtained as the urine collection preservation solution of the present invention, 400-600 g / L ethanol, 200-400 g / L polyethylene glycol, 2-10 g / L formaldehyde, 2-10 g / L acetic acid. 50-100 g / L of 1.3 butanediol, 20-100 g / L of 1.4 butanediol, and the remaining water. That is, according to such a composition, as shown in Examples described later, cell degeneration and bacterial contamination of a mixed urine sample can be prevented for one week or more.
尿細胞診検査においては、前記の採尿保存液を混合した尿検体を遠心分離器にかけ、含有細胞を沈渣させて上澄みを捨て、沈渣物をスライドグラスに塗抹し、常法に従って乾燥後に１〜２回のアルコール固定を行い、染色を施して顕微鏡による観察を行う。染色については、種々の細胞染色法があるが、鮮明さの点からパパニコロウ染色が好適である。しかして、本発明の採尿保存液は、尿細胞診検査に限らず、例えば尿蛋白の定性及び定量、尿糖の定性及び定量、ウロピリノーゲン定性、尿潜血の定性及び定量の如き一般検査や、沈渣検査、尿生化学検査等の他の種々尿検査に供する尿検体にも同様に適用できる。 In the urine cytological examination, the urine sample mixed with the above urine collection preservation solution is centrifuged, the contained cells are sedimented, the supernatant is discarded, the sediment is smeared on a slide glass, and dried according to a conventional method after 1-2. After fixing with alcohol twice, stain and observe with a microscope. Although there are various cell staining methods for staining, Papanicolaou staining is preferable from the viewpoint of clarity. Thus, the urine collection preservation solution of the present invention is not limited to urine cytodiagnosis examination, for example, urine protein qualitative and quantitative, urine sugar qualitative and quantitative, uropyrinogen qualitative, urinary occult blood qualitative and quantitative, and sediment The present invention can be similarly applied to urine specimens used for various other urine tests such as tests and urine biochemical tests.
実施例１
９５％エタノール水溶液 ・・・・３２．０ｌ
ポリエチレングリコール（平均分子量約１５００） ・・・・２５．０ｍｌ
３８％ホルマリン ・・・・ ２．０ｍｌ
９８％酢酸水溶液 ・・・・ １．０ｍｌ
９８％１・３ブタンジオール水溶液 ・・・・１０．０ｍｌ
イオン交換水 ・・・・３０．０ｍｌ
上記の各成分を混合して充分に攪拌したのち、混合液を濾過器に通して異物を除去し、採尿保存液を調製した。
Example 1
95% ethanol aqueous solution 32.0 l
Polyethylene glycol (average molecular weight about 1500) ... 25.0ml
38% formalin ... 2.0ml
98% aqueous acetic acid solution 1.0 ml
98% aqueous solution of 1.3 butanediol ... 10.0ml
Ion exchange water ... 30.0ml
After mixing each of the above components and stirring sufficiently, the mixed solution was passed through a filter to remove foreign substances, and a urine collection storage solution was prepared.
実施例２
９５％エタノール水溶液 ・・・・４０．０ｍｌ
ポリエチレングリコール（平均分子量約１５００） ・・・・２５．０ｍｌ
３８％ホルマリン ・・・・ １．０ｍｌ
９８％酢酸水溶液 ・・・・ １．０ｍｌ
９８％１・３ブタンジオール水溶液 ・・・・１０．０ｍｌ
精製水 ・・・・２３．０ｍｌ
上記の各成分を混合して充分に攪拌したのち、混合液を濾過器に通して異物を除去し、採尿保存液を調製した。
Example 2
95% ethanol aqueous solution 40.0 ml
Polyethylene glycol (average molecular weight about 1500) ... 25.0ml
38% formalin ... 1.0ml
98% aqueous acetic acid solution 1.0 ml
98% aqueous solution of 1.3 butanediol ... 10.0ml
Purified water ... 23.0ml
After mixing each of the above components and stirring sufficiently, the mixed solution was passed through a filter to remove foreign matter, and a urine collection storage solution was prepared.
実施例３
９５％エタノール水溶液 ・・・・３３．５ｍｌ
ポリエチレングリコール（平均分子量約１５００） ・・・・２５．０ｍｌ
３８％ホルマリン ・・・・ １．０ｍｌ
９８％酢酸水溶液 ・・・・ ０．５ｍｌ
９８％１・３ブタンジオール水溶液 ・・・・ ７．３ｍｌ
９８％１・４ブタンジオール水溶液 ・・・・ ２．７ｍｌ
精製水 ・・・・３０．０ｍｌ
上記の各成分を混合して充分に攪拌したのち、混合液を濾過器に通して異物を除去し、採尿保存液を調製した。
Example 3
95% ethanol aqueous solution 33.5 ml
Polyethylene glycol (average molecular weight about 1500) ... 25.0ml
38% formalin ... 1.0ml
98% acetic acid aqueous solution 0.5ml
98% aqueous 1.3 butanediol solution 7.3 ml
98% 1.4 butanediol aqueous solution 2.7ml
Purified water ... 30.0ml
After mixing each of the above components and stirring sufficiently, the mixed solution was passed through a filter to remove foreign substances, and a urine collection storage solution was prepared.
実施例４
９５％エタノール水溶液 ・・・・５０．０ｍｌ
ポリエチレングリコール（平均分子量約１５００） ・・・・２５．０ｍｌ
３８％ホルマリン ・・・・ ０．５ｍｌ
９８％酢酸水溶液 ・・・・ ０．５ｍｌ
９８％１・３ブタンジオール水溶液 ・・・・ ６．７ｍｌ
９８％１・４ブタンジオール水溶液 ・・・・ ３．３ｍｌ
精製水 ・・・・１４．０ｍｌ
上記の各成分を混合して充分に攪拌したのち、混合液を濾過器に通して異物を除去し、採尿保存液を調製した。
Example 4
95% ethanol aqueous solution 50.0 ml
Polyethylene glycol (average molecular weight about 1500) ... 25.0ml
38% formalin ... 0.5ml
98% acetic acid aqueous solution 0.5ml
98% 1.3 butanediol aqueous solution 6.7ml
98% aqueous solution of 1.4 butanediol ... 3.3ml
Purified water ... 14.0ml
After mixing each of the above components and stirring sufficiently, the mixed solution was passed through a filter to remove foreign matter, and a urine collection storage solution was prepared.
〔細胞保存性試験〕
上記実施例１〜４で調製した各採尿保存液について、その３ｍｌを予め収容した検体容器を多数用意し、各検体容器中に採取した尿７ｍｌを加えて２〜３回軽く振った上で尿検体として保管した。そして、この保管から１〜８日の各日数経過した尿検体を、尿細胞診検査の手法に準じ、各々遠心分離器にかけ、上澄みを捨てて沈渣物をスライドグラスに塗抹し、アルコール固定及びパパニコロウ染色を施し、顕微鏡で細胞を観察して細胞変性の度合と細菌汚染の状況を調べた。また、採尿保存液を加えなかった無添加の尿検体と、本発明の採尿保存液に代えて市販の採尿保存液を同量加えた尿検体についても、同様にして細胞変性の度合と細菌汚染の状況を調べた。その結果を次の４段階で評価し、表１に示す。
[Cell preservation test]
For each of the urine collection storage solutions prepared in Examples 1 to 4, a large number of sample containers containing 3 ml of them in advance were prepared, and after adding 7 ml of urine collected in each sample container and shaking lightly 2-3 times, urine Stored as a specimen. Then, the urine specimens that have passed each day for 1 to 8 days from this storage are each subjected to a centrifuge according to the method of urine cytological examination, the supernatant is discarded, and the sediment is smeared on a slide glass to fix alcohol and Papanicolaou. After staining, the cells were observed with a microscope to examine the degree of cell degeneration and bacterial contamination. In addition, the degree of cell degeneration and bacterial contamination were similarly applied to an additive-free urine sample to which no urine collection storage solution was added and a urine sample to which a commercial urine collection storage solution was added in place of the urine collection storage solution of the present invention. I investigated the situation. The results are evaluated in the following four stages and shown in Table 1.
〔保存性試験の評価〕
◎・・・・・保管前の初期状態と同様で検体として全く問題なし。
○・・・・・僅かに変化が認められるが、検査に支障なし。
△・・・・・かなり変化があって判定精度は落ちるが、検査は可能。
×・・・・・変化が著しく、検体として使用不能。
[Evaluation of preservation test]
◎ …… Similar to the initial state before storage, there is no problem as a sample.
○ …… Slight changes are observed, but there is no problem in the inspection.
Δ ························································ Although there is a considerable change, the inspection accuracy is reduced, but inspection is possible.
× …… Changes are significant and cannot be used as a specimen.
上表の結果から、本発明の採尿保存液の添加により、尿検体の細胞保存性が無添加のものや市販の採尿保存液を加えたものに比較して向上し、とりわけブタンジオールとして１・３ブタンジオールと１・４ブタンジオールを併用した実施例３，４の採尿保存液による効果が大きく、特に実施例４の採尿保存液によれば保存８日後でも保存前と変わらない状態を保ち得ることが判る。
From the results in the above table, the addition of the urine collection preservation solution of the present invention improves the cell preservation of urine specimens compared to those without addition or the addition of a commercially available urine collection preservation solution. The effects of the urine collection preservation solution of Examples 3 and 4 in which 3 butanediol and 1.4 butanediol are used in combination are large, and in particular, the urine collection preservation solution of Example 4 can maintain the same state as before the preservation even after 8 days of preservation. I understand that.
Claims (5)
A method for collecting and storing urine, which comprises mixing 0.1 to 1 volume times of the urine cytodiagnosis preservation solution according to any one of claims 1 to 4 with respect to the collected urine.
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